Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com’s coverage highlights our seven biggest and most influential stories from the week’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else this weekend, make sure you’re still in the know with MassDevice +7.
7. CardioMEMS CEO on FDA’s Champion ruling
CardioMEMS CEO Jay Yadav comments on the FDA ruling that failed to confirm that the benefits outweigh the risks of a his company’s implantable heart pressure monitor. The ruling cast a shadow on St. Jude Medical’s potential $375 million buyout.
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6. TFX sells aerospace arm
Teleflex Inc. completed the $280 million sale of its aerospace business to a subsidiary of AAR Corp. (NYSE:AIR) as it takes steps toward becoming a pure-play medical device maker.
5. iPhone glucose meter wins FDA clearance
Sanofi’s iPhone glucose meter, the iBGStar, landed 510(k) clearance from the FDA, making it the first iPhone glucose meter to win a nod from the federal watchdog agency.
4. MassDevice Q&A: Joe DeVivo
The newly minted CEO of AngioDynamics on his unique family business background, the importance of good neighbors and the company’s path along the mergers & acquisitions trail.
3. Former Philips manager charged with taking bribes
Federal prosecutors charged former Ohio Philips Healthcare facilities manager Pat Boyce, 63, of accepting bribes from a local construction company.
2. FDA recalls Draeger’s Infinity system
Draeger Medical’s Infinity Acute Care patient monitoring system got a Class I recall from the FDA over concerns that its weight-based drug dosage calculator may recommend up to ten times more than the indicated dosage.
1. CMS targets "unnecessary" med-tech
The Centers for Medicare & Medicaid Services unveiled a pre-reimbursement review program in 11 states, asking docs to provide up-front justification for certain medical equipment and types of claims.