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 ...
In 2005’s “ Why Software Fails ,” in IEEE Spectrum, a seminal article documenting the causes behind large-scale software ...
The move to home-based care is fundamentally changing how medical devices are designed and deployed. Manufacturers are now ...
Walking the myriad halls of the MEDICA convention gives a palpable sense of the innovation bursting at the seams of the ...
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 ...
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 ...
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 ...
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 ...
From solar energy optimization to infection-fighting medical devices, AltaSim Technologies is transforming product ...
According to DataM Intelligence, the U.S. Software as a Medical Device (SaMD) Market Size reached USD 205.12 million in 2024 and is forecast to climb to USD 715.00 million by 2033, expanding at a ...
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