June 15, 2017
Back in March, when President Donald Trump chose Dr. Scott Gottlieb to head up the FDA under his administration, MobiHealthNews noted that he had a history of advocating for a hands-off approach to mobile health regulation. Now, just three months later (and a little over a month after his confirmation to the post), Gottlieb has articulated his new -- and somewhat radical -- approach to mobile...
January 19, 2017
Apple periodically features groups of apps in its app store for particular use cases and audiences. Under “Apps for Patients” in its Medical section, the company highlights these 24 personal care apps, which range from well known apps like WebMD and Mayo Clinic to some more under-the-radar options. Some apps apply to people living with particular conditions, while others provide lifestyle help...
November 24, 2015
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...
October 8, 2015
By Bradley Merrill Thompson
If I invented an unprecedented mobile technology for treating tennis elbow, the law would require me to do substantial and expensive clinical trials before bringing it to market. In my last post, I argued that the FDA regulatory system is structurally biased against new technology, including novel software, even if it is low risk. By law, any medical device that is...
September 22, 2015
Netherlands-based Wolters Kluwer, which offers clinical reference information products like medical apps to students and professionals in the medical field, plans to expand its digital health division in India, according to Business Standard.
Many healthcare systems across a number of Indian cities already use one of Wolters Kluwer's most popular tools, a reference app called UpToDate. These...
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...
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...
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...
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...
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...