January 15, 2018
Last September, Tidepool — a diabetes data management platform — was among the nine companies chosen to participate in the FDA’s experimental pre-certification program pilot. Along with Apple, Samsung, Verily, Johnson & Johnson, and others, Tidepool would work with the agency to prove its overall development processes are responsible and safe, negating the need for product-by-product...
November 2, 2017
On Fitbit’s third quarter earnings call yesterday, the company shared that, between spending cuts and the launch of the its long-awaited smartwatch, the company is pulling out of the earnings slump it’s been experiencing. The call also saw CEO James Park talking more than ever about the fitness wearable’s clinical applications and the ways in which those ambitions are coming to fruition.
September 26, 2017
Just two months after announcing the applications for its pre-certification program pilot, the FDA has announced the nine companies that will be participating. The list includes major tech companies Apple and Samsung; health tech companies Verily, Pear Therapeutics, Tidepool, and Phosphorus; pharmaceutical companies Roche and Johnson & Johnson; and Fitbit — an interesting inclusion insofaras...
July 27, 2017
The FDA is moving forward surprisingly quickly with its plan to create a pre-certification program for digital health app developers, originally announced in a blog post by new FDA Commissioner Dr. Scott Gottlieb last month. Now the agency has opened up applications for a nine-company pilot program to develop the program.
The basic goal of the Pre-Cert program, which sets it apart from previous...