Nonprofit diabetes management startup Tidepool received 510(k) clearance for its Tidepool Loop, an automated insulin dosing app that can enable insulin delivery from a compatible Apple Watch.
The app can be used with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled pumps. An algorithm helps users determine whether basal insulin delivery should be increased...
Diabetes management startup Tidepool has just locked in a $6 million grant from the Leona M. and Harry B. Helmsley Charitable Trust and JDRF in order to kick off develop an app for hybrid closed-loop automated insulin delivery.
Eventually the company plans to bring the software to market as an FDA-regulated mobile app. Right now the plans are to build an app that is specifically designed to help...
Attendees to the Connected Health Conference in Boston this week got a sneak peek into the workings of the FDA's much-discussed Pre-Cert program. In a panel discussion at the event, representatives from Verily, Pear Therapeutics, Tidepool, and Johnson & Johnson candidly discussed their experiences so far with the program, describing an evolving process that is collaborative and rigorous.
"...
Evidation Health is teaming up with Tidepool to launch a connected device-powered study of nocturnal hypoglycemic events in people with Type 1 diabetes.
The research is novel in that connected devices — including Dexcom continuous glucose monitors, an Emfit sleep monitor, and a WHOOP activity tracker — will allow researchers to access data about overnight low blood sugar events that previously...
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...
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...
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...
