Early Alert for NOxBox Nitric Oxide Delivery System
NOxBox reported complaints of oxygen leaks due to failure of the oxygen tubing or tubing connection within the NOxMixer module of the NOxBoxi device, according to the FDA.
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Early Alert for NOxBox Nitric Oxide Delivery System
NOxBox reported complaints of oxygen leaks due to failure of the oxygen tubing or tubing connection within the NOxMixer module of the NOxBoxi device, according to the FDA.
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Early Alert for CooperSurgical Neonatal nCPAP Device
CooperSurgical has issued a letter to affected customers recommending certain ventilators be removed from where they are used or sold, according to a USFDA early alert.
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FDA Authorizes 11 Flavored Nicotine Pouches
The latest round of products brings the total number of FDA-authorized flavored nicotine pouches to 43.
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Early Alert for GE Healthcare Portrait Mobile Monitoring Software
GE HealthCare issued updated use instructions for all Portrait Mobile Monitoring Solutions operating on certain versions of Portrait Core Services software, according to an FDA early alert.
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Medline Recalls Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits
The FDA reports a nationwide recall of Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits by Medline Industries.
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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.
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Co-Diagnostics Submits Co-Dx PCR Flu A/B & RSV Test for FDA Clearance
Co-Diagnostics submitted a dual 510(k) premarket notification and CLIA Waiver by Application to the FDA for its Co-Dx PCR Flu A/B & RSV multiplex respiratory test.
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FDA Approves First mRNA Flu Vaccine
The FDA approved Moderna’s mFlusiva, the first seasonal influenza vaccine using mRNA technology to enter the US market.
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FDA to Review RSV Drug Enflonsia for Children 2 and Younger
Merck is seeking expand approval for its RSV drug Enflonsia to include children under age two through their second year of risk.
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FDA Approves Orzeyful for Narcolepsy Type 1
Orzeyful is the first drug to target the underlying loss of orexin signaling to address the full range of narcolepsy type 1.
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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.
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FDA Licenses First Freeze-dried Emergency Plasma
The room-temperature-stable freeze-dried plasma product provides a new option for patients in remote or austere environments where conventional frozen plasma is unavailable.
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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.
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FDA Issues Early Alert for Resmed Ventilators
Resmed has recommended corrections to certain Astral 100 and Astral 150 ventilators due to an issue that may result in interrupted therapy.
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FDA Accepts NDA for Apnimed Sleep Apnea Pill
The FDA will review a New Drug Application for Apnimed’s AD109, an investigational oral pill for the treatment of adults with obstructive sleep apnea with a target action date of Feb 28, 2027.
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FDA Authorizes Syncron-E Software for Patient-Ventilator Asynchrony
Autonomous Healthcare received FDA De Novo marketing authorization for Syncron-E, a software that supports the assessment of patient-ventilator asynchrony by detecting evidence of ineffective efforts.
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7 Pharma Companies Chosen for FDA PreCheck Pilot Program
The FDA’s PreCheck Pilot Program will expand domestic pharmaceutical manufacturing, increase production capacity, and strengthen US drug supply chain resilience.
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HHS Ends COVID-19 Emergency Use Authorizations
HHS secretary Robert F Kennedy, Jr signed determinations to end COVID-19 emergency use authorizations for drugs, biological products, and medical devices because the emergency circumstances no longer exist.
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FDA Expands Casgevy for Children 2+ with Sickle Cell Disease
The FDA approved the first gene therapy for children as young as 2 years old with sickle cell disease or transfusion-dependent beta thalassemia.
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Saline Nasal Spray Recalled Due to Contamination Risk
Beekeeper’s Naturals issued a voluntary nationwide recall for one lot of its saline nasal spray because of potential microbial contamination, according to an alert from the USFDA.
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FDA Clears AMDI Fast PCR Respiratory Panel for Point-of-Care Testing
The AMDI Fast PCR System provides point-of-care results for RSV, influenza, and COVID-19 in less than 10 minutes.
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FDA Campaign Prevents 444,000 Youth From Starting E-cigarette Use
New research shows “The Real Cost” educational efforts blocked millions in illegal e-cigarette sales and shifted youth attitudes toward nicotine addiction.
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National Youth Tobacco Survey Reveals Youth Tobacco Use Reaches Historic Lows
Data from 2022 to 2025 indicate that current tobacco use, including e-cigarettes and cigarettes, has decreased among US middle and high school students.
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FDA Authorizes Flavored Zyn Nicotine Pouches Despite Youth Risks
The FDA authorized 20 Zyn nicotine pouches, including 10 flavored products, despite concerns from health experts over increased youth use.
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