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Tag: Food and Drug Administration

Medtech leaders launch FDA-backed initiative to bolster diversity in device development

Vernessa Pollard (center) and Nada Hanafi (right of center) will lead a collaborative community started by MedTech Color to improve diversity in medical...

BD Highlights Five-Year ESG Achievements in 2020 Sustainability Report, Setting the Foundation for 2030+ Strategy

FRANKLIN LAKES, N.J., June 22, 2021 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today issued...

COVID-19 dual-antibody therapies effective against variants in animal study

COVID-19 therapies made from antibodies often are given to patients who are at high risk of severe illness and hospitalization. However, there have...

Medtronic Receives FDA Expanded Approval for Arctic Front™ Family of Cardiac Cryoablation Catheters for Initial Use for Recurrent Symptomatic Paroxysmal Atrial Fibrillation

Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced it received U.S. Food and Drug Administration (FDA) expanded approval for...

FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices

FDA: “Many medical devices are reusable and need preventative maintenance and repair during their useful life; therefore, proper servicing is critical to their...

Irrimax Receives FDA Clearance for Irrisept

Irrimax Corporation, manufacturer of Irrisept, announces new clearance from the U.S. Food and Drug Administration (FDA), making Irrisept the only self-contained irrigation system...

PSMA-targeted radiotracer pinpoints metastatic prostate cancer across anatomic regions

Credit: Images courtesy of Lantheus Holdings, Inc., Billerica, MA. Reston, VA (Embargoed until 3:00 p.m. EDT, Tuesday, June 15, 2021)–A phase III clinical...

Data and safety review board reports how it monitored the COVID-19 vaccine trials

Responsibility for the safety, integrity and scientific validity of the trials fell to 12 experts of the COVID-19 Vaccine Data and Safety Monitoring...

FDA Approves StrataGraft for the Treatment of Adults with Thermal Burns

Today, the U.S. Food and Drug Administration approved StrataGraft for the treatment of adult patients with thermal burns containing intact dermal elements (remaining...

The U.S. Has Hit 600,000 COVID Deaths, More Than Any Other Country

Enlarge this image Memorials hang from the front gate of Greenwood...

VoluMetrix Reports NIVA|HF for Heart Failure Patients Designated as Breakthrough Device by U.S. FDA

VoluMetrix, a Nashville-based biotech startup dedicated to creating a new wave of solutions for vital monitoring to enhance well-being, today announced that its...

Critical Blood Shortage Alert Issued in San Francisco

Beginning today, World Blood Donor Day, first-time donors can get a preview of their blood type when they give with Vitalant SAN FRANCISCO, Calif. (June 14, 2021) — On this World Blood Donor Day, Vitalant—which supplies donated blood to more than 900 hospitals across the U.S, including over 45 in the San Francisco Bay Area — announced that it has a critical blood shortage. The nonprofit organization is urging all eligible donors to make an appointment now to give at any of its nearly 120 donation centers or a community drive to replenish the blood supply in the coming days and

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