FDA

By Bradley Merrill Thompson April 11, 2018
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. Since the Medical Device Amendments of 1976, a hallmark of FDA’s regulation of medical devices has been the agency’s risk-based approach....
By MobiHealthNews April 6, 2018
In the last quarter the FDA gave the nod to 10 digital health devices. Innovations that aimed to help diabetes management were popular, ranging from the first integrated continuous glucose monitor, which was put out by Dexcom, to Glooko’s insulin titration tool.  Not all FDA news this quarter was good news. In February Roche’s Accu-Check Connect Diabetes Management App was recalled by the FDA for...
By Jonah Comstock April 3, 2018
Malay Gandhi, best known as the former CEO of Rock Health, has joined Evidation Health as SVP of Business Operations. Evidation Health cofounder and President Christine Lemke announced the hire in a tweet, saying "This makes me so happy. After years of helping @evidation from the outside, @malayhgandhi joins the team full time. Welcome!" Gandhi and Lemke also work together as the founding...
By Dave Muoio April 2, 2018
Smart inhaler company Adherium announced last week that it has received 510(k) clearance for over-the-counter sales of its inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler, called the SmartTouch for Symbicort. Adherium — which is headquartered in San Mateo, California, but holds currently offices in Melbourne, Australia; Auckland, New Zealand; and Amstelveen, The Netherlands...
By Laura Lovett March 28, 2018
Yesterday Dexcom got the nod from the FDA to market their Dexcom G6, an integrated continuous glucose monitoring system (iCGM), making it the first interoperable CGM to get the designation.  “We are a company of firsts, almost everything that has been done in our industry has been done by us first,” Dexcom CEO Kevin Sayer told MobiHealthNews, citing that Dexcom was the first company to have a...
By Laura Lovett March 27, 2018
The healthcare innovation industry is a multifaceted ecosystem: From the energetic new startup developing a product and the venture firm backing it, to the FDA regulating the new invention, there are plenty of forces working in concert. At The Economist’s Healthcare Forum in Boston today, healthcare industry leaders discussed the balancing act of working with key players in this system.  “It is a...
By Dave Muoio March 23, 2018
The FDA has launched a free mobile app version of its Drugs@FDA online database that offers consumers information on agency-approved drugs. The new app, called Drugs@FDA Express, is free and currently available for download on iOS and Android. “The FDA is continuously seeking ways to bring information to consumers in more accessible formats,” FDA Commissioner Dr. Scott Gottlieb said in a...
By Jonah Comstock March 15, 2018
Opternative, a Chicago-based purveyor of online and mobile refractive eye exams, received a warning letter from the FDA last fall. The October 30 warning letter was only recently made public by the agency. Addressed to then-CEO Aaron Dallek (Opternative named a new CEO, Brent Rasmussen, in January), the letter makes it clear that it considers Opternative's online eye exam to be a mobile medical...
By Dave Muoio March 13, 2018
A recently released analysis report from the Deloitte Center for Government Insights that examines the US’s current and proposed software as a medical device (SaMD) regulatory landscape, and includes suggestions on how the FDA’s pre-certification pilot program and other initiatives could better serve this fast-moving industry. “The exponential advancement of digital health technologies presents a...
By Jonah Comstock March 12, 2018
Medtronic has finally received FDA clearance for Guardian Connect, its smartphone-connected standalone CGM for patients who use multiple daily injections (MDI) for their insulin. Medtronic's closed-loop system for pump users was cleared in 2016. "Despite proven benefits and advances in technology, only a minority of insulin-using people with diabetes currently use continuous glucose monitors (CGM...