FDA

By Jonah Comstock August 24, 2016
In June, the FDA offered up a draft guidance document designed to help medical device makers better understand how the agency thinks about a patient's right to access their own data from a device. The guidance clarified that medical device makers can make a patient's data available to them without additional clearance, though it cautioned them to do so thoughtfully to keep the data private and...
By Jonah Comstock August 23, 2016
The FDA has granted de novo clearance to two concussion assessment software products from ImPACT Applications. The Pittsburgh-based company developed its original software in the 90s for computers, though the clearance also includes ImPACT Pediatric, a newer version of the tests for children that runs on an iPad. "ImPACT's FDA clearance is a huge step forward for the industry, for athletes and...
By Jonah Comstock August 10, 2016
Senseonics, a Germantown, Maryland-based company working on a longterm implantable continuous glucose monitor, announced preliminary results from its US pivotal trial, a major step toward receiving premarket approval from the FDA, on the same day as the company's second quarter earnings call. "We are at a significant point of change for not only acceptance and utilization but the recognition by...
By Jonah Comstock August 9, 2016
The FDA's Center for Devices and Radiological Health has been busy over the last couple of months, releasing several draft and final guidances that affect the makers of apps and connected devices. Lack of regulatory clarity is often cited as a force hampering innovation in digital health, so these moves by the FDA toward greater clarity are likely to be welcomed in many parts of the industry....
By Jonah Comstock August 3, 2016
Dexcom’s biggest triumph and its biggest let down this quarter both involved the FDA. On the positive side, a verdict from a special FDA panel means Dexcom may soon be able to change its CGM’s intended use to replace fingerstick glucometers. On the negative side, a voluntary device recall this quarter that potentially affected all of Dexcom’s receivers led to higher-than-expected Q2 losses....
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....