FDA

By Jonah Comstock June 29, 2016
Withings, the French connected device maker recently acquired by Nokia Technologies, has received FDA 510(k) clearance for Withings Thermo, the company's WiFi-enabled thermometer, MobiHealthNews has learned. The device was first announced in January at CES in Las Vegas. Rather than being inserted in the mouth or armpit, Thermo measures temperature from the temporal artery on the user's forehead....
By Jonah Comstock April 27, 2016
The FDA declined to approve what would have been the first mass market drug to incorporate Proteus Digital Health's ingestible sensor. The drug, a collaboration between Proteus and Otsuka Pharmaceuticals, combines the Proteus system with the antipsychotic pharmaceutical Abilify. “While we are disappointed in the FDA’s decision not to approve this digital medicine at this time, both Otsuka and...
By Aditi Pai April 20, 2016
Australia-based ResApp, a public company, has raised $9.74 million ($12.5 million Australian dollars) for its product, a smartphone-based system for diagnosing respiratory conditions. The company sold 62.5 million new ordinary shares at $0.16 ($0.20 AU) per share. ResApp’s offering essentially uses the smartphone microphone as a stethoscope to listen to a patient’s breathing. But instead of...
By Jonah Comstock April 13, 2016
As their famous rallying cry states, the patients behind the Nightscout project for creating a do-it-yourself mobile technology for diabetes management are not waiting for approval from the FDA. But that doesn't mean they aren't seeking it, or that they haven't been in contact with the regulatory organization to make sure Nightscout is as safe as it can be. In a new editorial published in the...
By Aditi Pai April 6, 2016
The Federal Trade Commission (FTC) has released a new interactive tool on its website, with help from the Office of National Coordinator for Health Information Technology (ONC), Office for Civil Rights (OCR) and the Food and Drug Administration (FDA), to help health app developers to determine whether certain regulations apply to their app. “Mobile app developers need clear information about the...
By Jonah Comstock April 5, 2016
Smartphone-based eye exams, the province of a growing number of digital health startups, has caught the attention of the American Optometric Association, who penned a letter to the FDA yesterday asking that the agency impose stricter guidance on Opternative, a smartphone-based eye exam startup that raised $6 million earlier this year. Politico first spotted the news. Opternative is registered...
By Jonah Comstock April 4, 2016
A smartphone-based system for diagnosing respiratory diseases achieved an accuracy of 89 percent in a recent clinical study of 524 pediatric patients conducted by the company at Joondalup Health Campus (JHC) and Princess Margaret Hospital (PMH) in Perth, Western Australia. Perth-based ResApp essentially uses the smartphone microphone as a stethoscope to listen to a patient’s breathing. But...
By Jonah Comstock February 9, 2016
Withings has added a new paid software feature to its Health Mate app, an algorithm called Hy-Result that will help patients analyze the blood pressure data they collect from Withings devices. “With cardiovascular disease being the leading global cause of death, accounting for 17.3 million deaths per year, everyday monitoring blood pressure becomes an increasingly important part of anyone’s...
By Jonah Comstock January 13, 2016
Neurometrix has received FDA clearance for a new smartphone-controlled version of Quell, its wearable for pain relief, the company announced last week. Like its predecessor, the device will use nerve stimulation to treat chronic pain by sending signals to the brain that cause it to release natural opioids. It's worn around the calf. “This 510(k) further advances Quell technology by allowing the...
By Aditi Pai December 2, 2015
Philosys has received an FDA 510(k) clearance for the Android version of its smart glucometer companion app, called Gmate Smart. The device now works with Samsung Galaxy S3, S4, and S5 devices that have an Android operating system 4.0 or higher as well as Apple iPhone, iPod Touch, and iPad with iOS version 5.0 or higher. Philosys received an FDA clearance for the iOS app last year, in August, but...

Editor's Pick