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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Spinal tech developer Spineology said today it won expanded FDA clearance for its Elite expandable interbody fusion system designed for spinal fusion procedures.
The Minneapolis, Minn.-based company said it won clerance for a narrower 10mm version of the device, as well as an extended indication allowing the device to be used with allograft bone. Read more
PQ Bypass said today it won CE Mark approval for 3 devices designed to treat patients with superficial femoral artery lesions due to peripheral artery disease.
The Sunnyvale, Calif.-based company said it won clearance for its Torus stent graft system, PQ Snare and PQ crossing device, all used in the company’s Detour procedure. Read more
Medtronic said today it won FDA 510(k) clearance for its next-gen Reveal Linq insertable cardiac monitor with TruRhythm Detection.
The Linq ICM with TruRhythm Detection offers exclusive algorithms which the Fridley, Minn.-based company said resulted in a 95% reduction in false bradycardia episodes and a 47% reduction in false pause episodes compared with the previous-gen version of the device. Read more
Johnson & Johnson’s Ethicon and DePuy Synthes said today they are launching customized wound closure kits designed for orthopedic surgery in the US.
The newly-launched kits include Ethicon’s Stratafix knotless tissue control devices and Dermabond Prineo skin closure system, which Somerville, N.J.-based Johnson & Johnson said allow for better customization during orthopedic procedures. Read more
Medtronic said today it won coverage from the US Centers for Medicare & Medicaid Services for its Micra transcatheter pacing system.
The Micra won reimbursement through Medicare’s policy of Coverage with Evidence Development, the Fridley, Minn.-based company said. Read more