Thursday, March 28, 2024

Thursday, March 28, 2024

Latest News

FDA: Coronavirus (COVID-19) Update: FDA Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts

U.S. Food and Drug Administration has taken an additional step in harnessing real-world data to help inform the agency’s overall response to the COVID-19 public health emergency.

FDA: Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts

U.S. Food and Drug Administration has taken an additional step in harnessing real-world data to help inform the agency’s overall response to the COVID-19 public health emergency.

RESPIRA TECHNOLOGIES, INC.: Announces plan to pursue FDA authorization for the RespiRxTM drug delivery platform as the first "vapor style" Nicotine Replacement Therapy targeting the 50% of smokers who want to quit

Respira announces plans to pursue FDA authorization of the RespiRxTM drug delivery platform as the first vapor style inhalable Nicotine Replacement Therapy (NRT) designed to significantly increase cessation therapy effectiveness in the U.S.

FDA: Coronavirus (COVID-19) Update: Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling

Diagnostic tests are an important tool in anticipating and meeting the continuing and evolving public health needs as we combat COVID-19.

CHILDREN'S NATIONAL HOSPITAL: FDA Grant and Gift from Entrepreneur Provide $250K in Awards for Pediatric Medical Device Competition Focused on COVID-19 Innovations

Virtual competition staged by National Capital Consortium for Pediatric Device Innovation (NCC-PDI) now accepting applications for devices addressing COVID-19 needs

MNA: FDA Reversal on COVID-19 Mask Decontamination Follows MNA Opposition, Demonstrates Urgent Need for Implementation of Frontline Nurse and Healthcare Professional Guidance

MNA nurses and healthcare professionals called for the halt of COVID-19 mask decontamination in April, finding lack of safety, efficacy evidence

LAMINATE MEDICAL TECHNOLOGIES: VasQ™ External Support Awarded Breakthrough Device Designation by the FDA

The FDA has designated Laminate Medical's VasQ™ External Support for the creation of arteriovenous fistulas (AVF) in hemodialysis patients as a Breakthrough Device.

CITIUS: Receives Positive FDA Feedback on Its Submitted Plan to Study Catheter Compatibility for Mino-Lok® Therapy

Compatibility plan includes testing representative samples of all commercially available CVCs and PIC

ACCESS MEDICAL: Announces Ultra Sonic Speed Results for SARS-CoV-2 Antibodies that is 100% sensitive and has an EUA from the FDA

The New 10 minute Antibody Test from Access Medical Labs sets a new standard after the CDC announced antibody testing may be wrong 50% of the time

FDA: Coronavirus (COVID-19) Update: FDA Takes Steps to Streamline Development of Tests With At-Home Sample Collection

The U.S. Food and Drug Administration took steps to further support the development of COVID-19 tests for at-home self-collection by including a voluntary EUA template for at-home sample collection kits to its website.

FDA: Coronavirus (COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection

The U.S. Food and Drug Administration took a new step to support the agency’s evaluation of diagnostic tests for COVID-19, by providing a SARS-CoV-2 reference panel.

ORTEQ® SPORTS MEDICINE: Announces Publication of 5-year Multi- Center Clinical Data for the Actifit® Meniscal Scaffold in the American Journal of Sports Medicine (AJSM), Receives FDA Breakthrough Device Designation

Orteq Sports Medicine Ltd. (www.orteq.com), a developer of joint preservation solutions for orthopedic patients, announces 5-year, multi center, peer-reviewed data published in the AJSM analyzing the Actifit meniscal scaffold that shows more than 87% survival rates with increased knee function and reduced pain.

FDA: Feed Your Mind with FDA's New Education Initiative on Genetically Engineered Foods

The U.S. Food and Drug Administration (FDA), with the U.S. Department of Agriculture (USDA) and U.S. Environmental Protection Agency (EPA), launched Feed Your Mind, a new Agricultural Biotechnology Education and Outreach Initiative. The Initiative aims to increase consumer awareness and understanding of genetically engineered foods or GMOs.

FDA: Coronavirus (COVID-19) Update: FDA Collaborations Promote Rigorous Analyses of Real-World Data to Inform Pandemic Response

We are announcing another step in our effort to harness diverse streams of data to understand and respond to COVID-19. The U.S. Food and Drug Administration has entered into an agreement with Aetion to collaborate on advanced analytical techniques to answer urgent coronavirus disease (COVID-19) research questions.

Q30 INNOVATIONS: Requests FDA Authorization for Q-Collar Device Designed to Aid in the Protection of the Brain from the Effects of Head Impacts in Contact Sports

After eight years of scientific research and clinical trials, Q30 Innovations announced that it has submitted a request for De Novo classification to the U.S. Food and Drug Administration, seeking authorization to market the Q-Collar in the United States.

FDA Reporter