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Extractables & Leachables

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

Physical and chemical characterization of medical devices

When designing medical devices and instruments, physical and chemical characterization of materials is a critical step in the process.

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.

Evaluating additively manufactured titanium per ASTM F3001

The continuous development of additive manufacturing processes for titanium medical devices opens the door to complex designs w/ improved anatomic geometries

Requirements and Impact of the New Guideline- ISO 10993-23: Tests for Irritation

Join us for an intense and informative discussion on this standard and learn what steps to take to incorporate this testing into your biocompatibility program.

03.04.21

The Many Hats of an Integrated Contract Manufacturer

Here are the five hats your fully-integrated CM should wear.

Cardiovascular

Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib

Will evaluate PulseSelect's pulsed electrical fields to interrupt irregular heart rhythms.

Sam Brusco, Associate Editor 03.04.21

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

Surgical

Memic Receives FDA Marketing Authorization for Hominis

Its robot-assisted surgical platform is now available for use in transvaginal gynecologic procedures including benign hysterectomy.

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

Solid Growth Forecast for Japan's MI Neurosurgical Devices Market

Minimally invasive procedures are preferred over open surgeries due to less exposure to brain structures, rapid recovery time, and less tissue scarring.

Michael Barbella, Managing Editor 03.02.21

Medtech Matters: 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

Mike on Medtech: Update on FDA's STeP Designation

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

FDA Clears Ava Fertility Tracking Wearable Device

The wearable is clinically proven as effective as LH tests in predicting ovulation—and with more fertile days detected.

Michael Barbella, Managing Editor 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

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

Japan to Lead APAC Assisted Reproductive Technology Devices Market

Sector forecast to grow 2.1 percent annually this decade.

Michael Barbella, Managing Editor 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

Digital Health

Terumo to Purchase Predictive Analytics Firm Health Outcomes Sciences

Will enable personalized, predictive insights at the point of care.

Sam Brusco, Associate Editor 02.24.21

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

FDA Approves Daytime Treatment for Sleep Apnea and Snoring

Signifier Medical’s proprietary therapy eXciteOSA is the first and only daytime genioglossal (tongue) muscle-neurostimulation technology approved in the U.S.

Michael Barbella, Managing 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

Masimo Releases softFlow High-Flow Nasal Cannula Therapy in U.S.

Provides respiratory support for patients with COVID-19 and other respiratory conditions.

Sam Brusco, Associate 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

Diagnostics

Rice University Researchers Receive Funding to Develop Covid-19 Sensor System

Real-time electronic system will be able to detect minute amounts of SARS-CoV-2.

Charles Sternberg, Assistant Editor 02.22.21

Diagnostics

BD Collaborates with Scanwell Health

Aims to create an at-home rapid test for SARS-CoV-2 using a BD antigen test and the Scanwell Health mobile app.

Charles Sternberg, Assistant Editor 02.22.21

Investment Advisor Joins Ra Medical's Board

New member has more than 20 years of experience advising corporate clients and their boards.

Michael Barbella, Managing Editor 02.22.21

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

South Korean HIV Testing to Reach Peak Market Value This Year

The sector's worth declined in 2020 due to COVID-19's impact in the country.

Michael Barbella, Managing Editor 02.19.21

FDA Clears B-Secur's HeartKey EKG/ECG Technology

The product's algorithms can be quickly integrated in semiconductors for devices in the medtech, health monitoring, and wellness sectors.

Michael Barbella, Managing Editor 02.19.21

Neurological

Medtronic Receives FDA Approval for Expanded MRI Labeling

Updated MRI Guidelines allow for a wider range of MRI scan parameters and shorter wait time between MRI scans.

Charles Sternberg, Assistant Editor 02.18.21

Diagnostics

Study Validates Vocalis Health’s COVID-19 Screening Tool

VocalisCheck obtains CE mark approval for medical use.

Charles Sternberg, Assistant Editor 02.18.21

Bicuspid Aortic Stenosis Treatment to Create Huge Market Potential for TAVR Devices

Up to 53 percent of adult patients with diagnosed severe aortic stenosis are estimated to have bicuspid valve anatomy.

Michael Barbella, Managing Editor 02.18.21

RDS Completes 3 Million Euros Seed Funding Round

Funding will be used for the first clinical trials of the MultiSense Connected Sensor Patch.

Michael Barbella, Managing Editor 02.18.21

Cardiovascular

Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval

Technology approved to treat calcified coronary plaque.

Charles Sternberg, Assistant Editor 02.17.21

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

Rapid Growth Expected for Global Smart Syringe Market

Sector is estimated to swell 11.3 percent annually through 2027.

Michael Barbella, Managing Editor 02.17.21

FDA Clears Pulse Biosciences' CellFX System

The product delivers Nano-Pulse Stimulation technology in dermatologic procedures.

