FDA is removing barriers to real-world evidence in device applications, allowing the use of de-identified patient data from ...

This week in Pedersen's POV, our senior editor finds humor in the European Commmission's plan to simplify the EU Medical ...

No one can predict what the medical device industry will look like in 2026. Still, the events of 2025 provide meaningful ...

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical ...

Unlike clinical-grade stimulators that require medical supervision or invasive procedures, Pulsetto is positioned within the ...

Neosoma, Inc. is excited to announce that it has received FDA 510(k) clearance for its Brain Mets software medical device. This clearance ushers in a new era in the assessment of brain metastases, ...

Women’s health neurotechnology applies brain stimulation using a wearable to PMS, menstrual pain, and mood—addressing gaps ...

As the life sciences sector continues to navigate scientific advances, regulatory evolution and shifting market dynamics, the Xtalks Life Science Podcast has served as a platform for in-depth ...

UK MHRA updates guidance on the Health Institution Exemption to support safe use of medical devices: United Kingdom Friday, December 19, 2025, 12:00 Hrs [IST] Patients across Engl ...

DJ Affluent Medical announces upcoming acquisition of Caranx Medical and Artedrone, becoming Carvolix, pioneering cardiovascular therapies. Affluent Medical Affluent Medical announces upcoming acquisi ...