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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

First Cases

Kardium runs first commercial Globe PFA cases in Arkansas

MedDevice Startups Staff · Oct 1 · 2 min read · Via MassDevice

Kardium reported its first commercial cases with the Globe Pulsed Field System on October 1, 2025, five weeks after FDA approval. Dr. Devi Nair performed them at St. Bernard's Medical Center in Jonesboro, Arkansas.

FDA approved the system under PMA P240044 on August 27, 2025, for drug-resistant atrial fibrillation treated with irreversible electroporation, with 510(k) clearances covering the introducer sheath and mapping software. The Globe catheter carries 122 individually selectable electrodes, so mapping and ablation run from one device; Kardium reported about 1.2 applications per vein.

Kardium is not young. Founded in 2007 in Burnaby, British Columbia by Amos Michelson and Doug Goertzen, it raised $250 million in July 2025 to fund the launch and now runs more than 600 employees, up from 200 in 2022. First cases came 18 years after founding, which is the honest number for a PMA-track cardiac ablation platform.

Questions & Answers

Where were the first commercial Kardium Globe PFA cases performed?

At St. Bernard's Medical Center in Jonesboro, Arkansas, by Dr. Devi Nair, chief of cardiac electrophysiology and EP research. Kardium reported them on October 1, 2025.

When did FDA approve the Kardium Globe Pulsed Field System?

FDA approved the Globe Pulsed Field System under PMA P240044 on August 27, 2025, for treating drug-resistant atrial fibrillation with irreversible electroporation.

What is different about the Kardium Globe catheter?

The Globe catheter carries a 122-electrode array that maps and ablates from the same device, so pulmonary vein isolation and high-density atrial mapping happen without a catheter swap. Kardium reported roughly 1.2 applications per vein on average.

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