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. Alere cuts outlook as it probes accounting snafu
Alere yesterday cut its outlook for the rest of the year and said it plans to filed its delayed annual report for 2015 “as soon as practicable” as it probes accounting snafus in Africa and China.
The Waltham, Mass.-based diagnostics giant said it now expects to post sales of $2.45 billion, down from its prior outlook for revenues of $2.48 billion to $2.50 billion. Read more
4. Medicare gets back on board with unique device identifier
The Centers for Medicare & Medicaid Services is on board with plans to create a unique device identifier for implantable medical devices, after years of resistance from the federal health insurer.
CMS had balked at implementing the FDA’s UDI program because of the cost and difficulty of integrating UDIs into electronic health records. Congress enacted the UDI law in 2007, intending to have the FDA use billing claims data with the UDI number to track medical device safety. Medtech companies began incorporating UDIs into their labeling in 2014. But CMS opposed the UDI plan, saying the project is too large and expensive to implement. Read more
3. Medtronic launches new oblique lateral spine tech
Medtronic said today that it’s launching several new components for its oblique lateral spinal fusion system.
Fridley, Minn.-based Medtronic said the Pivox system for its OLIF25 and Divergence-L for the OLIF51 system are slated to debut at the International Meeting on Advanced Spine Techniques in Washington this week. Read more
2. Report: Boston Scientific opens largest OUS R&D shop in India
Boston Scientific reportedly opened a new research & development facility in Gurgaon, India, today that is its largest R&D shop outside the U.S.
The 100,000-square-foot center, called the Institute for Advancing Science, also includes training and commercial facilities, according to the Business Standard. Read more
1. Survey: Medical device tax suspension boosts jobs, innovation
A survey of CEOs and board members at the Medical Imaging & Technology Alliance showed that the 2-year suspension of the medical device tax is resulting in increased hiring and more spending on research and development.
President Barack Obama in December 2015 signed into law an omnibus tax and spending bill that pauses the medical device tax for 2 years, hours after the U.S. Senate approved the $1.8 trillion measure on a 65-33 vote. The pause on the tax, a 2.3% levy on all U.S. sales of medical devices, is estimated to cost $3.4 billion, according to the Joint Committee on Taxation. The law also enshrined a research & development tax credit worth$113 billion over 10 years. Read more
