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Yeida to expand scope of Medical Device Park Yeida said that 40 new companies have registered to invest in the park, which will manufacture equipment for the prevention and treatment of serious ...

which reflects the FDA’s commitment to device innovation and protecting public health, is intended to help patients and health care providers receive more timely access to select medical devices.

Rising “indirect imports” from China coupled with falling exports have prompted domestic medical device manufacturers to seek intervention from the commerce minister Piyush Goyal. In a letter ...

--(BUSINESS WIRE)--Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today ...

The FDA regulates AI as a medical device under its Digital Health Software Precertification Program. • The Office of the National Coordinator for Health Information Technology (ONC) imposes ...

Dublin, April 16, 2025 (GLOBE NEWSWIRE) -- The "Market Authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Training Course" has been added to ResearchAndMarkets.com ...

Digital health is transforming the healthcare industry, with software aiding the diagnosis and treatment of illnesses. Software as a medical device (SaMD ... and outputs via clinical association ...

Credit: CGN089 / Shutterstock. The US Food and Drug Administration (FDA) has granted marketing authorisation for ActiveProtective Technologies’ (APT) Tango Belt, a prescription-only wearable medical ...

Artificial intelligence (AI), particularly machine learning (ML), is revolutionizing health care through software as medical devices (SaMD). SaMD refers to software that functions on standard ...

Despite the Trump administration's recent 90-day pause on reciprocal tariffs, hospitals and health systems remain concerned about the ongoing impact of tariffs on medical devices. Industry ...