Search

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…

Read More

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). 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 secretion management,…

Read More

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…

Read More

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…

Read More

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…

Read More

FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer

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. “Advances in precision oncology continue…

Read More

FDA Approves Treatment for Chronic Kidney Disease

kidney

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 important public health issue, and…

Read More

FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers

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 products, the leading cause of…

Read More

FDA Authorizes Marketing of First Device that Uses Artificial Intelligence to Help Detect Potential Signs of Colon Cancer

Colon

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 to better assist health care…

Read More

FDA Allows for First Point-of-Care Chlamydia and Gonorrhea Test to be Used in More Near-Patient Care Settings

Point-of-Care

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 Accreditation. This action is the…

Read More
1 2 3