FDA cleared apps

By Brian Dolan August 24, 2015
Los Altos, California-based Gauss Surgical has raised $3.3 million, according to a recent SEC filing. The company offers surgeons and their teams FDA-cleared apps that help track blood loss. This latest funding brings the company's total to about $11 million. It last raised funds at the end of 2014, when Gauss Surgical raised $1.5 million. The company was a participant in the StartX Stanford...
By Aditi Pai June 17, 2015
Australia-based Analytica has received FDA 510(k) clearance for PeriCoach, its smartphone-connected device that helps women monitor their pelvic floor exercises. The goal of PeriCoach is to reduce or stop urinary incontinence. It will commercially launch in the US next week. According to the company's website, one in three women experience a bladder leak at some point in their lives. And although...
By MHN Staff April 13, 2015
By Bradley Merrill Thompson With the growth of health apps, entrepreneurs often need to determine if FDA regulates their particular mobile app. As I’ve explained in other posts and indeed in a book, that question has a number of facets to it, but in this post I want to focus on the most important – the intended use of the app. This concept of intended use is indeed not just the determining factor...
By Aditi Pai March 30, 2015
Israel-based Voyant Health, a subsidiary of Germany-based medical technology company Brainlab, received FDA clearance for its iPad app, called TraumaCad Mobile, which helps orthopedic surgeons with their pre-operative surgical planning. “For over a decade, thousands of orthopedic surgeons have been using our TraumaCad technology to plan surgery," Brainlab General Manager of Orthopedics Marc...
By Jonah Comstock March 25, 2015
Vital Art and Science, developers of myVisionTrack, a vision test service for patients with age-related macular degeneration or diabetic eye disease, has received a second FDA clearance for their platform, which includes an app and a provider dashboard. They will also soon launch a major clinical trial in partnership with the Scripps Translational Science Institute and Roche, according to the...
By Aditi Pai March 17, 2015
Los Altos, California-based Gauss Surgical has received an FDA 510(k) clearance for its Triton iPad app, which can now estimate the surgical blood loss in canisters that hold blood. Surgeons can estimate blood loss in surgical suction containers using the iPad's camera. The app enables the user to take pictures of the surgical canisters and then send the images up to the cloud for analysis. At...
By Brian Dolan January 20, 2015
Bradley Merrill Thompson At the end of last week the FDA posted two draft guidance documents related to digital health. One focused on clarifying the line (PDF) between a general wellness device or app and a regulated medical device. The other intended to help clarify when an "accessory" device (PDF) to a regulated medical device, like a companion smartphone app, for example, would also fall...
By Brian Dolan October 22, 2014
Bethesda, Maryland-based cellular-enabled blood glucose meter company Telcare has raised $32.5 million led by Norwest Venture Partners with participation from Mosaic Health Solutions and existing backers The Qualcomm Life Fund and Sequoia Capital. The latest round of funding takes Telcare's total disclosed funding to north of $60 million. Telcare offers a diabetes management package that includes...
By Brian Dolan October 20, 2014
Last week the FDA granted 510(k) clearance to a mobile-based cognitive test called DANA (Defense Automated Neurobehavioral Assessment), which helps healthcare providers better assess the medical or psychological state of their patients. DANA was developed by Silver Spring, Maryland-based AnthroTronix, a digital health R&D company, and it was developed partially thanks to funding from the US...
By Brian Dolan September 24, 2014
MobiHealthNews has been tracking FDA clearances for smartphone-connected medical devices and standalone apps for many years. So far 2014 has had its fair share -- about two dozen digital health-related FDA clearances have been secured this year. Here's a roundup: New York City-based Kinsa Health received FDA 510(k) clearance for its Kinsa smart thermometer, which can be used, orally, under-arm,...

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