MassDevice.com +3 | The top 3 medtech stories for December 1, 2015

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. FDA: PMA approvals hit record high in fiscal 2015

The FDA this month said it approved a record 98% of the pre-market approval applications submitted for medical devices during fiscal 2015, its highest rate for the last 15 years.

The federal safety watchdog said it approved 86% of the PMAs submitted in fiscal ’14. The rate for the ’15 year, which ended Sept. 30, is the FDA’s highest PMA approval rate since 2001. Read more

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2. Nevro beats Boston Scientific’s patent challenges

Nevro Corp. yesterday beat a pair of challenges to 1 of its patents by Boston Scientific, after the U.S. Patent & Trademark office declined to institute inter partes reviews.

Nevro’s Senza device, which won pre-market approval from the FDA in May, is designed to deliver up to 10,000Hz to the spinal cord, allowing it to avoid the tingling sensation known as paresthesia that bothers some patients. The FDA allowed the company to label the device as superior to other spinal cord stimulators, including some made by Boston Scientific. Read more

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1. FDA: Class II recall for Medtronic’s InSync III pacemakers

A battery longevity issue prompted Medtronic this month warn doctors about some 96,787 of its InSync III pacemakers, an action the FDA labeled a Class II recall, although Medtronic said only about 22,000 of the devices are still active.

The Fridley, Minn.-based medical device titan sent a letter to physicians dated November 2015, warning that a high battery impedance issue “can result in the battery’s inability to supply sufficient electrical current.” Through Oct. 27, 30 devices of 0.03% were confirmed to have experienced the issue, Medtronic said, noting that it’s impossible to predict which of the InSync II devices, which are no longer distributed, might be affected by the battery problem. Read more

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