Category: FDA

Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.

FDA Grants AI-Powered Notal Vision...

May 16, 2024

“We are very excited to receive FDA authorization to market SCANLY Home OCT as the first-ever patient self-operated, home-use device that gives physicians remote access to high-resolution, cross-sectional retinal images and AI-based analytical biomarkers of their patients eyes between office visits,” said Kester Nahen, PhD, CEO of Notal Vision. “We look forward to supporting our referring physicians in navigating their wet AMD patients’ care.”

Atraverse Medical Receives FDA Clearance...

May 15, 2024

The HOTWIRE system, invented by Atraverse Medical Co-Founders Dr. Steven Mickelsen and Eric Sauter, introduces a paradigm shift in left-heart access.

FDA Grants AI-Powered Notal Vision Home OCT “SCANLY” De Novo Marketing Authorization

May 16, 2024

Boston Scientific Receives FDA 510(k) Clearance for the LUX-Dx™ Insertable Cardiac Monitor System

The new LUX-Dx™ Insertable Cardiac Monitor System is designed with a dual-stage algorithm that detects and then verifies potential arrhythmias before an alert is sent to clinicians, thereby providing actionable data for clinical decision-making.

June 29, 2020

Percept PC Deep Brain Stimulation System with BrainSense Technology Receives FDA Approval

BrainSense™ technology makes Percept the first and only DBS neurostimulation system with the ability to chronically capture and record brain signals while delivering therapy to patients with neurologic disorders associated with Parkinson’s disease, essential tremor, dystonia, epilepsy or obsessive-compulsive disorder.

June 25, 2020

SIGNAFUSE Bioactive Bone Graft Receives FDA Clearance

The biphasic mineral in SIGNAFUSE is composed of 60% hydroxyapatite and 40% beta- tricalcium phosphate; a ratio supported by multiple prospective2 and randomized controlled trials.3-5

June 25, 2020

Mainstay Medical Announces U.S. FDA Approval of ReActiv8® Neurostimulation System for Chronic Low Back Pain

ReActiv8 is designed to be a restorative treatment and represents a new option for patients suffering with chronic low back pain.

June 22, 2020

USGI Medical Receives FDA Approval to Expand US Pilot Study Evaluating Incisionless Weight Loss Procedure – POSE 2.0

The non-invasive, endoscopic procedure, known as POSE 2.0, is designed to evaluate weight loss for adults suffering from obesity with a body mass index of 35 to 40 kg/m and an obesity-related comorbidity, such as diabetes or hypertension.

June 18, 2020

FDA Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts

The FDA is announcing its participation in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics. The Diagnostics Evidence Accelerator is organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research.

June 18, 2020

Naviswiss Receives FDA Clearance for Its Miniature Hip Navigation

The clearance includes primary hip replacement and revision hip replacement surgery used in a variety of surgical approaches and compatible with most implants on the market.

June 18, 2020

Enexor Granted FDA Emergency Use Authorization for New Ventilator – X-VENT

The X-VENT is one of the very few FDA EUA approved ventilators that does not use a bag valve mask (BVM) resuscitator (often referred to colloquially by the proprietary name "Ambu-bag").

June 17, 2020

FDA Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic

The FDA is particularly concerned about unapproved injectable drug products labeled as homeopathic because they are injected directly into the body, often directly into the bloodstream and bypass some of the body's key natural defenses against toxins, toxic ingredients and dangerous organisms that can cause serious and life-threatening harm.

June 16, 2020