Regulatory
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Hospitals
RTI Surgical® Receives Regulatory Clearances, Expands Distribution of nanOss® Bioactive in Australia, Europe
September 19, 2016 ALACHUA, Fla. (DATE) – RTI Surgical (RTI) (Nasdaq: RTIX), a global surgical implant company, announced it has…
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Hospitals
Nation’s Leading Developer of Advanced Wound Care Technologies Urges FDA to Finalize Regulatory Guidance to Ensure Safety and Efficacy of Section 361 HCT/Ps
CANTON, Mass., Sept. 12, 2016 /PRNewswire/ — Organogenesis Inc., a global leader in FDA-approved and FDA-cleared advanced wound care innovation and technologies, today…
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Hospitals
VEXIM Announces the Registration of Its Products SpineJack® and Masterflow™ For the Treatment of Vertebral Fractures in Australia
September 06, 2016 TOULOUSE, France–(BUSINESS WIRE)–Regulatory News VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM / PEA‐PME), a medical device company specializing in…
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Hospitals
Tissue Regenix : Orthopaedics Update
07/11/2016 Leeds, 11 July 2016 – Tissue Regenix Group (AIM:TRX) (‘Tissue Regenix’ or ‘The Group’) the regenerative medical devices company…
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Hospitals
SpineCraft Obtains Regulatory Clearance to market the APEX Spine System® in China, the second-largest spine market in the world.
SpineCraft announced today that it has received clearance from the China Food and Drug Administration (CFDA) to market its APEX…
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Spine
Implanet granted regulatory clearance in the USA (510k) and Europe (CE) for the Jazz Claw
Bordeaux, Boston, May 23, 2016 – IMPLANET (Euronext: IMPL, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a medical technology company specializing in…
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Hospitals
Safe Orthopaedics expands its business to the Asia-Pacific region by entering into a distribution agreement covering Australia and New Zealand
Eragny-sur-Oise, April 13, 2016 – SAFE ORTHOPAEDICS (Euronext: FR0012452746 – SAFOR), a company developing and marketing an innovative range of…
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Spine
Implanet granted regulatory clearance in the U.S. (510k) and Europe (CE) for its new JAZZ Lock® implant
Bordeaux, Boston, 5 April 2016 – IMPLANET (Euronext: IMPL, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and…
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Hospitals
MCRA Hires Experienced Trauma And Total Joint Expert To Expand Its Leading Orthopedic Regulatory Team
WASHINGTON, March 1, 2016 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading medical device consulting firm and clinical research organization to…
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Uncategorized
Amplitude Surgical announces additional regulatory approvals in Australia
November 23, 2015 12:00 PM Eastern Standard Time VALENCE, France–(BUSINESS WIRE)–Regulatory News: Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME…
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Hospitals
Class 2 Device Recall DePuy Orthopaedics LCS COMPLETE RPS
The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced…
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Financial
U.S. says China to cut red tape on imports of medical devices, medicine
Dec 18 (Reuters) – China agreed to allow U.S. medicines and medical devices into local markets more quickly and open…
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Hospitals
The New Role of Regulatory Affairs in Medical Device Manufacturing
By Kellen Hills, Contributing Writer Today’s market realities have reshaped the role of regulatory affairs within the medical device development…
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Hospitals
Major Changes to Medical Device Registration Process in Japan
November 10, 2014 by Stewart Eisenhart Revised medical device registration and approval requirements in Japan will become law November 25,…
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Biologics
MCRA Assists Wright Medical Group, Inc. with Obtaining FDA PMA Approvable Decision for Augment® Bone Graft
WASHINGTON, DC, Nov. 6, 2014 – Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) announced today its role in the successful approvable…
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