FDA
The Auto Ejection Fraction Tool and the Auto Bladder Volume Tool both employed AI to help Butterfly iQ users more easily evaluate the patient's condition.
Nurx, Carbon Health and Everlywell have officially halted their mail-order testing-kit services. But at least one startup is still moving to secure an Emergency Use Authorization for its at-home rapid serology diagnostic.
The temporary policy also extends to some clinical decision support software used in conjuction with these remote monitor devices.
Zero Trust
"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 new algorithms integrate with Eko's digital stethoscope.
The system may now be used to target patients' internal globus pallidus, a portion of the brain associated with Parkinson's disease symptoms.