FDA Panel Supports the Alzheimer’s Drug Lecanemab
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Hear From the FDA Commissioner Who Approved Abortion Pill
When former U.S. Food and Drug Administration (FDA) commissioner Dr. Jane Henney approved the abortion pill mifepristone in 2000, she knew the decision was an important one for women’s health. It would also become incredibly contentious. Henney, now 76, finds herself still defending that approval more than two decades later in 2023. She talked to …
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NeuroRPM obtains FDA 510(k) for Parkinson’s monitoring on Apple Watch
Digital health technology company NeuroRPM has received FDA 510(k) clearance for its AI-enabled remote monitoring app that utilizes an Apple Watch to track common Parkinson’s symptoms such as bradykinesia, tremor and dyskinesia. Bradykinesia is slowness of movement, and dyskinesia is involuntary or erratic movements. The Washington D.C.-based company’s algorithms are embedded in the Apple Watch …
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FDA Requires New Info on Breast Density With All Mammograms
WASHINGTON — All U.S. women getting mammograms will soon receive information about their breast density, which can sometimes make cancer harder to spot. The new requirements, finalized Thursday by the Food and Drug Administration, are aimed at standardizing the information given to millions of women following scans to detect breast cancer. Regulators first proposed the …
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Seer Medical receives FDA 510(k) for its at-home epilepsy diagnosis aide
Australian company Seer Medical received FDA 510(k) clearance for its at-home electroencephalograph (EEG) system Seer Home that helps providers diagnose epilepsy. Seer Home’s EEG system enables patients to undergo week-long studies at home. Patients wear a device — the Seer Sense — around their shoulders with electrodes connected to the patient’s skull and chest to …
Seer Medical receives FDA 510(k) for its at-home epilepsy diagnosis aide Read More »
