Regulatory

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AGENCY LISTINGS

Oct. 18, 2019
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Regulatory

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Regulatory

FDA Expands Use of Insulet SmartAdjust Technology to Adults With Type 2 Diabetes

Aug. 28, 2024
This clearance provides a new option for insulin therapy in people with type 2 diabetes that could reduce the burden of living with the disease.
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Regulatory

FDA Approves Zurnai

Aug. 8, 2024
Zurnai is the first nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and...
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Regulatory

FDA Updates Number of Deaths Associated with Philips Respironics Devices

July 16, 2024
The number of deaths associated with its BiPAP V30, BiPAP A30, BiPAP A40 devices has been adjusted to 7.
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Regulatory

FDA Pens Letter Alerting Providers to Medtronic Endotracheal Tube Recalls

July 10, 2024
NIM Contact EMG Reinforced Endotracheal Tubes and NIM (Standard) EMG Reinforced Endotracheal Tubes from Medtronic have been recalled due to many potential health risks associated...
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Regulatory

FDA Approves Kisunla

July 3, 2024
Kisunla is an injection for the treatment of Alzheimer's disease.