Industry News
Medical Device Industry News
Boston Scientific Weaves a $1.16B Acquisition
The company plans to buy Silk Road Medical, one of the 25 Most Attractive Medtech M&A Targets.
Women Underrepresented in Clinical Trials for High-Risk Medical Implants
A review published in JAMA Internal Medicine found that women have less than 50% — some down to 20% — median trial representation in common cardiovascular and orthopedic clinical trials.
Former Medtech CEO Sentenced to Six-Year Prison Term for Healthcare Fraud
A useless piece of plastic implanted in patients to treat chronic pain was the downfall of Laura Perryman, founder and former CEO of Stimwave.
JACC Report Card Highlights Inequities in CV Care, Death Rates
JACC Incoming Editor-in-Chief Harlan M. Krumholz, MD, SM, FACC, said, the goal of the report card is to promote accountability and catalyze action that finally addresses this national tragedy.
ColdVentures Unveils First-of-its-Kind, Class 1 FDA Medical Device ColdVest to Prevent Heat-Related Deaths
ColdVest has the potential to save thousands of lives around the globe each year.” Heat stroke poses a particularly deadly threat to military personnel performing strenuous activities and wearing heavy gear in scorching environments; outdoor
Alveo’s Portable, Rapid Molecular Diagnostic Platform Proves Unshakable in Rigorous Ruggedness Tests
Alveo’s rapid molecular diagnostic platform has been designed to provide accurate, rapid test results at the point of need. The company tested its platform to demonstrate that it can perform reliably in harsh, real-world conditions,
How Otis Boykin’s Invention Put the ‘Pace’ in Pacemakers
Trivia Tuesday: The pacemaker would not be what it is today without what critical contribution from Otis Boykin?
Foldax Spells Out Regulatory Plans for Tria Surgical Heart Valve
The Salt Lake City, UT-based company will seek approval in India first and then bring the technology to the U.S.
Medline Reaps FDA Ire in Class I Endotracheal Tube Recall
The company has been under FDA spotlight since its link to the China plastic syringe manufacturing safety communication was announced earlier this year.
VitaFlow Liberty ™ Granted EU CE-MDR Mark
Jeff Lindstrom, President of CardioFlow, stated, "The certification of VitaFlow Liberty by the CE regulatory body under MDR, is a testament to CardioFlow's world-class R&D, quality, and clinical capabilities. This recognition will expedite the global
Philips Zenition 90 Motorized receives FDA 510(k) Clearance
“During complex procedures, it’s vital to be able to rely on surgical imaging systems. As clinicians navigate their way through challenging anatomy, the priority is to quickly visualize small anatomical details while limiting X-ray dose,”
Neuromod’s FDA-Approved Lenire Device Now a Treatment Option for 2.9 Million US Veterans with Tinnitus
The Lenire Device is the first bimodal neuromodulation device to receive a Federal Supply Schedule (FSS) Contract. It can be prescribed when appropriate by a trained healthcare clinician for the treatment of tinnitus.
Surgical Suction Instruments Market to Hit USD 503 Million by 2029, Driven by 6.1% CAGR
The global surgical suction instruments market is projected to reach USD 503 million by 2029, growing at a CAGR of 6.1% from USD 375 million in 2024, driven by increasing adoption of minimally invasive surgery
Gyrolab Generic Anti-AAV Kit to Support Gene Therapy Development | Introduced by Gyros Protein Technologies
The Gyrolab Generic Anti-AAV Kit supports identification of pre-existing immunity that may interfere with the efficacy of AAV-based gene therapy delivery.
Awards Recognize Unsung Heroes in Sterile Medical Packaging
This year’s superstars in sterile awareness work tirelessly — often behind the scenes — to ensure patient safety and prevent healthcare acquired infections or HAIs.
Getinge Sevoflurane Vaporizer Recall Gets Class I Rating
The device was recalled after the company reported potential exposure to hydrogen fluoride.
Teleflex Arrow FiberOptix and UltraFlex (IAB) Catheter Kits Recall Identified as FDA Class I
The company, along with its subsidiary Arrow International, recalled the devices after finding that a manufacturing error had the potential to cause the catheter’s balloon to become overtwisted.
5 Things We’re Talking About in June
Your quick visual roadmap for the hottest medtech topics in June 2024.
Venus Medtech VenusP-Valve Completed First Implantation in IDE Pivotal Clinical Study in U.S.
The VenusP-Valve PROTEUS STUDY, abbreviated from Evaluation of the PerfoRmance Of The VEnUsP-Valve System in Patients with Native Right Ventricular Outflow Tract (RVOT) Dysfunction, is a prospective multi-center non-randomized interventional study in patients with RVOT
Pfizer Reports | ELREXFIO ™ Shows Median Overall Survival of More Than Two Years in People with Relapsed or Refractory Multiple Myeloma
“These compelling overall survival data support the clinical benefit ELREXFIO has already demonstrated and its potential to be a transformative treatment option for people with multiple myeloma,” said Roger Dansey, M.D., Chief Development Officer, Oncology,