Cirrus Dx, Inc. (CirrusDx), an infectious disease laboratory and diagnostics company, received Emergency Use Authorization (EUA) from the US Food & Drug Administration (FDA) to perform SARS-COVID-19 testing.
Emergency rescue device developed by Vent Multiplexor LLC in collaboration with Yale New Haven Hospital is the first ever device designed to enable individualized ventilation care for two patients sharing a single mechanical ventilator.
Agency Continues Effort to Protect Public Health from Fraudulent and Potentially Harmful Products
Every step we have taken as part of our approach to COVID-19 testing has been a careful balancing of risks and benefits in order to meet the urgent public health needs as we combat this new pathogen.
Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the PROLIFT Lateral Fixated System.
Mesenchymal Stem Cells for Treatment of Hospitalized COVID-19 Patients
Seegene, Inc. announced that U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for its Allplex™ 2019-nCoV Assay, a Real-time RT-PCR test for SARS-CoV-2, the novel coronavirus responsible for the COVID-19 disease.
IMBRUVICA plus rituximab demonstrated superior progression-free survival against the chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR) for previously untreated patients with chronic lymphocytic leukemia (CLL)
The U.S. Food and Drug Administration has issued warning letters to two companies for illegally selling unapproved products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act).
VisCardia Inc., a privately held medical device developer, announced today it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its implantable VisONE® system designed for the treatment of moderate to severe heart failure with reduced ejection fraction and preserved ventricular synchrony.
Only filter set available in the U.S. to reduce pro-inflammatory cytokine levels in the blood, including use in continuous renal replacement therapy (CRRT), for confirmed COVID-19 cases admitted to the ICU with confirmed or imminent respiratory failure who require blood purification
Agency Additionally Warns Consumers about Hand Sanitizer Sold with Fraudulent Claims
Caris Life Sciences®, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, today announced the submission of two Pre-Market Approval (PMA) applications for MI Exome™ CDx and MI Transcriptome™ CDx to the U.S. Food and Drug Administration (FDA).
Phase 1 Dose-Escalation Trial in Therapy-Refractory Solid Tumors to Begin in 2020
Lungpacer Medical announced today that the U.S. Food and Drug Administration has issued Emergency Use Authorization (EUA) for the Company's novel Diaphragmatic Pacing Therapy System (DPTS) for immediate use in patients on invasive mechanical ventilators at high risk of weaning failure, including COVID-19 patients.
Dermapose Access enables quick and easy fat removal for transfer
ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its supplemental new drug application (sNDA) for Cortrophin® Gel.
Morrisville, N.C., company provides resources and direction for medical device authorization under FDA Emergency Use Authorization Guidance.
Alpha Cognition Inc. (ACI) today announced that in a pre-Investigational New Drug (Pre-IND) meeting, the U.S. Food and Drug Administration (USFDA) agreed upon a clinical and regulatory pathway for the approval of Alpha-1062, a patented new chemical entity, to treat Alzheimer's disease.
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