Stellan Medtech Intelligence
Device Competitor PulseNo. 7 · October 2026
Device Competitor Pulse · Cardiac rhythm managementData to 30 September 2026
Pulsed field ablation takes two in five tender euros
US decisions in the therapy area rose by a third on a year ago, and European hospital buyers are now awarding ablation lots to pulsed field systems faster than electrophysiologists told us they would switch
1US decisions
FDA issued 14 decisions in cardiac rhythm management in September and 34 across the third quarter. The increase on a year ago came mostly from 510(k) clearances for mapping software and catheter line extensions, and from panel track supplements that widen the indications of pulsed field systems already on the market.1
| Pathway | Sep 2026 | Aug 2026 | Q3 2026 | Q3 2025 |
|---|---|---|---|---|
| 510(k) clearances | 9 | 7 | 24 | 19 |
| De Novo grants | 1 | 0 | 1 | 1 |
| PMA originals | 1 | 0 | 2 | 1 |
| PMA panel track supplements | 3 | 2 | 7 | 4 |
| All decisions | 14 | 9 | 34 | 25 |
Source: FDA 510(k), De Novo and PMA databases, decision dates to 30 September 2026
2Tender awards in Europe and Asia
Pulsed field systems won 44 per cent of awarded ablation catheter value in European tenders in the three months to September and 31 per cent in the Indian and Singaporean tenders we read. Across both, the share reached 41 per cent, more than double the 18 per cent of a year earlier.2
Source: FDA 510(k), De Novo and PMA databases, EUDAMED certificate records, TED, GeM and GeBIZ award notices, Stellan Medtech Intelligence analysis
| Buyer | Notice | Lots | Value | Awarded to |
|---|---|---|---|---|
| Spanish regional health service | TED | 4 | 6.2 | US diversified maker |
| German university hospital group | TED | 2 | 3.8 | European EP specialist |
| Italian regional purchasing body | TED | 6 | 9.4 | US diversified maker |
| Indian central government hospitals | GeM | 3 | 2.1 | Japanese catheter maker |
| Singapore public healthcare cluster | GeBIZ | 2 | 1.7 | US cardiac specialist |
| Five awards | 17 | 23.2 |
Source: TED, GeM and GeBIZ award notices published in September 2026
3European certificates
Notified bodies issued 14 MDR certificates for cardiac rhythm devices in the quarter. Ablation catheters led with five, three of them for pulsed field designs. Two implantable defibrillator certificates replaced legacy directive certificates that would otherwise lapse at the end of 2027.
Source: EUDAMED certificate records and notified body notices, July to September 2026
4Against our Clinician Intent Panel
5What to watch in October
Two pending PMA decisions on pulsed field systems from a European specialist and a Japanese maker, the award of a large French regional ablation tender due in late October, and the fourth quarter panel, which asks clinicians for the first time about mapping system preference.
How this pulse is built
- Decisions are counted by FDA decision date and assigned to the therapy area by product code
- Tender share uses awarded value, not published estimates, and counts a lot once even when split between suppliers
- Every entry links to the public decision, certificate or notice held on file for subscribers who ask
Approved for subscribersImogen FairlieHead of Cardiovascular Research · 8 October 2026
1 Cardiac rhythm management covers ablation, mapping, pacing, defibrillation and implantable monitoring devices.
2 Values are converted to euros at the European Central Bank reference rate on the award date.