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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Medical device accelerator the Global Center for Medical Innovation has issued its 1st grant to Linear Health Sciences, developer of the Orchid safety release valve designed to prevent dislodgment of IVs.
The Oklahoma City-based company said it is developing safety release valves for a variety of medical tubing. It’s 1st product, the Orchid SRV, is designed to prevent unwanted dislodgements of IVs to reduce the potential for infections, infiltrations and phlebitis, as well as improving IV integrity and customer satisfaction. Read more
Humacyte said today that the FDA granted its investigational human acellular vessel, Humacyl, the regenerative medicine advanced therapy designation. The regulatory win means that the FDA will expedite its review of the HAV for patients in need of life sustaining hemodialysis.
The designation is new and follows the model of other FDA programs such as the breakthrough therapy designation. Read more
InVivo Therapeutics said today it submitted its 1st nonclinical study model to the FDA as part of its humanitarian device exemption submission for its neuro-spinal scaffold.
The neuro-spinal scaffold is designed to be surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting, the Cambridge, Mass.-based company said. Read more
NuVasive Inc. said today that the U.K.’s National Industry for Clinical Excellence issued updated guidance which supports the use of lateral interbody fusion in the lumbar spine, including its eXtreme Lateral Interbody Fusion procedure.
The San Diego-based company touted that the majority of the evidence submitted to NICE to support the guidance change came from peer-reviewed journal articles covering over 14-years of data from the company’s XLIF procedure. Read more
Abbott released 1-year outcomes from the largest study to-date of real-world experiences for its MitraClip system in transcatheter mitral valve repair procedures in the US at the ACC 2017 annual meeting.
The Abbott Park, Ill.-based company’s MitraClip was designed to treat patients with degenerative mitral regurgitation who were not eligible for surgery to repair or replace the mitral valve. Read more