Labeling AI mental health chatbots as medical devices would stymie progress in helping people in need with simple tools that ...

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 ...

Siemens Healthineers has launched Syngo.CT Coronary Cockpit, a new software that integrates with the company’s dual-source ...

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

According to the U. S. Food and Drug Administration records, in an average year over 2,500 medical device recalls are issued ...

The pharmaceutical and medical device industries stand at an inflection point. After decades of reliance on traditional ...

Charette, who has been writing about software failures for this magazine for the past 20 years, is a renowned risk analyst ...

A new doctoral dissertation from the University of Vaasa, Finland, argues that health care cybersecurity will remain fragile ...

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

Nordic Semi has unveiled a new member of the nRF54L series: the nRF54LV10A ultra-low-power, low-voltage Bluetooth LE SoC ...

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 ...

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