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Carevature Medical Announces Pioneering Cervical Spinal Decompressions in the US
Spine Top Stories

Carevature Medical Announces Pioneering Cervical Spinal Decompressions in the US

TEL AVIV, Israel, June 12, 2017 /PRNewswire/ — Carevature Medical Ltd., developer of advanced orthopedic surgery solutions, announced today the first cervical decompression cases using its proprietary Dreal™ system in the US. The procedures were performed by Dr. John Peloza of the Center for Spine Care, Dallas, TX. Dr. Peloza, […]

K2M First-to-Market with 3D-Printed Expandable Interbody System Following FDA Clearance of MOJAVE™ PL 3D
Regulatory Spine Top Stories

K2M First-to-Market with 3D-Printed Expandable Interbody System Following FDA Clearance of MOJAVE™ PL 3D

LEESBURG, Va., June 22, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that its MOJAVE™ PL 3D Expandable Interbody System has received 510(k) clearance from the U.S. […]

Implanet announces the commercial launch of the new JAZZ™ braid in Europe and the United States
Regulatory Top Stories

Implanet announces the commercial launch of the new JAZZ™ braid in Europe and the United States

June 22, 2017 BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News: IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has obtained marketing clearance from the U.S. and European regulatory authorities to market its new JAZZ™ braid. The […]

Zyga Receives New Patent Allowances for SImmetry® Sacroiliac Joint Fusion System
Regulatory Spine Top Stories

Zyga Receives New Patent Allowances for SImmetry® Sacroiliac Joint Fusion System

MINNETONKA, Minn., June 21, 2017 /PRNewswire/ — Zyga Technology, Inc., a medical device company focused on the design, development and commercialization of minimally invasive devices to treat underserved conditions of the lumbar spine, today announced the issuance of a new US Patent representing continued advancement of the SImmetry Sacroiliac Joint Fusion […]

SpineGuard and XinRong Medical Group Sign Exclusive Distribution Agreement For PediGuard® in China
Spine

SpineGuard and XinRong Medical Group Sign Exclusive Distribution Agreement For PediGuard® in China

June 21, 2017 PARIS & SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News: SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices designed to make spine surgery safer, announced today an exclusive distribution agreement with XinRong Medical Group for PediGuard® in China, Hong Kong and Macau. China’s spine […]

Medicrea Announces Capital Raise of € 13 Million Through a Successful Private Placement
Financial

Medicrea Announces Capital Raise of € 13 Million Through a Successful Private Placement

June 19, 2017 LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (ISIN : FR0004178572 – ALMED, eligible to PEA-PME), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, announced today the successful capital increase for the benefit of a specific category of beneficiaries […]

Kuros receives CE certification for Neuroseal®, a novel dural sealant
Biologics Regulatory Top Stories

Kuros receives CE certification for Neuroseal®, a novel dural sealant

Schlieren (Zurich), Switzerland, June 21, 2017 – Kuros Biosciences (SIX:KURN) announced today that it has received CE certification for its novel dural sealant, Neuroseal® . The CE certification allows for the commercialization of the product anywhere in the European Economic Area. As part of the supporting evidence, Neuroseal® has been […]

EIT Emerging Implant Technologies Moves Toward Commercialization of its 3D Printed Cellular Titanium Implants in the United States
Spine Top Stories

EIT Emerging Implant Technologies Moves Toward Commercialization of its 3D Printed Cellular Titanium Implants in the United States

Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by utilizing additive manufacturing, announces major milestones in preparation of its expected 510(k) approval later this year. EIT Cellular Titanium® is a porous titanium structure that has been designed according to […]

K2M Introduces First-of-Its-Kind SAHARA™ AL Expandable Stabilization System
Spine Top Stories

K2M Introduces First-of-Its-Kind SAHARA™ AL Expandable Stabilization System

LEESBURG, Va., June 20, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced the introduction of the SAHARA™ AL Expandable Stabilization System, the Company’s first expandable offering […]

ConforMIS Announces FDA 510(k) Clearance for iTotal Hip System
Recon Regulatory Top Stories

ConforMIS Announces FDA 510(k) Clearance for iTotal Hip System

BILLERICA, Mass., June 20, 2017 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that offers knee replacement implants customized to fit each patient’s unique anatomy, today announced it has received FDA 510(k) clearance of the Company’s primary iTotal Hip replacement system. “Having treated over 50,000 patients with customized […]

Next Generation Lumbar Fusion Devices by Meditech Spine Aims to Improve Surgical Outcomes, Receives FDA Clearance
Regulatory Spine

Next Generation Lumbar Fusion Devices by Meditech Spine Aims to Improve Surgical Outcomes, Receives FDA Clearance

ATLANTA, June 19, 2017 /PRNewswire/ — Spine surgery offers a new lease on life for patients experiencing back pain and discomfort. With an estimated 450,000+ lumbar fusions performed each year in the United States, surgeons are familiar with Meditech Spine’s Talos® Lumbar Peek devices as essential components in the procedures […]