April 16, 2020
The FDA released new guidance on digital health devices for treating psychiatric disorders that waives several regulatory requirements – such as need to submit a 510(k) premarket notification – for the duration of the COVID-19 emergency.
"Device availability may increase patient access to digital therapeutics while individuals are following 'stay at home' orders or practicing social distancing,...
March 27, 2020
Yesterday, Pear Therapeutics announced the regulatory clearance of Somryst, its prescription digital therapeutic for chronic insomnia. And while the product is noteworthy for these patients and Pear's broader business, it also stands as a major milestone for the digital health industry – the first product to be evaluated throught the FDA's Digital Health Software Precertification Program.
March 23, 2020
Last week saw a number of diagnostic testing startups, telehealth providers and others announce new services that would deliver at-home COVID-19 testing-kits to consumers. But the majority of these of offerings have since been rescinded or hang in doubt thanks to new warnings and regulatory clarifications issued this weekend by the FDA.
On Friday evening, the agency released an alert to consumers...
January 28, 2020
Update: HIMSS20 has been canceled due to the coronavirus. Read more here.
About the author: Naomi Fried, PhD, is the CEO of Health Innovation Strategies, which provides digital health strategy and innovation-program design and optimization consulting to healthcare stakeholders including pharma, payers and providers. Her previous positions include the first chief innovation officer at Boston...
December 4, 2019
Setting its sights on the European market, yesterday California startup VivaLNK announced that it landed a Class IIa medical device CE Mark for its multi-vital medical wearable sensor and software development kit.
Researchers and clinicians can use the technology to continuously stream a patient’s ECG rhythm, respiratory rate, heart rate, RR interval and three axis acceleration.
November 19, 2019
Device regulation is a hurdle for any medical tech company, but doubly so for startups hoping to strike it big with their very first digital health product. With limited resources and experience, pushing a device through the FDA’s door and onto the market is a multi-year gauntlet of validation, documentation and, unfortunately, frustration.
To help young companies take a bit of the guesswork out...
September 26, 2019
This morning the FDA released two guidance documents relating to the regulation of various digital health software devices.
The first is a draft guidance outlining categories of clinical decision support (CDS) products that would or would not require direct regulatory oversight from the agency. This is an update to a CDS draft guidance released in 2017, with the noteworthy addition of a risk-...
February 25, 2019
The FDA is taking a new approach to the regulation of digital medicine solutions.
“Digital tools are rapidly evolving, and to keep pace with its promising innovation, the FDA must modernise its approach to regulation,” FDA Commissioner Scott Gottlieb said in a statement at the beginning of the year.
The regulatory framework for the Software Precertification (Pre-Cert) Pilot Program has now been...
August 5, 2015
By Bradley Merrill Thompson
Healthcare in America needs disrupting. The media has widely reported on the high cost of, and poor outcomes produced by, the US health care system. Fortunately, attracted by possible profit in a market that currently constitutes over 17 percent of GDP, quite a few startups are anxious to do the needed disrupting. Indeed, innovators from many places outside of...
March 16, 2010
Within the healthcare chapter of the FCC's National Broadband Plan, which the agency published this morning, the FCC recommended that it work together with the FDA to clarify regulatory requirements and the approval processes for converged communications and health care devices. The FCC specifically pointed to mobile health apps, smartphone remote monitoring apps, point of care diagnostic...