In 2005’s “ Why Software Fails ,” in IEEE Spectrum, a seminal article documenting the causes behind large-scale software ...

December 1, 2025Sara Brenner, M.D., MPHPrincipal Deputy CommissionerU.S. Food and Drug Administration10903 New Hampshire Ave.Silver Spring, MD 20993Submitted ElectronicallyRE: FDA-2025-N-4203 Request ...

Walking the myriad halls of the MEDICA convention gives a palpable sense of the innovation bursting at the seams of the ...

Improve the reliability of your own products by borrowing proven testing strategies from safety-critical medical devices.

Philips has launched a new image management platform that includes a web-based imaging viewer that aims to advance how ...

Diogo Geraldes, director of regulatory strategy, Europe at Veeva MedTech, discusses the potential of digital submissions to ...

Generative AI systems are rapidly advancing, rendering existing regulatory frameworks insufficient for overseeing their broad ...

Sanctuary Software Studio streamlined an app that lets sleep apnea patients and their doctors control electrodes implanted ...

The evolving European regulatory landscape presents significant market opportunities in digital medical devices with AI components. By understanding and navigating key regulations like the EU MDR, AI ...

This cardiac device maker focused on atrial fibrillation saw a notable insider sale following a year of flat share ...

Akura Medical, a Shifamed portfolio company, announced today that it completed the first close of its Series C financing, raising $53 million.

St. Cloud State University (SCSU) sits in the heart of Minnesota’s “Medical Alley,” a dense cluster of device makers, large health systems and fast-growing start-ups. For alumni like Tony Rizzardi and ...