![]() "I'll try not to overdo it, but I think it's a big deal," said D-Dad Howard Look, founder of Tidepool, a nonprofit open data startup selected for the pilot. Indeed, if you look at the list, diabetes is definitely in focus. The other two companies selected for the FDA pilot program are Pear therapy in Boston, designing prescription digital health tools for a variety of conditions, and phosphorus In New York, a biochemical company focused on the human genome and related software and data platforms. Verily (formerly Google Life Sciences): Google's health spin-off, best known in diabetes, has teamed up with Dexcom to develop a next-generation penny-sized CGM sensor.Tidal pools (puddles left on coastal reefs after low tide): The Palo Alto nonprofit startup emerged in 2014, changing the conversation around open-D data and creating a new way to upload various diabetes devices to a single hub in the cloud.Samsung: South Korea-based consumer electronics giant has become active in healthcare, including with Medtronic for next-generation smartwatch connectivity, including CGM data displays.rock: Like J&J, it's not just about diabetes, but important given Accu-Chek Connect's growth over the years and its recent acquisition of the mySugr platform for diabetes data.Johnson & Johnson: Its OneTouch, LifeScan and Animas products clearly have a long-term presence in diabetes (although the company has "strategically assessed" the future of these divisions).Fitbit: A smartwatch and health tracking company that recently partnered with Dexcom, as well as Medtronic and others in healthcare and diabetes apps.Apple: The giant behind the iPhone, iPad, Apple Watch and HealthKit, which recently pushed its foray into diabetes.Notably, for our diabetes community, seven of the nine companies have a direct relationship with diabetes: Today, the FDA has selected nine companies (out of more than 100 applicants) under the initial pilot program. In late July, the agency announced pre-certification of a software pilot program that would rate certain companies and qualify them as "trustworthy," giving their products the regulatory green light they needed without the need for approval. The FDA is looking to change the way it reviews mobile apps and digital health software in what can only be described as a pretty groundbreaking move to speed up the regulatory process and get these products in front of people so they can get started.
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