What I am about to share with you is a guide to medical device regulatory classification. In this guide, I will provide you with a step-by-step approach for determining how your medical device will be ...

Please provide your email address to receive an email when new articles are posted on . The FDA issued a final rule that implements modifications made by the FDA Safety and Innovation Act, as well as ...

The FDA is excluding eight software functions that were previously classified as medical device status under the 21st Century Cures Act. The FDA released the new provisions in an April 19 document in ...

PHILADELPHIA, Jan. 04, 2022 (GLOBE NEWSWIRE) -- AnPac Bio-Medical Science Co., Ltd. (“AnPac Bio,” the “Company” or “we”) (ANPC), a US and China-based biotechnology company focused on early cancer ...

Connected medical devices can improve patient care and operational efficiency. However, they also introduce new privacy and security risks. Healthcare providers should rethink their privacy and ...

Dublin, Aug. 24, 2020 (GLOBE NEWSWIRE) -- The "Medical Device Market by Device Type, Function, Durability, Therapeutic Segment, Risk Classification, Manufacture Method, Delivery/Acquisition, ...