Regulatory

Orthocell Granted European Tendon Regeneration Patent
Regulatory Sports Medicine

Orthocell Granted European Tendon Regeneration Patent

December 14, 2017 PERTH, Australia–(BUSINESS WIRE)–Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell” or the “Company”) is pleased to announce it has been granted a key European Patent. The patent is entitled ‘Culture medium, culturing method and use of tenocytes’ protecting the method of manufacturing tendon regeneration cells (Tenocytes) to form […]

THINK Surgical, Inc. Receives CE Mark Approval for the TSolution One® Surgical System for Total Knee Arthroplasty
Recon Regulatory Robotics

THINK Surgical, Inc. Receives CE Mark Approval for the TSolution One® Surgical System for Total Knee Arthroplasty

FREMONT, Calif., Dec. 11, 2017 /PRNewswire/ — THINK Surgical Inc., a global medical device manufacturer of the only active robotic surgical system for orthopaedic surgery, announces that it has received CE Mark approval for the TSolution One® Surgical System, bringing active robotic precision to Total Knee Arthroplasty (TKA). The TSolution One Surgical System […]

Camber Spine Announces FDA Clearance Of Spira™-C Open Matrix Cervical Interbody
Regulatory Spine

Camber Spine Announces FDA Clearance Of Spira™-C Open Matrix Cervical Interbody

WAYNE, Pa., Dec. 7, 2017 /PRNewswire/ — Camber Spine announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its SPIRA™-C Open Matrix Cervical Interbody device, an innovative interbody fusion implant, second in the SPIRA™ family to employ a novel arched design as well as […]

Omnia Medical: First PEEK-OPTIMA™ HA Enhanced Vertebral Body Replacement System to Enter US Market
Regulatory Spine

Omnia Medical: First PEEK-OPTIMA™ HA Enhanced Vertebral Body Replacement System to Enter US Market

THORNTON CLEVELEYS, UK (PRWEB) DECEMBER 07, 2017 ‘Omnia Medical VBR’ has been granted the first US FDA 510(k) clearance for a vertebral body replacement (VBR) system manufactured from PEEK-OPTIMA™ HA Enhanced polymer, from Invibio Biomaterial Solutions, for use in the thoracolumbar spine to replace a collapsed, damaged, or unstable vertebral body. […]

In2Bones Announces FDA Clearance of the CoLink® View “See-Through” Plating System
Extremities Regulatory Top Stories

In2Bones Announces FDA Clearance of the CoLink® View “See-Through” Plating System

December 05, 2017 MEMPHIS, Tenn.–(BUSINESS WIRE)–In2Bones Global, Inc. today announced that its In2Bones USA, LLC subsidiary has received U.S. Food and Drug Administration (FDA) clearance for an addition to its CoLink® Forefoot Bone Plating System used to stabilize bones during the post-surgical healing process. The addition will be marketed under the CoLink View brand […]

SeaSpine Announces FDA 510(k) Clearance of OsteoBallast™ Demineralized Bone Matrix in Resorbable Mesh
Biologics Regulatory Spine

SeaSpine Announces FDA 510(k) Clearance of OsteoBallast™ Demineralized Bone Matrix in Resorbable Mesh

CARLSBAD, Calif., Nov. 30, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for use of its OsteoBallast™ Demineralized […]

PAVmed Files 510(k) Submission with FDA for CarpX™ Device to Treat Carpal Tunnel Syndrome
Regulatory Top Stories

PAVmed Files 510(k) Submission with FDA for CarpX™ Device to Treat Carpal Tunnel Syndrome

November 28, 2017 NEW YORK–(BUSINESS WIRE)–PAVmed Inc. (Nasdaq: PAVM, PAVMW), a highly differentiated, multiproduct medical device company, today announced that it has filed a 510(k) premarket notification submission with the U.S. Food and Drug Administration (FDA) for its CarpX™ minimally invasive device designed to treat carpal tunnel syndrome. “We are […]

Regentis Biomaterials Performs the First Cases in GelrinC Pivotal Study
Biologics Regulatory

Regentis Biomaterials Performs the First Cases in GelrinC Pivotal Study

PRINCETON, New Jersey and OR AKIVA, Israel, November 28, 2017 /PRNewswire/ — Regentis Biomaterials announced today the start of its Phase III pivotal clinical trial of GelrinC for the treatment of focal knee cartilage defects with successful surgery on three patients in the U.S. and Denmark. These procedures are part of a Food and Drug Adminstration […]

Medicrea Receives FDA Clearance for 3D-Printed Titanium Interbody Devices and Introduces AdapTEK™ Surgeon-Adaptive Technology
Regulatory

Medicrea Receives FDA Clearance for 3D-Printed Titanium Interbody Devices and Introduces AdapTEK™ Surgeon-Adaptive Technology

November 22, 2017 LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea® Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ Adaptive Spine Intelligence™ (ASI) technology, announced today the Company has received Food and Drug Administration (FDA) clearance for its […]

MiMedx Market Leadership Well Positioned In Light Of FDA New Guidance Document
Biologics Regulatory

MiMedx Market Leadership Well Positioned In Light Of FDA New Guidance Document

MARIETTA, Ga., Nov. 17, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that the Food and Drug Administration (FDA) issued numerous Final and Draft Guidance documents.  Among […]

Federal Jury Returns $247 Million Verdict in Defective Hip Implants Case
Regulatory Top Stories

Federal Jury Returns $247 Million Verdict in Defective Hip Implants Case

DALLAS, Nov. 16, 2017 /PRNewswire/ — A federal court jury in Texas returned a $247 million verdict on behalf of six people who suffered serious medical complications caused by the defective metal-on-metal hip implants made by Johnson & Johnson (NYSE: JNJ) and its subsidiary DePuy Orthopaedics Inc. The one-man, seven-woman jury deliberated for 14 hours before reaching its […]

MedShape Announces FDA Clearance for the DynaNail® XL
Regulatory

MedShape Announces FDA Clearance for the DynaNail® XL

ATLANTA, Nov. 14, 2017 /PRNewswire/ — MedShape, Inc., the industry leader in orthopaedic devices using advanced functional materials, announced today that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the DynaNail® XL TTC Fusion System. The DynaNail XL is available in 260mm and 300mm lengths, thus expanding the product’s […]

IntraFuse Receives FDA 510(k) Clearance for  FlexThread™ Fibula Pin System
Extremities Regulatory Top Stories

IntraFuse Receives FDA 510(k) Clearance for FlexThread™ Fibula Pin System

LOGAN, Utah, November 1, 2017 – IntraFuse, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures, announces that it has received FDA 510(k) clearance for its FlexThread™ Fibula Pin System. The IntraFuse FlexThread™ Fibula Pin System provides percutaneous fixation of distal fibula […]