Viant

MEDICAL & BIOTECH MANUFACTURING

ISO 13485:2016 • FDA Registered

Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

Neela Paykel is serving as general counsel and Tom Teisseyre assumes the chief product officer position.

Business Wire 09.22.21

Tubing & Extrusion

Accu-Tube Appoints Matthew Haddle as CEO

Haddle has a track record of leading organizations through strategic expansions across the medical device, aerospace, and industrial sectors.

Accu-Tube 09.22.21

Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings

The two deals will strengthen Heraeus' healthcare and medtech portfolio.

Heraeus 09.22.21

Surgical

Olympus Corporation Launches Powerseal Advanced Bipolar Surgical Energy Products

Deliver consistent sealing reliability in an ergonomic, multifunctional design that promotes procedural efficiency.

Olympus Corporation 09.21.21

CE Mark Granted to Predictive Software for Kidney Allograft Survival

Algorithm gives the probability the graft will still be functional at three, five, and seven years after evaluation by a healthcare professional.

Cibiltech 09.21.21

Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech

Electroducer Sleeve based on a medical technique called Direct Wire Pacing, which was invented by the company’s founder.

Electroducer 09.21.21

Surgical

Precision Coating Merges with N2 Biomedical

Expands its medical coatings platform.

Ampersand Capital Partners 09.20.21

Picarro Unveils EtO Gas Concentration Analyzer

Analyzers are now available for CEMS, stack testing, fenceline, and ambient monitoring systems.

PR Newswire 09.20.21

Medical Devices Market to Top $671.49 Billion by 2027

Wearables and rising cases of chronic diseases will help fuel growth, industry data predicts.

Precedence Research 09.16.21

Indago Announces $10 Million Financing Close and Name Change

Lazurite Holdings is developing technology to create the operating room of the future.

Business Wire 09.15.21

Surgical

Molli Surgical's Breast Tumor Marker

MPO's Sean Fenske speaks with Dr. Fazila Seker of MOLLI Surgical about the benefits of her company’s breast tumor marking system.

Sean Fenske, Editor-in-Chief 09.14.21

Vertigo Treatment Receives FDA Breakthrough Device Designation

The device's developer—Otolith Labs—closes $3.3 million in seed financing.

Business Wire 09.13.21

RapidPulse Closes $15 Million Series A Financing

Two industry veterans join the team to support the development of a cyclic aspiration system for ischemic stroke.

Globe Newswire 09.10.21

Contract Manufacturing | R&D & Design

Midwest Products & Engineering Acquires MindFlow Design

Design firm to enhance MPE's concept to completion model.

PR Newswire 09.10.21

Vicarious Surgical Opens New Corporate Headquarters in Massachusetts

The new space houses a full-scale operating room for robotics testing as well as R&D and company operations.

Business Wire 09.09.21

Luis J. Malavé Joins Integrity Applications Board

New member has more than 30 years of leadership experience in the medtech industry, primarily in diabetes management.

Globe Newswire 09.08.21

Surgical

Stryker Buys Gauss Surgical

Gains Triton AI-enabled platform for real-time monitoring of blood loss during surgery.

PR Newswire 09.07.21

CE Mark Granted to Expandable, Biodegradable Biliary Stent

The UNITY-B Percutaneous Balloon Expandable Biodegradable Biliary Stent is intended to facilitate the drainage of obstructed ducts requiring larger openings.

PR Newswire 09.07.21

Cardiovascular

Abbott Buys Walk Vascular, a Thrombectomy System Maker

Adds mechanical thrombectomy devices for treating patients with peripheral blood clots.

PR Newswire 09.02.21

Chronic Disease

Glooko’s Remote Patient Monitoring for Diabetics

MPO's Sean Fenske speaks with Russ Johannesson of Glooko about the advantages of being able to monitor diabetes remotely.

Sean Fenske, Editor-in-Chief 08.31.21

Electronics | R&D & Design

Closed Loop Thermal Control in Medical Devices

A closed-loop feedback approach is an effective mechanism to address thermal control challenges.

Kenneth MacCallum, P.Eng., Principal Engineering Physicist, StarFish Medical 08.30.21

Molding

Westfall Technik Opens New Medical Molding Plant and Clean Room

The 40,000-square-foot facility near Chicago features three Class 8-certified clean rooms and one white space for helping firms meet GMP requirements.

Business Wire 08.30.21

Ramin Mousavi Appointed CEO of CathWorks

New leader worked at Baxter International and Edwards Lifesciences.

PR Newswire 08.27.21

PartsSource Unveils New Operations Dashboard

New dashboard gives clients real-time insights across the medical device supply chain.

Business Wire 08.26.21

Putnam Plastics Corporation Completes Facility in CT

New addition provides additional space for the company to continue to grow and support the growing needs of its partners within industry.

Putnam Plastics Corporation 08.24.21

Patient Monitoring

Valencell’s Wearable Biomedical Sensors

MPO's Sean Fenske speaks with Dr. Steven LeBoeuf of Valencell about the advantage of biomedical sensors that can be integrated into many devices.

Sean Fenske, Editor-in-Chief 08.24.21

Packaging & Sterilization

Amcor Launches Enhanced Heat Seal Coating Technology

New heat seal adhesive helps medical device manufacturers better mitigate risk for greater patient safety.

Amcor 08.23.21

Butterfly Network Building New Corporate Headquarters in Massachusetts

New facility will have the capacity for approximately 275 people with the ability to expand further.

Business Wire 08.19.21

Cala Health Expands its Executive Team

Steve Higa and Greg Schulte add deep strategic experience, operational excellence to the company's management.

Business Wire 08.19.21

Machining & Laser Processing

The Importance of Metal Fabrication in the Innovation of Medical Devices

How metal fabrication powered by CNC machines has come to the rescue of the innovation of medical devices.

Peter Jacobs, senior director of marketing at CNC Masters 08.17.21

R&D & Design

Trelleborg Launches Rapid Development Center in Minnesota

Provides Trelleborg’s healthcare and medical customers a single partner for design, rapid prototyping, development and serial production.

Trelleborg 08.16.21

Minnesota Rubber and Plastics Announces New Innovation Center

Will offer customers an engineer-to-engineer collaboration experience designed to improve product performance and enhance speed-to-market.

Minnesota Rubber and Plastics 08.13.21

Health Canada Approves Butterfly iQ+ Platform

The second-generation handheld device is now available in 20 countries worldwide.

Business Wire 08.13.21

First Clinical Use of SoundBite Medical's Active Wire Platform

Doctors tout strong results with the company's Active Wire 0.014-inch platform in severely calcified peripheral lesions.

Business Wire 08.13.21

Molding Modern Medtech

Insights on best practices and technologies for successfully specifying molded components.

08.12.21

Tubing & Extrusion

A Quality Validation Program for Extrusion—MPO Videobites

Tim Steele of Microspec Corporation offers insights on the importance of a validation program for extrusion for medical device makers.

Neurological | Software & IT

FDA OKs SpinTech's STAGE MRI Software

Allows scanning the entire brain in roughly five minutes.

PR Newswire 08.09.21

Materials

Pandemic has Accelerated Nearshoring Medtech Materials

Buying materials from overseas may be cost-effective, but it can create an environment with less collaboration and less room for innovation.

Michael Barbella, Managing Editor 08.06.21

How to Become ISO 13485 Certified

Complying to ensure lifelong quality of medical devices and gain access to certain medical device markets.

Emily Drinks, Digital Content Consultant with WebFX 08.05.21

Digital Health

How Medical Device Connectivity Is Improving Accessibility in Healthcare

The fifth generation of wireless connectivity sets the stage for better medical devices.

Adrian Johansen 08.03.21

Materials

Smaller Devices Require More Efficient Material Integration

Silicones are becoming increasingly well-suited for implantable medical devices and combination products.

