LivsMed Inc. receives 510(k) clearance from the FDA for its ArtiSential™ articulating bipolar energy instruments for electrosurgical cutting and coagulation. ArtiSential™ devices feature the patented, double-jointed end effector, which allows surgeons to overcome the challenges presented by difficult angles of approach, especially in complex procedures.
The U.S. trial for CE-marked CBSO is designed to enroll up to 250 patients in a staged study approach
Engage Surgical, a privately held orthopedic implant company, announces FDA 510(k) clearance of the only cementless partial knee system available in the USA.
Kroger Health's new testing model combines at-home convenience with telehealth technology, with most results confirmed in less than 72 hours
At-home test by Phosphorus will reduce commute to testing centers and help companies conduct tests for their employees
As part of continued action to protect the American public, the U.S. Food and Drug Administration is warning consumers and health care professionals about hand sanitizer products containing methanol, or wood alcohol — a substance often used to create fuel and antifreeze that is not an acceptable active ingredient for hand sanitizer products and can be toxic when absorbed through the skin as well as life-threatening when ingested.
In a phase III study, a majority (60%) of heavily treatment-experienced adults randomized to receive Rukobia with an optimized background therapy achieved and maintained viral suppression through 96 weeks, addressing a critical unmet need
Soterix Medical Inc. announces it has received FDA Investigational Device Exception (IDE) to launch a trial of transcranial Direct Current Stimulation-Limited Total Energy (tDCS-LTE) neuromodulation at-home for patients with Major Depressive Disorder (MDD).
FDA clearance expands product portfolio with the introduction of a miniaturized and disposable IV infiltration and extravasation detection sensor
Next-generation Gallant™ implantable cardioverter defibrillator family of devices offers Bluetooth® capability for a more meaningful connection between patients and their doctors
Approval also includes extending the Nucleus 7 Sound Processor to the first U.S. cochlear implant recipients, Custom Sound Pro fitting software to enhance support for hearing professionals
Company Completes Critical Milestone in Development of "Universal Donor" Stem Cell Therapy for Stroke
AI-powered reading aid for screening mammography improves Radiologists' performance in cancer detection
The U.S. Food and Drug Administration has been thoughtfully and deliberately determining the safest and most appropriate time to resume prioritized domestic inspections of FDA-regulated facilities and other associated activities since we first announced postponement in March.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for a generic version of Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg.
Saladax is advancing personalized medicine by providing psychiatrists with the first commercially available antipsychotic test in the U.S.
Subsidiary to Advance Commercial Development of Diagnostic Tests for Virology, COVID-19, Oncology
Announce FDA’s New Era of Smarter Food Safety Blueprint.
Latest NeuroBlate System software delivers superior visualization for neurosurgeons
Innovative Negative Pressure Wound Therapy Device for Surgical Incisions