The FDA this week named Amy Abernethy, the chief medical officer for Roche subsidiary Flatiron Health, as principal deputy commissioner to replace Rachel Sherman, who is retiring in January.

“She’s a highly regarded thought leader who has held numerous positions of leadership in her fields of interest and distinguished herself for her intellect, her passion for patient care and science, and her collegiality,” FDA commissioner Dr. Scott Gottlieb wrote in a staff memo, according to Forbes.

“In my wildest dreams, I wouldn’t have imagined Scott could come up with somebody this highly qualified,” added former commissioner Dr. Robert Califf, who the magazine described as a mentor of Abernethy’s. “So I think it’s really good for the country. I’m really excited about it.”

“I had always thought I would go into government service, and I have always believed that one of the ways you make change is through policy and regulation,” Abernethy said. “The more we have precision medicine the more it means we stop doing things that don’t work.

“This is not my chance to solve the set of problems I think are important,” she says. “It’s a chance to spend 100% of my time solving problems that are important for human health,” she told the magazine.

Abernethy said she would accede to FDA conflict-of-interest rules regarding her role at Flatiron.

“I happen to be a methods expert in data, that is what my expertise is in, full stop. As the issue is how to use data, you would argue that Flatiron is a data company and FDA is a data agency,” she said. “I will follow the rules.”

 Livongo taps ex-Cerner prez Burke as CEO

Livongo Health said it tapped former Cerner (NSDQ:CERN) president Zane Burke as CEO, replacing Glen Tullman, who’s slated to become chairman.

“Zane spent two decades building relationships with the top health systems in the world. He knows the healthcare challenges facing employers, providers, and those with chronic conditions,” Tullman said in prepared remarks. “Livongo is growing rapidly with significant opportunities on the horizon. I believe Zane is the perfect person to take the Company to the next level and to lead Livongo through this period of rapid expansion.”

“With six in ten people living with a chronic condition, the time is right for Livongo’s experiential, fresh approach to improving the quality of life and the health status of people who live with these conditions,” Burke added. “As CEO, my focus will be working with this incredible team to grow the company so that we can create better health and care experiences for our Members, and more appropriately manage the resources consumed in managing those conditions for anyone paying for that care.”

Livongo also said it promoted chief medical officer Dr. Jennifer Schneider to president.

“The opportunity to partner with Jenny and the rest of the Livongo executive team to build on the success Livongo has enjoyed to date is something I’m very much looking forward to,” Burke said in a press release.

“I’m excited about the possibilities in front of us as the leader in applied health signals,” Schneider added. “The marketplace is recognizing our differentiated offering, and we’re now serving more than 600 of the largest, most innovative self-insured employers in the U.S., the two largest pharmacy benefit managers and a growing number of payers and health services organizations. As we rapidly grow our business and build new capabilities, we are able to aggregate and interpret more data on more conditions, and deliver actionable, personalized and timely health signals to more and more people with chronic conditions empowering them get and stay healthy.”

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 iCad makes it official with interim CEO Klein

The board of directors at iCad (NSDQ:ICAD) made it official with interim CEO Michael Klein last week, removing the “interim” from his title.

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 Italian TMVR firm InnovHeart names Bottiglieri as CEO

Milan-based transcatheter mitral valve replacement developer InnovHeart said it named Jason Bottiglieri as CEO, with founder & CEO Giovanni Righini continuing as CTO and director.

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 CLSA names Guerra to succeed Radcliffe as CEO

The California Life Sciences Assn. said yesterday that it appointed Mike Guerra to succeed Sara Radcliffe as president & CEO effective Jan. 7, 2019. Radcliffe is departing to pursue “new opportunities,” the association said.

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• Bovie Medical, soon to be Apyx Medical, names Semb as CFO
• NorthStar Medical Technologies taps Estrem for CFO
• Rox Medical appoints Sackner-Bernstein as CMO, clinical & regulatory EVP
• Ra Medical names Fogarty chief commercial officer
• LeClair tapped for Glytec outpatient GM
• Avanos Medical catches Ball as supply & procurement SVP

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