JD Supra

FDA Approvals of AI Medical Devices Rise Rapidly

Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a record high of 221 last year, according to data tracing ...
Medical Xpress

As FDA slashes workforce, number of new medical devices reaching the public has fallen

U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low for the January to March period, as sources say recent layoffs have had ...
JD Supra

FDA's Guidance on the Use of Real-World Evidence for Medical Devices

Recently, the U.S. Food and Drug Administration (FDA) issued a guidance document entitled Use of Real-World Evidence to Support ...

FDA clears first at-home brain device for depression

FDA approves first brain stimulation device for home depression treatment. Flow Neuroscience's FL-100 headset uses electrical ...

FDA Qualifies MolecuLightDX Wound Measurement as a Medical Device Development Tool (MDDT) for Evaluating New Products in Wound Care

MolecuLight today announced that its MolecuLightDX® wound measurement has been qualified by the U.S. Food and Drug ...
Nasdaq

Envoy Medical receives FDA approval to initiate study for hearing device

Envoy Medical (COCH) announces that its Investigational Device Exemption, IDE, application for its pivotal study of the Acclaim Fully Implanted Cochlear Implant has been approved by the U.S. Food and ...
Becker's ASC

IOM Calls for Overhaul of FDA Device Approval Process; MDMA Disagrees

A new $1.3 million report by the Institute of Medicine calls for a complete overhaul of the FDA’s 150(k) approval process for medical devices. “The 510(k) process cannot achieve its stated goals –– to ...
Nasdaq

Merit Medical Receives FDA Approval for WRAPSODY Cell-Impermeable Endoprosthesis to Enhance Dialysis Patient Care

Merit Medical Systems, Inc. announced that its WRAPSODY® Cell-Impermeable Endoprosthesis has received premarket approval from the FDA, allowing for commercialization in the U.S. starting in 2025. This ...
Hosted on MSN

US FDA medical device clearance demystified – what investors need to know

FDA classifies medical devices based on the type of device and the level of risk it poses Three main FDA clearances for medical devices are 510(k), de novo and pre-market approval Several ASX ...
Becker's Hospital Review

Most medical devices used in kids are not FDA-approved for pediatric populations: 3 things to know

The majority of medical and surgical devices used to treat children are not cleared by the Food and Drug Administration for use in pediatric populations, according to a new report from the American ...