Healthcare Sales & Marketing Network: FDA : Medical Device and Pharmaceutical News

Healthcare News Roundup: FDA

HSMN NewsFeed - 13 Oct 2021
Varian Receives FDA "Breakthrough Device Designation" For Embozene(R) Microspheres For Genicular Artery Embolization For Symptomatic Knee Osteoarthritis
Devices Interventional FDA

HSMN NewsFeed - 13 Oct 2021
FDA Approves Verzenio(R) (abemaciclib) as the First and Only CDK4/6 Inhibitor for Certain People with HR+ HER2- High Risk Early Breast Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 7 Oct 2021
Venclose MAVEN Earns FDA Clearance to Treat Incompetent Perforator Veins
Devices Interventional FDA

HSMN NewsFeed - 6 Oct 2021
U.S. FDA Accepts COUR Pharmaceuticals Investigational New Drug Application (IND) for a Proof-of-Concept Study for the Treatment of Primary Biliary Cholangitis (PBC)
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Oct 2021
Amber Implants VCFix(R) spinal system receives US FDA Breakthrough designation
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 29 Sep 2021
TransMedics Receives FDA Approval for its OCS Liver System for Preservation and Assessment of Donor Livers for Transplantation
Devices FDA

HSMN NewsFeed - 23 Sep 2021
MolecuLight i:X(R) Receives FDA 510(k) Clearance for the Device's Ability to Detect Wounds Likely to Contain Pseudomonas aeruginosa (PA)
Devices Wound Care FDA

HSMN NewsFeed - 22 Sep 2021
Kleiner Device Labs Receives FDA Market Clearance for KG2 Surge Flow-Thru Interbody System
Devices Neurosurgery Orthopaedic FDA

HSMN NewsFeed - 21 Sep 2021
FDA Approves LEXETTE (R) for Adolescent Plaque Psoriasis
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 8 Sep 2021
Intelivation Technologies received FDA approval for the Advantage-C(TM) PEEK Cervical Interbody Fusion device
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 6 Sep 2021
U.S. FDA Placed a Clinical Hold on BMN 307 Phearless Phase 1/2 Gene Therapy Study in Adults with PKU Based on Interim Pre-clinical Study Findings
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Sep 2021
Intelivation Technologies received FDA approval for the Golden Isles Pedicle Screw System(TM)
Devices Neurosurgery Orthopaedic FDA

HSMN NewsFeed - 1 Sep 2021
Tyber Medical Receives Largest FDA 510(k) Clearance For Expanded Line Of Anatomical Plating Systems
Devices Orthopaedic FDA

HSMN NewsFeed - 31 Aug 2021
MicroTransponder(R) Receives FDA Approval for Breakthrough Device Benefiting Stroke Survivors
Devices Neurology FDA

HSMN NewsFeed - 30 Aug 2021
Poseida Therapeutics Announces FDA Clearance of Investigational New Drug Application for P-BCMA-ALLO1, an Allogeneic CAR-T Candidate for Relapsed/Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 30 Aug 2021
Visby Medical(TM) Receives FDA Clearance and CLIA Waiver at the Point of Care for PCR Sexual Health Test
Diagnostics FDA

HSMN NewsFeed - 30 Aug 2021
Zimmer Biomet and Canary Medical Announce FDA De Novo Classification Grant and Authorization to Market the World's First and Only Smart Knee Implant
Devices Orthopaedic FDA

HSMN NewsFeed - 26 Aug 2021
FDA Clears Thermo Scientific EliA SmD(P)-S Test For Use In U.S.
Diagnostics FDA

HSMN NewsFeed - 24 Aug 2021
InDex Pharmaceuticals receives FDA clearance to start the phase III study CONCLUDE with cobitolimod
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 23 Aug 2021
Shoulder Innovations Announces FDA 510(k) Clearance For InSet(TM) Reverse Shoulder Platform Technology
Devices Orthopaedic FDA

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