Michael Barbella, Managing Editor 08.03.21

Chronic Disease

Abbott Fined $160M to Resolve Medicare Diabetes Lawsuit

Resolves allegations Abbott companies Arriva and Alere made, or caused, claims to Medicare that were false.

U.S. Department of Justice 08.02.21

Non-Profit Group Launches Initiative to Diversify Medtech Workforce

Collaborative Community developing ways to recruit and retain minority physicians, researchers, and other stakeholders in research and product development.

Business Wire 08.02.21

Materials

Pandemic Underscores Importance of Medtech Material Innovation

Materials must meet the changing needs of medtech and society in general through preventative, diagnostic and therapeutic solutions.

Michael Barbella, Managing Editor 07.30.21

Neurological

Nevro Corp Receives FDA Approval for Senza System

The 10 kHz high frequency spinal cord stimulation therapy is designed for treatment of chronic pain associated with painful diabetic neuropathy.

Nevro Corp. 07.29.21

Outset Medical Appoints Katie Szyman to its Board

Szyman joins four other female leaders on the company's Board of Directors.

Outset Medical Inc. 07.29.21

Confluent Medical Expanding Costa Rica Manufacturing Facility

Company is adding capacity for nitinol processing and catheter manufacturing.

Business Wire 07.29.21

Global Peripheral Intravenous Catheter Market to Reach $7.3B by 2027

Driving the sector are trends such as the increasing incidence of chronic and life threatening diseases.

Business Wire 07.27.21

Gary Baldwin Joins Xenter as CTO

Company also hires Scott Heuler as senior vice president of Global Sales and Marketing.

Business Wire 07.27.21

Materials

Disinfectant Resistance is Crucial in Medtech Material Selection

Understanding the kinds of materials that stand up to healthcare-grade disinfectants can help ensure device longevity.

Michael Barbella, Managing Editor 07.27.21

Materials

Electronics Integration Impacting Medtech Materials

Conductive materials are becoming a necessary part of medical devices as digital healthcare continues to evolve.

Michael Barbella, Managing Editor 07.23.21

BD Acquires Velano Vascular

Will use innovative needle-free blood draw technology to reduce pain and discomfort of multiple needlesticks.

BD 07.22.21

3D/Additive Manufacturing | Molding

Metal Injection Molding and Metal 3D Printing Examination

Both MIM and metal AM serve as alternative options to machining for medtech manufacturers requiring metal components.

Mark Crawford, Contributing Writer 07.22.21

Pratip Dastidar Joins Establishment Labs as Head of Global Operations

New hire will also lead the company’s digital transformation initiatives.

Business Wire 07.20.21

Knobbe Martens Talks Trade Secrets

MPO's Sean Fenske speaks with Adam Powell of Knobbe Martens about a company’s trade secrets and how to protect them.

Sean Fenske, Editor-in-Chief 07.20.21

MDIC Partners With Booz Allen on Device Cybersecurity

Companies will identify best practices in cybersecurity benchmarking that can be replicated by manufacturers to ensure patient safety and security.

Business Wire 07.19.21

Catheter and Medical Design Hires Two Industry Experts

Rich Abraham and Scott Olson will lead business development and customer relationships in the East Coast and Midwest markets.

Catheter and Medical Design LLC 07.16.21

VistaMed, OneProjects and Tyndall Receive €5.1 million to Improve Treatment of Cardiac Arrhythmias

Project aims to provide a catheter to deliver direct 3D, intraprocedural analysis of the success of cardiac ablation, in the treatment of atrial fibrillation.

VistaMed 07.14.21

Tubing & Extrusion

Thousands of Stock Components for Medtech—MPO Videobites

Jeff Cushner of Qosina speaks with MPO's Sean Fenske about how his company fulfills medical device component needs rapidly.

Cardiovascular

Endologix Launches ALTO Abdominal Stent Graft System in Canada, Argentina

Company expands global reach with latest endovascular aneurysm repair technology.

07.13.21

Patient Monitoring

Canary Medical’s ‘Smart’ Implants

MPO's Sean Fenske speaks with Dr. Bill Hunter of Canary Medical about his firm’s smart implant technology for orthopedics.

Sean Fenske, Editor-in-Chief 07.13.21

Avanos Medical Fined $22M for MicroCool Surgical Gown Misbranding

Gowns were falsely labeled as providing the highest level of protection against fluid and virus penetration.

U.S. Department of Justice 07.12.21

Xenter Appoints Four Healthcare Industry Leaders to its Board

Company also closes a $12 million Series A stock offering.

Business Wire 07.12.21

Testing

EAG Expands Medical Device Testing Services With New Lab

The laboratory includes a dedicated medical device polymer analysis area.

Business Wire 07.12.21

Contraline Expands Board of Directors

Medical device industry veteran Martin J. Emerson has joined the company's board.

Business Wire 07.09.21

Santen Granted Health Canada Approval of PRESERFLO MicroShunt

The product is currently available in Europe.

Business Wire 07.07.21

EU MDR Preparedness: How Is COVID-19 a Factor?

Properly plan ahead so that your company can tackle regulatory hurdles without any struggles.

Jon Speer, Founder of Greenlight Guru 07.06.21

Cardiovascular

Implicity’s Cardiac Device Remote Monitoring

MPO's Sean Fenske speaks with Dr. Arnaud Rosier of Implicity about the cardiac device monitoring solutions his company offers.

Sean Fenske, Editor-in-Chief 07.06.21

Cardiovascular | Surgical

Surmodics Buys Vetex Medical

Adds ReVene Thrombectomy Catheter to the company's portfolio.

Business Wire 07.06.21

Contract Manufacturing

MPE Inc. Expands Into EMEA Market

Company has hired a director of International Markets to help lead the expansion.

PR Newswire 07.06.21

Molding

Why is it Suddenly Difficult to Buy Plastic Components in 2021?

Analyzing the pandemic’s impact on the bioprocess and medical device industries.

Dave Splett , VP of Business Development at Injectech, LLC 07.02.21

Surgical

FDA Clears Standard Bariatrics' Stapling Technology for Sleeve Gastrectomy

The Titan SGS design ensures more consistent staple formation across the entire 23-centimeter cutline.

PR Newswire 07.02.21

R&D & Design

Medical Device Development: Three Tips for Success

Analyzing the design phase of the medical device development process.

Shrinidh Joshi, medtech consultant on Kolabtree 07.01.21

OnLume Surgical Completes $7 Million Series A Financing

Funding supports commercial launch of novel fluorescence image-guided surgery system.

Business Wire 07.01.21

Diagnostics

How an MDQMS Can Lead to More Efficient and Sustainable Diagnostic Tests

Leveraging technology to improve speed to market without sacrificing quality.

Brandon Henning, VP of Product at Greenlight Guru 07.01.21

Precision Medical Device Molding & Manufacturing

Scalable, High-Performance Thermoplastic Injection Molding Experts

Surgical

The Future of AI and OR Medical Devices

Bringing artificial intelligence to the operating room.

Michael Hutton, Upper GI Specialist at Royal Cornwall Hospitals NHS Trust 06.30.21

Diagnostics

PixCell's Rapid Blood Test Diagnostics

MPO's Sean Fenske speaks with Hanan Ben-Asher of PixCell Medical about the opportunities enabled with rapid blood diagnostics.

Sean Fenske, Editor-in-Chief 06.29.21

TÜV SÜD North America Gains FDA Accreditation for Device Testing

TÜV SÜD offers ASCA-accredited laboratory testing of medical devices at five U.S. locations and in Canada.

Business Wire 06.29.21

Cardiovascular

FDA Approves AtriCure's EPi-Sense System for Persistent Afib

Trial showed a 29 percent difference in effectiveness at 12 months, a 35 percent difference in effectiveness at 18 months for long-standing persistent Afib.

