Regulation

By Jonah Comstock 11:09 am September 21, 2015
The HHS Office of the National Coordinator for Health IT (ONC) recently released a whitepaper, based on a workshop held last April, on designing telehealth and remote visits for consumers. The 20-page document is interesting, extensive, and hits on some good points about how to make telehealth convenient and effective for consumers. Yet both the whitepaper and the workshop excluded the viewpoint...
By Jonah Comstock 08:54 am September 15, 2015
The ACT device paired with a previous phone. LifeWatch, a Swiss remote cardiac monitoring company that has been connecting to mobile phones since 2009, has received FDA clearance for a new version of its Ambulatory Cardiac Telemetry (ACT) system that will run on Android devices. Currently, the system runs on Microsoft Windows phones. Patients use the mobile software to answer a couple...
By MHN Staff 09:00 am September 10, 2015
by Bradley Merrill Thompson Let’s say no one had ever invented the tongue depressor, but this year, in a flash of inspiration, I came up with the idea. Indeed, let’s say there’s nothing else like it. To bring the first tongue depressor to market, it’s quite likely I would have to spend years conducting clinical trials, to be followed up by perhaps a year of FDA review. For a tongue depressor. Why...
By Jonah Comstock 05:59 am September 10, 2015
After years of using its digital health feedback system in clinical trials and studies, Proteus Digital Health, and partner Otsuka Pharmaceuticals, are poised to launch the first mass market drug to incorporate Proteus's ingestible sensor. The companies have submitted a sensor-embedded version of the antidepressant Abilify for FDA approval. “Today, patients suffering from severe mental illnesses...
By Aditi Pai 06:37 am September 2, 2015
Berkeley, California-based Eko Devices has received FDA 510(k) clearance for its smartphone-enabled stethoscope, called Eko Core as well as the companion smartphone app. Eko Devices, which describes itself as a "Shazam for heartbeats", has previously received an investment from two Shazam cofounders, as well as Founder.org, Stanford StartX, former HHS advisor John Noonan. The company has raised...
By Jonah Comstock 07:09 am September 1, 2015
Pictured above: A device from Cambridge-based MC10, a company focused on flexible electronics. The US Department of Defense is making a big bet on flexible electronics, an area of technology with close ties to mobile health. The DoD announced last week that it will invest $75 million in a public-private partnership called the Manufacturing Innovation Institute for Flexible Hybrid Electronics,...
By Brian Dolan 07:09 am August 27, 2015
During a campaign stop in Iowa this week, former Secretary of State Hillary Clinton touted the importance of telemedicine, Politico reported this morning. The entire speech is available from Clinton's campaign, but here's the relevant passage: "And we also need to do better on health care. Decades ago, I led a commission on rural health in Arkansas that worked on increasing access in remote parts...
By Aditi Pai 11:16 am August 26, 2015
The National Cancer Institute (NCI) has awarded Chrono Therapeutics a Small Business Innovation Research (SBIR) grant of up to $2.3 million for product development of the digital portion of the company's smoking cessation therapy offering. The new grant will fund Chrono's final clinical trial for its product. This is the second grant Chrono has received from the NCI. The first, $2.23 million...
By Aditi Pai 08:22 am August 25, 2015
The FDA has approved San Diego, California-based Dexcom for a Bluetooth-enabled continuous glucose monitor (CGM), called the G5 Mobile CGM system. Correction: A previous version of this article incorrectly stated the device had a 510(k) clearance when in fact it had a PMA approval. Unlike the company's previous connected CGM devices, the G5 Mobile CGM System has Bluetooth built right in to the...
By Brian Dolan 07:27 am August 24, 2015
Amsterdam-based dermatology app company SkinVision has raised $3.4 million from pharmaceutical company Leo Pharma with contributions from SkinVision's existing investor and majority stakeholder Dutch investment firm Personal Health Solutions Capital. The complany plans to use the funding to move its app's capabilities beyond melanoma recognition and into other skin conditions, according to a...