Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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The FDA today announced that it reclassified Levita Magnetics’ magnetic surgical system, cleared for gallbladder removal surgeries, as a Class II device.
The system is designed to retract and maneuver the gallbladder using magnetic fields, which the San Mateo, Calif.-based company said “reduces the number of incisions” necessary for the procedure and prevents damage to the abdominal wall. Read more
Researchers at the VTT Technical Research Centre of Finland have reportedly created an app and a thumb-sized device that can detect irregular heartbeats and prevent cerebral infarctions at an early stage.
The Android-compatible app Beat2Phone can identify individual heartbeats, the interval of time between heartbeats, and detect when the user is under stress. The device also includes position and activity sensors. Read more
W.L. Gore & Associates yesterday released 1-year data from a Japanese study of its Viabahn stent graft, touting a nearly 90% primary patency rate at 12 months.
Data comes from a 103-patient single-arm study which enrolled a “challenging patient population” with lesions greater than 10cm, Newark, Del.-based Gore said. Read more
The FDA, in association with the Duke Margolis Center for Health Policy, released a report yesterday establishing guidelines for the development of the National Evaluation System for health Technology.
The NEST aims to operate as a “cooperative network of partners working to use data, advanced methodologies, and good governance to improve the state of medical device evidence generation,” according to a release from the Duke Margolis Center for Health Policy. Read more
A U.S. House committee launched a probe of the FDA’s criminal office, raising questions about the unit’s management and handling of cases involving devices, food and drugs.
The U.S. House Energy & Commerce Committee told FDA commissioner Dr. Robert Califf that it’s “examining management concerns” and “possible morale concerns with the field offices” of the federal safety watchdog’s Office of Criminal Investigations. The Sept. 20 letter, signed by committee chairman Rep. Fred Upton (R-Mich.) and Rep. Tim Murphy (R-Pa.), chairman of the subcommittee on Oversight & Investigations, seeks answers to a detailed list of questions by Oct. 12. Read more