WALTHAM, Mass., Sept. 26, 2018 (GLOBE NEWSWIRE) -- Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, today announced that the U.S. Food and Drug Administration (the FDA) has granted a Type C meeting on October 30, 2018 to discuss the
September 27, 2018 CHARLOTTE, N.C.--(BUSINESS WIRE)--The United States Department of Justice and the United States Attorney’s Office for the Western District of North Carolina announced that HEALTH MANAGEMENT ASSOCIATES, INC. (“HMA”), now known as Health Management Associates, LLC, and its parent, will pay over $260 million to resolve false hospital billing and kickback allegations. This
CARLSBAD, Calif., Sept. 26, 2018 (GLOBE NEWSWIRE) -- Alphatec Holdings, Inc. (“ATEC” or the “Company”) (Nasdaq: ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its OsseoScrew® System,
September 25, 2018 COLLEGEVILLE, Pa.--(BUSINESS WIRE)--Synergy Biomedical, LLC, a developer of innovative biomaterial products, announced today that it has received FDA 510(k) clearance of BIOSPHERE® FLEX. Based on Synergy’s patented BioSphere® Technology, BIOSPHERE® FLEX is a strip-format bone graft product composed of porous, bioactive glass that is dimensionally integrated within a collagen and sodium hyaluronate scaffold. The porosity
14th September 2018 Contaminated pedicle screws cost hundreds of thousands of US dollars a year, and through an increase in surgical site infections result in additional and avoidable patient morbidity. Anand Agarwal (University of Toledo, Toledo, USA) and colleagues are calling for a change in the standard of care revolving around implant handling and delivery,
September 21, 2018 CEDAR KNOLLS, N.J.--(BUSINESS WIRE)--b-ONE Ortho Corp., an emerging orthopedic technology company dedicated to the development of innovative healthcare solutions, today announced it has received 510(k) clearance for its first device, the b-ONETM Total Hip System, from the U.S. Food and Drug Administration (FDA). The b-ONETM Total Hip System is a cementless total hip system
ATLANTA, Sept. 18, 2018 /PRNewswire/ -- Meditech Spine has received FDA 510(k) clearance to market the Cure™ Opel-C Plate System, an add-on technology to its already cleared CURE™ ACP System and Talos®-C (HA) Interbody Systems. With this approval, Meditech will now offer two additional CURE™ ACP plating options with its Talos® line of cervical interbodies made with the
ANTONY, France--(BUSINESS WIRE)--SpineVision announced today that it has received CE mark for its next-generation Pivot Link Universal System (P.L.U.S.) spine deformity-correction system. SpineVision will introduce the next-generation P.L.U.S. to spine surgeons at “EuroSpine 2018” (Booth #24C) in Barcelona, Spain (Sept. 19-21), and “NASS 2018” (Booth #1311) in Los Angeles (Sept. 26-29). Deformity of the spine includes any abnormality of the formation, alignment, or shape of the vertebral
BILLERICA, Mass., Sept. 17, 2018 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ:CFMS), a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that fit each patient’s unique anatomy, announced today that it has entered into a settlement and license agreement with Smith & Nephew that resolves
September 17, 2018 ANTONY, France--(BUSINESS WIRE)--SpineVision announced today that it has received FDA clearance and CE mark for its next-generation titanium 3D laser-printed HEXANIUM TLIF (Transforaminal Lumbar Interbody Fusion) cage for back surgery. SpineVision will introduce its new product to spine surgeons at “EuroSpine 2018”(Booth #24C) in Barcelona, Spain (Sept. 19-21), and “NASS 2018” (Booth #1311) in Los Angeles (Sept. 26-29). Spine fusion surgery is often
