While many advocate that oversight of AI analyses of lab data be handled through CLIA, some stakeholders say that FDA should play a role.

Europe’s life sciences sector faces acute talent shortages in specialist roles: Despite a position of strength – generating €585 billion in 2024 and employing 950,000 professionals directly – the ...

For two straight seasons, the Dallas Stars and Edmonton Oilers have met in the Western Conference finals, with the Oilers winning both matchups. Are these teams headed on yet another collision course ...

The "A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU (European Union) and UK Training Course (Apr 29, 2026)" training has been added to ResearchAndMarkets.com's ...

The European Commission on Monday proposed changes to simplify medical and in-vitro diagnostic regulations. The proposals, which were praised by industry group MedTech Europe, aim to simplify the ...

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical devices and IVDs have undergone a profound change. Manufacturers are now ...

This table of contents is a navigational tool, processed from the headings within the legal text of Federal Register documents. This repetition of headings to form internal navigation links has no ...

Registrar Corp., a unit of Paine Schwartz Partners, acquired Spanish medical device consulting services provider CMC Medical Devices, expanding the U.S.-based compliance specialist's global reach. The ...

The Elena and Miles Zaremski Law Medicine Forum presents: Medical Device Regulation: Going from Bad to Worse...or Better? with George Horvath Innovations in medical device technology hold the ...

The landscape of FDA medical device regulation has undergone a significant transformation. Today's regulatory environment presents both familiar challenges and entirely new complexities that device ...

Neuromod Devices announced today that it received significant regulatory nods to bring its Lenire device to Europe and other geographies. Dublin, Ireland-based Neuromod won approval to the Medical ...

Many of President Trump’s executive orders (EOs) and legislative measures have been designed to curtail federal regulation, reduce the size of the administrative state, and withdraw the U.S. from ...