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

Qosina and EcoVadis Set to Improve Supply Chain Sustainability for Medical, Pharma and Beauty

Qosina Corp. has partnered with EcoVadis, the world’s most trusted provider of business sustainability ratings

Digital Health

Discussing Cybersecurity in Medical Devices

MPO's Sean Fenske speaks with Alan Grau of Sectigo about the importance of cybersecurity in connected medical devices.

Sean Fenske, Editor-in-Chief

SpectraWAVE Announces $13.2 Million Series A-2 Financing

Funds will accelerate the development of its intracoronary imaging technology and support a regulatory filing.

Michael Barbella, Managing Editor 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

Medtech Matters: 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

Diagnostics | Digital Health | Software & IT

Pioneering AI Solutions to Reinforce Healthcare Services

Can AI live up to its hype in the healthcare landscape?

Sunil Jha, Senior Research Content Developer, Global Market Insights 02.12.21

Diagnostics

Suitcase Laboratory to Detect COVID-19 in Development

Mobile laboratory for rapid detection of SARS-CoV-2 for Africa.

Sam Brusco, Associate Editor 02.12.21

Cardiovascular | Neurological

Cerus Endovascular's Contour Neurovascular System Gains Breakthrough Status

Indicated for the treatment of intracranial aneurysms.

Sam Brusco, Associate Editor 02.12.21

Diagnostics

BD Earns EUA, CE Mark for Combo SARS-CoV-2, Influenza A+B Test

Also shows ability to detect U.K., South African variants of COVID-19.

Sam Brusco, Associate Editor 02.12.21

Festo is Omnipresent in the Automated Production of Today

Developing individual customer solutions and market-specific products for the Life Science market.

10 Key Areas to Consider When Evaluating Suppliers

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Where Component Design Functionality and Cost Reduction Converge

Cold Formed Medical Devices vs. Traditional Manufacturing Techniques

Less is more: How One OEM Saved $1.9 Million in Project Costs by Consolidating Suppliers

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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

Brian P. Kemp Unveils Georgia Made Medical Manufacturing Act

Incentivizes the production of medicines and medical devices in Georgia.

Charles Sternberg, Assistant Editor 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

Refurbished Medical Imaging Equipment Market to be Worth $21.14 Billion By 2027

The market's growth will be driven primarily by increasing demand for cost-effective medical imaging equipment.

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

Diagnostics

Rapid Medical Diagnostic Kits Market Size Worth $23.04 Billion By 2027

A desire to provide rapid disease treatments is driving the market's growth.

Michael Barbella, Managing Editor 02.09.21

Cardiovascular

Medtech Matters: 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

Surgical

Apollo Endosurgery to Welcome New Leader

Charles (Chas) McKhann will become CEO of the company on March 1.

Sam Brusco, Associate Editor 02.08.21

Cardiovascular

Study Links 79 Percent Survival Rate to Impella 5.5 With SmartAssist

Data show an 86 percent survival rate for cardiomyopathy cardiogenic shock patients.

Michael Barbella, Managing Editor 02.08.21

Machine Learning Tool Predicts Respiratory Failure in COVID-19 Patients

To develop the ML clinical models, scientists used measurements commonly recorded in the ER, such as vitals and labs, as well as demographics.

Michael Barbella, Managing Editor 02.08.21

Cardiovascular

FDA Clears Wearable Electrocardiogram Sensor

The product offers extended ambulatory ECG recording up to three weeks.

Michael Barbella, Managing Editor 02.08.21

BMP Medical - Delivering Custom Plastics Manufactured Solutions

Medical Contract Manufacturing, Design, Assembly & Packaging

First Use of SoundBite Medical's Active Wire to Treat Calcified Below-The-Knee CTOs

The product is a unique and novel first-in-class wire-based active device (active wires) for crossing CTOs.

Michael Barbella, Managing Editor 02.04.21

Hemostasis and Tissue Sealing Agents Market to Swell to $6.6 Billion by 2026

An increase in demand globally for MI surgeries and the rise in geriatric patients with chronic conditions are driving the growth.

Michael Barbella, Managing Editor 02.04.21

Digital Health | Patient Monitoring | Software & IT

FDA OKs CLEW's AI-Based ICU Predictive Analytics Tech

CLEWICU predicts hemodynamic instability in adult patients.

Sam Brusco, Associate Editor 02.04.21

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

Global Trends in Medtech: OEMs and the Supply Chain

MPO Webinar Series covering The OEM Landscape and Business Drivers, Consolidating Supply Chain vs. Tiering Supply Chain, and panel discussions.

