Nasdaq

ReShape Lifesciences Achieves EU MDR and UKCA Certification for Medical Devices, Enhancing Patient Safety and Market Access in Europe

ReShape Lifesciences has achieved EU MDR and UKCA certifications for its medical devices, enhancing market access and ensuring safety compliance. ReShape Lifesciences announced that its Quality ...
Nasdaq

Spectral AI’s DeepView SnapShot® Wound Imaging System, Achieves UKCA Mark and FDA Class 1 Medical Device Classification

DALLAS, Oct. 19, 2023 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI; MDAIW) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster ...
Business Wire

Nortech Systems Suzhou Facility Certified to Produce Class II Medical Devices for Asia Market

MINNEAPOLIS--(BUSINESS WIRE)--Nortech Systems Incorporated (Nasdaq: NSYS) (the "Company"), a leading provider of engineering and manufacturing solutions for complex electromedical and ...
News Medical

Medical Device Categories Explained

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...
Fierce Healthcare

CMS, FDA announce new program to speed up Medicare coverage of breakthrough medical devices

The RAPID pathway is designed to accelerate access to certain FDA-designated Class II and Class III devices for people with Medicare coverage, CMS and FDA officials said. (Inna Knot/GettyImages) The ...