FDA Approves Osimertinib plus Chemotherapy for EGFR-mutated NSCLC
The FDA approved osimertinib (Tagrisso) with platinum-based chemotherapy for certain patients with non-small cell lung cancer (NSCLC).
The FDA approved osimertinib (Tagrisso) with platinum-based chemotherapy for certain patients with non-small cell lung cancer (NSCLC).
The AI-powered chest X-ray triage solution was designed to triage and prioritize emergency cases such as pleural effusion and pneumothorax immediately after the exam.
The US Food and Drug Administration has granted De Novo clearance to an over-the-counter, foot-worn medical pulse oximetry solution for infants.
The US Food and Drug Administration has granted BodiMetrics 510k clearance for its circul pro ring as a pulse oximeter.
Read MoreThe US FDA has granted 510(k) clearance to the alveoair digital spirometer, according to a press release by the manufacturer, alveofit.
Read MoreLivaNova has received FDA 510(k) clearance for its Essenz In-Line Blood Monitor, which provides continuous measurement of blood parameters to perfusionists throughout cardiopulmonary bypass procedures.
Read MoreThe US FDA expanded Pfizer’s Abrysvo (RSV vaccine) for use during pregnancy to prevent LRTD caused by RSV in infants from birth through 6 months of age.
Read MoreThe wearable, wireless monitoring solution provides a real-time view of patients while monitoring dual vector respiration rate, SpO2, and pulse rate continuously.
Read MoreGE HealthCare’s Portrait Mobile platform enables real-time continuous monitoring with a personalized view of the patient’s vitals while keeping patients mobile during critical recovery periods, especially after surgery or discharge from the intensive care unit.
Read MoreThe FDA approved an expanded indication for Merck’s Ervebo vaccine, which is now indicated for the prevention of disease caused by Zaire ebolavirus in individuals 12 months of age and older.
Read MoreThe stent is indicated for the non-emergency treatment of pulmonary artery stenosis in pediatric patients who weigh at least 10 kg with two ventricle anatomy.
Read MoreA remote monitoring platform called AeviceMD that includes a smart, wearable stethoscope has received clearance from the US FDA, according to manufacturer Aevice Health.
Read MoreThe US Food and Drug Administration approved a 3-milligram naloxone hydrochloride nasal spray for over-the-counter, nonprescription use for the emergency treatment of known or suspected opioid overdose.
Read MoreBeyfortus is the first preventive option approved to protect a broad infant population, including those born healthy at term, preterm, or with specific health conditions that make them vulnerable to severe RSV disease.
Read MoreDräger has received 510(k) clearance from the US FDA for its Evita V600, V800, and Babylog VN800, ventilators.
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