Regulatory

Medovex Corporation Completes Phase II CE Mark Audit with Notified Body LNE/GMED
Regulatory Top Stories

Medovex Corporation Completes Phase II CE Mark Audit with Notified Body LNE/GMED

ATLANTA, GA–(Marketwired – Feb 15, 2017) – Medovex Corp. ( NASDAQ : MDVX ), a developer of medical technology products, today announced that the Company successfully completed its final CE Mark audit meeting. The review of the Company’s DenerveX™ System was conducted February 7-9, 2017 by LNE/GMED, a French-based Notified […]

Centric Medical™ Announces FDA Clearance of Metatarsal Hemi Implant System
Regulatory

Centric Medical™ Announces FDA Clearance of Metatarsal Hemi Implant System

February 14, 2017 HUNTLEY, Ill.–(BUSINESS WIRE)–Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the Metatarsal Hemi Implant System. The Metatarsal Hemi […]

SpineGuard Extends the Utility of Its Dynamic Surgical Guidance (DSG ™) Technology Platform by Receiving US Patent for “Bone Quality Measurement” Application
Regulatory

SpineGuard Extends the Utility of Its Dynamic Surgical Guidance (DSG ™) Technology Platform by Receiving US Patent for “Bone Quality Measurement” Application

PARIS & SAN FRANCISCO–(BUSINESS WIRE)– SpineGuard (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices to make spine surgery safer, announced today it has been granted a patent by the US Patent Office for the application of its Dynamic Surgical Guidance technology for a new application: […]

MiMedx Comments On FDA Decision Not To Finalize HCT/P Guidance Documents This Year
Regulatory

MiMedx Comments On FDA Decision Not To Finalize HCT/P Guidance Documents This Year

MARIETTA, Ga., Feb. 3, 2017 /PRNewswire/ — MiMedx Group, Inc. MDXG 2.31%, the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, commented today regarding […]

Spinal Simplicity Announces Receipt of FDA Clearance for Minuteman® G3-R Removable End Fusion Implant
Regulatory

Spinal Simplicity Announces Receipt of FDA Clearance for Minuteman® G3-R Removable End Fusion Implant

OVERLAND PARK, KANSAS (PRWEB) FEBRUARY 03, 2017 Spinal Simplicity, a medical device company developing innovative solutions to treat complex surgical problems, has received its third 510(k) clearance from FDA for the Minuteman G3-R spinal implant, part of the Minuteman family of supplemental fusion and fixation devices. The Minuteman G3-R may […]

Medtronic, Intuitive Surgical Lead Japan Surgical Navigation and Robotics Systems Market Driven by Changes in Regulatory Policy
Regulatory Robotics

Medtronic, Intuitive Surgical Lead Japan Surgical Navigation and Robotics Systems Market Driven by Changes in Regulatory Policy

VANCOUVER, BC–(Marketwired – February 01, 2017) – According to a new series of reports on the Japanese robotics and surgical navigation market by iData Research (www.idataresearch.com), the market in the region is still in its infancy. While several systems have regular sales and a growing installed-base, a number of companies […]

VEXIM Strengthens Its Intellectual Property Protection for the SpineJack® in Asia: Two Patents Granted in China and Japan
Regulatory

VEXIM Strengthens Its Intellectual Property Protection for the SpineJack® in Asia: Two Patents Granted in China and Japan

February 02, 2017 TOULOUSE, France–(BUSINESS WIRE)–Regulatory News: VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM / PEA‐PME eligible), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announces the expansion of its SpineJack® patent portfolio in Asia. The issuance of new patents in Japan and China further confirms […]