FDA Early Alert for Draeger Breathing Circuit
Draeger issued a letter to affected customers recommending certain VentStar Resus Neo hoses be removed from where they are used or sold, according to an FDA early alert.
Category: Industry & Regulatory News
Industry & Regulatory News
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Industry & Regulatory News
Latest
Hamilton Medical Recalls Breathing Circuit Set
Hamilton Medical issued a recall for certain coaxial breathing circuit sets used with C1, T-1, and MR1 ventilators, ordering them removed from where they are used or sold, according to an FDA alert.
Industry & Regulatory News
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FDA Clears Masimo Pediatric Sedation Monitoring Tool
Masimo received FDA 510(k) clearance for the Patient State Index (PSi) , a new monitoring index that helps clinicians track brain activity and sedation levels in children during surgery and intensive care.
Association News
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3 Things to Know About Expanded Access Programs
An American Lung Association initiative aims to educate patients and healthcare providers about investigational treatment options for severe and rare lung diseases.
Business News
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Magnolia Diagnostics Pays $24M to Settle Medicare Respiratory Testing Fraud Claims
Magnolia Diagnostics and its owners allegedly billed Medicare for unnecessary respiratory panels performed on seniors during the pandemic, according to the US Justice Dept.
FDA Approvals
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FDA Clears HoneyNaps Ai Software for Sleep Apnea Analysis
The USFDA granted 510(k) clearance for the HoneyNaps Somnum V3.0 Ai-based software for polysomnography (PSG) analysis, according to the company.
Recalls & Advisories
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Early Alert for Baxter Duo-Vent Solution Sets
Baxter has recommended removal of certain Duo-Vent solution sets used for administration of fluids to the patient's vascular system.