Category: medical science
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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…
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Boston Scientific Receives FDA Clearance for EXALT™ Model B Single-Use 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…
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Rigel Pharmaceuticals Provides Update on COVID-19 Program
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.…
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FDA Approves StrataGraft for the Treatment of Adults with Thermal Burns
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…
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FDA Seeks Further Investments in Critical Public Health Infrastructure and Medical Product Safety Programs
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…
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FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer
The U.S. Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The FDA also approved the Guardant360 CDx (Guardant Health Inc.) as a companion diagnostic for Rybrevant today.…
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FDA Approves Treatment for Chronic Kidney Disease
Approval is First to Cover Many Causes of Disease The U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression. “Chronic kidney disease is an…
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FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers
Efforts to ban menthol cigarettes, ban flavored cigars build on previous flavor ban and mark significant steps to reduce addiction and youth experimentation, improve quitting, and address health disparities The U.S. Food and Drug Administration announced it is committing to advancing two tobacco product standards to significantly reduce disease and death from using combusted tobacco…
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FDA Authorizes Marketing of First Device that Uses Artificial Intelligence to Help Detect Potential Signs of Colon Cancer
Today, the U.S. Food and Drug Administration authorized marketing of the GI Genius, the first device that uses artificial intelligence (AI) based on machine learning to assist clinicians in detecting lesions (such as polyps or suspected tumors) in the colon in real time during a colonoscopy. “Artificial intelligence has the potential to transform health care…
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FDA Allows for First Point-of-Care Chlamydia and Gonorrhea Test to be Used in More Near-Patient Care Settings
Today, the U.S. Food and Drug Administration announced it is allowing the use of the Binx Health IO CT/NG Assay at point-of-care settings, such as in physician offices, community-based clinics, urgent care settings, outpatient health care facilities and other patient care settings, operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of…