Business Wire 06.29.21

MedTech Innovator Selects 20 Firms for Asia Pacific Accelerator

Finalist companies comprised of promising entrepreneurs from the Asia Pacific Region.

Business Wire 06.22.21

Avania Purchases IMARC

Acquisition of the medical device CRO fuels rapid global expansion and growth.

Business Wire 06.22.21

Second U.S. Patent Awarded to Alvalux for Wearable Light Therapy Device

Company received its first patent earlier this year for a wearable dermal repair system marketed under the CicaLux brand.

PR Newswire 06.21.21

Electronics | Neurological

Brain Scientific to Merge with Piezo Motion

Closing contemplates minimum $5M capital investment for combined company.

GlobeNewswire 06.16.21

Philips Recalls Certain Sleep and Respiratory Care Devices

Mitigates potential health risks related to the sound abatement foam component.

GlobeNewswire 06.14.21

Validant Acquires Greenleaf Health

Greenleaf Chief Executive Patrick Ronan named new CEO of Validant.

Business Wire 06.14.21

Aptar CSP Technologies Earns ISO 13485 Certification

Recognition comes as the company prepares to commercialize a new medical device using its proprietary 3-Phase Activ-Polymer platform technology.

Aptar CSP Technologies 06.14.21

NanoVibronix Begins Real World Patient Study of UroShield

Patient recruitment underway; interim results expected in October.

Business Wire 06.11.21

Tubing & Extrusion

Zeus Acquires CathX Medical

Will integrate the catheter-based contract manufacturer.

Zeus Industrial Products Inc. 06.10.21

Cardiovascular | Surgical

FDA Clears Neurescue's Intelligent Balloon Catheter

Cleared for hemorrhage control and IDE approved for cardiac arrest.

Business Wire 06.10.21

Qosina Expands Class VI Tubing Portfolio for Single-Use Medical Device and Bioprocess Applications

Ronkonkoma, NY, USA, June 9, 2021

Top 483s of 2020—Mike on Medtech

Mike Drues and Sean Fenske discuss the issues medical device manufacturers had during inspections last year.

Sean Fenske, Editor-in-Chief 06.08.21

Intertek Granted ASCA Recognition by FDA for Medical Device Premarket Testing

he ASCA Pilot Program is a voluntary program developed to provide increased confidence in testing results.

Michael Barbella, Managing Editor 06.04.21

Bodyport Names Amit Rushi as Chief Commercial Officer

Phyllis Whiteley, Ph.D., is appointed board chairman.

Michael Barbella, Managing Editor 06.04.21

Freudenberg Medical's Dr. Sherry Gray Retires as VP/GM

Gray will be succeeded by Ana Quesada.

Charles Sternberg, Assistant Editor 06.04.21

Will Recent Changes in CMS Rules Sink Us?

As of Jan. 1, CMS started cutting its list of inpatient-only services.

Dawn A. Lissy, Founder & President, Empirical 06.02.21

Contract Manufacturing

Resonetics Acquires Distal Solutions

Adds interventional medical device design and development services to Resonetics' portfolio.

Sam Brusco, Associate Editor 06.01.21

Digital Health

Philips, Ibex Medical Analytics Partner to Accelerate Adoption of AI-Powered Digital Pathology

Combination of Philips’ digital pathology solutions and Ibex’s AI-powered Galen platform has improved reporting efficiency by 27 percent.

Michael Barbella, Managing Editor 05.27.21

Minnetonka, Minnesota Cardiovascular Testing

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Your Most Trusted R&D Testing Partner

Bringing innovative medical device technology to the marketplace is a high risk venture.

3M Unveils Silicone Adhesive for People With Fragile Skin

Product is breathable, conformable, enables up to a seven-day wear time, and minimizes skin cell removal.

Michael Barbella, Managing Editor 05.18.21

Contract Manufacturing

A Contract Manufacturer Selection Handbook

This article will offer considerations and best practices for selecting the right partner for your medical device development project.

Ashley Turrell, Director of Strategy, Natech Plastics 05.13.21

Digital Health

Empowering Value-Based Care Through Interoperability

EHR interoperability and medical device connectivity enable healthcare providers to meet the shift toward value-based care and reimbursement.

Josh Hetler, Executive Vice President, Business Intelligence, DataLink 05.13.21

Chronic Disease

NXgenPort Enters License Agreement with Mayo Clinic

Collaboration advances the company’s development and product testing efforts.

Charles Sternberg, Assistant Editor 05.12.21

Contract Manufacturing

Leveraging Your Outsourcing Relationship for Success—A Medtech Makers Q&A

A contract manufacturer should complement the OEM in every step of the product development process, from concept to commercialization.

Diagnostics

RSIP Vision Launches Prostate MRI-to-Ultrasound Registration Tool

Module creates a warped MRI scan that matches real-time ultrasound results to precisely locate clinically relevant regions & reduce procedural risks to patients

Charles Sternberg, Assistant Editor 05.07.21

Lumendi Introduces its EZ Glide Hydrophilic Coating

The coating is activated by water or saline and improves endoscopic performance of the DiLumen EIP.

Michael Barbella, Managing Editor 05.07.21

FDA Approves Helius Medical's Stimulator Device for Gait Improvement

The product is a short-term treatment for gait deficit as a result of mild to moderate symptoms from multiple sclerosis.

Michael Barbella, Managing Editor 05.06.21

PolyVascular Awarded $2 Million Grant to Study Pediatric Heart Valve

Company hires Will Clifton as COO to manage the path to human trials in the United States.

Michael Barbella, Managing Editor 05.06.21

Surgical

PENTAX Appoints Former Philips VP Ojas A. Buch as President, Americas

Buch also held leadership roles at GE Healthcare, St. Jude Medical (Abbott), and CareFusion (Yvaire).

Sam Brusco, Associate Editor 05.05.21

Wytech Industries Appoints President

David Ohmann brings 25 years of experience in international, orthopedic, and advanced surgical medical device segments.

Charles Sternberg, Assistant Editor 05.05.21

Digital Health

How Can a Device End User Aid in Cybersecurity?

MPO's Sean Fenske gets tips from Alan Grau of Sectigo about how a medical device end user, whether physician or patient, can help ensure the unit is secure.

Sean Fenske, Editor-in-Chief

Preparing for the EU’s MDR

As the clock to the deadline is in the final minutes, this article offers a few tips to help ensure companies meet with the requirements.

Nick Tippmann, Vice President of Marketing, Greenlight Guru 04.29.21

Materials

The Plastics Problem—Infection Control vs. Medical Equipment

Due to harsh chemicals, medical device manufacturers need a solution to the problems caused by regular cleaning of healthcare equipment.

Ryan Hoobler, VP of Engineering, Code Corporation 04.29.21

Diagnostics | R&D & Design

5 Guidelines for Productizing an Optically Based Medical Device

Pitfalls most relevant to optical medical devices, but many are applicable to medical devices without optics.

Brian King, Principal Optical Systems Engineer, StarFish Medical 04.29.21

Cardiovascular

Ceryx Medical Appoints Chas Taylor as Chairman

New leader founded three international cardiovascular businesses.

Michael Barbella, Managing Editor 04.27.21

Device Companies to Help AI Market Reach $52 Billion in 2024

Medtronic and Royal Philips recently invested in AI and machine learning technologies.

Michael Barbella, Managing Editor 04.26.21

Digital Health

What Could Medical Device Hacking’s Future Look Like?

MPO's Sean Fenske and Alan Grau of Sectigo discuss potential hacking strategies for future instances of gaining access to medical technology.

Sean Fenske, Editor-in-Chief

Patient Monitoring

Cipher Skin's Biomechanics Measuring Mesh

MPO's Sean Fenske speaks with Dr. Shaka Bahadu of Cipher Skin about his measurement mesh and the healthcare applications for it.

