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.
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.
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.
Centinel Spine®, LLC, the largest privately-held spine company focused on anterior column reconstruction, announced FDA approval of two-level indications for the prodisc® L Lumbar Total Disc Replacement (TDR) system.
FDA Sets Prescription Drug User Fee Act (PDUFA) Goal Date of July 23, 2020
The Boston-based green chemistry company's trial will study the industry's first all-natural, silk-based dermal filler
Hand Sanitizer Utilizing FDA/CDC Approved Formula Begins Shipping this Week
Amid COVID-19 pandemic, remote healthcare solutions are a priority now more than ever
EIDD-2801, an oral broad-spectrum antiviral proceeding into Clinical Trials
Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that its Logix Smart™ Coronavirus COVID-19 Test has obtained Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) to be used for the diagnosis of SARS-CoV-2.
Easy to use, palm-sized system will enable broader use across healthcare facilities closer to the patients and will begin shipping immediately
NEXVOO®, a global innovation leader in unified communications products, announces that it is assisting with the US and global pandemic by shifting resources to help with shipping FDA Certified N95 mask supplies into the US.
World's only FDA-cleared six-lead personal ECG will be used by healthcare professionals to monitor QT duration in patients receiving medications that can cause potentially life threatening QT prolongation.
Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert® Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19.
Biostage, Inc. (OTCQB: BSTG) (Biostage or the Company), a bioengineering company developing next-generation esophageal implants, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug application (IND) for the Cellspan Esophageal Implant (CEI) to treat patients with end-stage esophageal disease that require a segmental surgical resection to repair the diseased tissue.
The test will be used on the company's m2000 RealTime system that is currently available in hospitals and molecular laboratories in the U.S.
Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, based in Hyderabad India, received FDA approval for their generic version of Thiotepa 15mg and 100mg vials for injection.