Tarver Will Take Reins At FDA’s Medical Device Division
Dr. Michelle Tarver, an ophthalmologist with a background in epidemiology, will lead the unit that reviews products key to medical diagnosis and surgery. Also in the news: legacy medical devices, wheelchair repairs, and more.
The New York Times:
FDA Names A New Chief Of Medical Devices
The Food and Drug Administration on Tuesday announced that Dr. Michelle Tarver, an agency veteran, will be the new director of the medical device division. Dr. Tarver will face a slate of pressing tasks, that include addressing calls to strengthen standards to protect the public from issues like racial bias in artificial intelligence software and hastily authorized and faulty cardiac devices, like external defibrillators. (Jewett, 10/22)
MedTech Dive:
Legacy Medical Devices Keep Regulators Up At Night
New regulations are designed to ensure future devices are secure, but one thing still keeps regulators up at night: legacy medical devices, or machines that have outdated or unsupported software. Many legacy devices or systems are currently in operation in hospitals. They perform as intended but may have outdated operating systems, which can present cybersecurity vulnerabilities, said Suzanne Schwartz, director of the Office of Strategic Partnerships and Technology Innovation at the Food and Drug Administration’s device center. (Reuter, 10/17)
The Boston Globe:
Mass Offers Financial Rewards For Quick Wheelchair Fixes
Wheelchair users are applauding new state regulations that address painfully long wait times for wheelchair repairs but worry the initiatives don’t go far enough to ensure people will no longer be immobilized for weeks or months as they await urgent fixes. “The people who are doing the repairs do need to put more effort into this service,” said Rich Levasseur, a wheelchair user from Tewksbury who spoke at a virtual public hearing Monday about the new regulations. “People can’t be without a repair for months at a time. It’s cruel and inhumane.” (Laughlin, 10/22)
The San Diego Union-Tribune:
Global Medical Technology Firm Shifts Some Of Its California Manufacturing To Mexico
CareFusion, a San Diego company that produces health care tools and technology, is relocating its San Diego manufacturing operations to Tijuana, in addition to conducting some layoffs. Together, the two moves will impact about 180 local jobs. The Sorrento Valley-based company is a subsidiary of New Jersey’s medical technology giant BD, or Becton Dickinson and Company. BD acquired CareFusion in 2014 for $12.2 billion. (Rocha, 10/22)
Medical Device Network:
Oxford Medical Products Touts Positive Safety Data For ‘Mechanical’ Weight Loss Pill
The surge of popularity of weight loss drugs has created a rivalry with traditional device orientated approaches, but a new technology aims to tread a fine line in between. Oxford Medical Products has developed a pill that works not by pharmacological activity, but by mechanical intervention. The UK-based company calls its product Sirona – and the device has just produced positive data in a first-in-human clinical study. The pill, made of inert dual-polymer hydrogel, works by expanding once in the stomach to occupy space and mechanically suppress appetite via distension on the stomach wall. The device remains in the stomach for several days and provides a continuous reduction in appetite. (Barrie, 10/22)