Sean Fenske, Editor-in-Chief 04.22.21

Machining & Laser Processing

Developing Leaders in the Workforce—MPO Videobites

Dax Strohmeyer of Triangle speaks with MPO’s Sean Fenske about the company’s establishment of a program to address the need for future leaders.

Sean Fenske, Editor-in-Chief

Software & IT

Realizing the Value of Today’s Connected Worker—A Medtech Makers Q&A

Connected workers gain an advantage while in the workplace as they can maintain oversight of the systems and projects they are tied to at any moment.

Gynesonics Appoints Susan Stimson to Its Board of Directors

Executive with extensive commercialization experience to provide key insights on global launch strategies.

Michael Barbella, Managing Editor 04.20.21

Seed Grants Awarded to Five Proposals for Pediatric Medical Device Development

Projects address infant feeding development, neonatal jaundice, pediatric dysphagia, unplanned extubations, and adrenal crisis.

Michael Barbella, Managing Editor 04.19.21

Digital Health

Real-World Medical Device Hacking Tales

MPO's Sean Fenske gains some insights from Alan Grau of Sectigo on examples of real-world healthcare device hacking incidents and the details involved.

Sean Fenske, Editor-in-Chief

Nagarro Achieves ISO 13485 Certification

Company's iife sciences and healthcare business unit offers new opportunities in digital disruption and connected medical devices.

Michael Barbella, Managing Editor 04.14.21

Electronics

Mastering Motion for Robotic Surgical Systems—A Medtech Makers Q&A

maxon's Peter van Beek provides insights on critical factors and considerations of motion control for robotic surgical systems.

MICRO Expands with New Facility in Costa Rica

Increases its cleanroom assembly capacity to better serve its medical device customers.

Charles Sternberg, Assistant Editor 04.13.21

Glooko Raises $30 Million in Series D Funding

Investment follows most successful year in company history.

Michael Barbella, Managing Editor 04.13.21

Digital Health

Thinklabs' Digital Stethoscope for Digital Health

MPO's Sean Fenske speaks with Clive Smith of Thinklabs about his digital stethoscope and how it was used during the pandemic.

Sean Fenske, Editor-in-Chief 04.13.21

Software & IT

Three Future Trends and Opportunities in Quality Assurance

As regulated companies, medical device firms must stay abreast of the latest developments to ensure they adopt new protocols to maintain quality assurance.

David Jensen, Staff Writer, MasterControl 04.09.21

Software & IT

Adopting a Data-Driven Quality Model

Employing a data-driven quality model helps you apply quality processes more holistically throughout the organization.

David Jensen, Staff Writer, MasterControl 04.09.21

Viant Completes Expansion of Costa Rica Facility

New capabilities will boost speed to market for complex medical devices.

Charles Sternberg, Assistant Editor 04.08.21

Cardiovascular

Digging into the Cardiac Arrhythmia Monitoring Device Market

The overall market is set to reach an annual valuation of $9 billion by 2026.

Saloni Walimbe, Research Content Developer, Global Market Insights 04.08.21

Contract Manufacturing | R&D & Design

Moving from Concept to Design—MPO Videobites

Mike Schultz of Spectrum Plastics Group speaks with MPO’s Sean Fenske about the Launch Pad Engineering Service the firm offers for medical device manufacturers.

Sean Fenske, Editor-in-Chief

SMC Ltd. Expands Costa Rica Facility

Doubles the current facility, bringing it to 120,000 square feet in the Coyol Free Zone Park in Alajuela, Costa Rica.

Charles Sternberg, Assistant Editor 04.07.21

FreeMind Group Explains Non-Dilutive Funding

MPO's Sean Fenske speaks with Guy Har-Chen of FreeMind Group about non-dilutive funding and the future of digital health.

Sean Fenske, Editor-in-Chief 04.06.21

Packaging & Sterilization

BD to Invest $65M in Tucson, Arizona Supply Chain Hub

Operations for the final-stage manufacturing and sterilization facility are planned to begin in mid-2022.

Sam Brusco, Associate Editor 04.01.21

Cardiovascular

Cardiovascular Device Market Expands to Tackle Higher Disease Burden

The market is likely to exceed a valuation of $10 billion by 2027.

Vinisha Joshi, Research Content Developer, Global Market Insights 04.01.21

Chronic Disease | Digital Health | Patient Monitoring

CGM: Digital Health Meets a Very Large Opportunity

Continuous glucose monitors (CGMs) are one of the most formidable diabetes management tools to be developed in decades.

Maria Shepherd, President and Founder, Medi-Vantage 04.01.21

Surgical

Biomechanical Engineer, Heal Thyself

Choosing a treatment option for spinal disorders can be tricky with extensive knowledge of the industry.

Dawn A. Lissy, Founder & President, Empirical 04.01.21

Molding | Surgical

Optimizing MIM in Medical Device Manufacturing

Metal injection molding (MIM) is a good choice for producing medium- to high-volume medtech parts.

Steve Santoro, Executive Vice President, MICRO 04.01.21

Diagnostics

PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market

With smart onshoring strategies, the medical device industry can collaborate to fix supply chain issues.

Claudio Hanna and Ralph Tricomi , Web Industries 04.01.21

Testing

The Evolution of Chemical Characterization for Medical Devices

Evaluation of biological safety of devices is experiencing some of the most significant changes in history.

Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec Medical Device Testing 04.01.21

Digital Health

How Digital Health Fits into the Medtech Mold

Healthcare will need to adopt digital technologies that streamline and enhance connectivity.

Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 04.01.21

Global Supply Chain Wisdom from Coronavirus-Colored Lenses

There are precious pearls of wisdom from this past year that will come in handy during the next “crisis.”

Chris Oleksy, Founder and CEO, Oleksy Enterprises and Co-Founder Next Life Medical; CEO, Emergent Respiratory 04.01.21

Four Considerations When Selling to a Private Equity Fund

A private equity partner can help medtech firms expand into new markets and serve existing clients better.

Bill Hadler and Anisa Mohanty, McDermott Will & Emery 04.01.21

The Reality of Virtual Experiences for Medtech

VR presents a great way to expose doctors and other medical professionals to new technologies.

Sean Fenske, Editor-in-Chief 04.01.21

Materials

Outward Appearance: Reviewing Surface Treatment Options

Surface modifications and coatings imbue medical devices with a slew of valuable properties.

Sam Brusco , Associate Editor 04.01.21

Neurological

Encora's Tremor Reducing Wristband Gains Breakthrough Status

Indicated to provide temporary hand tremor relief in adult essential tremor or Parkinson's patients.

Sam Brusco, Associate Editor 03.31.21

Diagnostics

Diagnosing the IVD Market: An Interview with TEAM Technologies

Chief revenue officer Steve Lents discusses the in-vitro diagnostic market and manufacturing rapid antigen POC COVID-19 tests.

Sam Brusco, Associate Editor 03.30.21

Why Is Manufacturing Demand Increasing for IV Bags?

Many types and sizes of IV bags are in short supply, putting a strain on the industry.

Emily Newton, Editor-in-Chief, Revolutionized 03.30.21

BDP Reimbursement Delay—Mike on Medtech

Mike Drues and Sean Fenske discuss the causes for the delay in rolling out the four-year reimbursement policy for breakthrough devices.

Sean Fenske, Editor-in-Chief 03.30.21

Cardiovascular

FDA Approves Medtronic's Harmony TPV for Congenital Heart Disease

Less invasive option to treat pulmonary valve regurgitation for patients with a native or surgically-repaired right ventricular outflow tract.

Sam Brusco, Associate Editor 03.26.21

Digital Health

NuroKor Teams Up With Medi-Launch Partners to Develop Wearable Pain Tech

U.K. bioelectronics company sets its sights on the U.S. market following a series of new investors, new product developments and a 156 percent sales surge.

