MassDevice

Supira gets FDA green light to conduct ventricular assist device study

Supira Medical announced today that it received FDA approval to initiate a new trial of its percutaneous ventricular assist ...
InvestorsHub on MSN

Artivion secures FDA approval for NEXUS aortic arch device, weighs Endospan acquisition

Artivion Inc. (NYSE:AORT) said the U.S. Food and Drug Administration has approved the premarket application for the NEXUS ...
D Magazine

Perimeter Medical Receives FDA Approval for AI Imaging Device for Breast Cancer Surgery

Dallas-based Perimeter Medical Imaging AI earned premarket FDA approval for Claire—its AI-powered imaging device for breast cancer surgery. Claire is the first AI-enabled device cleared in the U.S. to ...
MedTech Dive

FDA, medtech industry near MDUFA VI agreement

The FDA said it intends to hire “substantial numbers” of medical device review staff as part of the agreement for the next ...

CorTec Receives FDA Breakthrough Device Designation for Its Brain Interchange System in Stroke Rehabilitation — the First BCI Worldwide Designated for Stroke Motor Rehabilitation

CorTec GmbH, a pioneer in fully implantable brain-computer interfaces (BCI), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the ...
Medical Design & Outsourcing

FDA removes pediatric VADs from device shortage list, adds others

The FDA has removed pediatric ventricular assist bypass devices (VADs) from its device shortage list in an update this month.
MedTech Dive

VDyne secures FDA nod to start pivotal trial for tricuspid valve

With approval to study the transcatheter replacement device in patients with severe tricuspid regurgitation, VDyne is ...

FDA approves Anumana’s pulmonary hypertension algorithm

The algorithm integrates with EHR systems and ECG platforms, operating within the health system without external data ...
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 ...
The American Journal of Managed Care

FDA Approves First-in-Class Optune Pax Device for Pancreatic Cancer

FDA approved Optune Pax with gemcitabine/nab-paclitaxel, applying alternating electric fields to disrupt mitosis via abdominal arrays, expanding noninvasive, home ...
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 ...