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FDA

By Dave Muoio | 04:56 pm | March 25, 2020
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. 
By Dave Muoio | 05:32 pm | March 23, 2020
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.
By Dave Muoio | 05:50 pm | March 20, 2020
The temporary policy also extends to some clinical decision support software used in conjuction with these remote monitor devices.
Zero Trust
By Dave Muoio | 12:56 pm | March 04, 2020
"SweynTooth" impacts several microchip and medical device manufacturers, and could allow bad actors to wirelessly crash or access these products, according to the agency.
By Dave Muoio | 05:38 pm | February 07, 2020
Caption Health's tool instructs non-expert medical staff on how best to produce high-quality diagnostic images in real time.
By Dave Muoio | 02:44 pm | February 05, 2020
Also: Proof of concept for a metabolite-monitoring wristwatch; Qynapse's 510(k) clearance.
By Laura Lovett | 02:36 pm | February 03, 2020
The new system lets clinicians share or capture videos and images from the OR. 
By Dave Muoio | 02:16 pm | January 30, 2020
Also: FDA launches mobile-friendly HIV medication database; Gates Foundation grant will bring machine vision diagnostic tool to underserved regions.
By Laura Lovett | 12:51 pm | January 28, 2020
The new algorithms integrate with Eko's digital stethoscope. 
By Dave Muoio | 02:40 pm | January 27, 2020
The system may now be used to target patients' internal globus pallidus, a portion of the brain associated with Parkinson's disease symptoms.