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

Surgical

J&J Granted FDA Approval for Monofocal IOL

TECNIS Eyhance and TECNIS Eyhance Toric II IOLs help treat cataract patients.

Sam Brusco, Associate 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

Pulse Biosciences Granted CE Mark Approval for CellFX System

Product delivers nano-pulse stimulation technology to clear hard-to-treat benign skin lesions.

Michael Barbella, Managing Editor 02.03.21

Surgical

CooperSurgical Buys AEGEA Medical

Gains endometrial ablation treatment that uses water vapor to treat heavy menstrual bleeding.

Sam Brusco, Associate Editor 02.02.21

Surgical

Medtech Matters: 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

Stericycle Settles Environmental Violations at Its Medical Waste Incinerator

Agreement includes Supplemental Environmental Project to provide low-emitting school buses to local school district.

Michael Barbella, Managing Editor 02.01.21

Cardiovascular

Medtronic Expands Release of Radial Artery Access Portfolio

Completes first-in-patient procedure with newly acquired catheters.

Charles Sternberg, Assistant Editor 02.01.21

Endo Tools Therapeutics Secures 8 Million Euros in Series D Funding

The company plans to seek regulatory clearance in the U.S. and reimbursement in European countries.

Michael Barbella, Managing Editor 02.01.21

New Biomaterials Can be ‘Fine-Tuned’ for Medical Applications

Animal testing has confirmed the material's safety and biocompatibility.

Michael Barbella, Managing Editor 02.01.21

Patient Monitoring

Hillrom Buys EarlySense's Contact-Free Continuous Monitoring Tech

EarlySense's contact-free continuous monitoring, analytics tech was integrated into the Centrella Smart+ med-surg bed.

Sam Brusco, Associate Editor 02.01.21

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

North American Medtech Deals Fall 17 Percent in Q4 2020

Venture financing experienced the most activity, according to estimates.

Michael Barbella, Managing Editor 01.29.21

India's NIPT Testing Market Driven by Demand for Non-Invasive Genetic Assessments

Not surprisingly, the market lost value last year due to COVID-19.

Michael Barbella, Managing Editor 01.29.21

Nonin Medical Adds Four New Board Members

Healthcare industry leaders to support the company's next phase of growth.

Michael Barbella, Managing 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

Europe Marks its First Successful Remote Robotic-Assisted Coronary Angioplasty

The procedure was carried out on an animal model late last year.

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

Inogen to Undergo Leadership Transition

Longtime BD exec Nabil Shabshab succeeds retiring Scott Wilkinson as president and CEO.

Sam Brusco, Associate Editor 01.27.21

Asia-Pacific Advanced Wound Management Market to Undergo Robust Expansion

The market is being driven by a global aging population, increasing patient awareness levels, and rising disposable incomes.

Michael Barbella, Managing Editor 01.27.21

Molding

Medtech Makers: Material Science for Micromolding

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

Cardiovascular

Alleviant's Transcatheter Tech Obtains Breakthrough Status

The technology offers a no-implant interatrial shunt therapy for heart failure patients.

Sam Brusco, Associate Editor 01.25.21

At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities

Public health officials need to stress the importance of mass testing and contact tracing even with several vaccines approved.

Michael Barbella, Managing Editor 01.25.21

QT Imaging Signs Distribution Agreement With Freedom Ventures for Breast Scanner

Transmission ultrasound breast imaging now to become available in EMEA markets.

Michael Barbella, Managing Editor 01.25.21

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

Are you prepared for EUDAMED actor registration module? Let’s get started

Through this webinar, participants will be able to focus exclusively on “Actor Registration Module” which is key to accessing and using EUDAMED.

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

Endoscopic Hemostasis Devices Market Valued at $730 Million

Value has driven by the recent approval of new devices.

Michael Barbella, Managing Editor 01.22.21

Henry Schein Buys Majority Interest in Prism Medical Products

PRISM will operate as a subsidiary of Henry Schein Medical and will be managed separately as an individual division.

Michael Barbella, Managing Editor 01.22.21

Neurological

Boston Scientific's Vercise Genus DBS Earns FDA Approval

Fourth-generation DBS portfolio features full-body MR conditional devices.

Sam Brusco, Associate 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

Neurent Medical Closes $25 Million Series B Financing

Supports the expansion of the company’s clinical and commercial operations.

Charles Sternberg, Assistant Editor 01.21.21

Diagnostics

FDA OKs Canon Medical's AI-Powered, 90cm Bore CT

Company claims the Aquilion Exceed LB CT offers the industry's largest bore opening.

Sam Brusco, Associate Editor 01.21.21

Eitan Medical Receives FDA Clearance for Sapphire Infusion System

Upgraded infusion system provides advanced performance and customization capabilities within hospital, pre-hospital and ambulatory environments.

