FDA
-
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…
Read More » -
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…
Read More » -
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…
Read More » -
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…
Read More » -
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…
Read More » -
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…
Read More » -
Regulatory
ZKR Orthopedics announces FDA Breakthrough Device designation for the LIFT Implant Technology
KENTFIELD, Calif., Oct. 09, 2023 (GLOBE NEWSWIRE) — ZKR Orthopedics, Inc., a clinical stage medical device company, today announced that…
Read More » -
Biologics
U.S. FDA Grants Lipogems® Second IDE Approval For A Clinical Trial On The Treatment For Knee OA
ATLANTA, Oct. 4, 2023 /PRNewswire/ — The U. S. Food and Drug Administration (FDA) has awarded Lipogems another Investigational Device Exemption (IDE) study…
Read More »