Focus 42 LLC

RSNA News: Royal Philips Introduces Patient Management System

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

Royal Philips 11.30.20

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

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

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

Chronic Disease | Patient Monitoring

FDA OKs Baxter's Homechoice Claria with Sharesource

Sharesource is a two-way remote patient management platform for patients on peritoneal dialysis.

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

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

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

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

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

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

Foldax Strengthens its Scientific and Medical Advisory Boards

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

Business Wire 11.17.20

Cardiovascular | Surgical

Boston Scientific Recalls, Discontinues LOTUS Edge Aortic Valve

Voluntary recall is related solely to the delivery system.

PR Newswire 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

Indago Appoints President and General Counsel

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

Business Wire 11.16.20

RenovaCare CEO is Elected Board President

Chief executive assumed role in November 2019.

Globe Newswire 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

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

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

Software & IT

BD Acquires CUBEX's Medical Business

Broadens automated dispensing portfolio across care continuum.

PR Newswire 11.12.20

Patient Monitoring

Prevounce Health Launches Remote Patient Monitoring Module

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

PR Newswire 11.10.20

Diagnostics

Smartphone-based Solutions Boost Infectious Disease POC Testing Market 70.2 Percent

Study reveals that digital POC platforms will enable diagnostic testing beyond the clinic, transforming how assay results are gathered and analyzed.

Frost & Sullivan 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

Syneo Acquires Integrated Medical Holdings

Expands the equipment, tooling, and service offerings of the combined companies.

Syneo 11.06.20

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

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

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

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

keepMED Raises Funding for Regulatory Clearance of its Sleep Apnea Device

Company's technology mobilizes the user’s respiratory system to deliver just the amount of PAP needed, intermittently and with minimal airflow.

Business Wire 11.04.20

Philips Releases BiPAP A40 EFL Non-Invasive Ventilator

Expands its home care portfolio for COPD patients.

GlobeNewswire 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

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

Cardiovascular

FDA Approves Boston Scientific's Ranger Drug-Coated Balloon

Drug-eluting stent and drug-coated balloon treats patients with peripheral artery disease.

PR Newswire 11.03.20

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

Surgical

MMI Launches Symani Surgical System

Advances robotic microsurgery with the smallest wristed surgical instruments.

MMI 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

NeuroMetrix Issued New U.S. Patent for Quell Wearable Technology

The patent covers core Quell technology that regulates electrical stimulation.

Globe Newswire 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

Cardiovascular

CoreMap Completes $10.5 Million Series A Financing

Round led by Qure Ventures will accelerate development of CoreMap’s technology to enable curative, patient-specific treatment of atrial fibrillation.

Globe Newswire 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

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

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

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

7 Steps to Create Your Own Medical Device Marketing Plan

A successful strategy will result in increased leads while saving time and money.

Robert Jordan, Media Relations Manager, InfoClutch Inc. 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

Packaging & Sterilization

Brenda Chamulak named President of Tekni-Plex Packaging Products

Comes from Jabil Packaging Solutions where she was CEO, SVP and president.

Tekni-Plex 10.08.20

Randall Sword Named CEO of Catheter and Medical Design

Joins following his previous position as president and CEO of N2 Biomedical.

Catheter and Medical Design LLC 10.07.20

CE Marking Received for Osprey Medical's DyeVert Power XT Device

Second-generation device is expected to be a core product in the product portfolio being commercialized by GE Healthcare.

Business Wire 10.05.20

Contract Manufacturing | Electronics

Innovation, Miniaturization are Top Priorities for Electronic Components Manufacturers

But many companies are hesitant to start new development projects while the coronavirus is still rampant.

Michael Barbella, Managing Editor 10.05.20

Digital Health

AdvaMed Proposes Modernized CMS Policies for Digital Health

AdvaMed CEO Whitaker calls on CMS to “eliminate bureaucratic obstacles” to digital health.

AdvaMed 10.02.20

Former Guidant CEO Named AdvaMed Lifetime Achievement Award Recipient

Ron Dollens was named CEO when the company spun out from Eli Lilly to form the standalone firm.