Eitan Medical 01.20.21

Materials

Researchers Successfully ‘Fine Tune’ New Thermoplastic Biomaterial

Enables both the rate at which it degrades in the body and its mechanical properties to be controlled independently.

University of Birmingham 01.20.21

CHF Solutions Appoints CEO

Nestor Jaramillo Jr succeeds John Erb.

Globe Newswire 01.19.21

Neurological

Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

Next-generation digital therapeutic is designed for the treatment of Alzheimer’s disease.

Business Wire 01.14.21

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

Patient Monitoring

Unique Contact Lens Sensor System & Manufacturing Process Developed

New multifunctional lens can provide diversified signals from eyes.

Surrey University 01.12.21

Surgical

Medtech Matters: 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

Patient Monitoring

CES News: Philips Highlights Healthcare at Home

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

Royal Philips 01.11.21

Diagnostics

Olympus and Hitachi Sign Five-Year Contract

Will jointly develop Endoscopic Ultrasound Systems.

Olympus Corporation 01.11.21

Cardiovascular

Acutus Medical Launches AcQCross Transseptal System in Europe

The product is designed to improve safety and efficiency in any procedure requiring left heart access.

Globe Newswire 01.08.21

Study Shows Lungpacer System Improves Diaphragm Strength by More Than 300 Percent

System is designed to stimulate the diaphragm during mechanical ventilation to strengthen the muscle.

Business Wire 01.08.21

Solvay Partners With PrinterPrezz on 3D Printing for Medical Devices

Companies are collaborating on 3D printing selective laser sintering (SLS) solutions for implants and other medical devices.

Solvay 01.08.21

New Clinical Trial Data Supports BD Libertas Wearable Injector as a Drug Delivery System

The results show the device effectively delivers dose volumes up to 5 mL subcutaneously.

B3C newswire 01.08.21

Diagnostics

Quantitative Transmission Ultrasound Outperforms Mammography

QT Imaging completes first-in-human study of transmission ultrasound as a new imaging technology for breast health screening.

PRNewswire 01.07.21

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

Packaging & Sterilization | Surgical

Olympus Releases ScopeLocker Endoscope Storage Cabinet

HEPA hinged door endoscope storage system addresses infection prevention needs in busy GI suites.

Olympus 01.06.21

Vesper Medical Announces First Enrollment in the VIVID Trial

Company initiates pivotal clinical study for next-generation deep venous stent.

Vesper Medical 01.06.21

Acutus Medical Launches AcQBlate Force Sensing Ablation System in Europe

Gold-tipped force sensing ablation catheter earns CE Mark.

Globe Newswire 01.06.21

Katena Products Welcomes New CEO

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

Business Wire 01.06.21

Thyroid Function Tests Market in India to Reach $125 Million in 2025

Thyroid stimulation hormone tests are expected to account for more than 75 percent of the market.

GlobalData 01.06.21

Steady Growth Expected for APAC Sterilization Market Through 2030

A robust waste management strategy is needed, however, as the use of plastic-based single-use devices has increased.

GlobalData 01.05.21

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

3D/Additive Manufacturing

Researchers Develop New Combined Process for 3D Printing

Enables active medical agents to be incorporated into pharmaceutical products or luminous liquids to be integrated into materials.

Martin-Luther-Universität Halle-Wittenberg 12.18.20

FOREFRONT MEDICAL TECHNOLOGY ANNOUNCES UNIQUELY-DESIGNED COVID-19 TEST SWAB

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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

Impact of COVID-19 on the Medtech Supply Chain

Agility, reliability, and resiliency all describe objectives of a company’s supply chain management system.

Joe McBeth, Vice President, Global Supply Chain, Jabil 12.16.20

PTC to Acquire SaaS PLM Leader Arena Solutions

PTC reaffirms its cash flow targets for fiscal year 2021.

PR Newswire 12.16.20

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

New Home Use Indication Granted for the Passio Pump Drainage System

Product is designed for the drainage of recurrent and symptomatic pleural effusion.

PR Newswire 12.15.20

Mike on Medtech: Communicating with the FDA

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

TSK Laboratory Offering Free Patent Licenses for its Needle Technology

Company's Low Dead Space needle is expected to reduce wasted COVID-19 vaccine.

TSK Laboratory Europe B.V. 12.15.20

New CEO Named at Alpha Source Group

Company expands customized service solutions to focus on OEM partnerships.

Alpha Source Group 12.15.20

Cardiovascular

Pandemic May Hinder Growth in Peripheral Drug-Coated Balloon Market

Percutaneous transluminal angioplasty balloon procedures declined by almost 30 percent in 2020.

GlobalData 12.15.20

Cardiovascular

Innovative Health Obtains Patent for Microlumen Reprocessing Technology

Paves the way for future innovation in the field by the company.

