FDA names Flatiron Health’s Abernethy as deputy commish | Personnel Moves, December 19, 2018

December 19, 2018 By Brad Perriello Leave a Comment

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.”

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

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.

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.

Read more

MTD Micro Molding late president to be inducted into Plastics Hall of Fame
MTD Micro Molding this week announced that its late president Dennis Tully will be inducted into the Plastics Academy’s Plastics Hall of Fame. Tully is one of six posthumous inductees this year, who are elected by living members of the Hall of Fame after a screening process. “These new posthumous inductees proudly represent the length… […]
This neural implant can be both remotely charged and programmed
Engineers at Rice University’s Brown School of Engineering are touting the first neural implant capable of being programmed and charged remotely with a magnetic field. Kaiyuan Yang, Jacob Robinson, Zhanghao Yu and Joshua Chen collaborated to develop the integrated MagNI (magnetoelectric neural implant) microsystem, which could allow imbedded devices such as a spinal cord stimulator… […]
Integer shares up after Street-beating Q4
Integer Holdings (NYSE:ITGR) shares were up at close today on fourth-quarter results that topped the consensus forecast, despite a big dip in profits. The Plano, Texas-based company posted profits of $11 million, or 33¢ per share, on sales of $325.6 million for the three months ended Dec. 31, 2019, for a 57.2% bottom-line slide on sales… […]
These young medtech companies raised the most money in 2019
Medical device industry insiders may very well remember 2019 as the year that IPOs came back — but another sign that the U.S. economy has left the Great Recession far behind. Among the top investment deals in the space, half involved public offerings, according to the MoneyTree report from PricewaterhouseCoopers (PwC) and CB Insights. Total investments in… […]
Teleflex Medical OEM acquires medical tubing company
Teleflex Medical OEM (Wayne, Pa.), today announced the acquisition of IWG High Performance Conductors (HPC), a medical tubing and wire components manufacturer. The addition bolsters Teleflex Medical OEM’s position in the arena of custom-engineered medical devices and its ability to provide clients with technologies used in electrophysiology, drug- and stent-delivery and neurovascular interventions, according to… […]
Integer expands to Israel
Integer Holdings (NYSE:ITGR) today announced it has acquired medtech manufacturer Inomec, formally establishing its presence in Israel. The Plano, Texas-based company said the acquisition will enable it to create an R&D and sales center in the region and adds important catheter design, clinical and pilot manufacturing capabilities to its portfolio. “Acquiring Inomec strengthens our research… […]
Why non-magnetic capacitors matter in medical imaging
The quality of an MRI image depends on the homogeneity, or uniformity, of the magnetic field. Component material choice is paramount; even the smallest trace of magnetism inside an MRI scanner can disrupt the field and harm the quality of an MRI image. Peter Matthews, Knowles Precision Devices Magnetic resonance imaging (MRI) equipment uses a… […]
This heart valve can adapt as a child grows
Boston Children’s Hospital is touting a new design that could allow children to maintain the same prosthetic heart valve until adulthood, which could also benefit adults with heart valve defects. Current prosthetic heart valves implanted in children with congenital heart disease are fixed in size, which requires multiple open-heart surgeries during childhood to replace the… […]
Simulating Reality With 3D Printed Medical Models
The medical breakthroughs that cure disease, restore health and prolong life aren’t created in a vacuum. They rely on the convergence of visionary minds and cutting-edge technology. This case study explores how the Jacobs Institute is leveraging 3D printing technology from Stratasys® to elevate medical device innovation and training, using ultrarealistic anatomical models created by… […]
These ‘smart’ bandages could heal chronic woulds
UConn biomedical engineers are touting a wirelessly controlled “smart” bandage and corresponding platform for delivering medications to chronic, non-healing wounds. UConn’s School of Dental Medicine, School of Medicine and School of Engineering comprise the biomedical engineering department, which contributed to developing the smart bandage. Ali Tamayol, an associate professor at UConn, led the development of… […]
How to cook up a successful medtech company
New medical device companies need much more than money to get their businesses started. A medtech-specific accelerator can help with seed funding and positioning for a Series A round. Shai Policker, MEDX Xelerator As we dive into 2020, the medtech sector will continue to offer tremendous opportunity for innovators and investors alike, with growth projected… […]