Forbes

User Fees for Medical Devices: Third Time Lucky?

President Obama just signed the Food and Drug Administration Safety and Innovation Act. The Act includes the third authorisation of user fees, paid by the medical-device industry to the FDA, so that ...
Becker's Hospital Review

Unique device identifiers required for class II medical devices this fall

Starting in September, class II medical devices will be required to be equipped with a unique device identifier to be in compliance with UDI regulations. The U.S. Food and Drug Administration passed ...
BioWorld

Six classes of medical devices reclassified in Australia to align with EU MDR

PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) fall under new classification requirements on Nov. 25, 2021, following numerous ...
Business Wire

Tasso+™ Device Earns FDA 510(k) Class II Medical Device Clearance

SEATTLE--(BUSINESS WIRE)--Tasso, Inc., the leading provider of convenient, clinical-grade blood collection solutions, today announced that the U.S. Food and Drug Administration (FDA) has cleared its ...
heise online

Clinical co-pilot receives first approval for Class IIb medical device

"Prof. Valmed", an AI-supported chatbot for the medical sector, is the first class IIb medical language AI to receive approval. The system uses a large language model to search for specific validated ...
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 ...