Examining The FDA's Recommendations For AI-Enabled Medical Devices
The FDA stated that its published medical device cybersecurity requirements from 2023 do include AI in a broad sense. However ...
More than 1.2 million medical device side-effect reports not submitted within legal timeframe, analysis finds
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
MedTech Dive3d
New FDA pulse oximetry guidelines could stall under Trump
The draft guidance addresses concerns that pulse oximeters are less accurate for people with dark skin tones. Experts raised ...
EurekAlert!2d
Over 1.2 million medical device side-effect reports not submitted within legal timeframe
Over 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) within the deadline set by federal regulations, finds an analysis of recent data ...
USFDA Inspection On The Rise Over Indian Medtech Industry
I3CGlobal FDA INSPECTION BANGALORE, INDIA, March 14, 2025 /EINPresswire / -- Indian pharmaceutical, nutraceutical, and medical devic ...
Medical Design & Outsourcing9d
Regulatory consultant offers help for FDA’s tougher pulse oximeter draft guidance
MethodSense says it is helping pulse oximeter manufacturers with FDA draft guidance to enhance accuracy across diverse skin ...
MedPage Today on MSN1d
FDA's Deadline Ignored in Nearly 30% of Device Safety Reports
Nearly 10% of postmarket device safety reports in MAUDE were submitted over 6 months after the safety event occurred.
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 ...
FDA Issues Clearance for ReWalk 7 Exoskeleton
MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, March 13, 2025 (GLOBE NEWSWIRE) -- Lifeward Ltd., (Nasdaq: LFWD) (“Lifeward” or the “Company”), a ...
Manila Standard3d
FDA goes digital with eServices Portal System
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device Notification (CMDN) for Class A ...
PharmiWeb2d
Global Preclinical Medical Device Testing Services…
The global preclinical medical device testing services market share analysis is poised for significant growth, with projections estimating a CAGR of 5.3%, reaching USD 2,842.1 million by 2035. This ...