All News

Viseon, Inc. Announces US FDA Clearance and Clinical Use of its Advanced High-Definition Real Time Imaging Technology for Minimally Invasive Spine Surgery

September 19, 2019  IRVINE, Calif.–(BUSINESS WIRE)–Viseon, Inc. today announced US FDA clearance and initial clinical use of their Voyant System, integrating minimally invasive surgical (MIS) access with real time high definition imaging technology for more efficient procedural workflow, which enhances a clinician’s intraoperative visualization, providing a more accurate, precise and unimpeded view of the operative …

Globus acquires StelKast for $28.4m

SEPTEMBER 19, 2019 / BY NANCY CROTTI Globus Medical (NYSE:GMED) has acquired most of the assets of privately held orthopedics manufacturer StelKast for $24.1 million. The purchase price could increase by $4.3 million if certain product and sales milestones are met, including a robot-assisted system for joint reconstruction expected to launch in late 2020. McMurray, Penn.-based StelKast designs, manufactures …

OR Pet Peeves: A Spine Surgeon Speaks

by Elizabeth Hofheinz, M.P.H., M.Ed., September 18, 2019 What bugs surgeons in the OR? We decided to ask one high-volume spine surgeon. He had a l… Oh no! It looks like you aren’t an OSN Premium Subscriber yet. Click here to sign up or login below. Username or E-mail Password Remember Me     Forgot …

1 in 5 surgeons plans to retire early due to physical toll, survey finds

by Joanne Finnegan | Sep 19, 2019 At the same time that the country faces a predicted shortage of physicians, one in five surgeons plan to retire early because of the physical toll of their work, a new survey reveals. Nearly 20% of surgeons in the U.S. think they may need to retire early due to the physical …

FDA continues to take steps to fulfill its commitment to strengthen and modernize the 510(k) medical device program

SILVER SPRING, Md., Sept. 19, 2019 /PRNewswire/ — The U.S. Food and Drug Administration today announced that, as a first step toward implementation of the recently established Safety and Performance Based Pathway for medical devices, the agency is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies for four specific types of devices. These …

The TBI Gait Lab: Making the Subjective, Objective

by Elizabeth Hofheinz, M.P.H., M.Ed., September 18, 2019 How much is, “I can bend my leg more” in concrete terms? What does, “I am a lot steadier … Oh no! It looks like you aren’t an OSN Premium Subscriber yet. Click here to sign up or login below. Username or E-mail Password Remember Me   …

Active Implants Receives FDA Breakthrough Device Designation for NUsurface® Meniscus Implant

September 19, 2019 MEMPHIS, Tenn.–(BUSINESS WIRE)–Active Implants, LLC, a developer of orthopedic implant solutions for joint preservation, today announced that the NUsurface® Meniscus Implant has been granted a Breakthrough Device Designation from the U.S. Food and Drug Administration. The NUsurface® Meniscus Implant is the first “artificial meniscus” to be marketed in Europe and, if cleared …

Rodrigo Bianchi Appointed as New LimaCorporate Advisory Board Member

SAN DANIELE DEL FRIULI, Italy, Sept. 18, 2019 /PRNewswire/ — LimaCorporate is pleased to announce that Rodrigo Bianchi will join the LimaCorporate Advisory Board. Rodrigo Bianchi Rodrigo Bianchi is a Senior Global Executive in the Medical Device Industry with over 30 years of experience in some of the most important Orthopedic companies. Recently, he served as President International Markets for Smith & …

Episurf Medical reaches milestone of 600 implants

WED, SEP 18, 2019 Episurf Medical (NASDAQ: EPIS B) today announces that the company has reached another milestone by the planning of the 600th surgery with the Episealer® implant in the coming weeks. The company recently communicated that the patient groups who have had the implant for more than 2 and 3 years had grown, …

SpineGuard Reports Six-Month 2019 Financial Results

September 18, 2019  PARIS & BOULDER, Colo.–(BUSINESS WIRE)–Regulatory News: SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that deploys its DSG® (Dynamic Surgical Guidance) sensing technology to secure and streamline the placement of bone implants, announced today financial results for the half year ending June 30, 2019, as approved by the Board of Directors on September …

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