Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.
3. TransEnterix puts up $100m for Sofar’s ALF-X robot-assisted surgery device
TransEnterix said that it acquired the Telelap ALF-X robot-assisted surgery device from Italy’s Sofar SpA in a deal worth $99.8 million.
The Telelap ALF-X device has CE Mark approval in the European Union for minimally invasive surgery procedures. Research Triangle Park, N.C.-based TransEnterix makes the SurgiBot robot-assisted surgery device. The deal included $25 million in up-front cash and some 15.5 million TRXC shares worth another $43.7 million, the companies said. Another $31.1 million (€27.5 million) is on the line in potential milestones, according to the companies. Read more
2. Medtronic launches real-world study for SuperDimension lung device
Medtronic said that it launched a huge, real-world study of the SuperDimension lung device it acquired along with Covidien earlier this year.
The 2-year, 2,500-patient Navigate trial is designed to evaluate the performance of the LungGPS electromagnetic navigation bronchoscopy technology the SuperDimension device uses to navigate the lungs. The single-arm, multi-center post-market observational study also aims to measure how often doctors use the system to obtain biopsies from surrounding lymph nodes and place markers to guide future procedures, Medtronic said. Read more
1. Essure complaints spike nearly 1,400% in 3 years
The FDA logged a nearly 1,400% spike in complaints filed over the Essure permanent female sterilization treatment made by Bayer, according to a review released ahead of an FDA advisory panel meeting this week.
Essure, the only approved permanent birth control device in the U.S., is a small metal coil that is placed in the fallopian tubes via catheter. The FDA approved the device in November 2002. Read more