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. Medtronic wins extended FDA indication for bone cement
Medtronic said today that it won 510(k) clearance for its Kyphon Xpede bone cement for the fixation of pathological fractures of the sacral vertebral body using sacral vertebroplasty or sacroplasty.
The regulatory win expands the product’s original indications beyond treating vertebral fractures due to osteoporosis, cancer or benign lesion. Read more
4. Senate confirms Verma to head CMS as debate intensifies over Obamacare replacement
The U.S. Senate voted yesterday 55-43 to confirm Seema Verma to head the Centers for Medicare and Medicaid Services.
Verma is the founder & CEO of SVC Inc, a healthcare consulting firm, and worked with now-Vice President Mike Pence when he was governor of Indiana to redesign the state’s Medicaid program. Read more
3. Medtronic wins expanded FDA indication for Melody TPV
Medtronic said today it won extended FDA approval for its Melody transcatheter pulmonary valve, now indicated for implantation in patients whose surgical bioprosthetic pulmonary heart valves have failed.
The Fridley, Minn.-based company touted the Melody TPV as the 1st transcatehter pulmonary valve to win such an indication from the federal watchdog. Read more
2. AdvaMed throws support behind Trumpcare bill
Medtech industry lobbying group AdvaMed has split from other medical associations and thrown its support behind the newly drafted GOP healthcare bill looking to repeal and replace Obamacare, according to the Boston Globe.
AdvaMed is supporting the bill mainly as a way to eliminate the 2.3% tax on medical device sales initially imposed to help cover costs in Obama’s ACA bill, according to a Boston Globe interview with chief advocacy officer J.C. Scott. A hold on the 2.3% tax on U.S. medical device sales went into effect at the beginning of 2016 and is slated to expire by the end of this year. Read more
1. Stryker launches Mako robotic platform total-knee application
Stryker said today it launched the robotic-arm assisted total knee arthroplasty application for use with its Mako System, touting it as the 1st and only robotic technology which can be used for total knee, hip and partial knee replacement procedures.
The Kalamazoo, Mich.-based company’s Mako Total Knee utilizes both Stryker’s robotic platform and its Triathlon Total Knee System, guided through CT-based 3D modeling of bone anatomy which allows physicians to create personalized surgical plans for each patient’s anatomy. The system also allows for intra-operative planning and assists in bone resectioning procedures, Stryker said. Read more
The post MassDevice.com +5 | The top 5 medtech stories for March 14, 2017 appeared first on MassDevice.
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