Healthcare Sales & Marketing Network: FDA News Roundup

Healthcare News Roundup: FDA

HSMN NewsFeed - 18 Apr 2019
TELA Bio(R) Announces 510(k) Clearance for Restella(TM) Reconstructive BioScaffolds for Reconstructive Surgery
Devices Surgery FDA

HSMN NewsFeed - 18 Apr 2019
Beckman Coulter's Early Sepsis Indicator Receives 510(k) Clearance from the U.S. Food and Drug Administration
Devices Diagnostics FDA

HSMN NewsFeed - 17 Apr 2019
FDA Grants Breakthrough Device Designation For Advanced Prenatal Therapeutics' Targeted Apheresis Column For Preeclampsia
Devices FDA

HSMN NewsFeed - 16 Apr 2019
Viracta Receives Orphan Drug Designation from the US FDA for its Lead Epigenetic Drug Candidate Nanatinostat for EBV-Associated Cancers
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 16 Apr 2019
Aprea Therapeutics Receives FDA Fast Track Designation and Orphan Drug Designation for APR-246 for the Treatment of Myelodysplastic Syndromes (MDS)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 10 Apr 2019
Getinge Receives 510(k) Clearance From US FDA for Software Upgrade in Servo-u(R) and Servo-n(R) Ventilator Platform
Devices FDA

HSMN NewsFeed - 9 Apr 2019
Innoblative's SIRA(TM) RFA Electrosurgical Device Receives FDA Clearance
Devices Surgery FDA

HSMN NewsFeed - 9 Apr 2019
FDA Clears VITROS(R) XT Chemistry Product Slides from Ortho Clinical Diagnostics
Diagnostics FDA

HSMN NewsFeed - 8 Apr 2019
BD Unveils Platelet Quality Control Media to Help Reduce the Incidence of Sepsis in Patients Requiring Platelet Transfusion
Diagnostics FDA Product Launch

HSMN NewsFeed - 4 Apr 2019
Magstim TMS Receives FDA Clearance for 3- minute Theta Burst Treatment
Devices Neurology FDA

HSMN NewsFeed - 4 Apr 2019
Daiichi Sankyo Provides Update on Ongoing FDA Review for Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 3 Apr 2019
CSA Medical, Inc. Receives FDA Breakthrough Device Designation and IDE Approval for its RejuvenAir(R) System for COPD Patients with Chronic Bronchitis
Devices FDA

HSMN NewsFeed - 27 Mar 2019
FDA advances landmark policy changes to modernize mammography services and improve their quality
Devices Radiology Oncology FDA

HSMN NewsFeed - 27 Mar 2019
FDA Clears the Cervella Cranial Electrotherapy Stimulator for Treatment of Anxiety, Insomnia, and Depression
Devices Neurology FDA

HSMN NewsFeed - 27 Mar 2019
Lannett Receives FDA Approval For Aspirin And Extended-Release Dipyridamole Capsules, 25 mg/200 mg
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 27 Mar 2019
Novartis receives FDA approval for Mayzent(R) (siponimod), the first oral drug to treat secondary progressive MS with active disease
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 25 Mar 2019
Zimmer Biomet Receives FDA Clearance of ROSA(R) ONE Spine System for Robotically-Assisted Surgeries
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 21 Mar 2019
Beckman Coulter's Compact, Low-volume Hematology Analyzer Receives FDA 510(k) Clearance
Devices Diagnostics FDA

HSMN NewsFeed - 21 Mar 2019
Soliton Files 510(k) with FDA for its Rapid Acoustic Pulse Device
Devices Dermatology FDA

HSMN NewsFeed - 21 Mar 2019
Enzyvant's Investigational Farber Disease Enzyme Replacement Therapy, RVT-801, Receives FDA Fast Track and Rare Pediatric Disease Designations
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Mar 2019
Atreon Orthopedics Received FDA Clearance for Rotator Cuff Regeneration Product
Devices Regenerative Medicine Orthopaedic FDA

HSMN NewsFeed - 18 Mar 2019
Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD
Biopharmaceuticals FDA Regulatory

HSMN NewsFeed - 18 Mar 2019
Allergan Announces FDA Approval of AVYCAZ(R) (ceftazidime and avibactam) for Pediatric Patients
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Mar 2019
Via Surgical Receives FDA Clearance for Its FasTouch(TM) Absorbable Fixation System
Devices Surgery FDA

HSMN NewsFeed - 14 Mar 2019
FDA Approves New Indication for Valve Repair Device to Treat Certain Heart Failure Patients with Mitral Regurgitation
Devices Interventional Cardiology FDA

HSMN NewsFeed - 14 Mar 2019
BD Receives U.S. FDA Approval for First Venous Stent to Treat Iliofemoral Venous Occlusive Disease
Devices Interventional FDA

HSMN NewsFeed - 13 Mar 2019
FDA Grants De Novo for the HemoSonics Quantra(R) QPlus System; This Revolutionary Diagnostic Provides Unique Information for Accessing Coagulation at the Point of Care; Now Commercially Available in US
Devices Diagnostics FDA

HSMN NewsFeed - 11 Mar 2019
Alcyone Lifesciences Receives Breakthrough Device Designation from U.S. FDA for the ThecaFlex DRx(TM) System
Devices Neurology Oncology Drug Delivery FDA

HSMN NewsFeed - 11 Mar 2019
Eisai and Imbrium Therapeutics Announce U.S. FDA Filing Acceptance of New Drug Application for Lemborexant for the Treatment of Insomnia
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Mar 2019
Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine
Biopharmaceuticals FDA

HSMN NewsFeed - 7 Mar 2019
FDA Accepts Supplemental Biologics License Applications (sBLAs) for BOTOX(R) (onabotulinumtoxinA) for Pediatric Patients with Upper and Lower Limb Spasticity
Biopharmaceuticals FDA

HSMN NewsFeed - 6 Mar 2019
Ampio Updates Regulatory Status for Ampion
Biopharmaceuticals FDA

HSMN NewsFeed - 6 Mar 2019
Instrumentation Laboratory Receives US FDA Clearance For New Gem Premier Chemstat(TM) Testing System
Diagnostics FDA

HSMN NewsFeed - 5 Mar 2019
Perrigo Confirms Patent Challenge for Generic Version of Nascobal(R)
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 27 Feb 2019
Breckenridge Announces Final Approval of its ANDA for Exemestane Tablets (Aromasin(R))
Biopharmaceuticals Generics Oncology FDA

HSMN NewsFeed - 27 Feb 2019
eNeura, Inc. Receives FDA Clearance for Acute Treatment and Prevention of Migraine in Children 12 Years of Age and Older
Devices Neurology FDA

HSMN NewsFeed - 25 Feb 2019
FDA Approves Taiho Oncology's LONSURF(R) (trifluridine/tipiracil) for Adult Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Biopharmaceuticals Oncology FDA

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