MedTech Dive1d
J&J’s Monarch robot wins FDA nod for AI software update
Using Nvidia and GE Healthcare technology, the robotic surgery system is intended to help doctors detect lung cancer earlier.
STAT1d
Study reveals how often medical device makers report safety incidents late to FDA
Most medical devices in the United States come to market with limited clinical data, and device surveillance is viewed as a ...
Medical Device Network on MSN1d
FDA grants 510(k) clearance for J&J MedTech’s Monarch Quest
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Johnson & Johnson (J&J) MedTech’s Monarch Quest ...
The BMJ1d
Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study
Objective To describe the extent of late adverse event reporting by manufacturers to the US Food and Drug Administration’s (FDA) Manufacturer And User Facility Device Experience (MAUDE) database as ...
NeuroOne® Accelerates Timeline of 510(k) Submission to FDA for the OneRF® Trigeminal Nerve Ablation System to Treat Facial Pain
Submission for New Intended Use That Leverages Company’s Patented OneRF® Technology Platform Expected in May 2025 EDEN PRAIRIE, Minn., March 11, ...
Medical Device Network on MSN4d
FDA grants 510(k) clearance to Zimmer’s new revision knee implant component
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Zimmer Biomet's new revision knee implant component ...
MassDevice7d
FDA clears revision knee implant from Zimmer Biomet
Zimmer Biomet (NYSE: ZBH) announced today that it received FDA 510(k) clearance for its Persona Revision SoluTion Femur.
National Institute for Health and Care Excellence14d
New drug approved for inherited clotting disorder, offering simpler dosing and enhanced quality of life.
Efanesoctocog alfa (also called Altuvoct and made by Swedish Orphan Biovitrum) can be given as a once-weekly injection instead of some current treatments that are given several times a week. Affecting ...
Yahoo Finance15d
Ventripoint Diagnostics Announces U.S. FDA 510(k) Clearance for VMS+(TM) 4.0 Automated Radiological Image Processing Software/System
Earlier versions of Ventripoint's scanning technology received FDA, Health Canada and E.U. regulatory approvals and are being used by leading hospitals in the U.S., E.U., U.K. and Canada.
STAT15d
There’s a better way to get drugs on the market: progressive approval
Perakslis is a medical and privacy researcher and has served in the FDA. Stebbins is a health and science consultant and served in the White House. The public and pharmaceutical companies are ...