AdvaMed 10.01.20

National Pediatric Medical Device Competition Announces Six Winners

Winning devices in virtual pitch event on track to advance pediatric cardiovascular, NICU, and orthopedic and spine device innovations.

National Capital Consortium for Pediatric Device Innovation 10.01.20

Contract Manufacturing

Medtech Makers: Expediting Time to Market

Donatelle’s Mike Kaiser and Todd Owens provide insights on speeding up development to get products out to market more quickly.

Contract Manufacturing

Innovation and Expertise Drive Evolution in Medical Device Manufacturing

MICRO’s president offers a look at the company his family founded 75 years ago as well as the industry it’s supported.

Brian Semcer, President, MICRO 09.29.20

Software & IT

Adopting a Data-Driven Approach to Quality with an MDQMS

FlexLogical is making quality a competitive advantage through its software solution.

Jon Speer, Founder and VP of QA/RA, Greenlight Guru 09.24.20

Software & IT

FDA OKs Varian's Eclipse v16.1 Proton Therapy Treatment Planning Software

Integration of Dual Energy CT images in planning process reduces range uncertainty and helps clinicians spare healthy tissue.

PR Newswire 09.16.20

Beaufort CRO Names Senior VP of Regulatory and Quality

Industry thought leader and veteran strategist to lead the further expansion of global regulatory and quality services.

Business Wire 09.11.20

NextPhase Medical Device Announces New CCO

Industry veteran, Robert Olsen, named chief commercial officer for the company.

NextPhase Medical Devices 09.10.20

STEWART Industries Launches Medical Device Division

Company will manufacture, source, and supply medical products and PPE on a national scale.

Globe Newswire 09.09.20

Korean Ophthalmic Medical Device Developer Launches U.S. Subsidiary

Three-year-old company developed a surgical endoilluminator with a chopping function for cataract surgery.

PR Newswire 09.01.20

Facts to Ensure MDR Success

Even with the delay of the European Union’s MDR deadline until May 26, 2021, the race to reach compliance is still on for medical device manufacturers.

Sherry Parker, Ph.D. and Bob Pryzgoda, Ph.D. 09.01.20

Electronics

Disruptive Medical Device Cybersecurity Solution

A new technology offers a different approach to cybersecurity for implantable devices.

Daniel L. Greene, Ph.D., COO, and James M. Hair III, Ph.D., CSO—Tueor Technologies 08.27.20

Diagnostics

QIAGEN to Launch Digital, Portable COVID-19 Antibody Test

Access Anti-SARS-CoV-2 is an easy-to-use 10-minute test on a portable device that provides highly accurate results on Total Ig antibodies.

QIAGEN 08.26.20

Software & IT

Areas to Consider in Medical Device Risk Management

How to ensure the production of safe and effective medical devices.

Jon Speer, Founder and VP of QA/RA at Greenlight Guru 08.24.20

SaaS Solution Introduced for Guided Compliance in Medtech Product Development

Cognition Corporation's solution is designed to automate the product development process in compliance with industry standards.

PR Newswire 08.24.20

Diagnostics

FDA Clears Siemens Healthineers AI-Based Software

New assistants free radiologists from routine activities during MRI examinations.

Siemens Healthineers 08.20.20

Florida Medical Device Symposium

...

08.03.20

MED-EL is First Hearing Implant Producer to Earn MDR Certification

Delayed by one year, the MDR will apply to all manufacturers selling medical devices within Europe.

MED-EL 08.03.20

McGill, Montreal General Hospital Foundation, & HeroX Launch ‘Made for All’ Challenge

Invite thousands of innovators to develop an affordable ventilator.

PRNewswire 07.28.20

Software & IT

Haemonetics Sheds Blood Bank, Hospital Software Subsidiary Inlog

Inlog was sold to French private equity firm Abénex.

PR Newswire 07.24.20

NCC-PDI Announces Winners of COVID-19 Medical Device Competition

Judges awarded grants for eight medical devices that address COVID-19-related needs.

Children's National 07.22.20

Diagnostics

Study Shows AI Software is Comparable to Radiologists in Triaging Suspected COVID-19

CAD4COVID was developed and validated by two Dutch companies using 24,678 chest X-ray images.

