BIPRI, LLC: Solving Migraines With Unique FDA-Registered Vibration Massage Therapy Device
The BIPRI 8-Motor Headband Is Changing the Game for Chronic Migraine Sufferers.
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ABSORPTION SYSTEMS: Awarded 5-year IDIQ Contract by the U.S. Food and Drug Administration
To conduct preclinical testing of locally-acting topical dermal and ophthalmic drug product formulations
Taxpayers Protection Alliance recommends FDA reforms
The U.S. Food and Drug Administration (FDA) holds primary responsibility for approving and regulating various human and animal prescription drugs, medical and tobacco products and the nation’s food supply.
BECKMAN COULTER: DxA 5000 total laboratory automation solution receives U.S. FDA 510(k) clearance
Beckman Coulter, a global leader in clinical diagnostics, announced that the DxA 5000 total laboratory automation solution has received FDA 510(k) clearance and is now available for sale in the United States.
ALLSCRIPTS: Veradigm Health joins Harvard Pilgrim to develop next phase of FDA’s Sentinel System
Five-year award signals FDA’s commitment to national program utilizing electronic healthcare data to monitor the safety of FDA-regulated drugs and other medical products
FDA Update: recent animal drug approvals
Federal law dictates that drug companies can’t manufacture and market medicines for animals unless they get the approval of the U.S. Food and Drug Administration.
THINK SURGICAL: Receives FDA Clearance to Market Active Robot for Total Knee Replacement Procedures in the United States
Approval follows multi-center investigational clinical trial evaluating safety and efficacy of TSolution One® Total Knee Application
WONTECH: Receives FDA Clearance for 'HairBoom Air'
WONTECH (Reno Kim, CEO of WONTECH, www.wtlaser.com) a leading Korean laser and energy based medical aesthetic device company announced that its LLLT hair loss treatment device, HairBoom Air, received U.S. Food and Drug Administration 510(K) clearance.
OSSDSIGN AB: Receives US FDA Clearance for Cranial PSI Accessories - Strengthening Business Position in the US
OssDsign AB (publ) ("OssDsign" or the "Company") today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance (K190523) to market OssDsign Cranial PSI Accessories in the US.
SOLITON, INC.: Soliton's FDA Cleared RAP Device is Granted Two Additional Key Patents
Rapid Acoustic Pulse device granted patents in Taiwan and Japan
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