Medical Product Outsourcing

FDA OKs ALung Hemolung Respiratory Assist System to Treat COVID-19

Hemolung can be a valuable tool to be used in conjunction with invasive mechanical ventilation.

Business Wire 04.27.20

HeartVista Forms Medical and Scientific Advisory Board

Governing body comprised of leaders from Stanford University and the University of Wisconsin.

Business Wire 04.16.20

Stroke Care Expert Joins Ischemia Care Advisory Board as Chairman

Newest member has led or participated in numerous Phase II and III clinical stroke trials over the past 20 years.

Business Wire 04.09.20

Pentax Medical to Pay $43 Million Over Misbranded Endoscopes

Company shipped medical devices without approved instructions for use and failed to file FDA-required adverse event reports of serious infections.

U.S. Department of Justice 04.08.20

Mack Molding Names Vice President of Business Development

Company also has added positions and/or promoted workers in quality, business development, customer management, manufacturing, purchasing and human resources.

Mack Molding 04.02.20

R&D & Design

Why Outsourcing Is in: Piecing Out Projects Makes Sense

Getting outside help is a trend both large and small medical device companies are following as outsourcing engineering services continues to gain traction.

Dawn A. Lissy, President & Founder, Empirical 04.01.20

AngioDynamics Appoints Interim CFO to Permanent Position

New CFO also serves as general counsel; company will now search for a replacement.

Business Wire 03.20.20

Neurological

Axonics Challenges Medtronic's Sacral Neuromodulation Patents

Contests validity of each of the patents Medtronic alleged to be infringed by Axonics.

Business Wire 03.16.20

Neurological

LivaNova's Symmetry VNS Therapy Gains CE Mark for Difficult-to-Treat Depression

Symmetry sends mild electric pulses to the vagus nerve, which is connected to areas of the brain that control mood.

Business Wire 03.09.20

Packaging & Sterilization

FDA Clears 15-Minute Hydrogen Peroxide Sterilization System

Advanced Sterilization Products claims process is 38 percent faster than competitors.

Business Wire 03.09.20

Cardiovascular

Getting to the Heart of the Matter: An Examination of Transcatheter Heart Technologies

Transcatheter structural heart therapies stand to replace their open-heart counterparts thanks to technological innovations and expanded patient access.

Sam Brusco, Associate Editor 03.04.20

Optimizing Medtech Founder Value

Would optimizing valuation at seed and A rounds minimize founder dilution for better outcomes?

Scott Phillips, CEO, StarFish Medical 03.04.20

Dawn of a New Decade: Looking Ahead to Medtech’s Future

The start of the '20s offers the industry an opportunity to build value through new tech., collaborations, clinical validations, and value-based outcomes.

Mark Bonifacio, President, BCS LLC 03.04.20

Cardiovascular

FDA OKs Access Vascular's Next-Gen HydroPICC

Biomaterial platform in peripherally inserted ventral catheter (PICC) may virtually eliminate clot accumulation.

PR Newswire 03.04.20

Patient Monitoring

FDA Clears Masimo for Continuous RRp Monitoring

Both continuous and spot-check RRp are now available in the US.

Business Wire 03.02.20

StimGuard Welcomes Former Zimmer Executive as CFO

New finance chief has more than two decades of experience in medtech.

Business Wire 03.02.20

Former Intersect ENT Finance Chief Joins Cardiva Medical Board

Latest addition currently serves on the board of directors and as audit committee chair of Novocure, Minerva, and SI-Bone.

Business Wire 02.18.20

Patient Monitoring

FDA Clears Q-NRG+ from Baxter and COSMED

Expected to launch in the US in March 2020.

Baxter International Inc. 02.12.20

Neurological

Abbott's New Trial to Assess Therapy Option for People at Risk of Stroke

The CATALYST trial will examine Abbott's Amplatzer Amulet device compared to non-vitamin K oral anticoagulants.

Abbott 02.03.20

Cardiovascular

Medtronic Receives CE Mark for Portfolio of Defibrillators

Next-gen tech automatically adjusts to patient needs and offers heart failure diagnostic insights.

Globe Newswire 01.30.20

Patient Monitoring

Security Risks Found in Some GE Healthcare Monitoring Devices

An attacker could remotely take control to silence alarms, generate false alarms, or interfere with the function.

U.S. Food and Drug Administration 01.24.20

New CFO Assumes Role at Intersect ENT

Owens & Minor executive has more than two decades of experience in healthcare.

Business Wire 01.22.20

Electronics

ATL Technology Sell CRI Business; Expands Costa Rica Operations

CRI, a manufacturer of interventional catheters and medical device assemblies, was sold to Biomerics.