Innovative Health Inc. 12.11.20

Surgical

Olympus Adds 3D, IR, Novel Light Tech to MIS Imaging Platform

Expanded VISERA ELITE II surgical imaging capabilities may help reduce costs, improve efficiency.

Olympus

Finding the Upside to a Challenging Year

Despite its complete transfiguration of modern life, COVID-19 had important lessons to teach the medtech industry.

Michael Barbella, Managing Editor 12.11.20

Cardiovascular

Abbott Launches OCT Virtual Reality Training for Cardiologists

VR training improved cath lab staff learning engagement by 45 percent, knowledge retention by 72 percent.

Abbott Laboratories 12.09.20

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

BellaSeno Establishes High-Throughput Additive Manufacturing Facility for Resorbable Implants

Manufacturing at the facility will be based on the no-touch approach to significantly improve the safety and sterility of medical implants.

BellaSeno GmbH 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

Home Oxygen Therapy to Drive Oxygen Concentrators Market Growth in India

Last year, portable oxygen concentrators accounted for more than 60 percent of the country's oxygen concentrators market.

GlobalData 12.09.20

Chronic Disease

Medtronic Launches Pediatric/Neonatal Acute Dialysis Machine

The Carpediem system is designed to treat patients requiring renal replacement therapy weighing between 2.5 and 10 kilograms (5.5 to 22 pounds).

PR Newswire 12.08.20

Materials

DURECT to Sell LACTEL Absorbable Polymer to Evonik for $15M

Expands Evonik's position as a global CDMO for drug delivery solutions.

PR Newswire 12.08.20

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

Medtech Matters: Talking Medtech with 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

Chronic Disease

New Research Sheds Light on Potential Glaucoma Treatment

Hydrogels could provide an alternative to drugs or surgery.

Georgia Institute of Technology 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

Diagnostics

CRISPR-Based COVID-19 Test Uses Smartphone Camera

The rapid, one-step mobile test could help combat the pandemic and fully reopen communities.

PR Newswire 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

Molding

Tooling Precision is Key to Micromolding Success

Tool quality dictates part quality for all sizes of medical components.

Michael Barbella, Managing Editor 12.03.20

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

Cybersecurity Remains a Critical Consideration for Healthcare Industry

The number of attacks are rising, along with the associated costs.

GlobalData 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

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Surgical

Medtech Matters: A Robotic Surgery Subscription

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

Materials

Best Practices in Venting of Medical Devices

Learn how to design the best venting solution for your medical device using custom-engineered porous polymers in this webinar for medical device engineers.

12.01.20

RSNA News: Royal Philips Introduces Patient Management System

Offers personalized care to patients during the COVID-19 pandemic.

Royal Philips 11.30.20

Diagnostics

RSNA News: RADLogics’ AI-Powered COVID-19 Medical Imaging Solutions

The company’s latest algorithm enhancements to help radiologists distinguish between coronavirus and other abnormalities.

RADLogics 11.30.20

Diagnostics

RSNA News: Siemens Introduces Cios Flow Mobile C-arm System

Easy-to-use system helps make surgical interventions more efficient and patient-friendly.

Siemens Healthineers 11.30.20

Molding

Smaller Cavity Features Not Always Sensible for Micromolded Products

Though the need to reduce size is crucial, small cavity characteristics may be challenging to reproduce in volume.

Michael Barbella, Managing Editor 11.24.20

Tubing & Extrusion

On Line Controls Celebrates 40 Years

The firm manufactures MicroAir technologies for tubing extrusion.

On Line Controls Inc. 11.24.20

R&D & Design

New Project-Based Rapid Precision Prototyping Program

Your First Step Is the Most Important

Chronic Disease

Increasing Comfort for Chemotherapy Patients

Leveraging a freelance researcher in bringing the Chemo Mouthpiece to market—A case study.

Ramya Sriram, Digital Content Manager, Kolabtree 11.24.20

Cardiovascular

Draper Develops Noncontact ECG Sensor

Enables direct measurement of the heart’s three-dimensional (3D) bioelectric field.

Draper 11.24.20

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

Cardiovascular

VitalConnect Lanches VitalPatch RTM Cardiac Monitoring Solution

Monitors for 21 cardiac arrhythmias through a unique AI-based ECG analysis solution and captures data on four key vital signs.

Business Wire 11.23.20

Software & IT

GE Healthcare Launches X-ray AI for COVID-19 Patients' Endotracheal Tube Placement

A necessary and important step when ventilating critically ill COVID-19 patients.

Business Wire 11.23.20

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

First Patient Enrolled in NovaSignal's Intelligent Ultrasound Clinical Trial

The FDA-cleared NovaGuide is designed to autonomously locate major blood vessels and assess blood flow.

