Considering recent events, big name consumer brands are more likely than ever to move into regulated medical devices.
Two weeks ago Apple CEO Tim Cook told a newspaper that while his company wouldn't put the Apple Watch through the motions of an FDA clearance process, Cook "wouldn't mind putting something adjacent to the watch through it." He said that before adding maybe that'd be an app or...
Austria-based diabetes app company mySugr has raised $4.8 million from Roche Ventures and iSeed Ventures. Existing investor XLHealth also contributed to the round, which will help mySugr scale up its user base in the US and other other countries. iSeed Ventures is a new fund that has only made a half dozen investments so far, and it is led by former iHealth Lab head Adam Lin.
MySugr offers a...
Burlingame, California-based Misfit, formerly Misft Wearables, today launched Misfit Flash, its second wearable device that tracks various activities and sleep. The sub-$50 Flash's pricepoint isn't the only difference between it and Misfit's original device, Shine. Flash is made out of "soft-touch" plastic instead of the Shine's stainless steel body. Flash comes in a variety of colors including "...
New York City-based medical device maker Philosys received FDA 510(k) clearance this week for its smartphone-connected glucose meter, Gmate Smart.
To use the Gmate Smart glucometer, users launch the device's connected app, plug in their Gmate glucometer through the audio jack, insert a test strip into the glucometer, add a blood sample, and view results on the app. Gmate Smart's app is only...
Voluntis's app (not shown here) was one of the first to work with Sanofi's IBGStar connected glucometer.
Paris, France-based Voluntis, a developer of companion apps for medical devices, has raised $29 million in its fourth round of funding. The round was led by Bpifrance Large Venture and international venture capital firm Innovation Capital. Other contributors included Luxemburg-based...
"Here at HIMSS it's all about hospital-to-patient, doctor-to-patient, nurse-to-patient. Why is no one talking about patient-to-patient?" HelpAround Co-founder and CEO Yishai Knobel said during an interview at HIMSS 2014 in Orlando this week. "Especially when research has shown that peer support drives medical outcomes."
Knobel's startup Israel-based HelpAround is poised to be one of the first to...
Israel-based LabStyle Innovations announced CE mark certification for its smartphone-based glucose monitor Dario, according to a press release. In the coming months, the company will plan a soft launch of Dario in Europe to collect customer feedback and refine its roll-out strategy.
In May, LabStyle raised $10 million by common stock and planned to use the money to develop, market and manufacture...
The Scripps Translational Science Institute (STSI) has announced the official launch of its Wired for Health mobile trial, which had begun recruiting last month, when the Institute brought on Dr. Steven Steinhubl as director of digital medicine.
"We are excited to embark on one of the first robust, cross-industry studies using multiple mobile medical sensors to determine whether we can lower...
It seems like there's a new digital health device announced every day. Last week alone, Melon finished a Kickstarter campaign for a wearable head band to track concentration and potentially sleep, Basis launched a mobile app to accompany its Basis Band and Glooko relaunched its mobile diabetes management device. Still, in an increasingly competitive market, a few digital health devices have...
Last month the US Food and Drug Administration gave three medical devices 510(k) Class II clearances that aim to help people with diabetes better manage their condition via glucose meters that connect to apps on smartphones and tablet devices.
Palo Alto, California-based Glooko received its second 510(k) clearance for glucose monitoring logbook app and cable that connects various off-the-shelf...
