Regulatory

Latest News

FDA Approves Abbott’s Dissolving Stent System for Chronic Limb-Threatening Ischemia in Arteries Below the Knee
FDA Approves Abbott’s Dissolving Stent System for Chronic Limb-Threatening Ischemia in Arteries Below the Knee

May 1st 2024

Treatment marks the first dissolving stent approved in the United States for treating chronic limb-threatening ischemia in arteries below the knee.

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Wearable Device for Osteopenia in Postmenopausal Women Granted FDA Clearance

January 24th 2024

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FDA Accepts BLA for Novel Positron Emission Tomography Imaging Agent for Renal Cell Carcinoma

January 5th 2024

FDA Awards Breakthrough Device Designation to Roche's Neurofilament Light Chain Test for MS
FDA Awards Breakthrough Device Designation to Roche's Neurofilament Light Chain Test for MS

November 9th 2023

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FDA Releases Draft Guidance for Regulatory Considerations for Prescription Drug-Use-Related Software

September 26th 2023

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