Monthly Archives: September 2018

Safe Orthopaedics’ Continues to Improve Results over the First Six Months of 2018

September 28, 2018 ERAGNY-SUR-OISE, France--(BUSINESS WIRE)--Regulatory News: SAFE ORTHOPAEDICS (FR0012452746 – SAFOR) (Paris:SAFOR), Safe Orthopaedics (FR0012452746 – SAFOR), a company specialized in the development and marketing of implants and single-use instruments that improve the minimally invasive treatment of spinal fracture conditions, today announced its revenue for the six-month period ending on the 30th June 2018. Safe Orthopaedics’

By |2018-09-28T22:42:57+00:00September 28th, 2018|Financial|
Read More

Renovis Surgical Receives FDA Clearance for Tesera Trabecular Technology 3D-Printed Lateral Interbody Fusion System

REDLANDS, Calif. and AUSTIN, Texas, Sept. 26, 2018 /PRNewswire/ -- Renovis Surgical Technologies, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Tesera® X Lateral Interbody Fusion System. Tesera X is the latest product to utilize Renovis' proprietary 3D-printed porous architecture, which is made using additively manufactured titanium alloy, and

By |2018-09-28T22:26:34+00:00September 28th, 2018|Regulatory, Top Stories|
Read More

4WEB Medical, TeDan Surgical Innovations and Lattus Spine Announce Exclusive Partnership To Provide Best In Class Total Lateral Solution

LOS ANGELES, Sept. 26, 2018 /PRNewswire/ -- 4WEB Medical, the industry leader in 3D printed implant technology, announced today at the North American Spine Society (NASS) Annual Meeting that the company has entered into an exclusive partnership with both TeDan Surgical Innovations and Lattus Spine, LLC to market a turnkey, best in class, Total Lateral Solution. "Today is

By |2018-09-27T22:59:14+00:00September 27th, 2018|Spine|
Read More

Stryker announces 510(k) clearance of SpineJack® Implantable Fracture Reduction System

KALAMAZOO, Michigan, USA, Sept. 26, 2018 /PRNewswire/ -- Stryker announced today that it has received FDA 510(k) clearance to market the SpineJack Implantable Fracture Reduction System.  The SpineJack system is indicated for use in the reduction of painful osteoporotic vertebral compression fractures. In the SAKOS clinical study, the SpineJack system demonstrated superiority to balloon kyphoplasty (BKP) for the

By |2018-09-27T22:22:18+00:00September 27th, 2018|Regulatory, Spine|
Read More

Histogenics to Meet With FDA to Discuss NeoCart Phase 3 Clinical Trial Data and Potential Regulatory Pathway

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

By |2018-09-27T18:15:46+00:00September 27th, 2018|Regulatory|
Read More

Kuros Reports First Patient Treated in Randomized Controlled Trial of MagnetOs in Spinal Fusion

SCHLIEREN (ZURICH), Switzerland, Sept. 27, 2018 (GLOBE NEWSWIRE) -- Kuros Biosciences (SIX: KURN) today announced that the first patient has been treated in an investigator-led multicenter randomized controlled study comparing MagnetOs with autologous bone in posterolateral spinal fusion. The University Medical Center Utrecht (UMCU) in the Netherlands is the principal investigating site for the study,

By |2018-09-27T17:38:49+00:00September 27th, 2018|Spine|
Read More

North Carolina Physicians’ Whistleblower Lawsuit Leads to Second Multi-Million-Dollar Recovery in Ground-Breaking Emergency Room Fraud Case

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

By |2018-09-27T17:14:06+00:00September 27th, 2018|Regulatory, Top Stories|
Read More

Centinel Spine Announces STALIF C® Integrated Interbody™ Milestone Usage in Australia

New York, NY, September 26, 2018 –Centinel Spine, LLC announced today that Dr. Arvind Dubey, MD, FRACS, Neurosurgeon and Spine Surgeon at Hobart Brain and Spine Centre in Hobart, Tasmania, Australia, performed a milestone procedure implanting his 1,000th level of the STALIF C-Ti™ Anterior Cervical Integrated Interbody®device.  The procedure was a 2-level ACDF and took place

By |2018-09-27T15:56:18+00:00September 27th, 2018|Spine|
Read More

Alphatec Advances Clinical Distinction With OsseoScrew® Clearance

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,

By |2018-09-26T22:34:33+00:00September 26th, 2018|Regulatory|
Read More

SeaSpine Announces Launch of Regatta™ Lateral System

CARLSBAD, Calif., Sept. 26, 2018 (GLOBE NEWSWIRE) -- SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the launch of the Regatta™ Lateral System, featuring NanoMetalene® technology. Regatta is a comprehensive, minimally invasive lateral interbody fusion system designed to efficiently and reproducibly treat the

By |2018-09-26T22:07:01+00:00September 26th, 2018|Spine|
Read More
Odysseus Medical Solutions 2018
RssEmail