For those with Class IIa or above AI-related devices, compliance with the EU’s AI Act is likely to be akin to the EU MDR.

There are four risk classification levels of the medical devices (class I-IV, based on the risk level). For every country, the regulatory requirements are different. Global regulations for medical ...

In his March 2023 budget, the then UK Chancellor, Jeremy Hunt, accordingly announced that from 2024 the Medicines and ...

Helius Medical Technologies, Inc. is a neurotech company in the medical device industry that focuses on neurological wellness. The firm develops, licenses and acquires non-invasive platform ...

Baird Medical Investment Holdings Ltd. (NASDAQ: BDMD) ("Baird Medical" or the "Company"), a leader in minimally invasive ...