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New device expected to cut down infection risk during surgery

By Heather Pollauf   It’s called the No-Touch Pre-Sterilized Pedicle Screw System. It was developed by Spinal Balance, a company made up of researchers at the University of Toledo. It’s designed to cut down on the risk for infection during surgery. The company’s president and CEO, Dr. Anand Agarwal, also a former surgeon, says this is […]

StemCells terminates mid-stage study; to wind down ops

Tue May 31, 2016 – Reporting by Amrutha Penumudi in Bengaluru StemCells Inc said on Tuesday it had terminated a mid-stage trial testing its therapy in spinal cord injury and that its board had decided to wind down the company. The company’s shares plummeted 75 percent to 75 cents in premarket trading. The magnitude of the treatment’s […]

FDA Issues Draft Guidance on Additive Manufactured Devices

By: Carolyn LaWell   Page 1 of 2 FDA recently published draft guidance on technical considerations for additive manufactured devices in response to the technology’s advancements and investments. Orthopaedic device companies and suppliers are among those in the medical device community leading the technology’s adoption, and in so doing, driving the conversation with FDA. Therefore, […]

Clinical Study in UK to Evaluate ReGenerCell for Diabetic Foot Ulcer Treatment

NORTHRIDGE, CA and PERTH, AUSTRALIA and CAMBRIDGE, UNITED KINGDOM — (Marketwired) — 05/30/16 — Avita Medical Ltd. (ASX: AVH) (OTCQX: AVMXY) Study will evaluate preliminary safety and effectiveness in a cohort of up to 24 patients Innovative regenerative technology will use patients’ own skin cells to try to close chronic Diabetic Foot Ulcer (DFUs) DFUs […]

RTI Surgical Inc (RTIX) Shares Bought by Gagnon Securities LLC

by Trevor Kearing – May 31, 2016   Gagnon Securities LLC boosted its stake in shares of RTI Surgical Inc (NASDAQ:RTIX) by 21.1% during the first quarter, according to its most recent filing with the Securities and Exchange Commission (SEC). The institutional investor owned 262,950 shares of the company’s stock after buying an additional 45,830 shares […]

NuVasive to Participate in Investor Events in June 2016

SAN DIEGO, CA –(Marketwired – May 31, 2016) – NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today that management will participate in the following investor events in June 2016: Goldman Sachs 37th Annual Global Healthcare Conference at the Terranea Resort in Ranchos Palos […]

Spine Wave Announces Completion of $11M Financing

SHELTON, CT –(Marketwired – May 31, 2016) – Spine Wave, Inc., today announced the closing of an $11M round of new financing. The round was led by existing investors New Enterprise Associates (NEA) and Acadia Woods LLC. Other participating investors include Compass Global Fund, Industry Ventures, Collinson, Howe and Lennox, California Technology Partners and MB […]

Injectable sponges used for first time to stop soldier’s bleeding

By Rob Verger   A U.S. military surgical team used an innovative device to staunch the bleeding on a gunshot victim, RevMedx, the company that makes it, recently announced. That marks the first documented occasion that the device has been used in a patient clinically, the company said. The XSTAT, as the device is called, […]

Senate bill looks to streamline CMS pathway for “breakthrough” devices

MAY 27, 2016 BY FINK DENSFORD   The U.S. Senate has introduced a bill to expedite Centers for Medicare and Medicaid Services decision making for new medical devices. The bill, titled the “Ensuring Patient Access to Critical Breakthrough Product Act” will help “bridge a gap” between the FDA and CMS and “improve patient access to […]

Shoulder Surgery Is the New Testing Ground for Painkiller Alternatives

By LAURA LANDRO, May 23, 2016   A common shoulder surgery has become a testing ground for some novel painkilling techniques as doctors seek to reduce the use of prescription narcotics known as opioids. Rotator-cuff surgery, which aims to repair a shoulder tendon that can get torn from sports, a bad fall or simple wear and […]

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