Tidepool's diabetes management tool receives 510(k) clearance

Tidepool's diabetes management tool receives 510(k) clearance unknown

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, decreased or suspended based on the iCGM readings and predicted glucose values.

It can also recommend and deliver correction boluses when it predicts glucose values will exceed predefined thresholds.

Tidepool presents its app as a way to alleviate the burden for Type 1 diabetes patients six years and older who have to continuously check their blood glucose level.

The company said it has a development partnership with Dexcom, a company focused on developing and distributing continuous glucose monitors, and noted it will finalize agreements with other unnamed device partners.

"We are excited about the opportunities to make lasting change in the diabetes community," John Lister, Tidepool's COO, told MobiHealthNews in an email.

THE LARGER TREND

In 2017, Tidepool became one of nine companies to participate in the FDA's pre-certification pilot program, which focused on the safety and responsibility of firms and developers during the development process as opposed to a particular product, providing the possibility of negating the need for product-by-product regulation.

The company was the only nonprofit chosen to participate in the pre-cert program and did so alongside much larger companies like Apple, Samsung, Verily and Johnson & Johnson.

One year later, the diabetes management company scored a $6 million grant from Leona M. and Harry B. Helmsley Charitable Trust and JDRF to begin development of their now FDA-cleared app.