Michael Barbella, Managing Editor 03.26.21

Software & IT

Using Quality as an Advantage in 2021

Report finds despite pandemic, 79 percent of medical device professionals expect modest or strong revenue growth in 2021.

Jon Speer, Founder, Greenlight Guru 03.25.21

J&J Executive, CNN On-Air Commentator Appointed to Glaukos Board

With latest additions, the governing body now consists of nine directors.

Michael Barbella, Managing Editor 03.24.21

Tissium Appoints VP of Global Operations

Thierry Darnis brings a deep background as a global leader managing major medical device design and production units at world-class companies.

Charles Sternberg, Assistant Editor 03.23.21

Shockwave Medical CEO to Chair Gala Therapeutics Board

New leader also worked for Boston Scientific Corp.

Michael Barbella, Managing Editor 03.23.21

Surgical

XACT Robotics' Robotic-Driven Percutaneous Procedures

MPO's Sean Fenske speaks with Chen Levin of XACT Robotics about a self-steering robot for ablation, biopsy, and drug delivery.

Sean Fenske, Editor-in-Chief 03.23.21

U.K. Medical Pendant Market to Top $25.5 Million by End of 2027

The increasing incidence of healthcare-associated infections is a major factor fueling the market's growth.

Michael Barbella, Managing Editor 03.22.21

J. Knipper and Company Appoints Chief Financial Officer

New hire has 30 years of diverse experience in accounting, financial management, M&A, and operations.

Michael Barbella, Managing Editor 03.22.21

Contract Manufacturing | Molding

Molding Validation Optimization—A Medtech Makers Q&A

PTI’s Steve VanderKooi offers advice to help manufacturers avoid pitfalls and delays to ensure a timely and repeatable validation protocol.

BGF Invests in Vascular Closure Devices Firm

Financing marks BFG's seventh Irish investment in the past two years.

Michael Barbella, Managing Editor 03.19.21

Olympic Bobsledder Named New Board Chairman at PathogenX

World Cup medalist has spent half his sales and management career in the medical device and healthcare technology sector.

Michael Barbella, Managing Editor 03.18.21

Junkosha Announces Technology Innovator of the Year Award

Celebrates revamped brand image with new corporate logo and website.

Charles Sternberg, Assistant Editor 03.17.21

Catheter and Medical Design Acquires VitalDyne Medical Inc.

Provides customers with greater speed, flexibility, and value.

Charles Sternberg, Assistant Editor 03.16.21

Materials

TISSIUM's Biomorphic Programmable Polymers

MPO's Sean Fenske speaks with Christophe Bancel of TISSIUM about remarkable new materials that can be used to replace human tissue.

Sean Fenske, Editor-in-Chief 03.16.21

Software & IT

Three Reasons Automation and Training Are Essential in Your MDQMS

Having the proper tools in place to ensure all training activities are occurring when and how they should is critical to quality.

Jon Speer, Founder, Greenlight Guru 03.15.21

Testing

NAMSA Appoints New CEO, Board Chairman

Dr. Christophe Berthoux will begin leading the company March 22; former AdvaMed Chairman Nadim Yared to become NAMSA Chairman.

Sam Brusco, Associate Editor 03.15.21

Four Ways Remote Freelance Experts Can Help Medtech

Changes in the regulatory landscape and working-from-home scenarios reduce the degree of change when working with remote consultants.

Ramya Sriram, Digital Content Manager, Kolabtree 03.15.21

Cardiovascular

Cardinal Health to Sell Cordis Biz to Hellman & Friedman for $1B

Transaction is expected to close in the first half of Cardinal Health's fiscal year 2022.

Sam Brusco, Associate Editor 03.12.21

Cardiovascular

Global Cardiovascular Devices Market to Exceed $62 Billion by 2025

Sector to be driven in part by the robust performance of cardiac assist products.

Michael Barbella, Managing Editor 03.12.21

Testing

Sotera Health Acquires BioScience Laboratories

Strengthens Sotera Health’s antimicrobial and antiviral lab testing capabilities.

Charles Sternberg, Assistant Editor 03.11.21

An Overview of the ASCA Pilot Program

The FDA published a three-part final guidance on the voluntary program.

David Jensen, Staff Writer, MasterControl 03.11.21

Medical Device Cross Border Deal Activity in U.S. Rises in Q4 2020

Venture financing was the industry's leading deal category.

Michael Barbella, Managing Editor 03.11.21

Ventec Life Systems Appoints New Leader

Former Philips exec Jim Alwan takes the helm of the respiratory therapy firm.

Sam Brusco, Associate Editor 03.10.21

First Human Trial Begins for Contactless Hemodialysis Imaging Surveillance System

Trial to provide initial experiences in fistula surveillance for early detection and prediction of fistula stenosis.

Michael Barbella, Managing Editor 03.09.21

Digital Health

Market for Virtual Critical Care Solutions to Nearly Double

With critical care becoming increasingly data intensive, companies will need to collaborate with cloud solutions providers.

Michael Barbella, Managing Editor 03.09.21

Extractables & Leachables

Element Materials Technology provides Tailored solutions that shorten time to market & ensure sustainability of your pharmaceutical and medical device products.

Reusable device validation

The medical industry is familiar with the use of autoclaves in operating rooms and laboratory settings for sterilization.

Deciding whether to insource or outsource your testing

The medical device industry is filled with motivated medical entrepreneurs who have the next most significant concept to better human life.

Plastikos Medical Begins Phase II of Expansion

Will more than double the size of its current ISO-7 cleanroom.

Charles Sternberg, Assistant Editor 03.03.21

NAMSA Acquires American Preclinical Services

Enhances its preclinical solutions with a broader range of laboratory models and analysis tools.

Charles Sternberg, Assistant Editor 03.02.21

FDA Breakthrough Device Designation Awarded to BrainCool AB's Cooral System

The Cooral System was CE marked in June 2020 as an invasive medical device.

Michael Barbella, Managing Editor 03.02.21

OrthogenRx on FDA’s Ambiguity on Hyaluronic Acid

MPO's Sean Fenske speaks with Mike Daley of OrthogenRx about the role HA plays in alleviating knee pain and the challenges with the FDA over it.

Sean Fenske, Editor-in-Chief 03.02.21

Update on FDA's STeP Designation—Mike on Medtech

Mike Drues and Sean Fenske discuss the final guidance for the FDA’s STeP designation and who should use it.

Sean Fenske, Editor-in-Chief 02.26.21

First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System

The product received CE Mark approval in January.

Michael Barbella, Managing Editor 02.26.21

Digital Health

Artificial Intelligence, Machine Learning Adoption in Healthcare to Grow Considerably

The FDA’s five-part action plan is expected to drive the surge.

Michael Barbella, Managing Editor 02.26.21

Electronics | Testing

Refurbished Medical Equipment Testing and Certification Under the NEC

The National Electric Code (NEC) has been updated to better ensure refurbished or reconditioned products' safety and performance.

L. Matthew Snyder, Director of Certification, Intertek 02.25.21

Portescap Slotless Brushless DC Motors Receive ISO 13485 Certification

Meet the highest quality standards for manufacturing.

Charles Sternberg, Assistant Editor 02.25.21

Cardiovascular

FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump

Puzzle Medical Device's ModulHeart helps patients avoid open-heart surgery and reduces blood trauma.

Michael Barbella, Managing Editor 02.25.21

Millstone Medical Outsourcing Reaches 600-Employee Milestone

Posts year-over-year growth of 16% in its 20th year of business.

Charles Sternberg, Assistant Editor 02.23.21

Apple iPhone 12 Magnet Can Deactivate Implantable Cardiac Devices

Doctors say manufacturers and implanting physicians should inform patients about the potentially dangerous magnet-implantable cardiac device interaction.

Michael Barbella, Managing Editor 02.23.21

Contract Manufacturing | R&D & Design

SteriPack Acquires HS Design

Provides flexible and responsive design, development, and contract manufacturing solutions.

