Swedish neurotech startup Flow Neuroscience has secured FDA approval for the first brain stimulation device for home use in ...

Many Medtech startups view FDA and similar regulatory bodies as a roadblock. Something that is there to get in their way, slow them down, and cost them a fortune. Smart companies see regulations as an ...

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 ...

As we look ahead to 2026, we are continuing to execute on our strategy with purpose and momentum to create value for all our stakeholders.” OTI’s rapid self-test for CT/NG is built on the Sherlock ...

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 ...

A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses to oversee other in vitro diagnostics and medical devices—saying the agency ...

ProMed, a leading contract manufacturer specializing in medical-grade silicone and plastic components, provides comprehensive support for medical device, pharmaceutical, and combination drug-device ...

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 ...

The global market for contract manufacturing of medical devices is estimated to grow from $96.4 billion in 2025 to reach $155.2 billion by 2030, at a compound annual growth rate (CAGR) of 10% from ...