SOLITON, INC.: Soliton's FDA Cleared RAP Device is Granted Two Additional Key Patents
Rapid Acoustic Pulse device granted patents in Taiwan and Japan
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SUBTLE MEDICAL: Receives FDA 510(k) Clearance for AI-Powered SubtleMR™
Subtle Medical, a healthcare technology company focused on improving the quality, efficiency, and accessibility of medical imaging, announced today 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market SubtleMRTM. SubtleMR is an image processing software that uses denoising and resolution enhancement to improve image quality.
Sen. Blumenthal calls on FDA to issue regulatory framework for CBD
U.S. Sen. Richard Blumenthal (D-CT) recently held a press conference in which he pleaded with the U.S. Food and Drug Administration (FDA) to establish a regulatory framework for the safe use of CBD.
MD Anderson's Hahn a frontrunner for FDA Commissioner
Stephen Hahn, M.D., Chief Medical Executive of The University of Texas MD Anderson Cancer Center, is the top candidate to be the next commissioner of the U.S. Food and Drug Administration (FDA).
FIDMI MEDICAL: Receives FDA Regulatory Clearance for Low-profile Enteral Feeding Device
Fidmi Medical Ltd. a portfolio company of The Trendlines Group Ltd. ("Trendlines") (SGX: 42T) (OTCQX: TRNLY), announced today that it received 510K regulatory clearance from the United States Food and Drug Administration (FDA) for its low-profile enteral feeding device.
CARBOFIX: Extends Its CarboClear® Carbon Fiber Spinal Product Line With Its FDA Cleared Vertebral Body Replacement (VBR) System
The product to be officially launched during the Congress of Neurological Surgeons (CNS) in San Francisco, October 21-23, 2019
SHIONOGI: U.S. FDA Advisory Committee Recommends Approval of Cefiderocol for Treatment of Complicated Urinary Tract Infections
Shionogi & Co., Ltd. (hereafter “Shionogi”) announced that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee voted to recommend approval of the investigational antibiotic cefiderocol for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in patients with limited or no alternative treatment options.
FDA Update: 2019 animal product recalls
The U.S. Food and Drug Administration recalled 28 animal products from January through September of 2019, the agency reported.
Former FDA official responds – in part – to Taxpayers Protection Alliance's suggested reforms
Dr. David Gortler, former Food and Drug Administration (FDA) official, drug safety and FDA regulatory affairs expert and pharmacology professor, responds to the Taxpayers Protection Alliances’ (TPA) list of recommendations to improve business strategies released Oct. 3.
ORTHO CLINICAL DIAGNOSTICS: FDA Clears ORTHO™ Sera ID-MTS for Use on the ORTHO VISION® Analyzer
Fully Automated Technology from Ortho Clinical Diagnostics Aids in Extended Antigen Phenotyping and Ensures Delivery of Safe Blood to Transfusion Patients
MICROPHYT: Microphyt’s PhaeoSOL Receives New Dietary Ingredient (NDI) Status from the FDA
PhaeoSOL is a natural microalgae-based nutritional ingredient aiming at improving the well-being of the elderly and preventing certain metabolic disorders
ENLIGHTENVUE: enlightenVue's Single Use Micro-Endoscope complies with new FDA recommendations to increase patient safety
The innovative micro-endoscope with multiple working channels is single use, eliminating the risk of transmitting infections among patients.
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UNITED THERAPEUTICS: Announces FDA Approval Of Updated Label For Orenitram Reflecting Results Of FREEDOM-EV Study
United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplement to the New Drug Application for Orenitram® (treprostinil) Extended-Release Tablets reflecting data from the FREEDOM-EV study in patients with pulmonary arterial hypertension (PAH).
BAYER: Submits Supplemental New Drug Application to FDA for Intrauterine Device (IUD) Mirena® (levonorgestrel-releasing intrauterine system) 52 mg
Application Seeks to Extend Duration of Use Up to Six Years for Mirena
HERON THERAPEUTICS: Announces FDA Approval of Supplemental New Drug Application to Expand CINVANTI® Label for Single-Dose Regimen for Patients Receiving Moderately Emetogenic Chemotherapy (MEC)
Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food and Drug Administration (FDA) has approved Heron's supplemental New Drug Application (sNDA) for CINVANTI (aprepitant) injectable emulsion for intravenous (IV) use. The sNDA requested FDA approval to expand the recommended dosage to include the 130 mg single-dose regimen for patients receiving MEC.
Johnson & Johnson announces recall after FDA test confirms asbestos in batch of baby powder
Legal teams pursuing numerous lawsuits against Johnson & Johnson on behalf of ovarian cancer victims alleging that asbestos in the manufacturer's baby powder made them sick are saying that J&J's announcement Friday of a voluntary recall of the product should help prove their claims.
FDA needs more oversight of regenerative medicine, Penn professor says
For nearly 20 years, regenerative medicine such as cell and gene therapies have gradually shown much promise in repairing or replacing damaged and infected cells, tissues and organs in order to cure ailments including organ failure, spinal cord injuries, multiple sclerosis and other traumatic wounds and diseases.
GARWOOD MEDICAL DEVICES: FDA Grants Breakthrough Device Designation to BioPrax™ Biofilm Disruption Device
Garwood Medical Devices, a company focused on advancing infection control through innovation, announces today that it has been granted Breakthrough Device designation by the Food and Drug Administration (FDA) for its BioPrax™ device.
U.S. FDA: FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease
FDA is also working quickly to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD
FDA approved record number of generic drugs in 2018
A new report on the U.S. Food and Drug Administration's (FDA) generic drug program highlights the agency's all-time record number of approvals for fiscal year 2018.