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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5. CareFusion recalls IV sets on cracked back-check valves
Becton Dickinson subsidiary CareFusion recalled some IV sets today after reports that cracks in the secondary set back-check valve caused infusion fluid to leak. The company said the secondary sets are attached to a needle-free device that has been cleaned with isopropyl alcohol and CareFusion thinks that causes the plastic to crack.
Leakage in the back-check valve connection could unintentionally delay the start of infusion, expose patients to chemicals, cause under-infusion without an alarm or interrupt infusion, CareFusion reported. Read more
4. Hologic faces patent infringement suit from Minerva Surgical over NovaSure device
Hologic is facing a patent infringement suit from Minerva Surgical over patents related to its NovaSure Advanced endometrial ablation system.
Redwood City, Calif.-based Minerva filed a complaint in federal court in San Francisco yesterday, and said it could seek an injunction to block the US sales of the NovaSure Advanced system, which is designed to treat heavy menstrual bleeding. Read more
3. Smithfield to explore pig-human transplants
The world’s largest pork producer, Smithfield Foods, has reportedly launched a bioscience unit to expand its role in supplying pig parts for medical uses. The unit’s ultimate goal is to sell pig organs for transplantation into humans.
Although pig-human organ transplants are years away, recent scientific advances are helping scientists overcome obstacles that halted prior attempts to use pigs to supply replacement parts for sick or injured patients. Read more
2. Report: Apple taps biomed engineers for stealthy diabetes program
Apple reportedly tapped a roster of biomedical engineers to develop non-invasive continuous glucose monitors in a secret program that was the brainchild of its late founder Steve Jobs.
The 5-year-old effort has progressed to feasibility studies and Apple has also hired regulatory consultants, CNBC reported, citing “3 people familiar with the matter.” Jobs, who died in 2011, wanted to create wearable devices like the Apple Watch that could monitor vital signs including blood glucose levels. The stealthy glucose project involved about 30 people as of a year ago, the network reported, and is centered on optical sensors. Read more
1. FDA warns Abbott on St. Jude Medical plant in California
The FDA yesterday issued another warning letter about a St. Jude Medical plant in California, now owned by Abbott, that makes cardiac rhythm management products.
It’s at least the 2nd time the federal safety watchdog has flagged the plant in Sylmar, which makes defibrillators and the Merlin home cardiac monitor. In 2012 the FDA slapped St. Jude with a warning letter over problems with the manufacture of its Durata defibrillator leads; that letter was closed out in July 2014. Abbott paid $25 million earlier this year to acquire St. Jude. Read more
