ide
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Hospitals
CartiHeal Announces FDA IDE Approval of Its Agili-C Implant for the Treatment of Joint Surface Lesions
KFAR SABA, Israel, Dec. 20, 2016 /PRNewswire/ — CartiHeal (2009) Ltd., developer of a cell-free, off-the-shelf implant for use in…
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Hospitals
Regentis Receives IDE Approval for Pivotal GelrinC Clinical Trial
Princeton, NJ and Or Akiva, Israel, September 26 — Regentis Biomaterials, a developer of hydrogels for tissue regeneration, announced it…
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Hospitals
BONESUPPORT™ Receives FDA Approval to Initiate IDE Clinical Study with CERAMENT™G
Lund, Sweden, 9 August – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone…
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Hospitals
FDA: IDE review times reduced by nearly a year
By Fink Densford The FDA released a report detailing improvements in clearing medical devices, stating it reduced investigational device exemption…
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Recon
OrthoSpace Enrolls First Patients in US IDE Study
CAESAREA, Israel, July 6, 2015 /PRNewswire/ — OrthoSpace Ltd. (“OrthoSpace” or “Company”) announced today the enrollment of the first three patients in its…
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Extremities
Anika Therapeutics Files Investigational Device Exemption to Initiate Phase III Study to Expand Indication of MONOVISC® to Treat Pain Caused by Osteoarthritis of the Hip
BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc., (NASDAQ: ANIK), a leader in products for tissue protection, healing, and repair based on hyaluronic…
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Hospitals
Mainstay Medical Gains Approval to Start US Clinical Trial of ReActiv8®
Dublin – Ireland, 29th May 2015 – Mainstay Medical International plc (“Mainstay” or the “Company” listed on Euronext Paris: MSTY.PA…
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Hospitals
Regulatory affairs for medical device startups
February 13, 2015 by Andrew Ahn Instilling a robust quality management system as soon as possible is crucial in becoming a successful…
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FDA Unveils Plan for Expedited Device Approvals
The U.S. Food and Drug Administration (FDA) has unveiled a proposal designed to speed up development and approval of medical…
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Spine
Simpirica Spine Receives Approval to Begin U.S. IDE Pivotal Study of Its LimiFlex(TM) Spinal Stabilization System
SAN CARLOS, Calif., Mar 15, 2012 (BUSINESS WIRE) — Simpirica Spine Inc. developer of minimally invasive, flexion-restricting stabilization devices for…
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Hospitals
Medical device review took the FDA 37% longer in 2010 than 2006
MASSDEVICE ON CALL — Medical device consulting firm Emergo Group released results from a study of the U.S. Food &…
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Scripps Clinic Surgeon Participates in New Back Pain Investigational Device Clinical Study
LA JOLLA, Calif.–(BUSINESS WIRE)–Robert Eastlack, M.D., of Scripps Clinic and the Scripps Clinical Research Center announced recently that he is…
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VertiFlex®, Inc. Announces 100th Patient Enrolled in Superion™ IDE Trial
SAN CLEMENTE, Calif.–(BUSINESS WIRE)–VertiFlex, Inc., a leading innovator of minimally invasive and motion preserving spinal surgery technologies, today announced that…
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Strategic orthopaedic-related 510(k)s issued in December 2009 include:
Pivotec Lumbar Interbody Fusion Device ( Captiva Spine) Align 360 Medialized Patella Component ( Cardo Medical) Anterior Cervical Plate (…
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