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 ...

Physiologic monitoring devices are so ubiquitous in hospitals that it’s difficult to recall a time without them. The success of integrating this technology into patient care as a regular part of the ...

Outset Medical plans to begin shipping the updated platform during the second quarter of 2026.

Capsule Tech, Inc., the leading global provider of medical device information systems (MDIS), today announced its DataCaptor™ software has been named Category Leader for medical device integration ...

As the number of connected medical devices continue to rise, and as artificial intelligence (AI) continues to influence the broader healthcare ecosystem, network infrastructure is becoming the ...

The Food and Drug Administration has finalized a regulation that provides a less-burdensome path to market for certain hardware and software products used with medical devices, according to an FDA ...

A popular medical monitor is the latest device produced in China to receive scrutiny for its potential cyber risks. However, it is not the only health device we should be concerned about. Experts say ...

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 ...

St. Jude Medical announced new features for its Merlin.net remote patient monitoring offering, Patient Care Network (PCN), including mobile alerts for physicians and improved data export to EHRs.

Symphoni platform delivers real-time in-line quality assurance for medical devices, up to 320 parts per minute with 90% less ...