August 27, 2019 BOSTON–(BUSINESS WIRE)–ApiFix Ltd., a leading motion-preservation scoliosis correction company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) via a Humanitarian Device Exemption (HDE) to market the Minimally Invasive Deformity Correction (MID-C) system for the treatment of progressive adolescent idiopathic scoliosis (AIS). AIS is the most …
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MINNEAPOLIS, Aug. 27, 2019 (GLOBE NEWSWIRE) — Relievant Medsystems, a privately-held medical device company transforming the treatment of Chronic Low Back Pain (CLBP), today announced the publication of significant and clinically-meaningful outcomes from a prospective, open-label, single-arm, multi-center study in the European Spine Journal. This study follows previous publication of two Level I, randomized, controlled multi-center …
KFAR SABA, Israel, Aug. 27, 2019 /PRNewswire/ — CartiHeal, developer of Agili-C™, a proprietary implant for the treatment of cartilage lesions in arthritic and non-arthritic joints, announced today the first implantation of the Agili-C™ implant, as part of Investigational Device Exemption (IDE) clinical study by Joseph M. Berman, MD at Arlington Orthopedics Associates (AOA), Arlington, TX. The clinical study will involve …
August 20, 2019 The Healthcare Technology Report is pleased to announced The Top 25 Medical Device Executives of 2019. This is our inaugural year publishing this awards feature. The following accomplished individuals were selected based on a successful track record in the industry both in terms of product portfolios managed as well as departments led. …
ALEX KACIK / August 23, 2019 A recent False Claims Act lawsuit claiming that a medical device company paid kickbacks to doctors illustrates an increasingly tenuous arrangement that may spur more whistleblower cases. The Department of Justice intervened in the whistleblower suit against Life Spine seeking millions of dollars of damages for allegedly paying kickbacks in the …
by Elizabeth Hofheinz, M.P.H., M.Ed., August 23, 2019 While competition drives business and healthcare, when it comes to the latter, consumers have little chance of making an informed decision on quality, says Jon J.P. Warner, Chief of the Shoulder Service at Massachusetts General Hospital. “You can go online to look at most products and services, …
WASHINGTON, August 22, 2019 /PRNewswire/ — MCRA, LLC (www.mcra.com), a leading medical device advisory firm and Clinical Research Organization (CRO) integrating US and international regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance, is pleased to announce a change in executive leadership. With the goal to support the company’s plan to drive future growth by …
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