BOX BIOSCIENCE: Works Overtime To Provide FDA Approved Sanitizer
BOX BioScience has formed a joint venture with Singlepoint (OTC: SING) to distribute hand sanitizer products manufactured out of Carlsbad, CA.
Latest News
FDA: Insight into FDA's Revised Policy on Antibody Tests: Prioritizing Access and Accuracy
By: Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs, FDA, and Jeff Shuren, M.D., Director, Center for Devices and Radiological Health
FDA: Coronavirus (COVID-19) Update: FDA Includes Ventilator Developed by NASA in Ventilator Emergency Use Authorization
The U.S. Food and Drug Administration included, under the ventilator emergency use authorization (EUA), a ventilator developed by the National Aeronautics and Space Administration (NASA), which is tailored to treat patients with COVID-19.
METHODSENSE: Creates Resource Website to Assist in Medical Device FDA Authorization Submissions
Morrisville, N.C., company provides resources and direction for medical device authorization under FDA Emergency Use Authorization Guidance.
FDA: Coronavirus (COVID-19) Update: FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Addresses Safety Concerns
Agency Additionally Warns Consumers about Hand Sanitizer Sold with Fraudulent Claims
VISCARDIA: Announces Its Novel Heart Failure Therapy Receives Breakthrough Device Designation From the FDA
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.
SEEGENE: Seegene's Allplex™ 2019-nCoV Assay receives FDA Emergency Use Authorization
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.
FDA: Coronavirus (COVID-19) Update: Serological Test Validation and Education Efforts
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.
FDA: Coronavirus (COVID-19) Update: FDA Continues User-Fee Related Reviews Through COVID-19
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: FDA Clears New Disposable Fog-Free Articulating 5mm Laparoscope
Xenocor, Inc. announced the FDA cleared the new Xenocor Disposable 5mm Articulating Laparoscope for minimally invasive abdominal and thoracic surgery.
ACCURATE DIAGNOSTIC LABORATORIES: EUA FDA Clears First Saliva Collection for Coronavirus COVID-19 (SARS-CoV-2), Made Possible by Collaborative Efforts of Accurate Diagnostic Labs and RUCDR Infinite Biologics at Rutgers University
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
NEPTUNE: Successfully Completes Submission to U.S. FDA for Registration of its Conover, NC Facility for Production of Hand Sanitizers
Registration as an over-the-counter drug manufacturer to prepare alcohol-based hand sanitizers accelerates anticipated timeline to initial production
M SQUARED ASSOCIATES: Providing Pro Bono Consulting Services to Expedite COVID19-Related FDA Applications for Critical Medical Supplies
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).
MBIO: To Seek FDA Approval for LightDeck® Platform
Future Use in Outbreak Management Expected, via DARPA Partnership
HALO LABS: Raises $12M in Series B1 Financing Round and Enters into the FDA Market
Halo Labs, a life science instrumentation company developing tools for biologics researchers, announced it has closed a $12M Series B1 financing round led by Research Corporation Technologies (RCT).
FDA: Coronavirus (COVID-19) Update: FDA takes further steps to help mitigate supply interruptions of food and medical products
During this COVID-19 pandemic, the FDA is working around the clock to make sure that Americans have access to safe food and medical products.
FDA: Coronavirus (COVID-19) Update: FDA takes action to help increase U.S. supply of ventilators and respirators for protection of health care workers, patients
The U.S. Food and Drug Administration took action to help increase the supply of ventilators, ventilator tubing connectors, and ventilator accessories, as well as filtering facepiece respirators (FFRs) due to shortages during COVID-19, as part of our commitment to ease burdens on the health care system during this pandemic.