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FDA Statement on Medical Device User Fee Amendments (MDUFA)

black and white dentist chair and equipment

The FDA and representatives from the medical device industry have reached an agreement on proposed recommendations for the fifth reauthorization of the medical device user fee program. Under the new agreement, the FDA would be authorized to collect at least $1.78 billion in user fees over five years, plus additional funding, for a total of up to $1.9 billion to further…

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Olympus Announces FDA Clearance of the CELERIS™ Single-Use Sinus Debrider

The only single-use debrider on the market streamlines patient care in an office setting without requiring any capital investment. Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, announced today FDA clearance for its CELERIS™ single-use sinus debrider system with a full market availability in the near future. The CELERIS system contains the…

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National Scoliosis Center Hosts Lunch & Learn Events for Medical Professionals

National Scoliosis Center is hosting quarterly scoliosis-themed ‘Lunch & Learn’ events to educate and connect with others in the medical field. While these events are primarily for medical professionals who wish to learn more about advances in scoliosis treatment, anyone interested is invited to attend as well. The Lunch & Learn events are free, and each event features a prominent medical professional providing extensive…

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What makes an mRNA vaccine so effective against severe COVID-19?

Shots trigger exceptional antibody response by activating key helper immune cells The first two vaccines created with mRNA vaccine technology — the Pfizer/BioNTech and Moderna COVID-19 vaccines — are arguably two of the most effective COVID vaccines developed to date. In clinical trials, both were more than 90% effective at preventing symptomatic infection, easily surpassing the 50% threshold the Food…

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Why Mosquitoes Bite Some People More Than Others

  Veritasium Mosquitoes are attracted to me and it’s likely due to my genes. This video is sponsored by 23andMe https://23andme.com/veritasium Huge thanks to Prof. Immo Hansen and team: http://ve42.co/hansen References: Genome Wide Association Study for self-reported mosquito attractiveness: http://ve42.co/MossieGWAS The twin study showing correlated attractiveness is stronger for identical twins: http://ve42.co/MossieTwins

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FDA Clears First Major Imaging Device Advancement for Computed Tomography in Nearly a Decade

Today, the U.S. Food and Drug Administration cleared the first new major technological improvement for Computed Tomography (CT) imaging in nearly a decade. “Computed tomography is an important medical imaging tool that can aid in diagnosing disease, trauma or abnormality; planning and guiding interventional or therapeutic procedures; and monitoring the effectiveness of certain therapies,” said Laurel Burk, Ph.D., assistant director…

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Boston Scientific Receives FDA Clearance for EXALT™ Model B Single-Use Bronchoscope

Bronchoscope

MARLBOROUGH, Mass. — Boston Scientific Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the EXALT™ Model B Single-Use Bronchoscope, designed for use in bedside procedures within the intensive care unit (ICU) and operating room (OR). [videopack id=”77860″]https://videos.files.wordpress.com/eMUusxOt/8707354_exalt_model_b_sizzle_v5_0809_mnr_mp4_hd.mp4[/videopack] https://www.multivu.com/players/English/8707354-boston-scientific-fda-clearance-exalt-model-b-single-use-bronchoscope/ The EXALT Model B Bronchoscope can be used for a wide range of bronchoscopy procedures such as…

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Rigel Pharmaceuticals Provides Update on COVID-19 Program

Rigel Pharmaceuticals

SOUTH SAN FRANCISCO, Calif. — Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that clinical data submitted in late-May from a 59-patient NIH/NHLBI-sponsored Phase 2 trial of fostamatinib to treat hospitalized patients suffering from COVID-19 are insufficient for an emergency use authorization (EUA) at this time. The FDA noted in their…

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FDA Approves StrataGraft for the Treatment of Adults with Thermal Burns

thermal burns, StrataGraft

The U.S. Food and Drug Administration approved StrataGraft for the treatment of adult patients with thermal burns containing intact dermal elements (remaining deep skin layers) for which surgical intervention is clinically indicated (also referred to as deep partial thickness burns). Thermal burns are typically caused by direct contact with an external heat source such as steam, scalding water, hot surfaces…

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FDA Seeks Further Investments in Critical Public Health Infrastructure and Medical Product Safety Programs

Critical Public Health

Fiscal Year 2022 Budget Request Reflects Nearly 8% Increase from Previous Year and Focuses on Agency’s Immediate Priorities   The U.S. Food and Drug Administration is requesting a total budget of $6.5 billion as part of the President’s fiscal year (FY) 2022 budget – a nearly 8% ($477 million) increase over the agency’s FY 2021 funding level for investments in…

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