Flowonix Medical, Inc.announced approval from the United States Food and Drug Administration (FDA) to market the Prometra II® 40 mL Programmable Pump and its associated programmer software.
Surface Modifying Macromolecules in Dialyzers and Bloodlines are Paired with Dialysate Formula to Prevent Clots
A research team from the School of Chinese Medicine at Hong Kong Baptist University (HKBU) has successfully developed a novel aptamer, i.e. a single-stranded piece of DNA, for the treatment of osteogenesis imperfecta (OI) with the aid of artificial intelligence (AI) technology. It is the first time a drug in Hong Kong has been granted orphan drug designation by the US Food and Drug Administration (FDA).
FDA recommends including a boxed warning and other elements in breast implant labeling
FDA is also working quickly to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD
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.
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.
Application Seeks to Extend Duration of Use Up to Six Years for Mirena
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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).
The innovative micro-endoscope with multiple working channels is single use, eliminating the risk of transmitting infections among patients.
PhaeoSOL is a natural microalgae-based nutritional ingredient aiming at improving the well-being of the elderly and preventing certain metabolic disorders
Fully Automated Technology from Ortho Clinical Diagnostics Aids in Extended Antigen Phenotyping and Ensures Delivery of Safe Blood to Transfusion Patients
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.
The product to be officially launched during the Congress of Neurological Surgeons (CNS) in San Francisco, October 21-23, 2019
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.
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.
Rapid Acoustic Pulse device granted patents in Taiwan and Japan
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.
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.
Approval follows multi-center investigational clinical trial evaluating safety and efficacy of TSolution One® Total Knee Application