fda

Mar
23

Alio receives second FDA Clearance

Alio receives second FDA Clearance dschroeder19 Company secures second FDA clearance for its remote patient monitoring platform, adding three new
3 min read
Mar
23

FDA Clears Viz.ai\'s AI Algorithm for Abdominal Aortic Aneurysm

FDA Clears Viz.ai\'s AI Algorithm for Abdominal Aortic Aneurysm sbrusco@rodmanmedia.com (Sam Brusco) Viz.ai has
1 min read
Mar
16

TytoCare receives FDA 510(k) for wheeze detection software

TytoCare receives FDA 510(k) for wheeze detection software unknown Virtual primary care company TytoCare received FDA 510(k) clearance
1 min read
Mar
13

Singaporean startup Respiree gets US FDA 510(k) for respiration monitor

Singaporean startup Respiree gets US FDA 510(k) for respiration monitor unknown Respiree, a med tech spinoff of Singapore'
1 min read
Mar
11

FDA updates for Week of March 6, 2023

FDA updates for Week of March 6, 2023 unknown FDA approves novel nasal spray for migraine. The FDA has approved
5 min read
Mar
05

Theranica receives FDA 510(k) for migraine prevention device

Theranica receives FDA 510(k) for migraine prevention device unknown Prescription digital therapeutic developer Theranica announced it had received FDA
1 min read
Mar
05

The FDA Regulatory Landscape For AI In Medical Devices

The FDA Regulatory Landscape For AI In Medical Devices unknown By Michele Buenafe, Jake Harper, and Andrew Gray In recent
6 min read
Mar
05

FDA Updates for Week of Feb. 27, 2023

FDA Updates for Week of Feb. 27, 2023 unknown FDA approves Kevzara for inflammatory rheumatic disease. The FDA has approved
4 min read
Feb
25

FDA Updates for Week of Feb. 20, 2023

FDA Updates for Week of Feb. 20, 2023 unknown FDA approves weekly hemophilia A therapy. The FDA has approved Altuviiio
5 min read
Feb
23

STAT+: The FDA plans to regulate far more AI tools as devices. The industry won’t go down without a fight

STAT+: The FDA plans to regulate far more AI tools as devices. The industry won’t go down without a
1 min read