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510(k) filed

Baird Medical's partner files a 510(k) for an irreversible electroporation system

MedDevice Startups Staff · 1 day ago · 2 min read · Via Baird Medical release (GlobeNewswire)

Baird Medical said on November 5 that its partner Alpmed filed a 510(k) for an irreversible electroporation system and applied for CE conformity assessment in the European Union. Both submissions went in during the fourth quarter, less than three months after the two signed a cooperation agreement. Baird leads regulatory interactions in both reviews and holds worldwide commercial rights. The companies are targeting clearance and a CE mark in 2027.

Alpmed, part of Saixiang Group in Tianjin, commercialized China's first domestic IRE product for malignant liver and pancreatic tumors. Baird Medical, listed on Nasdaq as BDMD, sells an FDA-cleared microwave ablation system that it is launching in the United States mainly for benign thyroid nodules. IRE kills cells with high-voltage pulses rather than heat, which is the argument for using it near nerves and ducts. Neither company named the product or the predicate, and the predicate is the detail to watch on a non-thermal ablation filing.

Questions & Answers

What did Baird Medical and Alpmed submit to FDA in November 2026?

Baird Medical said on November 5, 2026 that its partner Alpmed filed a 510(k) with FDA for an irreversible electroporation system and applied for CE conformity assessment in the European Union, both in the fourth quarter of 2026.

Who holds commercial rights to the Alpmed irreversible electroporation system?

Baird Medical holds worldwide commercial rights to the Alpmed irreversible electroporation system and leads regulatory interactions during the FDA and EU reviews. The companies are targeting FDA clearance and a CE mark in 2027.

What is irreversible electroporation?

Irreversible electroporation is a non-thermal ablation method that uses high-voltage electrical pulses to disrupt cell membranes and kill cells. Alpmed has already commercialized an IRE product in China for malignant liver and pancreatic tumors.

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