Thirona 07.21.20

R&D & Design

‘COVID-19-Edition’ of Medical Device Competition Announces Finalists

Winners will receive grant awards of up to $50,000.

Children's National 07.13.20

Annual Pediatric Medical Device Competition Reveals 10 Finalists

Cardiovascular, NICU, and orthopedic and spine device innovators gain access to a new pediatric accelerator.

National Capital Consortium for Pediatric Device Innovation 06.30.20

How Are MPO’s Top 30 Addressing COVID-19?

J&J's Janssen moves the start of its Phase 1/2a vaccine clinical trial from September to the first half of July.

Sam Brusco, Associate Editor 06.09.20

Packaging & Sterilization

Six Key Design Features to Ensure Medical Device Packaging Meets ASTM D4169

Well-thought-out packaging is an oft-delayed but essential part of ensuring a medical device operates safely and effectively in the field.

Nigel Syrotuck, Mechanical Engineering Team Lead, StarFish Medical 06.04.20

Minerva Surgical Acquires Boston Scientific Intrauterine Health Products

Combines the Minerva Endometrial Ablation System with the Genesys HTA Endometrial Ablation System.

PRNewswire 05.12.20

Molex Welcomes New SVP and President

Paul Chaffin joins the company from a Minnesota-based Fortune 500 company.

Phillips-Medisize. 05.12.20

Cardiovascular

HRS 2020 Science: Mobile VPG Technology Used to Monitor Pulse Rates

New study shows AI-based facial recognition can enable patient mobile devices to detect AF.

Heart Rhythm Society 05.08.20

Sporting Goods Brand Now Making Millions Of Face Masks

Company will donate face masks to those in need including hospice workers, nursing homes, assisted living facilities, and first responders.

StringKing 04.27.20

GlobalData: Medtronic’s MI Business to Exhibit Slow Growth

Aliyah Farouk, Medical Device Analyst at GlobalData offers her view.

GlobalData 04.24.20

Diagnostics

Siemens Healthineers to Expand SARS-CoV-2 Testing

With a demonstrated sensitivity and specificity of more than 99 percent, the test is expected to exceed the stringent FDA quality guidelines.

Siemens Healthineers 04.23.20

Cardiovascular

VisCardia's Heart Failure Therapy Gains Breakthrough Designation

Designed for the treatment of heart failure with reduced ejection fraction and preserved ventricular synchrony.

NewsWire 04.23.20

The Medtech Supply Chain and COVID-19

How are service providers and component suppliers adjusting to life during a pandemic to ensure they maintain quality?

Sean Fenske, Editor-in-Chief 04.22.20

Medtronic Sees Revenue Losses Due to COVID-19 Pandemic

The company says it is well positioned for recovery.

Globe Newswire 04.22.20

Diagnostics

FDA Clears Siemens Healthineers' Aidan AI

The latest technology enables new features and enhanced security.

Siemens Healthineers 04.22.20

Itamar Medical to Evaluate Impact of CPAP Therapy on Patients with COVID-19

The clinical trial will assess the efficacy of CPAP in COVID-19 confirmed or suspected patients.

Globe Newswire 04.22.20

Terumo's Mirasol Shows Efficacy Against Virus Causing COVID-19 in Plasma, Platelets

The pathogen reduction system is designed to add an extra layer of safety to the blood supply.

Terumo BCT 04.20.20

Diagnostics

bioMérieux Revenue Will Continue to Grow, Says GlobalData

New COVID-19 respiratory panel test is currently in development.

GlobalData 04.20.20

Contract Manufacturing | Diagnostics

Medtech Matters: AdvaMed's Scott Whitaker on Medtech's COVID-19 Response

MPO Editor-in-Chief Sean Fenske speaks with Scott Whitaker, AdvaMed President and CEO, about how the medtech industry is assisting in the COVID-19 effort.

Sean Fenske, Editor-in-Chief 04.17.20

Baxter’s Q1 Earnings Forecasted to Increase, GlobalData Says

Job postings triple as demand increases.