Globe Newswire 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

Patient Monitoring

CE Mark Granted for Automated Glycemic Control and Continuous Diagnostics System

PrecisionOne provides automated glucose regulation and real-time analysis of blood chemistry values for critical care patients.

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

Surgical

FDA Clears Penumbra's Lightning 12 Aspiration Catheter for Pulmonary Embolism

Indigo Aspiration System with Lightning 12 removes these difficult-to-access, life-threatening clots.

Business Wire 11.20.20

Chronic Disease

Varian Begins First Human Trial of FLASH Therapy for Cancer

ProBeam particle accelerator was modified to enable radiation therapy delivery at ultra-high dose rates.

PR Newswire 11.20.20

Diagnostics

GE Healthcare Pioneers Photon Counting CT with Prismatic Sensors Buy

Gains Deep Silicon detector technology for photon counting computed tomography (PCCT).

Business Wire 11.20.20

New Study Validates the Efficacy of Ethicon’s LINXReflux Management System

LINX eliminated daily dependance on acid-reflux medications in 79% of GERD patients.

Ethicon 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

Thirteen Percent Revenue Shortfall Expected in Capsule Endoscopes Market

Market was down nearly 60 percent in Q2 as COVID-19 forced the cancellation or postponement of elective procedures.

GlobalData 11.19.20

Cardiovascular

CARMAT Receives Funding to Conduct Artificial Heart Study in France

Two-thirds of the study's total cost will be financed by the French state.

CARMAT 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

Global Neurovascular Devices Market to Surpass $3.18 Billion by 2027

Product launches are expected to help drive the market's growth.

Business Wire 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

Sommetrics' aerSleep II Sleep Apnea Treatment Earns Breakthrough Designation

aerSleep II applies negative pressure over the external surface of the neck to hold airway open during sleep.

Business Wire 11.17.20

Diagnostics | Patient Monitoring

Digital Radiology Ushering Innovations in the Medical Imaging Market

Radiology is on the cusp of revolution following the soaring popularity of digital radiography.

Sunil Jha, Research Content Developer, Global Market Insights 11.17.20

Cardiovascular

First Patients Treated With Pulsed Electric Field Cardiac Ablation System

Galaxy Medical's Centauri System is designed as an open energy platform with proprietary interface hardware and waveform control algorithms.

PR Newswire 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

Foldax Strengthens its Scientific and Medical Advisory Boards

Company adds two new members to each of the governing bodies.

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

Comar Holds Groundbreaking Ceremony in Vineland, NJ

Celebrates the start of a new manufacturing facility.

Comar 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

Mentice to Acquire Vascular Simulations

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

Mentice AB 11.13.20

Chronic Disease

Medtronic Launches InPen with Real-Time Guardian Connect CGM Data

Real-time glucose data coupled with InPen’s dose calculator helps users make better dosing decisions.

Medtronic plc 11.12.20

Patient Monitoring

Implantable Sensor Could Measure Bodily Functions, Then Safely Biodegrade

Can monitor various forms of nitric oxide and nitrogen dioxide gas in the body.

Penn State 11.12.20

3D/Additive Manufacturing | Surgical

Biodegradable 3D Printed Stents Treat Esophageal Inflammation

Stent with esophageal-derived bioink helps treat radiation esophagitis.

POSTECH 11.12.20

Surgical

OnLume Surgical Awarded $2 Million Grant to Develop Fluorescence-Guided Surgery Device

The company's FGS imaging technology illuminates critical anatomy in real-time during surgery to optimize precision.

Business Wire 11.12.20

Intersect ENT Closes Deal for Fiagon AG Medical Technologies

The purchase enhances Intersect ENT's offering with a portfolio of balloons, navigation, and localized drug delivery technology.

Business Wire 11.12.20

Urinary Tract Stent Market to Lose 11.4 Percent in Revenue Due to Coronavirus

Boston Scientific Corp., Cook Group and BD will be most impacted by the deficit.

GlobalData 11.12.20

Software & IT

BD Acquires CUBEX's Medical Business

Broadens automated dispensing portfolio across care continuum.

PR Newswire 11.12.20

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

Alucent Biomedical Closes $35 Million Series B Financing Round

Funding will support clinical trials to evaluate the company’s treatment for peripheral artery disease.

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

University Develops AI Algorithm to Analyze Chest X-Rays for COVID-19

Academic team created algorithm using 100,000 X-rays of patients who did not have COVID-19 and 18,000 X-rays of patients who did.

Globe Newswire 11.10.20

Study: NEUWAVE System With Ablation Confirmation Software Leads to Improved Outcomes

Data showed the MI technology helps improve precision and accuracy in ablation procedures, which is critical to achieving technical success.

