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Medtronic Receives FDA Clearance, CE Mark For Its Affera Prism-2 Mapping Software, Also Receives CE Mark For PulseSelect ProxBox Adapter

Sep 30, 2026 · 09:04 AM ET· updated 2h ago

Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced regulatory milestones for software used with two cardiac ablation platforms. This includes U.S. Food and Drug Administration (FDA)

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Why It Matters

Medtronic got official approval for new heart surgery mapping software. This means the company can sell these tools in the U.S. and Europe now.

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Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.

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