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FDA 510(k)

By Laura Lovett | 04:16 pm | January 23, 2020
The latest platform provides developers and providers direct control over streaming health data. 
By Dave Muoio | 12:13 pm | January 22, 2020
A newly published notice from the FDA suggests a new capability for the Alphabet subsidiary's clinical research wearable.
By Dave Muoio | 04:18 pm | January 09, 2020
The Air Next is designed for patients with respiratory conditions such as asthma, COPD and cystic fibrosis.
By Dave Muoio | 05:23 pm | October 01, 2019
The company has struck deals with VivaLNK and MIR, and is eying "more than 50 integrations by the end of next year."
By Dave Muoio | 10:44 am | September 12, 2019
The new tool is a clinical-grade ACR test used to identify chronic kidney disease.
By Dave Muoio | 12:45 pm | August 29, 2019
Biobeat's connected remote monitoring device is currently available as either a wristwatch or an adhesive patch.
By Dave Muoio | 04:11 pm | July 30, 2019
The company's latest algorithm extracts raw data from a variety of sensors and unifies them into a uniform vital signs reading, MobiHealthNews exclusively learned.
By Laura Lovett | 04:14 pm | July 15, 2019
The technology has a built-in sensor that can send usage data to a corresponding smartphone app. 
By Dave Muoio | 03:30 pm | June 17, 2019
Both companies are ramping up the pace of their FDA clearances. 
By Dave Muoio | 09:07 am | April 24, 2019
Recently deployed in US and UK hospitals, the company's upper-arm wearable and accompanying platform may now go home with the patient.