Ethicon 11.10.20

Patient Monitoring

Prevounce Health Launches Remote Patient Monitoring Module

The module combines digital spirometry, smart nebulizers, and pulse oximetry.

PR Newswire 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

Medtech Makers: Collaborating with Full-Service Design and Development Providers

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

Electronics

Big Data's Role in Sensor Design

Insight into device use is driving trends in miniaturization, low-power options, and conversion to digital sensing.

Michael Barbella, Managing Editor 11.09.20

Patient Monitoring

Sony Updates NUCLeUS Imaging Platform

Adds new functionality and features for use in hospitals.

Sony 11.05.20

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

Harvard Professor Joins ExThera Medical Board

New member is recognized as a leading authority on competitive strategy, the competitiveness and economic development of nations and regions.

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

Fixing Face Mask Form and Function

Masks for the general public are varied in both style and effectiveness.

Sam Brusco, Associate 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

Digital Health

Digital Health Delivers During a Year for the Ages

Internet of Medical Things technologies have emerged as the key enabler of a much more holistic and complete disease-state management toolbox.

Brad Womble, Senior Director of Strategy, Marketing, and Mergers & Acquisitions, Jabil Healthcare 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

COVID 19: Supply Chain Professionals’ Ultimate Reality Challenge

Having been a part of the medtech supply chain for 40 years, I can say there has never been a more difficult time for supply chain professionals.

Chris Oleksy, Founder and CEO, Oleksy Enterprises and Next Life Medical; CEO, Emergent Respiratory 11.04.20

Congress Examines Additional COVID-19 Relief and Recent Regulatory Changes

The legislative year is nearly coming to a close as Washington survives yet another tumultuous election cycle.

Jeffrey J. Kimbell, Eric P. Juhl, JD and David C. Rudloff, Jeffrey J. Kimbell & Associates Inc. 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

Company Developing a COVID-19 Severity Risk Test for U.S. Government

The technology, known as host-response diagnostics, rapidly reads the immune system using multiple mRNA biomarkers and a machine learning algorithm.

Inflammatix 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

OmniVision Introduces the World’s First Medical RGB-IR Image Sensor

The sensor reduces endoscope size, cost, power, and heat by half.

OmniVision Technologies Inc. 11.04.20

Former Medtronic, St. Jude Executive Assumes CCO Role at JenaValve

Company is pursuing FDA pre-market approval for its Pericardial TAVR System.

Business Wire 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

Qosina Stocks Popular SmartSite™ Swabbable Needle-free Injection Sites

...

Machining & Laser Processing | Surgical

Resonetics Acquires Hutchinson Technology's Medical Business

Adds photochemical machining, metal forming, and sensor technology for minimally invasive surgical devices.

PR Newswire 11.03.20

Neurological

Salvia BioElectronics' Neurostim System for Chronic Migraine Earns Breakthrough Status

Bioelectronics solution addresses drug-refractory chronic migraine.

PR Newswire 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

Babson Diagnostics Closes $13.7 Million Series A Financing

Money will be used to democratize blood testing.

Business Wire 11.03.20

Pandemic to Reduce Global Robotic Surgery Systems Market Revenue by Nearly 8 Percent

A second wave of new COVID-19 cases might generate further delays in elective procedures.

GlobalData 11.03.20

GLEAMER Raises 7.5 Million Euros to Develop AI Radiology Product Line

Company is seeking FDA clearance of its traumatic injury detection tool.

GLEAMER 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

Diagnostics

Imec Developing Five Minute COVID Test

Approach will use virus particles in exhaled breath to identify positive cases and confirm contagion risk.

Imec 10.30.20

Digital Health

How AI Is Improving Predictive Analytics in Healthcare

Predictive analytics and artificial intelligence can enable a more efficient pathway to a better treatment protocol.

Thomas Lanigan, Technical Writer 10.30.20

Diagnostics

FDA OKs Cognita Labs' PulmoScan Home-Usable Lung Assessment device

The first-of-its-kind lung assessment device measures airway resistance and elastance.

PR Newswire 10.28.20

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

Solid Growth Expected for Global Intraoperative Monitoring Electrodes Market

Sector is forecast to expand 7.1 percent annually through 2027.

Coherent Market Insights 10.28.20

Global Central Venous Catheter Market to Surpass $3.06 Billion by 2027

The increasing prevalence of cancer and end-stage renal disease is fueling market growth.

Business Wire 10.26.20

Materials

Ulbrich Launches Braid Wire Accelerator Program

Fast-tracks device development timelines.

Ulbrich 10.26.20

RapidAI Announces $25 Million in Series B Funding

Company to use the funds to expand AI-enhanced cerebrovascular imaging worldwide.

