FDA 510(k)

Senseonics gets FDA clearance for Eversense, will sell implantable glucose monitor directly in US
By Jonah Comstock | 12:58 pm | June 22, 2018
MC10 gets its first FDA clearance for BioStamp nPoint, a sensor platform for clinical trials
By Jonah Comstock | 05:30 pm | May 16, 2018
Kinsa launches QuickCare, an FDA-cleared wireless connected thermometer
By Jonah Comstock | 04:10 pm | February 09, 2018
Empatica's consumer-facing epileptic seizure-detecting wearable gets FDA clearance
By Jonah Comstock | 01:01 pm | February 05, 2018
Fifty-one connected health products the FDA cleared in 2017
By MobiHealthNews | 03:00 pm | December 21, 2017
Voluntis gets FDA clearance to add last two basal insulins to app
By Jonah Comstock | 05:31 pm | November 16, 2017
Software that allows clinicians a "surgical dress rehearsal" gets FDA nod
By Laura Lovett | 12:52 pm | November 16, 2017
Butterfly IQ gets FDA clearance for chip-based, smartphone-connected ultrasound
By Jonah Comstock | 04:52 pm | October 31, 2017
With new FDA clearances, ZIO is poised to finally add realtime, connected monitoring
By Jonah Comstock | 02:23 pm | June 08, 2017
Clarify gets FDA clearance for connected home phototherapy device
By Jonah Comstock | 06:06 pm | June 06, 2017