Sam Brusco, Associate Editor 02.23.21

Navient Receives Chinese Regulatory Clearance for ENT Applications

The surgical navigation system is already approved in the United States, Europe, Canada, South Korea, Brazil, and Taiwan.

Michael Barbella, Managing Editor 02.22.21

Global Medical Device Venture Financing Deals Total $3.84 Billion in Q4 2020

Most transactions were concentrated in North America.

Michael Barbella, Managing Editor 02.22.21

Trademark Plastics Inc. Partners with MedAccred

Reaffirms its commitment to complete quality assurance.

Charles Sternberg, Assistant Editor 02.19.21

FDA Appoints its First Cybersecurity Director

University of Michigan associate professor to serve a one-year term within the Center for Devices and Radiological Health.

Michael Barbella, Managing Editor 02.17.21

4 Trends Driving Medical Manufacturing in 2021

Manufacturers across the sector had to manage disruptions last year, but economists say recovery may begin soon.

Emily Newton, Editor-in-Chief, Revolutionized 02.16.21

J. Knipper and Company Adds to its Executive Team

Trio is charged with launching the company's third-party logistics (3PL) unit for 2021.

Michael Barbella, Managing Editor 02.16.21

Diagnostics

Hologic’s Breast Health Happenings

MPO's Sean Fenske speaks with Jennifer Meade of Hologic about the company’s recent M&A as well as its initiatives in women’s health.

Sean Fenske, Editor-in-Chief 02.16.21

Flosonics Medical Closes $14 Million Financing Round

Company also expands its Board of Directors.

Michael Barbella, Managing Editor 02.12.21

The 8 Major Types of PPE Supply Chain Fraud

Medical device manufacturers need to be aware of what’s happening within the space if they are making protection equipment themselves.

Richie M. Hecker, Managing Director, TS Health Supplies Division, Traction & Scale LLC 02.10.21

Cybersecurity Measures are Crucial as COVID-19 Drives Adoption of Remote Access Devices

Cybercriminals are taking advantage of the health crisis to breach hospitals and healthcare systems.

Michael Barbella, Managing Editor 02.10.21

Digital Health

Evolving Trends in the Medical and Orthopedic Devices Industry

There are a number of areas worth keeping an eye on within medtech in 2021 and beyond.

Jacqueline Trovato, Healthcare/Legal Writer 02.09.21

Diagnostics

ProPhase Labs Begins Saliva-Based, Viral RT-PCR Multiplex-Testing

System can be used for COVID-19, Influenza A & B, and other viruses.

Charles Sternberg, Assistant Editor 02.09.21

Report: Emergency Use Authorization a Top Health Hazard for 2021

The report also cites telehealth adoption among its perceived dangers.

Michael Barbella, Managing Editor 02.09.21

Cardiovascular

Optimize EP Is Optimizing Remote Electrophysiology Monitoring

MPO's Sean Fenske speaks with Dr. Maninder Bedi and Ravi Kartan of Optimize EP about the level of efficiency their technology offers.

Sean Fenske, Editor-in-Chief 02.09.21

R&D & Design

Pandemic-Level Playing Field: How COVID-19 Made Space for Progress

Pandemic restrictions may have diminished certain advantages large companies hold over small and mid-sized competitors.

Dawn A. Lissy, President & Founder, Empirical 02.03.21

Contract Manufacturing

Use Vertical Integration to Increase Productivity, Drive Innovation

The concept of vertical integration is simple: a company combining two or more stages of production that would normally be operated by separate companies.

Ryan Lipe, Senior Vice President of Sales & Marketing, MGS 02.03.21

Perspectives on Post-Pandemic: Expect Supply Chain Security to Increase

Dr. Mark Ostwald of Freudenberg Medical speaks to the changes to the supply chain as well as the benefits realized in communication options.

Dr. Mark Ostwald, President—Minimally Invasive Solutions and Europe, Freudenberg Medical 02.03.21

Testing

Element Material Technology Acquires Avomeen

Strengthens its life sciences business unit in North America.

Charles Sternberg, Assistant Editor 02.03.21

A Blueprint for Reducing Medtech Industry's Carbon Footprint

Global warming impact of “single-use” medical devices can be halved by using reprocessed products.

Michael Barbella, Managing Editor 02.03.21

Surgical

Medtronic's Robotic Surgery Status

MPO's Sean Fenske speaks with Linnea Burman of Medtronic about the Mazor system and what’s ahead for the firm.

Sean Fenske, Editor-in-Chief 02.02.21

Global Ventilators Market to Reach $1.6 Billion by 2030

But the sector is forecast to experience a downturn this year.

Michael Barbella, Managing Editor 02.01.21

Surgical

Penumbra Recalls JET 7 Reperfusion Catheter Over Distal Tip Damage

14 patient deaths have been reported.

Sam Brusco, Associate Editor 01.29.21

Kwivik Therapeutics, EirMed Partner to Accelerate Product Commercialization

Kwivik has developed a pipeline of products for certain respiratory, emergency medical, asthma, migraine/cluster headache, wound care, and skin care markets.

Michael Barbella, Managing Editor 01.27.21

FDA Clears 3D Acellular Dermal Matrix

The technology is supported by more than 150 peer-reviewed published articles.

Michael Barbella, Managing Editor 01.27.21

Molding

Material Science for Micromolding—A Medtech Makers Q&A

Patrick Haney of MTD Micro Molding shares his expertise and helps clarify value of understanding the reaction materials experience.

MedAcuity, Fathom Partner on Human Factors Engineering Services

Focused on facilitating safe and effective use of medical devices, HFE is a critical aspect of product development.

Michael Barbella, Managing Editor 01.25.21

Cretex Companies CEO Steps Down

Jeff Wollerman will succeed Lynn Schuler as CEO of the company.

Charles Sternberg, Assistant Editor 01.22.21

Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread

Company initiates VFE testing for its porous polymer-based materials; results show components protect against certain aerosolized viruses.

Michael Barbella, Managing Editor 01.22.21

TPI Partners with Zeiss

Enables TPI to deliver 3D X-Ray Measurement capabilities for Quality Assurance for its clients.

Charles Sternberg, Assistant Editor 01.21.21

Molding

Freudenberg Medical Expands Injection Molding Operations

Adds new machines at its Baldwin Park, California facility.

Freudenberg Medical 01.21.21

CHF Solutions Appoints CEO

Nestor Jaramillo Jr succeeds John Erb.

Globe Newswire 01.19.21

Surgical

Proximie Enables Surgeons to 'Scrub In' Virtually

MPO's Sean Fenske speaks with Dr. Nadine Hachach-Haram of Proximie about her company’s ability to bring surgeons to the table remotely.

Sean Fenske, Editor-in-Chief 01.19.21

CMS Expedites Breakthrough Device Access; Industry Applauds

New rule creates an accelerated Medicare coverage pathway for innovative products that the FDA deems ‘breakthrough.’

MPO Staff 01.13.21

Surgical

Talking Robotic Surgery with Zimmer Biomet

MPO's Sean Fenske speaks with Liane Teplitsky of Zimmer Biomet about the firm’s efforts in robotic surgery and its Rosa System.

Sean Fenske, Editor-in-Chief 01.12.21

Contract Manufacturing

Vonco Products Receives ISO 13485:2016 Certification

Both a packaging company and a components company, Vonco started as a custom equipment and packaging pioneer.

Business Wire 01.12.21

Patient Monitoring

CES News: Philips Highlights Healthcare at Home

Participates in the first-ever all-digital CES 2021.

Royal Philips 01.11.21

Neurological

BioSerenity Achieves FDA Clearance for Wearable Device System

Neuronaute EEG System and IceCap bring comprehensive remote electroencephalography monitoring services to people living with neurological disorders.