Business Wire 10.26.20

Cardiovascular

Prytime Medical Launches New ER-REBOA PLUS Catheter

Product was developed to help doctors preserve their clinical options for optimal care and best outcomes.

Business Wire 10.26.20

Cardiovascular

Shape Memory Medical Enrolls First Patient in AAA-SHAPE Study

The trial will enroll 15 patients outside the United States.

Business Wire 10.26.20

AOTI Expands Topical Wound Oxygen Product Portfolio

The expansion extends treatment to chronic wound patients with larger limbs, venous and diabetic foot ulcers.

PR Newswire 10.23.20

Antigen Testing is Crucial in Fight Against COVID-19 in India

Antigen testing can be easily done on the spot in doctor’s clinics, day care centers, hospitals, home care settings, and industries.

GlobalData 10.23.20

Global Coronary Stents Market to Exceed $15.1 Billion by 2027

Increase is being driven by the rising incidence of cardiovascular diseases, strategic collaborations and acquisitions among key players.

Business Wire 10.23.20

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

Chronic Disease

FDA Grants Breakthrough Device Designation to Cala Trio

Aims to treat action tremors in the hands of adults with Parkinson's disease.

Cala Health 10.22.20

Medtech Matters: Economical Orthopedic 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

BD Makes Executive Leadership Appointments

Names Patrick Kaltenbach as executive vice president and chief technology officer.

BD 10.22.20

Heated Face Mask Filters and Inactivates Coronaviruses

Includes heated copper mesh powered by a battery and surrounded by insulating neoprene.

Anne Trafton, MIT News Office 10.22.20

PENTAX Medical Launches J10 Series Endoscopic Ultrasound Gastroscopes in the U.S.

The gastroscopes provide a lightweight and ergonomic control body design to ensure stability and ease of intubation while reducing hand fatigue.

PR Newswire 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

First Patients Treated in Trial for Liver and Pancreas Sealant Patch

The patch is optimized to significantly reduce fluid leakage during the critical healing period after hepato-pancreato-biliary procedures.

B3C Newswire 10.22.20

SETi, Seoul Viosys Begin Mass Production of Coronavirus Sterilization Module

Product sterilizes 99.9 percent of coronavirus in three seconds.

Sensor Electronic Technology Inc. 10.22.20

Surgical

Level Ex Introduces Virtual Technique Guides

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

Level Ex

Global Ophthalmoscopes Market to Surpass $289.4 Million by 2027

Increasing product launches is expected to support growth of the market.

Coherent Market Insights 10.20.20

Patient Monitoring

Ingestible Capsule May Help Demystify the Gut-Brain Axis

A platform that can monitor and model gut microbiome serotonin activity.

University of Maryland 10.16.20

Cardiovascular | Patient Monitoring

FDA OKs First Prescriptible Wearable for Continuous Heart Monitoring

Will significantly improve screening and treatment of AFib and other chronic heart conditions.

PR Newswire 10.16.20

Cardiovascular

Livmor Wearable Cleared by FDA

Provides continuous monitoring of pulse rhythms for the detection of atrial fibrillation.

Livmor Inc. 10.15.20

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

Digital Health | Software & IT

GE Healthcare Introduces Edison HealthLink

New edge technology is designed to give clinicians rapid access to critical data.

PR Newswire 10.14.20

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

Miracor Medical Raises 24 Million Euros

Funds will be used for clinical studies and initiation of PiCSO commercialization.

Business Wire 10.14.20

Cutera Launches truSculpt flex in Canada

Product treats up to eight areas simultaneously, covering the largest area in the body sculpting industry.

Business Wire 10.14.20

ArchiMed Acquires Majority Interest in NAMSA

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

Business Wire 10.14.20

Diagnostics | Surgical

FDA OKs CrossBay Medical's CrossGlide ETS Plus

Performs frictionless, office-based endometrial biopsy procedure gently, effortlessly, and without a tenaculum.

Business Wire 10.14.20

Cardiovascular | Surgical

Medtronic Begins TAVR Study Comparing Evolut Against Edwards' Sapien Valve

Also begins feasibility study of Evolut in moderate and asymptomatic aortic stenosis patients.

PR Newswire 10.14.20

Vielight Launches COVID-19 Clinical Trial With Home-Use Device

Study will evaluate whether special light therapy is an effective coronavirus treatment.

Globe Newswire 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

Rapid Prototyping Comes to the Rescue During the Pandemic

When a regional hospital system needed additional battery packs for respirators, rapid manufacturing technologies were employed.

Michael Gillette, Founder, Nevada Jumpstarter 10.09.20

Teleflex Medical OEM to Expand Georgia Facility

Aims to meet growing demand for its products.

Teleflex Medical OEM 10.09.20

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