New cancer risk tool that flags patients early seeks FDA approval

The medical device analyzes patient cancer risk without them needed to do any additional tests or imaging.
RAPS

FDA updates manufacturer communications guidance to emphasize application to devices

The US Food and Drug Administration has updated its draft guidance on how the drug and medical device makers should communicate with payors and other stakeholders about their products. The updates are ...
Medical Design & Outsourcing

FDA rules, regulations and resources for artificial intelligence in medical devices

Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...
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 ...
RAPS

Report: FDA Drug, Device Approval Times Improving

A new report issued by the consulting group PricewaterhouseCooper (PWC) indicates that the US Food and Drug Administration (FDA) is making sustained improvements to its drug and medical device ...
MD&M East

Gore Secures New FDA Approval Amidst Endovascular Acquisition

W. L. Gore & Associates has secured FDA approval for the GORE VIABAHN FORTEGRA Venous Stent — previously known as the GORE VIAFORT Vascular Stent — the first device for the treatment of deep venous ...

Food and Drug Administration (FDA): What It Is and Does

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
The National Law Review

FDA Final Guidance on PCCP: Streamlining FDA Approval for AI-Enabled Medical Devices

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

SpinaFX Medical receives FDA Investigational Device Exemption (IDE) for Triojection®, its Breakthrough, Minimally-Invasive, Image-Guided Lumbar Disc Treat…

SpinaFX Medical, a clinical-stage medical device company specializing in minimally invasive, image-guided therapies for ...

FDA Confirms CardiAMP HF II May Support Premarket Approval of CardiAMP Cell Therapy for Ischemic HFrEF

The meeting minutes from FDA confirm that the ongoing CardiAMP Heart Failure II Trial may support Premarket Approval (PMA) for market clearance. PMA is the most rigorous type of device marketing ...
Healthline

Which Products Does the FDA Regulate?

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...