FDA

By Heather Mack April 7, 2017
In a true first, the Food and Drug Administration is allowing 23andMe to sell its direct-to-consumer genetic test kits that provide information about an individual’s risk to certain diseases such as Alzheimer’s or Parkinson’s disease. 23andMe’s $199 genetic tests are available with the FDA’s blessing nearly three and a half years after the agency first ordered 23andMe to immediately stop selling...
By Jonah Comstock March 31, 2017
The health subcommittee of the House Energy and Commerce committee met this week to question Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, about the medical device user fee amendments (MDUFA). MDUFA is an agreement between the FDA and industry in which the FDA agrees to do certain things in return for industry groups supporting the agency’s work by paying fees...
By Heather Mack March 31, 2017
In the first quarter of 2017, we tracked seven digital health-related FDA clearances. While the list isn’t long, it’s varied and relatively novel – from app and device integrations for diabetes treatment to a vest that maps cardiac rhythms. The beginning of this year also rang in some big changes, as the Trump Administration took root and nominated Dr. Scott Gottlieb as FDA deputy commissioner....
By Jonah Comstock March 15, 2017
The FDA is considering the creation of an Office of Patient Affairs, focused on soliciting the perspectives of patients and taking those insights into account as it sets regulatory policy. The move grows out of a provision in the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law by President Obama in 2012. FDASIA instructs the HHS secretary to  "develop and...
By Jonah Comstock March 13, 2017
Telemedicine company Teladoc has added a new position, executive vice president and chief revenue officer, and has tapped Peter Nieves for the role. Nieves was previously the EVP of employer markets at Optum, where he built that business up to be worth more than $1 billion according to a release from Teladoc. “Successfully advancing to the next level is always reliant on having the right people...
By Jonah Comstock March 13, 2017
With previous rumored Trump picks to lead the FDA, we’ve had to rely on speculation to gauge their approach to mobile and digital health. Not so with former FDA deputy commissioner Dr. Scott Gottlieb, Trump’s final pick as of Friday.  Gottlieb, who will still have to be confirmed by the Senate, has made his feelings about mobile health regulation very clear. In 2014, he co-authored a piece for...
By Heather Mack March 10, 2017
Former FDA deputy commissioner Dr. Scott Gottlieb is the rumored choice to head the agency, with the full nomination expected by the end of the day. Like most of the Trump Administration’s other high-office picks, Gottlieb is known for his anti-regulatory stance and is in favor of speeding up the drug-approval process, especially for older generics. Considered more mainstream than earlier choices...
By Jonah Comstock March 10, 2017
Medical device maker Zoll Medical Corporation has received FDA premarket approval for a wearable external defibrillator for use in the hospital. Zoll got approval last year for its LifeVest, a similar product designed for home use. "The HWD [Hospital Wearable Defibrillator] offers hospital care teams a new option for managing patients at risk of VT/VF by providing continuous protection even...
By Jonah Comstock February 27, 2017
EpiWatch, the Apple Watch-based ResearchKit study on epilepsy led by Johns Hopkins, shared some early results at a conference last week. The results shared were of 598 participants over 10 months who used the app to track their seizures and provided information to researchers about what was happening before the seizure struck. The most common trigger, named in 37 percent of cases, was stress....
By Jonah Comstock February 16, 2017
A Swiss medical device company is working on a medically accurate sensor, built into a smartphone, that could return results about heart rate, respiration rate, blood oxygenation, temperature, and -- the use case the company is initially focusing on -- blood pressure. Leman Micro Devices (or LMD or Elemdy) is beginning trials now to simultaneously submit the device for regulatory clearance with...

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