FDA
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Sports Medicine
ZKR Orthopedics Performs First U.S. Patella Lift Procedure Initiating FDA Trial
New Method for the Treatment of Patellofemoral Arthritis SAN FRANCISCO, Sept. 27, 2024 (GLOBE NEWSWIRE) — ZKR Orthopedics, Inc., a…
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Spine
MiRus Receives Breakthrough Device Designation for Spine Implant
ATLANTA, July 31, 2024 /PRNewswire/ — MiRus has received Breakthrough Device Designation from the FDA for the EUROPA® Posterior Cervical System, based on it’s…
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Top Stories
FDA tells providers to prepare for supply chain disruptions
The current hurricane season will require providers, manufacturers and distributors to make adequate supply chain preparations. Jeff Lagasse, Editor – June…
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Spine
Canary Medical’s Smart Spine Lumbar Cartridge Granted FDA “Breakthrough Device” Designation
Smart Spine Lumbar Cartridge is the fourth Canary Medical product to receive Breakthrough Designation through the FDA Breakthrough Devices Program…
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Spine
MCRA Partner Orthobond Granted De Novo for Innovative Pedicle Screw System with Ostaguard™ Coating
MCRA Responsible for Regulatory Strategy and Support for FDA Submission Process WASHINGTON, May 7, 2024 /PRNewswire/ — MCRA, the leading privately held…
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Spine
Facet Replacement FDA Study Garners Best Paper Award At Lumbar Spine Research Society Meeting
Premia Spine’s study on the TOPS® System, showcasing its advantages over traditional lumbar fusion, received the Best Paper award at the…
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Regulatory
OrthoPediatrics Corp. Receives “Breakthrough Device” Designation from FDA for eLLi™ Growing Rod System for Pediatric Patients with Scoliosis
WARSAW, Ind., May 02, 2024 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company focused exclusively on advancing the field of…
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Regulatory
Lipogems Announces Last Patient Enrolled in the U.S. FDA IDE Arise Study for the Treatment of Knee Osteoarthritis
Orthopaedic surgeon, Dr. Cristin Mathew, enrolls a patient in the Lipogems ARISE US FDA IDE Knee OA Study ATLANTA, April 10,…
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Regulatory
Lipogems Announces First Patient Enrolled in the Second U.S. FDA IDE Study for the Treatment of Knee Osteoarthritis
Orthopaedic surgeon, Dr. Yogesh Mittal, enrolls the first patient in the ARISE 2 Study for Knee Osteoarthritis ATLANTA, April 8, 2024 /PRNewswire/…
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Spine
Inside information: Bioretec has been granted FDA Breakthrough Device Designation status for its RemeOs™ Spinal Interbody Cage
TAMPERE, Finland, March 14, 2024 /PRNewswire/ — Bioretec Ltd., a pioneer in biodegradable orthopedic implants, has today been granted Breakthrough Device Designation…
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Regulatory
FDA Grants Breakthrough Device Designation to ORTHOSON’s Bio-Structural Gel
This designation assures enhanced FDA cooperation and priority regulatory review of the company’s novel medical solution for back pain due…
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Spine
3Spine Announces Completion of FDA Clinical Trial Enrollment Achieving 325 Surgeries in 2023
3Spine MOTUS Lumbar Total Joint Replacement Procedure CHATTANOOGA, Tenn., Jan. 10, 2024 /PRNewswire/ — 3Spine, Inc., a medical device company developing a…
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Biologics
Biocomposites’ investee Renovos Biologics receives FDA Breakthrough Device Designation for its synthetic nanoclay bone fusion gel, RENOVITE® BMP-2
RENOVITE® BMP-2 is being developed as an alternative to bone graft materials for interbody spinal fusion It is the first product…
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Biologics
CGBio’s ‘NOVOSIS PUTTY’ Receives FDA ‘Breakthrough Device Designation,’ Accelerate Entry into the US Market
The first Korean developed medical device for spine implantation Expecte to receive faster approval in the U.S. by priority support…
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Biologics
MCRA Announces the Hiring of Former FDA Leadership to Advance its Regenerative Medicine Expertise
WASHINGTON, Nov. 15, 2023 /PRNewswire/ — MCRA, LLC, a leading medical device and biologics focused clinical research organization (CRO) and advisory firm…
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