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

Healthcare News Roundup: FDA

HSMN NewsFeed - 12 Apr 2018
FDA Permits Marketing of IDx-DR for Automated Detection of Diabetic Retinopathy in Primary Care
Devices Ophthalmology FDA Product Launch

HSMN NewsFeed - 12 Apr 2018
TransMedics, Inc. Receives FDA Pre-Market Approval (PMA) for its OCS(TM) Lung System for Near-Physiologic Preservation and Assessment of Lungs for Transplantation
Devices Surgery FDA

HSMN NewsFeed - 9 Apr 2018
Fischer Medical Receives U.S. FDA 510(k) Clearance to Market Bloom2 Cardiac Stimulator
Devices Cardiology FDA

HSMN NewsFeed - 9 Apr 2018
RegeneRx Announces Outcome of FDA Discussions for Development of RGN-259 for Dry Eye Syndrome
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 6 Apr 2018
Teligent, Inc. Announces FDA Approval of Ciclopirox Shampoo, 1%
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 4 Apr 2018
Proteostasis Therapeutics Receives FDA Fast Track Designation for Triple Combination Program in Patients with Cystic Fibrosis
Biopharmaceuticals FDA

HSMN NewsFeed - 3 Apr 2018
FDA Approves GORE(R) CARDIOFORM Septal Occluder for PFO Closure to Prevent Recurrent Ischemic Stroke
Devices Interventional Cardiology FDA

HSMN NewsFeed - 2 Apr 2018
Endo Agrees to Extend Temporary Stay of FDA Litigation
Biopharmaceuticals FDA Litigation

HSMN NewsFeed - 27 Mar 2018
FDA Approves New Innovations on Hologic's 3Dimensions(TM) Mammography System, the Fastest, Highest Resolution Breast Tomosynthesis System Ever(1)
Devices Oncology Radiology FDA

HSMN NewsFeed - 27 Mar 2018
FDA approves Toujeo(R) Max SoloStar(R)
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 27 Mar 2018
Convexity Scientific Receives FDA Clearance For Its FLYP(TM) Nebulizer, Unveils The New Device At Medtrade Spring
Devices FDA Product Launch

HSMN NewsFeed - 26 Mar 2018
FDA approves inclusion of data from safety outcomes trial in the Tresiba(R) label
Biopharmaceuticals Endocrinology Cardiology FDA

HSMN NewsFeed - 26 Mar 2018
Bioness Receives FDA Clearance for myBioness(TM) iOS app for mobile control of the L300 Go(TM) System
Devices FDA

HSMN NewsFeed - 26 Mar 2018
DarioHealth Receives U.S. FDA Clearance for iPhone 7, 8 and iPhone X Smart Glucose Meter
Devices Monitoring Endocrinology FDA

HSMN NewsFeed - 22 Mar 2018
Respiratory Motion, Inc. is excited to announce FDA clearance for use of the ExSpiron(TM) 1Xi Minute Ventilation Monitor in Pediatric Patients
Devices FDA

HSMN NewsFeed - 20 Mar 2018
Therapix Biosciences Announces FDA Clearance of Investigational New Drug (IND) for Phase IIa Clinical Trial of THX-110 in the Treatment of Chronic Low Back Pain
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Mar 2018
Amplyx Pharmaceuticals Receives Fourth "Qualified Infectious Disease Product" (QIDP) Designation from the FDA for APX001
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Mar 2018
Q Biomed Inc. Announces FDA Filing for Approval of a New Manufacturing Facility for Non-Opioid Strontium Chloride SR89 Injection USP for Relief of Cancer Bone Pain
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 16 Mar 2018
FDA Approves Hizentra(R) (Immune Globulin Subcutaneous [Human] 20% Liquid) for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Biopharmaceuticals FDA

HSMN NewsFeed - 15 Mar 2018
Janssen Announces U.S. FDA Breakthrough Therapy Designation for Erdafitinib in the Treatment of Metastatic Urothelial Cancer
Biopharmaceuticals Oncology Urology FDA

HSMN NewsFeed - 15 Mar 2018
DxNow, Inc. Receives FDA 510(k) Clearance for ZyMōt(TM) ICSI and ZyMōt(TM) Multi Sperm Separation Devices
Devices FDA

HSMN NewsFeed - 14 Mar 2018
Cerapedics Receives FDA IDE Approval to Initiate Study of P-15L Bone Graft for Transforaminal Lumbar Interbody Fusion Surgery
Devices Orthopaedic FDA

HSMN NewsFeed - 13 Mar 2018
Exalenz Bioscience’s BreathID(R) Hp & BreathID Hp Lab Systems Receive FDA Clearance for Diagnosis of Helicobacter pylori Testing in Pediatric Patients
Diagnostics FDA

HSMN NewsFeed - 12 Mar 2018
Medtronic Receives FDA Approval for Guardian Connect Continuous Glucose Monitoring (CGM) System for People Living with Diabetes
Devices Monitoring Endocrinology FDA

HSMN NewsFeed - 9 Mar 2018
FDA Approves Pivotal Clinical Trial for Technology to Treat Overactive Bladder
Devices Urology FDA

HSMN NewsFeed - 7 Mar 2018
Perrigo Announces Final FDA Approval and Planned Launch for the Store Brand OTC Equivalent of Mucinex(R) DM Maximum Strength Extended Release Tablets
Biopharmaceuticals Generics FDA Product Launch

HSMN NewsFeed - 7 Mar 2018
Panther Orthopedics, Inc. Receives FDA 510(k) Clearance for the PUMA System(TM) - An Orthopedic Flexible Fixation Device
Devices Orthopaedic FDA

HSMN NewsFeed - 6 Mar 2018
FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes
Diagnostics Oncology FDA

HSMN NewsFeed - 5 Mar 2018
U.S. FDA Accepts New Drug Application for Prucalopride (SHP555) for Chronic Idiopathic Constipation
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 2 Mar 2018
Jazz Pharmaceuticals Announces FDA Acceptance of NDA for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
Biopharmaceuticals FDA

HSMN NewsFeed - 2 Mar 2018
FDA to Review DUPIXENT(R) (dupilumab) as Potential Treatment for Moderate-to-Severe Asthma
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Feb 2018
SnoreRx, Now Available at CVS, is First and Only FDA Certified Non-prescription Anti Snoring Treatment
Devices Product Launch

HSMN NewsFeed - 23 Feb 2018
Kazia Receives FDA Orphan Designation for GDC-0084
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 23 Feb 2018
Mallinckrodt Receives FDA Acceptance of Stannsoporfin New Drug Application Filing
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Feb 2018
Access Vascular Receives FDA Clearance For Its HydroPICC Catheter
Devices FDA

HSMN NewsFeed - 16 Feb 2018
Photocure Announces U.S. FDA Approval of New Indication for Blue Light Cystoscopy with Cysview(R)
Devices Oncology FDA

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