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  1. LabCorp is involved in FDA-approved drugs. Intuitive Surgical's systems were FDA-cleared. Masimo develops noninvasive patient monitoring technologies.

FDA Grants Masimo Clearance for Atrial Fibrillation Monitoring

1 report, 1 independent Updated 00:00
AI-generated briefing. Brind wrote this from the reports listed below. It can be wrong. Each section says how much you can rely on it, and the sources are linked so you can check.

What happened

Some supportReported by 1 outlet

Masimo received FDA 510(k) clearance for its Atrial Fibrillation (AFib) monitoring capability on the Radius VSM® device. This technology, combined with existing AI-enabled Opioid-Induced Respiratory Depression (OIRD) detection, uses advanced pattern recognition and AI signal analysis. The clearance allows the platform to help clinicians identify physiological changes associated with important clinical events.

From prnewswire.com

Why it matters

Some supportBrind's analysis of the reports

The clearance expands the use of Masimo's pulse oximetry platform beyond simple measurements to provide clinical insights. This advancement in noninvasive patient monitoring technology could support earlier evaluation and intervention in healthcare settings. As the parent company of Masimo, Danaher Corporation might see increased value related to the product's regulatory success.

Masimo develops noninvasive patient monitoring technologies, similar to systems previously cleared by the FDA for other uses.

From prnewswire.com

Who's involved

  • FDAThe regulatory body that granted the 510(k) clearance.
  • MasimoThe company that developed and received clearance for the AFib monitoring technology.
  • Danaher CorporationThe parent company of Masimo.

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LabCorp is involved in FDA-approved drugs. Intuitive Surgical's systems were FDA-cleared. Masimo develops noninvasive patient monitoring technologies. All 1 developments

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