FDA OKs improved MarginProbe device from Dune Medical

Dune Medical Devices said today it won pre-market approval from the FDA for modifications to its MarginProbe breast cancer surgical device designed for real-time detection of cancer in breast conserving surgeries.

Modifications to the Paoli, Penn.-based company’s device were made to conform to recent changes in the European Union’s Restriction of Hazardous Substances requirements, Dune Medical said. The company said it expects the U.S. to adopt similar requirements in the future.

“We are continuing to listen to our customers by investing in technology to enhance MarginProbe. Once completed, these changes will enable Dune Medical Device to continue to develop products that will improve the standard of care in breast conserving surgery and allow physicians and patients to be confident that ‘they got it all’ in the first surgery,” CEO Dan Hashimshony said in prepared remarks.

Dune Medical said it updated teh device with an updated screen for displaying results, as well as an updated operating system and stronger CPU.

“This is an exciting time for the company as we continue to expand our presence in the market and our technology platforms. It speaks to the tenacity of our team and the dedication we have as a company to improve the outcomes and experience for patients during a very difficult time in their lives,” Hashimshony said.

Last month, Dune Medical said it picked Lori Chmura, previous veep of North American sales and former exec with Maquet, Medtronic (NYSE:MDT) and Cordis, as its new president.

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