FDA Launches Pilot Program to Speed Early Clinical Trials
The FDA's Expedited Investigational New Drug (IND) Pilot pairs drug sponsors with research institutions to reduce startup delays for early human studies.
Category: Products & Treatment
Products & Treatment
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Products & Treatment
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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.
Products & Treatment
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Capnography and Pulse Oximetry in the PICU
For patients in the pediatric ICU, pulse oximetry and waveform capnography are valuable tools to monitor the effectiveness of respiratory support and to inform treatment decisions.
Industry & Regulatory News
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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.
Pharmaceuticals
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Merck Wants to Extend RSV Vaccine to Second Season
FDA will review Enflonsia's ability to protect high-risk children under 2 years of age during their second RSV season.
Diagnostics & Testing
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Increasing Use of Oscillometry for Lung Testing
A national survey shows that while most laboratories use oscillometry technology, lack of standardized guidelines and high costs limit its growth.
Monitoring & Treatment
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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.