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Healthcare News Roundup: FDA

 HSMN NewsFeed - 27 Nov 2024
PTC Therapeutics Enters into Agreement to Sell Priority Review Voucher for $150 Million
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Nov 2024
LifeSignals Receives FDA 510(k) Approval for UbiqVue(TM) 2A Multiparameter System
Devices Monitoring FDA
 HSMN NewsFeed - 22 Nov 2024
U.S. FDA Approves StemCyte Biologics License Application for REGENECYTE(TM) Cord Blood Cell Therapy Product
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Nov 2024
Medtronic Receives FDA Clearance for New InPen(TM) App, Paving the Way for its Smart MDI System Launch with Simplera(TM) CGM
Devices Monitoring FDA
 HSMN NewsFeed - 19 Nov 2024
THINK Surgical Receives FDA 510(k) Clearance to Use Freedom(R) Total Knee, Freedom Titan(R) Knee, and Freedom Primary PCK(R) System Implants with TMINI(R) Miniature Robotic System
Devices Orthopaedic FDA
 HSMN NewsFeed - 13 Nov 2024
SmartCardia Receives FDA Clearance for Outpatient Cardiac Telemetry for Its 7-Lead ECG Patch and Cloud Platform
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 11 Nov 2024
Momentis Surgical Receives FDA 510(k) Clearance for Second Generation Anovo(R) Robotic Platform, Introducing Haptic Feedback and Dual-Mode Articulation
Devices Surgery FDA
 HSMN NewsFeed - 8 Nov 2024
FDA Advisory Panel Votes in Favor of IceCure's ProSense(R) Cryoablation Benefit-Risk Profile in Early-Stage Low Risk Breast Cancer
Devices Oncology FDA
 HSMN NewsFeed - 1 Nov 2024
CARsgen(R) U.S. Clinical Holds Lifted by FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Oct 2024
FDA Grants Orphan Drug Designation to Capsida Biotherapeutics for Potential Treatment of STXBP1 Developmental and Epileptic Encephalopathy
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Oct 2024
Protega Pharmaceuticals Receives FDA Approval for ROXYBOND(TM) (oxycodone hydrochloride) Immediate-Release 10 mg Tablet with Abuse-Deterrent Technology for Management of Pain
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 Oct 2024
Pillar Biosciences Receives CPT(R) Code for FDA Approved oncoReveal(TM) CDx Pan-Cancer Solid tumor IVD Kit
Diagnostics Oncology Reimbursement
 HSMN NewsFeed - 24 Oct 2024
Accent Therapeutics Announces FDA Clearance of IND Application for ATX-559, a First-In-Class Oral DHX9 Inhibitor
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Oct 2024
Bracco Diagnostics Inc. and Subtle Medical Announce FDA Clearance of AiMIFY(TM) Software for Enhanced MRI
Devices Radiology FDA
 HSMN NewsFeed - 15 Oct 2024
Accure Acne Announces New FDA Clearance for the Long-Term Treatment of Acne
Devices Dermatology FDA
 HSMN NewsFeed - 8 Oct 2024
Regenity Biosciences Receives 510(k) Clearance for RejuvaKnee(TM), a Groundbreaking Regenerative Meniscus Implant Device to Redefine the Standard of Care
Devices Orthopaedic FDA
 HSMN NewsFeed - 8 Oct 2024
BTL's Emsculpt Neo Secures FDA Clearance for Treating Medical Diseases and Conditions, Expanding Market Reach
Devices FDA
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