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Healthcare News Roundup: FDA

 HSMN NewsFeed - 26 Sep 2023
Abyrx Receives FDA Clearance for MONTAGE(R) Settable Bone Putty for Use in Cardiothoracic Surgery
Devices Surgery FDA
 HSMN NewsFeed - 21 Sep 2023
Tyber Medical Gains FDA and MDR Clearance for its Implantable K-Wires and Steinmann Pins in Stainless Steel and Titanium Alloy
Devices Orthopaedic FDA
 HSMN NewsFeed - 20 Sep 2023
IceCure Medical Receives FDA Response to De Novo Classification Request for Breast Cancer
Devices FDA
 HSMN NewsFeed - 15 Sep 2023
SmartCardia Receives FDA Clearance for its 14-Day 7-Lead ECG Real-Time Patch and Cloud Platform
Devices Cardiology Monitoring FDA
 HSMN NewsFeed - 11 Sep 2023
OnPoint Surgical Receives 510(k) Clearance for the OnPoint Augmented Reality Spine System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 8 Sep 2023
Citius Pharmaceuticals, Inc. Receives Regulatory Guidance from the U.S. Food and Drug Administration (FDA) regarding the Planned Resubmission of the BLA for LYMPHIR(TM)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 31 Aug 2023
Mallinckrodt Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate Capsules and Launches Product Used to Treat Attention-Deficit/Hyperactivity Disorder (ADHD)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 23 Aug 2023
Fresenius Medical Care Announces FDA Clearance of Versi(R)HD with GuideMe Software
Devices FDA
 HSMN NewsFeed - 22 Aug 2023
Levita(R) Magnetics Wins FDA Clearance for Pioneering MARS(TM) System
Devices Surgery FDA
 HSMN NewsFeed - 21 Aug 2023
magAssist's NyokAssist(TM) granted Designation by the FDA as a Breakthrough Device
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 18 Aug 2023
FDA grants priority review for full approval of TARPEYO for the treatment of IgA Nephropathy
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 Aug 2023
Zumutor Biologics Inc Announces FDA Clearance of IND Application of ZM008, a Novel Monoclonal Antibody Drug Against Multiple Solid Cancers
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 10 Aug 2023
Baird Medical Submits Disposable Microwave Ablation Needle and MWA System Application to U.S. FDA for Treatment of Soft Tissue Microwave Ablation
Devices FDA
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