FDA
The temporary policy also extends to some clinical decision support software used in conjuction with these remote monitor devices.
Privacy & Security
"SweynTooth" impacts several microchip and medical device manufacturers, and could allow bad actors to wirelessly crash or access these products, according to the agency.
Caption Health's tool instructs non-expert medical staff on how best to produce high-quality diagnostic images in real time.
Also: Proof of concept for a metabolite-monitoring wristwatch; Qynapse's 510(k) clearance.
The new system lets clinicians share or capture videos and images from the OR.
Also: FDA launches mobile-friendly HIV medication database; Gates Foundation grant will bring machine vision diagnostic tool to underserved regions.
The system may now be used to target patients' internal globus pallidus, a portion of the brain associated with Parkinson's disease symptoms.
The latest platform provides developers and providers direct control over streaming health data.
A newly published notice from the FDA suggests a new capability for the Alphabet subsidiary's clinical research wearable.
The Air Next is designed for patients with respiratory conditions such as asthma, COPD and cystic fibrosis.