Healio

FDA grants 510(k) clearance to contact-free remote patient monitoring device

Please provide your email address to receive an email when new articles are posted on . The FDA granted class II 510(k) clearance to Sleepiz One+, a contactless remote patient monitoring device that ...
Health Service Journal

Getting classification right: Why remote monitoring safety depends on using the right level of medical device assurance

“Classification isn’t an administrative detail; it’s the foundation of patient safety,” he says. “If a platform is being used to support clinical decision-making, issue alerts or guide escalation, ...
Medscape

Class I Recall Issued for Intracranial Pressure Monitor

Integra is recalling the CereLink Intracranial Pressure (ICP) Monitor after reports that the device may display incorrect ICP values and out-of-range pressure readings. The recall includes 388 ...
Rolling Out

The ways sleep monitoring devices change how you sleep

The bedside table of the modern health enthusiast increasingly features sophisticated technology aimed at unlocking the mysteries of sleep. From advanced rings and watches that monitor heart rate ...