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
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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
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
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
THERAPIXEL: Receives FDA 510(k) clearance for MammoScreen™
AI-powered reading aid for screening mammography improves Radiologists' performance in cancer detection
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.
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.
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.
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
FDA: Launches New Era of Smarter Food Safety Initiative, Releases Blueprint and Pilot Study
Announce FDA’s New Era of Smarter Food Safety Blueprint.
MONTERIS: Announces FDA Clearance of NeuroBlate Fusion-S™ Software
Latest NeuroBlate System software delivers superior visualization for neurosurgeons
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
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
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
SOLITON: Receives FDA Acceptance for 510(k) Application
Rapid Acoustic Pulse ("RAP") device 510(k) Application Accepted for cellulite reduction
HD MEDICAL: Awarded FDA Clearance For HD Steth
Intelligent Stethoscope with Integrated ECG delivers Instant Cardiac Insights
VITLS INC.: Announces FDA Clearance of Its Clinical-Grade Platform for Accurate and Continuous Vital Sign Monitoring in the Hospital and Home
Vitls Platform Combines All the Vital Signs Required to Assess Patients Into One Wearable Device
ABIOMED: FDA Approves Data Streaming from the Impella Console, Setting the Stage for Artificial Intelligence Algorithms to Further Improve Patient Outcomes
The United States Food and Drug Administration (FDA) has approved one-way digital data streaming during patient support from Abiomed's (NASDAQ: ABMD) Automated Impella Controller (AIC), the external console used with Impella heart pumps.
CLINICAL COMPUTER SYSTEMS, INC.: Announces FDA 510(k) Clearance for OBIX BeCA® Fetal Monitor
Clinical Computer Systems, Inc. (CCSI), a leading provider of perinatal software, is looking forward to a successful launch of the new OBIX BeCA fetal monitor which recently obtained FDA 510(k) clearance.
QUEST DIAGNOSTICS: FDA Authorizes Quest Diagnostics COVID-19 Diagnostic Testing for Specimen Pooling for Emergency Use
First FDA authorization of laboratory technique for use in COVID-19 diagnostic testing