Malvern, PA | Nov 06, 2018 Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the Cios Spin, a new mobile C-arm that delivers precise 3D images for intraoperative quality assurance. By enabling surgeons to perform intraoperative corrections based on 3D images and confirm their results, the Cios Spin can help surgeons work with
HOLLAND, Mich., Nov. 5, 2018 /PRNewswire/ -- Shoulder Innovations announced today that they have received FDA clearance for their InSet Humeral Short Stem System. This is a key addition to their expanding shoulder portfolio and another milestone for their vision to offer a complete leading technology shoulder arthroplasty product line. The clearance covers products used for partial or total shoulder arthroplasty
WALTHAM, Mass., Nov. 01, 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 provided an update on the NeoCart regulatory pathway based on preliminary feedback from the Type C meeting held with the U.S. Food and
November 01, 2018 CASTEL SAN PIETRO, Switzerland & DALLAS--(BUSINESS WIRE)--Medacta International, the privately held, family-owned global leader in the design of innovative joint replacement and spinal surgery products, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for the GMK® Sphere – Kinematic Alignment instrumentation and surgical technique for total knee
MISSION VIEJO, CALIF. (PRWEB) OCTOBER 31, 2018 Innovasive, a privately-held spinal device company, focuses on developing and commercializing minimally-invasive, innovative spinal technologies. Today, Innovasive announced that they have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market their DualX technology, a titanium, dual expanding, interbody device for spinal fusion procedures in the
October 31, 2018 POMPANO BEACH, Fla.--(BUSINESS WIRE)--Stimwave Technologies, the leading innovator of wireless medical device bioelectronic technology, today announced that it has received FDA clearance for the WaveCrest MobileTM iOS Platform patient controllers for opioid free pain management. This revolutionary new system now gives patients iPhone® and Apple Watch® mobile control over WaveMasterTM multi-waveform automated programming for the Wireless
PARSIPPANY, N.J., Oct. 30, 2018 (GLOBE NEWSWIRE) -- Aetna has announced that they will reimburse select ambulatory surgical centers (ASCs) for the use of EXPAREL® (bupivacaine liposome injectable suspension) as part of a pilot program in Florida and New Jersey. The purpose of the program is to incentivize the use of non-opioid therapies for postsurgical pain
CARLSBAD, Calif., Oct. 25, 2018 (GLOBE NEWSWIRE) -- Aurora Spine Corporation (TSXV:ASG) ("Aurora Spine" or the "Company") announced today the grant by the European Patent Office (the “EPO”) of Aurora’s first European patent related to the ZIP®, minimally invasive spinal implant. The patent is titled “Dynamic and Non-Dynamic Interspinous Fusion Implant and Bone Growth Stimulation
WARSAW, Ind., Oct. 19, 2018 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (NASDAQ: KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new RESPONSE 4.5/5.0mm System for treating smaller stature younger patients with complex scoliosis. The system represents the
October 18, 2018 HUNTLEY, Ill.--(BUSINESS WIRE)--Centric Medical, a division of Life Spine®, Inc., which focuses on developing surgical implants for the treatment of lower distal extremity pathology, announced today That the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the SATURN External Fixation System which consists of rings, struts, threaded rods,
