December 11, 2014
Parents in California who have children who get chronic ear infections will soon have a more convenient way to get their kids care.
San Francisco-based CellScope, a Khosla Ventures-backed Rock Health alum, has begun taking preorders for its FDA registered smartphone-enabled otoscope, called Oto Home. The director-to-consumer device is priced at $79 and will ship in four to six weeks. A feature-...
May 5, 2014
Medical device giant Covidien has acquired sports and medical wearables company Zephyr Technology, MobiHealthNews has learned. The company has raised more than $13 million since its founding in 2003 -- back when health-sensing wearables were a relative rarity. Zephyr's investors included 3M New Ventures, Alsop Louie Partners and Motorola Solutions Venture Capital.
Neither Covidien nor Zephyr has...
March 20, 2014
Remote patient monitoring company HealthInterlink received FDA 510(k) class II clearance for Beacon 2.0, a mobile-centric software system that integrates data from various home health devices. Beacon was previously cleared as a class I medical device (MDDS). HealthInterlink plans to begin commercialization of the device in the US immediately.
Beacon 2.0 works on tablets, smartphones and via...
March 5, 2014
Last week South Korea's health regulatory agency, the Ministry of Food and Drug Safety (MFDS), announced that it would review the latest version of Samsung's Galaxy phone -- the S5 -- to determine whether the device, which includes a built-in heart rate sensor -- should be regulated as a medical device. According to a local media report from Yonhap, the agency defines medical devices in a similar...
January 7, 2014
iHealth's not yet FDA-cleared wearable ECG device
Mountain View, California-based iHealth Lab, a subsidiary of Chinese medical device company Andon Health, showed off three new smartphone-enabled, wearable health devices at CES in Las Vegas this week: a blood pressure monitoring vest, an ambulatory ECG device that sticks to the wearer's bare chest, and a wristworn pulse oximeter device.