wellness devices

Recent FDA guidances cover software changes, real world evidence, wellness devices

By Jonah Comstock 04:12 pm August 9, 2016

The FDA's Center for Devices and Radiological Health has been busy over the last couple of months, releasing several draft and final guidances that affect the makers of apps and connected devices. Lack of regulatory clarity is often cited as a force hampering innovation in digital health, so these moves by the FDA toward greater clarity are likely to be welcomed in many parts of the industry....

Tech giant Nokia to acquire digital health device maker Withings for $191 million

By Jonah Comstock 09:43 am April 26, 2016

Nokia Technologies will acquire French connected health device maker Withings for $191 million (170 million euros). Withings, which makes smartphone-connected weight scales, blood pressure cuffs, activity trackers, and, recently, thermometers, has raised $34 million to date, with the latest being a $30 million round in 2013. As we wrote last month, Nokia has been searching for a new focus area...

FDA clarifies the line between wellness and regulated medical devices

By Brian Dolan 05:39 am January 16, 2015

As promised in its FDASIA report, the FDA has published a draft guidance document that aims to help those creating wellness devices and apps to better understand when their product (or their marketing claims) crosses over into regulated medical device territory. As always the agency is seeking comment from the industry and the public on their new draft guidance for the next 90 days. "A general...