Luna G3 APAP Recalled Due to Firmware Defect
According to an FDA alert, BMC Medical Co Ltd retrospectively reported a recall of 20,160 Luna G3 APAP (Model LG3600) devices distributed in the United States due to firmware defect.
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Luna G3 APAP Recalled Due to Firmware Defect
According to an FDA alert, BMC Medical Co Ltd retrospectively reported a recall of 20,160 Luna G3 APAP (Model LG3600) devices distributed in the United States due to firmware defect.
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FDA Clears CPETWise Cardiopulmonary Exercise Testing Software
Medibyt’s CPETWise automated platform aims to cut cardiopulmonary exercise testing interpretation time in half and standardize clinical workflows.
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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.
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Recall for GE Healthcare Patient Monitoring System
GE HealthCare has issued updated use instructions for Portrait Mobile Monitoring Solutions devices operating on certain versions of Portrait Core Services software, according to an FDA alert.
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Application Accepted for Inhaled Pulmonary Fibrosis Treatment
If cleared by federal regulators, nebulized Tyvaso (treprostinil) Inhalation Solution would become the first inhaled option designed to treat idiopathic pulmonary fibrosis (IPF).
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FDA Approves Updated COVID-19 Vaccines for 2026-2027
Updated formulas from Pfizer, Moderna, and Novavax target the circulating XFG variant for older adults and high-risk populations.
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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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