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Healthcare News Roundup: FDA

 HSMN NewsFeed - 17 Jun 2021
Irrimax Receives FDA Clearance for Irrisept(R) as an Antimicrobial Wound Lavage for US Market
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Jun 2021
Elekta radiotherapy system designed for changing cancer landscape now available for U.S. patients
Devices Oncology FDA
 HSMN NewsFeed - 16 Jun 2021
Spark(TM) Aligners Receive FDA Clearance For Orthodontic Treatment Of Kids, Giving Parents A New Option With Significant Treatment Advantages Over The Leading Competitor
Devices Dental FDA
 HSMN NewsFeed - 14 Jun 2021
FDA Clears LPCN 1154 IND Application for a Phase 2 Postpartum Depression Study
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 Jun 2021
Nuvo Group Receives 510(k) FDA Clearance for Remote Monitoring of Uterine Activity
Devices Monitoring FDA
 HSMN NewsFeed - 10 Jun 2021
Cardinal Health(TM) Nuclear & Precision Health Solutions Receives U.S. Food and Drug Administration Approval for New LYMPHOSEEK(R) Pediatric Indication
Biopharmaceuticals Radiology Oncology FDA
 HSMN NewsFeed - 7 Jun 2021
FDA Approves First-of-its-Kind SenSight(TM) Directional Lead System for DBS Therapy
Devices Neurology FDA
 HSMN NewsFeed - 4 Jun 2021
Ortho Regenerative Technologies Receives Clinical Hold Letter From the U.S. FDA
Regenerative Medicine Orthopaedic FDA
 HSMN NewsFeed - 3 Jun 2021
Medtronic Gains FDA Clearance of UNiD(TM) Patient-Specific Rods for Use with CD Horizon(TM) Solera(TM) Voyager(TM) and Infinity(TM) OCT Spinal Systems
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 1 Jun 2021
Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 27 May 2021
FDA Grants Micro Interventional Devices, Inc. Breakthrough Device Designation for the MIA(TM)-T Percutaneous Tricuspid Annuloplasty System
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 26 May 2021
Varian Receives FDA "Breakthrough Device Designation" for its Cardiac Radioablation (CRA) System for Treatment of Refractory Ventricular Tachycardia (VT)
Devices Cardiology FDA
 HSMN NewsFeed - 24 May 2021
EndoFresh Obtains FDA 510(k) Clearance for Its Groundbreaking Disposable Digestive Endoscopy System
Devices Gastroenterology FDA
 HSMN NewsFeed - 24 May 2021
FDA Clearance of the Uro-G Completes UroViu Corporation's Suite of Portable, Single-Use, Disposable Cystoscopes
Devices Urology FDA
 HSMN NewsFeed - 19 May 2021
SoftWave Tissue Regeneration Technologies Receives FDA Clearance for Blood Circulation Increase, Minor Aches and Pains Relief and Connective Tissue Activation
Devices FDA
 HSMN NewsFeed - 17 May 2021
AffyImmune Therapeutics' AIC100 Granted Fast Track Designation for Treating Thyroid Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 14 May 2021
FDA Responds to Creative Medical Technology Holdings Regarding Its ImmCelz(R) IND for Stroke Treatment
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 13 May 2021
Heron Therapeutics Announces U.S. FDA Approval of ZYNRELEF(TM) (HTX-011) for the Management of Postoperative Pain for up to 72 Hours
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 May 2021
FDA Grants Bold Therapeutics' BOLD-100 an Orphan Drug Designation (ODD) in the Treatment of Gastric Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 10 May 2021
THINK Surgical and Ortho Development Announce FDA Clearance for Use of Balanced Knee System and BKS TriMax Implants with TSolution One Total Knee Application Active Robot System
Devices Orthopaedic FDA
 HSMN NewsFeed - 10 May 2021
Olympus Launches Line of Airway Mobilescopes
Devices FDA Product Launch
 HSMN NewsFeed - 5 May 2021
Genesis Software Innovations Announces FDA 510(k) Clearance For Preview(TM) 3D Shoulder Arthroplasty Planning Software
Devices Orthopaedic FDA
 HSMN NewsFeed - 4 May 2021
Standard Bariatrics(R) Titan SGS Stapling Technology for Sleeve Gastrectomy Receives FDA Clearance
Devices Surgery FDA
 HSMN NewsFeed - 30 Apr 2021
Therapeutic Solutions International Comes to Agreement with FDA on Clinical Trial Design for First Stem Cell Clinical Trial in Chronic Traumatic Encephalopathy (CTE) Patients
Regenerative Medicine FDA
 HSMN NewsFeed - 29 Apr 2021
Cerapedics Announces FDA Breakthrough Device Designation Granted for P-15L Bone Graft for the Treatment of Degenerative Disc Disease
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 29 Apr 2021
Soliton Receives FDA Clearance of Special 510(k)
Devices Dermatology FDA
 HSMN NewsFeed - 28 Apr 2021
Protalix BioTherapeutics and Chiesi Global Rare Diseases Receive Complete Response Letter for Pegunigalsidase Alfa from FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Apr 2021
Medtronic Receives FDA Breakthrough Designation for the Emprint(TM) Ablation Catheter Kit
Devices FDA
 HSMN NewsFeed - 27 Apr 2021
Medtronic Receives FDA Approval to Launch Clinical Study for Implantable Tibial Neuromodulation Therapy for Bladder Incontinence
Devices Urology FDA
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