PRNewswire 01.07.21

Greenlight Guru and Nelson Labs Partner

Alliance helps customers mitigate risk and go to market faster.

Greenlight Guru 01.06.21

Katena Products Welcomes New CEO

Company's chief executive worked for Cardinal Health, Covidien, and Medtronic.

Business Wire 01.06.21

Medtech Veteran Joins VivaLNK Board

Experienced healthcare industry professional to advise VivaLNK’s executive team and assist in its growth in digital health.

VivaLNK 01.05.21

New Company Formed to Develop Peripheral Venous Disease Treatments

VeinWay received a grant from the Ideation Incentive Program of the Israel Innovation Authority.

MEDX Xelerator 01.05.21

New Global Headquarters for Freudenberg Medical

The 37,000 sq. ft. Beverly, Mass. location is equipped with ISO Class 8 cleanrooms for medical molding and assembly.

CM&B Inc. 12.17.20

4D Biomaterials Awarded Funding for 3D Tissue Scaffolds

The company's new polycarbonate-based resins can be formed into materials that have good shape memory, and tuneable mechanical and chemical properties.

4D Biomaterials 12.16.20

Medtronic’s Mike Coyle to Lead iRhythm

Current president and CEO Kevin King to retire; change effective January 12, 2021.

iRhythm Technologies Inc. 12.16.20

Communicating with the FDA—Mike on Medtech

Mike Drues and Sean Fenske discuss methods of communicating with the agency and share best practices for doing so.

Sean Fenske, Editor-in-Chief 12.15.20

Packaging & Sterilization

Centerpiece to Open New North American ETO Sterilization Facility

The company will launch the new ethylene-oxide sterilization facility in Tijuana, Mexico early next year.

Centerpiece 12.14.20

Preparing Your Design Controls for FDA Approval

Design controls are a set of procedures to build into medical device design and development.

Adam Freeman, Freelance Medical Device and Combination Product Design Specialist, Kolabtree 12.09.20

Sofwave Medical Granted CE Mark for Skin Tightening, Wrinkle Reduction Device

Company's device also received regulatory approval from the Medical Device Division of the Israeli Ministry of Health.

PR Newswire 12.09.20

Survey Finds On-Site Inspections Plummeted by 93 Percent

Findings from Greenlight Guru survey reveal internal divides within organizations are making medical device companies less competitive.

Greenlight Guru 12.08.20

Patient Monitoring

Talking Medtech with TrueFuture's Joe Mullings

MPO's Sean Fenske speaks with Joe Mullings, medtech recruiter and host of TrueFuture, about what’s got him excited in the medtech space.

Sean Fenske, Editor-in-Chief 12.08.20

Molding

A 'Trial and Error' Approach to Micromolded Parts

The medical industry's stringent requirements makes innovation difficult for injection-molded components.

Michael Barbella, Managing Editor 12.07.20

Shimmer Research Receives CE Certification for Inertial Measurement Unit Sensor

The wearable sensor is now recognized as a medical device in Europe, capable of providing continuous, medical-grade measurements of a person’s activity.

Shimmer Research 12.07.20

Digital Health

Expert Roundup: Achieving Success in the 2021 Medical Device Landscape

Industry experts share their advice on factors medical device manufacturers need to consider for the coming year to stay ahead.

Nick Tippmann, Vice President Of Marketing, Greenlight Guru 12.04.20

Olympus Corporation to Acquire Veran Medical Technologies

Strengthens its position as a leading global medical device company.

JCN Newswire 12.04.20

Motion Dynamics Acquires ViaMed Holdings

Enables Motion Dynamics to provide a broader range of capabilities, products, and services.

Motion Dynamics LLC 12.03.20

3D Systems, Veterans Health Administration Collaborate to Improve Patient Care

Additive manufacturing solutions at the point of care aim to foster innovation and enhance patient care.

3D Systems 12.03.20

Materials

Setting the Standard: Protective Nanocoatings for Today's Medtech

Ensuring medical products are safe from the outside environment is a significant challenge that nanocoatings can help resolve.

Zsolt Pulai, EVP, Technology & Development, HZO Inc. 12.02.20

TRIMEDX Acquires Centurion Service Group

Expands TRIMEDX’s comprehensive clinical asset management solution.

TRIMEDX 12.02.20

Wytech Industries Names Henry Burmeister as CFO

Complex specialty core wire manufacturer adds to its management team.

Wytech Industries 12.02.20

Spectrum Plastics Group Acquires PeelMaster Medical Packaging Corporation

...

Surgical

Galen Robotics' Robotic Surgery Subscription Concept

MPO's Sean Fenske speaks with Bruce Lichorowic of Galen Robotics about the firm’s unique subscription plan for its robotic surgery system.

Sean Fenske, Editor-in-Chief 12.01.20

Molding

Medtech Miniaturization is Becoming a 'Way of Life'

Micromolding suppliers should be ready to take on potential roadblocks when designing small parts.

Michael Barbella 11.30.20

R&D & Design

New Project-Based Rapid Precision Prototyping Program

Your First Step Is the Most Important

Highly Flexible UV Curable Adhesive Meets ISO 10993-5 Standard for Cytotoxicity

Product: UV15X-6Med-2LV

Six Percent Growth Predicted for APAC Neurovascular Thrombectomy Devices Market

Medtronic is the leading player in the region, according to market data.

GlobalData 11.24.20

Advanced NanoTherapies Raises $5.3 Million in Seed-Round Financing

Company accelerates development of its nanoparticle-based drug delivery technology platform to treat peripheral artery disease and other applications.

Business Wire 11.23.20

Femtech Firm Launches Two-in-One Medical Device to Help Women With Conception

A $1.5 million seed accelerates manufacturing and shipping; app is updated to incorporate user feedback.

PR Newswire 11.23.20

Machine Solutions Acquires Beahm Designs

Expands its catalog of catheter manufacturing equipment and broadens its engineering resources.

Machine Solutions Inc. 11.20.20

Molding

Miniaturization of Medical Devices Creating Big Assembly Challenges

Extremely tight tolerances leave no room for error.

Michael Barbella, Managing Editor 11.20.20

Graham Partners Acquires Teamvantage, CMD, Paradigme

Will provide operational resources to foster a strong growth trajectory for the companies.

Teamvantage 11.19.20

Pandemic Could Help Indonesia Strengthen Medical Device Sector

The country aims to produce 70 percent of its medical supplies domestically as it realizes the need for being self-reliant.

GlobalData 11.19.20

The Big Challenges of Medical Device Miniaturization

Demand for micro-sized products is prompting micromolders to develop new processes and methods that are outside the norm of standard injection molding.

Michael Barbella, Managing Editor 11.17.20

FDA Agrees to Participate in MDIC's Collaborative Community Initiative

Effort is designed to help advance medical device quality and safety to achieve better patient outcomes.

Business Wire 11.17.20

Digital Health

Avail Medsystems Raises $100 Million in Series B Funding

Money will help the company meet demand for procedural telemedicine technology in the operating room.

Business Wire 11.17.20

R&D & Design

How Design Controls Can Prevent Medical Device Recalls

Incorporating risk management early in development will help eliminate problems before they impact the product’s manufacturing lifecycle.

Ramya Sriram, Digital Content Manager, Kolabtree 11.16.20

Three New Members Elected to Titan Medical's Board

Board now consists of a majority of independent corporate directors.

Business Wire 11.16.20

Vygon, Oncomfort Partner to Commercialize Virtual Reality Pain Relief Device

The collaboration will provide patients with a new personalized treatment option for medical interventions.

Vygon 11.16.20

Indago Appoints President and General Counsel

New leader has 15 years of experience in the life sciences industry.

Business Wire 11.16.20

Chronic Disease

Wrighting the MiMedx Ship: An Exclusive Interview

In this interview with the firm’s new CEO, MPO discovers what’s been done to turn the page on the company’s troubled past.

