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Ceribell clears three EEG algorithms under K261712 with no age limit Oura shelves its $2.2B Nasdaq IPO four weeks after filing VCD Medical clears VEnice, a clip that closes varicose veins without heat Sofinnova closes an 82 million euro fund to start six to eight device companies Nyxoah hires former Teleflex CEO Liam Kelly to run the Genio US launch SI-BONE clears Granite Onyx, its first compromised bone implant outside the pelvis Route 92 Medical clears the FreeClimb 46, the smallest catheter in its stroke line Insera clears the CLEAR aspiration system for peripheral clot removal under K253404 Webster Equity takes Lifecore Biomedical private at $6.28 a share plus CVRs Ceribell clears three EEG algorithms under K261712 with no age limit Oura shelves its $2.2B Nasdaq IPO four weeks after filing VCD Medical clears VEnice, a clip that closes varicose veins without heat Sofinnova closes an 82 million euro fund to start six to eight device companies Nyxoah hires former Teleflex CEO Liam Kelly to run the Genio US launch SI-BONE clears Granite Onyx, its first compromised bone implant outside the pelvis Route 92 Medical clears the FreeClimb 46, the smallest catheter in its stroke line Insera clears the CLEAR aspiration system for peripheral clot removal under K253404 Webster Equity takes Lifecore Biomedical private at $6.28 a share plus CVRs

Clearance

Medtronic clears Affera Prism-2 mapping software and CE marks a PulseSelect proximity adapter

MedDevice Startups Staff · 22 hrs ago · 2 min read · Via MassDevice

Medtronic said on September 30 that Affera Prism-2 cardiac mapping software has FDA clearance and a CE mark. The software runs on the Affera mapping and ablation system with the Sphere-9 catheter. It builds three-dimensional maps of cardiac electrical activity during ablation. Medtronic lists magnetic and impedance-based tracking, beat matching, pace tagging and a pacing stimulator workflow.

A second item, the PulseSelect ProxBox adapter with proximity indicator software, got a CE mark only. It reads impedance to tell the operator how close the catheter sits to target tissue before energy goes in. Contact assessment is the weak point of pulsed field ablation next to RF, where temperature and impedance give an operator more to work with. PulseSelect was the first pulsed field ablation catheter FDA approved, and Medtronic's electrophysiology sales rose 29.5 percent year over year last quarter.

Questions & Answers

What is Medtronic's Affera Prism-2 software cleared for?

Affera Prism-2 is Medtronic's cardiac mapping software for the Affera mapping and ablation system with the Sphere-9 catheter. Medtronic said on September 30, 2026 that it has FDA clearance and a CE mark, and that it builds three-dimensional maps of cardiac electrical activity during ablation.

Did Medtronic's PulseSelect ProxBox adapter get FDA clearance?

No. As of September 30, 2026 Medtronic reported a CE mark only for the PulseSelect ProxBox adapter with proximity indicator software. The adapter gives impedance-based feedback on catheter proximity to target tissue before energy delivery.

What does proximity indicator software do on the Medtronic PulseSelect system?

It uses impedance to tell the operator in real time how close the PulseSelect catheter is to the tissue being targeted, before pulsed field energy is delivered. Medtronic announced the CE mark for it on September 30, 2026.

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