Global Device Approvals, Weekly Snapshot: July 9-15, 2018
A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. This week, Stryker gets a go-ahead to enter the US flow diverter/aneurysm market, and nine CE marks are highlighted.
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Purchase of Surpass Medical for $135 million represents Stryker’s 10th acquisition since 2009. The company affirmed its acquisition strategy focused on core and key adjacent markets during its Oct. 17 earnings call, but also sought to ratchet down earnings growth expectations in the near term to account for headwinds, including the upcoming U.S. medical device excise tax.
NWW: Studies Back Nevro Pain Treatment, FTC Blesses Resonetics Nitinol Deal, Genetic Test Identifies Best RDN Patients
This week, studies supported Nevro’s spinal cord stimulation therapy and a VRx system that helps reduce pain; the American Medical Association found inconsistent insurance coverage of digital therapeutics; and Geneticure announced a cheek-swab test to identify which patients are most likely to benefit from renal denervation.
Relievant’s Intracept intraosseous nerve ablation system is the only FDA-cleared neuromodulation device indicated to treat vertebrogenic pain. Boston Scientific will pay $850m for Relievant, plus undisclosed milestone payments over the next three years.