MedCAD’s AccuStride receives US FDA 510(k) clearance
Dallas-based MedCAD received U.S. Food and Drug Administration (FDA) 510(k) clearance of its AccuStride Foot and Ankle System. The unique design of these devices, coupled with the company’s proprietary software, will enable foot and ankle surgeons to correct multiple related pathologies in a single procedure. The patent-pending AccuStride System marks the company’s first offerings for lower extremities; MedCAD also manufactures patient-specific, custom-designed implants, as well as virtual planning and surgical devices.
The AccuStride System is designed to improve proximal phalanx and metatarsal arthroplasty outcomes, and to provide custom solutions for Lapidus revisions and cavus foot corrections. Its components are constructed of UV-curable acrylate polymers or titanium alloy materials and can be delivered in as few as five days after receipt of medical imaging and surgeon design approval. The system is intended for use in patients 12 years and older. https://www.medcad.com/
FDA Breakthrough Device Designation for the eShunt System
CereVasc Inc. received its second Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its investigational eShunt System. This Breakthrough Device Designation is for the treatment of communicating hydrocephalus in pediatric patients aged 12 and older. The Breakthrough Device Designation was supported by data generated during pilot clinical studies of the device, as well as original research published in the Journal of NeuroInterventional Surgery.
“The recognition of Breakthrough Device Designation for the eShunt System in pediatric aged patients demonstrates the profound need for treatment innovation in this patient population and reinforces the potential safety and efficacy benefits that have already been observed with this minimally invasive, endovascular approach,” says Dan Levangie, chairman & CEO of CereVasc, Inc. “We are encouraged and committed to making the eShunt System available to as many patients as possible living with this debilitating disease.” http://www.cerevasc.com/
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