medtechdive19h
Former FDA head Gottlieb calls for less regulation of certain AI tools
Gottlieb, who led the agency during the first Trump presidency, supports a reversion to an earlier interpretation of the 21st Century Cures Act.
Govt drawing up parameters to gauge states for drug enforcement, improve quality of products
New Delhi: The Union government is drawing up an index to gauge states and union territories on their preparedness to enforce ...
dvm3605d
FDA notifies veterinarians of animal burn risk linked to human medical devices
Following a recall of grounding pads produced by Megadyne, a machinery industry company, the FDA is notifying veterinarians ...
medtechdive16h
Introducing CyberMed: 100% Focused on MedTech Cybersecurity with Guaranteed Results
From the founders of BoldType comes CyberMed, a new company dedicated exclusively to MedTech cybersecurity. With a mission to ...
Pharmaceutical Technology5d
Supernus wins FDA approval for Parkinson’s pump on fourth try
The US Food and Drug Administration (FDA) rejected three prior regulatory applications before granting approval.
Implantica announces Module 1 is accepted and closed by FDA in the PMA application for RefluxStop™
Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including a unique ...
The Pharma Letter6d
FDA nod at last for Supernus’ Parkinson’s infusion therapy
It is fourth time lucky for Supernus Pharmaceuticals, as its Parkinson’s specialist finally receives US approval for Onapgo ...
Heart Valve Devices Market Outlook: USD 38.2 Billion by 2034, Expanding at 11.7% CAGR with Rising Cardiovascular Cases | Exclusive report by TMR
The Heart Valve Devices Market is driven by advancements in aortic, mitral, tricuspid, and pulmonary valve technologies. It ...
Blue Goat Cyber Celebrates Milestone With The Release Of Its 10Th Episode On The Med Device Cyber Podcast
The Med Device Cyber Podcast FDA compliance shouldn't be a guessing game. The Med Device Cyber Podcast gives MedTech innovators a clear ro ...
Targeted Oncology1d
AI Prognostic Tool for NSCLC Earns FDA Breakthrough Designation
The FDA granted breakthrough status to Serial CTRS, an AI tool that improves survival predictions in non–small cell lung ...
Nightingale Health Oyj: Nightingale Health announces its updated regulatory plan in the United States
Nightingale Health Plc Press release 7 February 2025 at 2:15 p.m. (EET)Nightingale Health Plc ("Nightingale Health"), a pioneer in disease risk detection and preventative health announces its regulato ...