FDA clearance

RightEye gets FDA nod for eye-tracking technology
By Laura Lovett | 09:24 am | October 09, 2018
Maryland-based RightEye now has clearance for its software that helps clinicians assess reading skills, brain health and functional vision.
physIQ gets FDA nod for a-fib analytics system
By Laura Lovett | 03:51 pm | September 12, 2018
AI company physIQ landed FDA clearence for its atrial fibrillation detection analytics software. 
Masimo's respiration sensor receives FDA nod for neonatal, infant use
By Laura Lovett | 12:20 pm | September 10, 2018
Masimo's acoustic respiration sensor, the RAS-45 for Rainbow Acoustic Monitoring, is clearedfor use among infants and neotal patients 10kg and under. 
FDA grants Natural Cycles' contraception app de novo marketing approval
By Dave Muoio | 04:33 pm | August 10, 2018
Adherium receives additional FDA clearance for OTC sale of inhaler sensors in the US
By Dave Muoio | 03:36 pm | July 27, 2018
Zebra Medical Vision receives its first 510(k) clearance for coronary artery calcification algorithm
By Dave Muoio | 05:00 pm | July 11, 2018
FDA green-lights 14 digital health products, continues to evolve regulations
By MobiHealthNews | 05:11 pm | July 05, 2018
FDA expands approval of Medtronic MiniMed 670G to include kids 7 and up
By Laura Lovett | 12:11 pm | June 22, 2018
iSchemaView's CTA imaging platform gets FDA clearance
By Laura Lovett | 03:09 pm | May 02, 2018
PhysioWave's pulse wave velocity feature gets the all-clear from FDA
By Laura Lovett | 02:59 pm | March 23, 2018