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NSC: National Safety Council Statement on the FDA Advisory Panel Approval of COVID-19 Vaccine and Employers' Subsequent Role

The National Safety Council applauds today's formal recommendation of the Pfizer COVID-19 vaccine and the CDC recommendations that prioritize distributing the vaccine first to healthcare personnel and long-term care facility residents, who need it most urgently.

FDA: Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts

FDA: Statement on Vaccines and Related Biological Products Advisory Committee Meeting

The following is attributed to FDA Commissioner Stephen M. Hahn, M.D., and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

FDA: Authorizes First Direct-to-Consumer COVID-19 Test System

Test system is authorized for at-home sample collection with laboratory test processing

VERANTOS: Receives FDA Support to Demonstrate Advanced Approaches to Real-World Evidence

Verantos today announced it has received a grant award from the U.S. Food and Drug Administration (FDA) to implement a multi-year advanced real-world evidence (RWE) study.

CULTIVATE(MD): Medical Ingenuities Receives FDA 510(k) Clearance for PH Band

Novel radial artery occlusion device removes the guesswork from achieving Patent Hemostasis

WHOLISTIC PEDIATRICS & FAMILY CARE: Dr. David Berger of Tampa to Address FDA COVID-19 Vaccine Approval Committee Regarding Public Concerns and Hesitations

Dr. David Berger of Wholistic Pediatrics & Family Care presents to the FDA's vaccine approval committee regarding alleviating public concerns and hesitations.

VOLTA MEDICAL: VX1 AI software for use in atrial fibrillation mapping now FDA cleared

Volta Medical, a pioneering French-based HealthTech startup is pleased to announce that it has obtained FDA clearance for its revolutionary VX1 AI (artificial intelligence) software.

ACCP: Statement of Support for US FDA: Science & Evidence-based Review and Approval of COVID-19 Vaccines for Use in the US

The COVID-19 pandemic has resulted in an immense number of deaths, disrupted economies worldwide and is a public health emergency.

ENSEMBLE ORTHOPEDICS: Receives FDA Clearance For PyroCarbon CMC Interpositional Implant

Ensemble Orthopedics Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Ensemble CMC Implant. The Ensemble CMC was designed to treat patients with early-stage osteoarthritis of the carpometacarpal (CMC) joint using a minimally invasive, simple surgical procedure.

3B MEDICAL: FDA Grants 3B Medical Emergency Use for Lumin UV System Use in Nursing Homes, Ambulatory Care and Primary Care for SARS-CoV-2 N95 Re-Use

3B Medical announced receiving Emergency Use Authorization from the FDA to permit use of Lumin, a UVC system, on N95 respirators during the COVID-19 pandemic.

GUERBET LLC USA: US FDA Approves Guerbet's Optiray® (Ioversol Injection) Imaging Bulk Package

Guerbet (GBT), a global leader in medical imaging, announced today that it received US Food and Drug Administration approval for the commercial sale of the Optiray® Imaging Bulk Package (IBP) in the United States, as well as FDA clearance of the LF IBP Transfer Set.

ROCHE: Receives FDA Emergency Use Authorization for new semi-quantitative test to measure the level of SARS-CoV-2 antibodies

Elecsys® Anti-SARS-CoV-2 S test specifically detects antibodies against the SARS-CoV-2 spike protein

RVNC: FDA Defers Approval of DaxibotulinumtoxinA for Injection in Glabellar Lines Due to COVID-19 Related Travel Restrictions Impacting Manufacturing Site Inspection

Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, announced that the United States (U.S.) Food and Drug Administration (FDA) has deferred a decision on the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection, an investigational neuromodulator product for the treatment of moderate to severe glabellar (frown) lines.

CORTICOMETRICS: Announces FDA 510(k) Clearance of THINQ™ for MRI Brain Volumetric Reporting

CorticoMetrics announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for THINQ™, its AI-based software for use by radiologists and neurologists providing quantitative information to augment patient assessment for a number of neurological disorders and conditions.

FDA Reporter