“The departure of Scott Gottlieb from the U.S. Food and Drug Administration on Tuesday is a potential blow to Silicon Valley,” Christina Farr reports for CNBC. “In his two years as commissioner of the FDA, Gottlieb, a doctor and former venture capitalist, gained a reputation as a proponent of health-care innovation, including pharmaceutical companies bringing new drugs to market.”

“He helped to establish a digital health software program called Pre-Cert to provide a way for tech companies like Apple and Samsung to get quicker approval for low-risk health products,” Farr reports. “Last September, Apple received clearance to market an electrocardiogram app and sensor on its Apple Watch, the company’s biggest move into the health-care market. Gottlieb issued a statement at the time to encourage Apple and other tech companies to push into health care, especially if they could help consumers engage more proactively with their health.”

“Robin Goldstein, who worked on Apple’s health team before stepping down in late 2017, said Gottlieb’s efforts were applauded in the tech sector,” Farr reports. “In his resignation letter to Health and Human Services Secretary Alex Azar, Gottlieb didn’t say why he was leaving. President Trump sent two tweets announcing [Gottlieb]’s departure, but didn’t say what spurred the change.”

Read more in the full article here.

MacDailyNews Take: Hopefully, Gottlieb’s replacement will be just as, or even more, amenable to Apple’s future low-risk health products.

More info about the U.S. FDA’s Digital Health Software Pre-certification (Pre-Cert) Program here.

More info about the U.S. FDA’s Digital Health Innovation Action Plan here.

Apple Watch Series 4 ECG should pave way for more medical gadgets, U.S. FDA says – September 20, 2018
U.S. FDA selects participants, including Apple, for new digital health software precertification pilot program – September 26, 2017