PR Newswire 01.21.20

Patient Monitoring

Masimo's Monitoring Tech Investigates Incidences of Desaturation & Bradypnea

Study suggests use of a continuous and centralized respiratory monitoring system is desirable for post-op management.

Business Wire 01.16.20

R&D & Design | Software & IT

How Gamification Is a Boon to Medtech and Edtech

The positive attributes of gamification and why it works.

Online Exclusives Kelly Choo, Chief Marketing Officer and Co-Founder of Neeuro Pte Ltd. 01.16.20

Cardiovascular | Surgical

Abbott to Begin MitraClip Trial for Moderate Risk Patients

Will assess transcatheter mitral valve repair against the current standard of care surgery.

Abbott Laboratories 01.13.20

Cardiovascular | Patient Monitoring

Masimo Claims Apple Stole Health Monitoring Tech for Apple Watch

Masimo has filed a patent infringement lawsuit and alleges poaching of trade secrets.

Sam Brusco, Associate Editor 01.10.20

TISSIUM Closes 39 Million Euro Series B Funding Round

Money will be used to expand the firm's platform of polymers across various therapeutic fields, including nerve repair, cardiovascular and gastroenterology.

TISSIUM 01.10.20

Cardiovascular | Neurological

Terumo's MicroVention Wins FDA Nod for Aneurysm Flow Diverter

First flow diverter in the U.S. to use a self-expanding braided nitinol mesh to help re-direct blood flow and promote aneurysm occlusion.

PR Newswire 01.09.20

Allied BioScience Launches Line of Continuously Protected Antimicrobial Medical Equipment

Partnership with Blickman Industries adds a new layer of protection for key medical equipment.

Globe Newswire 01.09.20

Abbott Appoints New CFO

Robert E. Funck, Jr. will assume the chief finance role; departing CFO Brian Yoor will join CEO Miles White in retirement.

Sam Brusco, Associate Editor 01.08.20

Teleflex's UroLift Wins FDA Nod to Treat Larger Prostates

UroLift can now be used to treat benign prostatic hyperplasia in prostates between 80cc and 100cc.

GlobeNewswire 01.07.20

FDA Clears Masimo's Neonatal RD SET Pulse Oximetry Sensors with Improved Accuracy Specifications

Improved oxygen saturation accuracy now available for all patient populations.

Business Wire 01.02.20

New Year, New Chief Executive for Minnetronix Medical

Replacement for outgoing CEO will assume position on Feb. 1.

Business Wire 12.16.19

Neural Analytics Enrolls First Patient With Its Next-Generation Lucid Robotic System

The new IDE version of the technology is intended to improve performance and ease of use for the company’s robotic platform.

Business Wire 12.10.19

Cardiovascular

Bristol-Myers Squibb-Pfizer Alliance, Fitbit Partner to Address Gaps in Afib Detection

Companies are joining forces to develop atrial fibrillation educational content to help identify and support those at increased risk of stroke.

Businesswire 11.25.19

Miles D. White to Step Down as Abbott CEO

Current president and COO Robert B. Ford, a 23-year Abbott veteran, will succeed White as CEO.

PR Newswire 11.13.19

Patient Monitoring

Philips Debuts Vital Signs Monitor for Early Patient Intervention in General Care Setting

Early Warning Scoring, predictive trend analytics, and intelligent algorithms help detect patient deterioration earlier to enable timely intervention.

GlobeNewswire 11.05.19

Neurological

Medtronic Files Patent Suit Against Axonics

Medtronic alleges infringement of patents for minimally invasive sacral neuromodulation lead placement procedure and implant recharging technologies.

Medtronic 11.05.19

Packaging & Sterilization

Anxious Undertones: The 2019 Year in Review

Despite a healthy U.S. economy and solid corporate growth, the medtech industry was wracked with worries in 2019.

Michael Barbella, Managing Editor 11.04.19

Diagnostics

From Genome Sequencing to the World’s First Portable MRI

Dr. Jonathan Rothberg has risen about as high as a scientist can, save for the Nobel Prize.

Sam Brusco, Associate Editor 11.04.19

‘If You’re Reading This, You Need to Be at This Meeting’

The AAOS/FDA/Industry Townhall is taking place March 24, 2020, at the AAOS annual meeting in Orlando.

Dawn A. Lissy, President & Founder, Empirical 11.04.19

Impeachment, Executive Orders, and Must-Pass Congressional Legislation: A Fall Update

The final quarter of 2019 has begun, which means Congress and the Trump Administration are hard at work finalizing healthcare initiatives before year's end.

Jeffrey J. Kimbell, David C. Rudloff and Caroline P. Tucker, Jeffrey J. Kimbell & Associates Inc. 11.04.19

Cardiovascular