Sean Fenske, Editor-in-Chief 11.13.20

Mentice to Acquire Vascular Simulations

The combined portfolio will enhance Mentice’s endovascular simulation offerings with proven replication solutions.

Mentice AB 11.13.20

MDIC Welcomes New Vice President of Health Economics and Patient Value

New executive has more than 30 years of experience working directly with patients and from the administrative perspective.

Business Wire 11.11.20

Former Abbott Executive Joins Centricity Vision Board

New member has more than four decades of business and ophthalmology industry experience.

Business Wire 11.11.20

Contract Manufacturing

Vance Street Acquires Wytech Industries

Represents Vance Street’s fifth investment in the medical device space in the past four years.

Wytech Industries 11.10.20

Contract Manufacturing

Freudenberg Medical Completes New Manufacturing Operation

Establishes new facility in Beverly, Massachusetts.

Freudenberg Medical 11.10.20

R&D & Design

Collaborating with Full-Service Design and Development Providers—A Medtech Makers Q&A

Spectrum Plastics Group’s Paul Melnychuck speaks about the advantages of working with a full-service supplier and contract manufacturer.

Veteran Medical Device Executives Named to Dimension Inx Board

New members served as startup CEOs and Fortune 200 corporate executives.

Dimension Inx 11.05.20

HeartHero Inc. Awarded ISO 13485 Certification

Company to continue regulatory path for AED in collaboration with the American College of Cardiology.

Business Wire 11.05.20

Report: Nearly Three-Quarters of mHealth Apps Vulnerable to Data Breach

Findings also conclude that a majority of mHealth apps contain multiple security issues with data storage.

Business Wire 11.05.20

Chronic Disease

Pharmaceutical Focus: A Look at Combination Products

Combination products and drug delivery devices aid in patient compliance and a movement toward point-of-care at home.

Mark Crawford, Contributing Writer 11.04.20

3D/Additive Manufacturing

The Printed World: Additive Manufacturing in Medtech

Medical additive manufacturing experts discuss key factors impacting the market both during and post-pandemic.

Sam Brusco, Associate Editor 11.04.20

The Lost Year: 2020 Year in Review

Lessons learned from the global coronavirus pandemic.

Michael Barbella, Managing Editor 11.04.20

Cardiovascular

The Heart of the Matter: Trends in Cardiology

Of the three major segments of coronary stents, bioabsorbable stents are expected to have the highest growth between now and 2022.

Maria Shepherd, President and Founder, Medi-Vantage 11.04.20

Virtually the Same? The Challenges of Online Conferences

Like everyone else on the planet, I’m turning increasingly to virtual solutions to our physical challenges in the midst of a pandemic.

Dawn A. Lissy, Founder & President, Empirical 11.04.20

Advanced Technology for Staking and Swaging Medical Plastics

It reliably assembles heat- and vibration-sensitive components, and works with a wide range of plastic materials.

Priyank Kishor, Global Product Manager—PulseStaking, Branson at Emerson 11.04.20

Quality Assurance When Supply Chain Disruptions Arise

From supply chain disruptions to impromptu manufacturing modifications, the medical device industry has faced a whirlwind of complications in 2020.

Sandi Schaible and Peter Steen, WuXi AppTec Medical Device Testing 11.04.20

The Top 30 and M&A in 2021: What’s Next?

With three of the top five companies appointing new CEOs in the last year and the global pandemic eroding earnings, M&A strategies could look a lot different.

Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 11.04.20

3D/Additive Manufacturing

Additive Manufacturing: Debinding Fluids Must-Haves

As the pressure to produce more complex biomedical parts increases, medical device manufacturing using 3D printing is gaining widespread acceptance.

Venesia Hurtubise, Technical Chemist, MicroCare Medical 11.04.20

Diagnostics

How COVID-19 is Reshaping the Diagnostics Testing Sector

The short-term impact on the diagnostics sector is readily apparent as the pandemic has fueled overwhelming demand for effective SARS-CoV-2 testing solutions.

Eric Williams, Managing Director, Capstone Headwaters 11.04.20

My 2020 Holiday Wish List

There are many lessons to be learned from actions taken during the pandemic. Are there positives that can actually be taken from this mess?

Sean Fenske, Editor-in-Chief 11.04.20

Machining & Laser Processing

Heraeus Medical Components Buys Pulse Systems

Firm expands capabilities in interventional access and delivery with the acquisition of laser processing and manufacturing supplier.

Heraeus Medical Components 11.03.20

OmniVision Expands Medical Image Signal Processor Family for Endoscopes and Catheters

Two new additions to the OVMed ISP product line increase options for greater design flexibility and rapid integration into medical devices.

OmniVision Technologies Inc. 11.03.20

Electronics

Addressing the Non-Magnetic Inductor Need in Medical Electronics

A proprietary non-magnetic material developed by Gowanda Electronics provides inductance qualities.

Michael Barbella 11.03.20

Neurological

First-Ever Treatment Shown to Reverse Alzheimer’s Earns Breakthrough Status

Revolutionary clinical-stage head device to beat back Alzheimer’s disease at home.

Business Wire 10.28.20

Materials

Ulbrich Launches Braid Wire Accelerator Program

Fast-tracks device development timelines.

Ulbrich 10.26.20

Quasar Medical Devices Expands Headquarters

The company also announces a number of hirings of key personnel.

Quasar Medical Devices LLC 10.22.20

Supply Chain Study Offers Insights on Medtech Recovery

Concerns remain about data accuracy, distribution, surge-related delays, and shortages.

Supplyframe 10.22.20

The Orthopaedic Implant Company's Economical Implants

MPO's Sean Fenske speaks with Itai Nemovicher, CEO and founder of The Orthopaedic Implant Company, about the company’s orthopedic trauma technology offerings.

Sean Fenske, Editor-in-Chief 10.22.20

Summit Medical, Practico Solutions Develop Tracking Module for Robotic Instrument Reprocessing

Medical device manufacturer responds to recent FDA guidance update to ensure hospital compliance.

Business Wire 10.22.20

Surgical

Level Ex Introduces Virtual Technique Guides

Allow sales representatives to train surgeons located anywhere in the world.

Level Ex

Considerations in Designing 'Fail-Safe' Motor Drive Circuits

Products must be constructed to fail in a safe manner to protect both patients and physicians.

Michael Barbella, Managing Editor 10.15.20

Using Revenue-Based Financing to Grow in the Pandemic

One revenue-based funding investor shares real-world examples of firms that gained access to cash without giving up a piece of the company.

Wayne Cantwell, Co-Founder and Managing Director, Decathlon Capital Partners 10.14.20

ArchiMed Acquires Majority Interest in NAMSA

Investment to accelerate NAMSA’s global growth and strategic vision.

Business Wire 10.14.20

Molding

A Primer on the Benefits of Metal Injection Molding

High volume, high performance, complex surgical instrument parts are achievable at an affordable cost with the fabrication process.

Steve Santoro, EVP, MICRO 10.13.20

Surgical

First Pediatric Cases with TransEnterix's Senhance Surgical System

Pediatric patients successfully treated using 3mm instruments on digital laparoscopy platform.

Business Wire 10.13.20

Providence Enterprise Medical Device Manufacturing

Providence Enterprise is a Hong Kong medical device contract manufacturer of Class I and II medical devices with manufacturing in China & Vietnam.

Electronics

Capacitor Considerations for Medical Applications

Careful selection of even the smallest electronic components can make a significant difference in a device’s capabilities.

Rich Bestafka, Key Account Manager—Medical, Knowles Precision Devices 10.12.20

Electronics

Connected Health Driving Demand for Comprehensive Electronics Solutions

Medical electronics must be designed to handle the increased bandwidth, high-speed interconnects inclusive of fiber optics, and high signal integrity and speed.

Michael Barbella, Managing Editor 10.09.20

Materials