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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 […]

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 […]

Stryker announces definitive agreement to acquire NOVADAQ Technologies Inc.
Financial Top Stories

Stryker announces definitive agreement to acquire NOVADAQ Technologies Inc.

By GlobeNewswire Kalamazoo, Michigan – June 19, 2017- Stryker Corporation (NYSE:SYK) announced today a definitive agreement to acquire NOVADAQ Technologies Inc. (NASDAQ:NVDQ; TSX:NDQ) for US$11.75 per share, or US$701 million with a net purchase price of US$654 million, reflecting net cash of approximately US$47 million. NOVADAQ is a leading developer of fluorescence imaging […]

Medicrea Announces FDA Clearance and Initial Experience with PASS® TULIP Top-Loading Fixation
Regulatory Spine Top Stories

Medicrea Announces FDA Clearance and Initial Experience with PASS® TULIP Top-Loading Fixation

June 16, 2017 LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Alternext Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, announced today that it has received FDA 510(k) Clearance and performed first surgeries with PASS® TULIP top-loading […]

Medicrea Receives FDA Clearance for the UNiD™ HUB, a Data-Driven Digital Portal for Adaptive Spine Intelligence
Regulatory Spine Top Stories

Medicrea Receives FDA Clearance for the UNiD™ HUB, a Data-Driven Digital Portal for Adaptive Spine Intelligence

June 16, 2017 LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Alternext Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, announced today that it has received 510(k) Clearance from the Food & Drug Administration for UNiD™ HUB, […]

Image Stream Medical and Olympus introduce MedPresence™, the first Virtual Medical Presence Solution for the Hospital Enterprise
Financial Top Stories

Image Stream Medical and Olympus introduce MedPresence™, the first Virtual Medical Presence Solution for the Hospital Enterprise

CENTER VALLEY, Pa. and LITTLETON, Mass., June 12, 2017 /PRNewswire/ — Olympus Corporation of the Americas (OCA) and Image Stream Medical, Inc. today announced the medical industry’s first enterprise virtual presence solution, MedPresence™. The system enables surgical and interventional clinicians to virtually connect and collaborate in ways that have not […]

SANUWAVE Appoints Interventional Concepts as Territory Sales Manager and Partner to Access Clinical Trial Participation in Colombia; Revenue Expected Before Year End
Biologics Top Stories

SANUWAVE Appoints Interventional Concepts as Territory Sales Manager and Partner to Access Clinical Trial Participation in Colombia; Revenue Expected Before Year End

SUWANEE, GA–(Marketwired – Jun 14, 2017) –  SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the company has appointed Interventional Concepts, Inc. to act as Territory Sales Manager for sourcing and screening of potential distributors and access to clinical trials participation for SANUWAVE’s products in Colombia. André Mouton, […]