AI Integration In MedTech Devices And Diagnostics: Regulation And Investment Opportunities

GE HealthCare Technologies Inc. (NYSE: GEHC) leads with 100 FDA-approved AI devices, concentrating heavily on imaging and diagnostics. Their CleaRecon DL technology sharpens cone-beam CT images using ...

Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug ...

The "Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products Training Course (Mar 2nd - Mar 3rd, 2026)" training has been ...
MD&M East

FDA Staff Cuts & Global Tariffs Pose Challenges for Medical Device Development, Experts Warn

During an April 7 session of the Biopharma Congress, Janet Woodcock, MD, former acting FDA Commissioner and former principal deputy commissioner of food and drugs, called the recent FDA staff cuts a ...
MD&M East

Creating FDA Submissions That Tell A Story

Similar to building a solid house that requires detailed preplanning, an FDA submission should ensure that all product teams be on the same page from day one of concept, according to Matthias Kaeser, ...