HD MEDICAL: Awarded FDA Clearance For HD Steth
Intelligent Stethoscope with Integrated ECG delivers Instant Cardiac Insights
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SOLITON: Receives FDA Acceptance for 510(k) Application
Rapid Acoustic Pulse ("RAP") device 510(k) Application Accepted for cellulite reduction
GSK: Announces FDA advisory committee votes in favour of positive benefit/risk profile for belantamab mafodotin for patients with relapsed/refractory multiple myeloma
Recommendation based on review of DREAMM clinical trial programme, including the pivotal DREAMM-2 study
GI SUPPLY: Gets FDA Clearance of First Submucosal Lifting Agent in a Pre-filled 5mL Syringe
New EverLift™ device designed to reduce costs and enhance complete polyp resections
AATRU MEDICAL, LLC: Submits NPSIMS™ product to FDA for Class II Clearance and completes Series C funding
Innovative Negative Pressure Wound Therapy Device for Surgical Incisions
MONTERIS: Announces FDA Clearance of NeuroBlate Fusion-S™ Software
Latest NeuroBlate System software delivers superior visualization for neurosurgeons
FDA: Launches New Era of Smarter Food Safety Initiative, Releases Blueprint and Pilot Study
Announce FDA’s New Era of Smarter Food Safety Blueprint.
APPLIED DNA: Forms Clinical Testing Subsidiary to Maximize Utility of FDA EUA-Approved Linea™ COVID-19 Assay Kit and Expands Utility with Successful EUA Amendment
Subsidiary to Advance Commercial Development of Diagnostic Tests for Virology, COVID-19, Oncology
SALADAX BIOMEDICAL: Launches clozapine test in the US after FDA grants market authorization
Saladax is advancing personalized medicine by providing psychiatrists with the first commercially available antipsychotic test in the U.S.
AMNEAL: Launches Generic Fluphenazine Following ANDA Approval by FDA
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.
FDA: Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system
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.
THERAPIXEL: Receives FDA 510(k) clearance for MammoScreen™
AI-powered reading aid for screening mammography improves Radiologists' performance in cancer detection
CREATIVE MEDICAL TECHNOLOGY HOLDINGS: Completes AmnioStem™ Preclinical Studies Needed for FDA Investigational New Drug Application Filing
Company Completes Critical Milestone in Development of "Universal Donor" Stem Cell Therapy for Stroke
COCHLEAR LIMITED: Cochlear obtains FDA approval of Kanso 2 Sound Processor, first off-the-ear cochlear implant sound processor with direct smartphone connectivity
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
ABBOTT: Receives FDA Approval for New Heart Rhythm Devices Featuring Bluetooth Connectivity and Continuous Remote Monitoring
Next-generation Gallant™ implantable cardioverter defibrillator family of devices offers Bluetooth® capability for a more meaningful connection between patients and their doctors
IVWATCH: SmartTouch™ Sensor Receives FDA Clearance for Continuous IV Site Monitoring
FDA clearance expands product portfolio with the introduction of a miniaturized and disposable IV infiltration and extravasation detection sensor
SOTERIX MEDICAL INC.: FDA Grants Soterix Medical IDE Approval for Home-based tDCS-LTE Trial for Depression
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).
VIIV HEALTHCARE: Announces US FDA Approval for Rukobia (fostemsavir), a First-in-Class Treatment for HIV in Adults With Few Treatment Options Available
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
FDA: Coronavirus (COVID-19) Update: FDA Takes Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol
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.
CARE ACCESS RESEARCH: Validation Study of COVID-19 At-Home Saliva Test by Phosphorus is Granted EUA by FDA
At-home test by Phosphorus will reduce commute to testing centers and help companies conduct tests for their employees