FDA

By Jonah Comstock July 28, 2016
Companion Medical, a stealthy San Diego-based company that received funding last year from Eli Lilly and Company, has received FDA 510(k) clearance for its Bluetooth-connected smart insulin pen and associated mobile app, called InPen. "FDA clearance of the InPen and mobile app represents a significant advancement in diabetes care," CEO Sean Saint, a veteran engineer of Dexcom, Medtronic, and...
By Jonah Comstock July 27, 2016
Akron, Ohio-based Intellirod Spine, a sensor-enabled spine implant company, has raised more than $1 million in a round led by new and existing investors, including Queen City Angel First Fund V and JumpStart. Previous investors include the Kentucky Seed Capital Fund and the City of Akron, Ohio. Intellirod Spine is developing wireless sensors that will measure the strain being put on implanted...
By Heather Mack July 22, 2016
An FDA advisory panel has voted in favor of recommending a change to the intended use of Dexcom’s G5 Continuous Glucose Monitor (CGM). The G5 had already been FDA-approved, but with limitations as an adjunctive device, meaning it could only be used for tracking and trending interstitial fluid gluocose concentrations rather than as a full replacement for a traditional fingerstick blood glucose...
By Heather Mack July 21, 2016
We’ve compiled a list of our FDA-related coverage for first half of 2016. Eighteen companies received clearance for their devices, one was declined, and one group of patients published an editorial about their relationship with the FDA. Also this year, the FDA came out with some new guidance about how medical device makers should make data available to patients. Read on for our roundup of...
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...