December 30, 2019
The back half of 2019 saw an FDA in the midst of a transition — both in terms of personnel and in digital regulation strategy.
On the former, the agency seems to finally be regaining its legs since the unexpected March resignation of its former head, Dr. Scott Gottlieb. After a rotating door of acting commissioners — consisting of Dr. Ned Sharpless from the National Cancer Institute and more...
July 23, 2019
A little over six months after the FDA moved its PreCert pilot along to the Test Plan phase, the agency released its Mid-Year Update on the program. At this stage, the original nine FDA PreCert pilot companies are now in the midst of test-driving the new Working Model. This means companies seeking to approve new products will go through the new PreCert pathway and the traditional review process...
July 15, 2019
This morning Teva Pharmaceutical Industries announced that the FDA greenlighted its AirDuo Digihaler, a sensor-enabled inhaler. The product, classified as a maintenance asthma inhaler, has a built-in sensor that sends usage data to a corresponding app on a user's smartphone. This information can also be sent to the user’s provider.
The sensor technology is also able to monitor inspiratory flow...
September 12, 2018
Brainstorming, smart design, and clinical validation are all vital steps toward the deployment of any new health technology, but without regulatory approval many of the most groundbreaking innovations will never have a chance to make an impact on patients and consumers.
In the US, these processes could see some shakeup in the future — FDA Commissioner Dr. Scott Gottlieb has been consistently...
September 11, 2018
Since new FDA Commissioner Scott Gottlieb announced the FDA precertification program, the agency has been moving full speed ahead to re-invent its process for clearing digital health products. Pre-Cert will emphasize a focus on evaluating “standards of excellence” for the company or firm, rather than focusing on specific products. The idea is that trusted shops will be able to iterate...
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...
March 27, 2018
Israel-based DarioHealth has been granted 510(k) clearance for a version of its Blood Glucose Monitoring System that, alongside the Dario app, is compatible with iPhone 7, 8, and X, according to a statement from the company.
“We’ve been working tirelessly to bring forth a solution that would meet the rigorous standards required to achieve the FDA clearance,” DarioHealth CEO and Chairman Erez...
April 24, 2013
By Bradley Merrill Thompson
Some technology companies are sitting on the sidelines, or just dipping their toes in the mHealth waters, out of fear of the unknown. Will FDA regulate this space? If we get into healthcare, will we get sued if someone breaks a finger nail using our app? Will the FTC come after us if we don’t have a bunch of clinical trials to support every claim we make? Will a...