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.
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.
Agency Continues Effort to Protect Public Health from Fraudulent and Potentially Harmful Products
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.
The U.S. Food and Drug Administration announced a further expansion of COVID-19 testing options through the recognition that spun synthetic swabs – with a design similar to Q-tips – could be used to test patients by collecting a sample from the front of the nose.
The U.S. Food and Drug Administration’s User Fee programs help us fulfill our mission to protect public health while also helping to accelerate innovation in industry and bring new treatment options to the American public.
Xenocor, Inc. announced the FDA cleared the new Xenocor Disposable 5mm Articulating Laparoscope for minimally invasive abdominal and thoracic surgery.
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.
New Test Uses BD MAX™ System to Augment Supply from Existing Collaborations; Test Results in Under Three Hours
Accurate Diagnostic Laboratories and RUCDR Infinite Biologics through its Clinical Genomics Laboratory are pleased to announce they have implemented a test that will allow virtually anyone to test for COVID-19
FDA Sets Prescription Drug User Fee Act (PDUFA) Goal Date of July 23, 2020
The U.S. Food and Drug Administration issued the second emergency use authorization (EUA) to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings.
The Boston-based green chemistry company's trial will study the industry's first all-natural, silk-based dermal filler
Registration as an over-the-counter drug manufacturer to prepare alcohol-based hand sanitizers accelerates anticipated timeline to initial production
Agency Continues Effort to Protect Public Health from Fraudulent and Harmful Products
FDA has declared the COVID-19 outbreak a public health emergency and implemented an expedited pathway to market authorization for products crucial in addressing this crisis, the Emergency Use Authorization (EUA).
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
Future Use in Outbreak Management Expected, via DARPA Partnership