GlobalData 04.17.20

EU’s Parliament Adopts MDR Delay of One Year

Would allow authorities and manufacturers to prioritize the fight against COVID-19 if member states approve delay.

European Parliament 04.17.20

Molding

Vaupell Midwest Earns MedAccred Accreditation for Plastic Injection Molding

MedAccred is an oversight program designed to provide manufacturing supply-chain oversight for OEMs looking to partner with Contract Manufacturers.

Vaupell Midwest 04.16.20

Patient Monitoring

PulseCam Maps Blood Flow

New Rice U. tech could let doctors monitor blood perfusion in real time with a camera.

Rice University 04.13.20

Tolomatic Develops Open-Source, Ventilator Actuation Prototypes

The proposed technologies are the first step in creating innovative emergency ventilators for patients around the world.

Tolomatic 04.13.20

Industry Events Schedule Disrupted Due to Coronavirus—Full Event List

The medical device manufacturing industry has seen the postponement or cancellation of a number of upcoming events.

Sean Fenske, Editor-in-Chief 03.30.20

R&D & Design

Rice Joins U of U-Led Human Factors Consortium

Brings new expertise to the consortium, led by University of Utah.

University of Utah 03.30.20

Medtronic Shares Ventilator Design Specifications

The company aims to accelerate efforts to increase global ventilator production amid COVID-19.

Medtronic 03.30.20

FDA Grants Lucid Diagnostics Breakthrough Device Designation for Esophageal DNA Test

Test is designed to facilitate the diagnosis of Barrett’s Esophagus, with and without dysplasia.

Globe Newswire 03.30.20

Battelle Develops Decontamination System for Medical Protective Equipment

Organization receives FDA emergency use authorization to reprocess previously worn PPE.

Business Wire 03.30.20

Neil Tween Joins Owlstone Medical

Neil Tween appointed as Chief Financial Officer.

Owlstone Medical 03.30.20

Packaging & Sterilization

Mike on Medtech: EtO Sterilization Concerns

Mike Drues and Sean Fenske discuss the controversy surrounding the most commonly used sterilization method for medical devices—EtO.

Sean Fenske, Editor-in-Chief 03.30.20

Drug/Device and Device/Drug Combinations in the EU and USA

...

01.02.20

MedDevice MedTech Compliance Congress

...

01.02.20

Contract Manufacturing

Ask the Right Questions when Choosing a Contract Manufacturer

The selection process for a new supply partner can be challenging if you don’t know what to ask about.

Mike Fritschy, Vice President, Engineering and Product Development, SMC Ltd. 11.26.18

Software & IT

6 Best Practices for Complying with ISO 13485:2016

At this stage, companies have less than six months to be compliant.

Jon Speer, Co-Founder and VP of QA/RA, Greenlight Guru 10.17.18

With Trump’s Space Force Idea Gaining Steam, Could a U.S. Health Force Be Far Behind?

...

Chris Oleksy, Emergent Respiratory 10.16.18

Cardiovascular | Surgical

Merit Medical Buys Cianna Medical for Up to $200M

Cianna Medical is a leader in wire-free breast localization and has been focused on breast conservation for 11 years.

GlobeNewswire 10.02.18

Meddux Development Receives ISO 13485:2016 Certification

Firm offers engineering design and development of interventional and minimally invasive surgical devices.

Meddux Development Corporation 09.24.18

R&D & Design

The Impact of Changing Healthcare Economics on Device Design

...

Tony Freeman, President, A.S. Freeman Advisors, LLC 09.07.18

Clinical Innovations Acquires French Company MVF Disposables

Deal strengthens global growth strategy and European presence.

Clinical Innovations 09.05.18

Cardiovascular

CHLA/USC Researchers Design Novel Micropacemaker

The researchers team up to design and implant a minimally-invasive device in area around the heart.

Business Wire 08.09.18

Packaging & Sterilization | Surgical

Hoya's Pentax Medical Acquires Majority Stake in PlasmaBiotics SAS

PlasmaBiotics is a company focused on the ultra-fast channel drying and active storage of endoscopes.

PR Newswire 08.01.18

14. B. Braun

...

07.26.18

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