By Dave Muoio 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...
By Jonah Comstock 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...
By Jonah Comstock September 22, 2017
Continuous glucose monitoring company Dexcom, which already allows users to monitor their CGM data on their phones and Apple Watch, is now making some patient data available to third parties via an API. "If you look back at the past when our hardware was all proprietary, we’ve evolved from that to an app company where our CGM now works as an app on the phone," Dexcom CEO Kevin Sayer told...