The Food and Drug Administration is treating the data systems and IT infrastructure that capture information from medical devices as low-risk, as a way to encourage innovation. The data systems that ...

The U.S. Food and Drug Administration issued a guidance saying it will not regulate medical device data systems and systems related to medical image storage, as they don’t pose a high risk to patients ...

Hospitals that are considered device manufacturers under the new medical device data system regulation may be subject to FDA inspections, according to an Association for the Advancement of Medical ...

Hospitals and medical device manufacturers must team up to help create a secure environment to protect the personal health information derived from patient monitors and other medical devices. For some ...

On Friday the FDA issued a draft guidance document that revealed the agency intends to further deregulate medical device data systems (MDDS) and some medical image transfer systems. The FDA wrote that ...

FDA is making an example out of Abiomed, which Johnson & Johnson bought last year for $16.6 billion. In a warning letter that comes about a year after the agency issued guidance on its regulation of ...

Based on medical device cybersecurity predictions from the beginning of 2025, let's revisit what was expected to shape the ...

Under a new FDA rule, hospitals that are considered device manufacturers may be investigated by the agency for compliance, according to an Association for the Advancement of Medical Instrumentation ...

Deep brain stimulation (DBS) is a neurosurgical procedure involving the placement of a medical device called a neurostimulator. — Image by Hellerhoff, via Wikipedia (CC BY-SA 3.0) Deep brain ...