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Tigermed-Jyton Supports FDA Clearance of Ruidi's Steep Pulse Ablation System

Recently, the Steep Pulse Ablation System independently developed by Hangzhou Ruidi Biotechnology, Ltd. (hereinafter referred to as "Ruidi") received approval for market launch from the U.S. Food and Drug Administration (FDA). Tigermed-Jyton provided professional 510(k) registration and submission services for this product, ensuring its smooth approval.

Ruidi's Steep Pulse Ablation System is a tumor ablation product that has obtained both China's NMPA Green Channel for Innovative Medical Devices and the US FDA Breakthrough Device Designation. It was officially approved for market launch by China's NMPA at the end of 2024, subsequently entered the European market smoothly, and has now received FDA approval for market launch, completing the "Grand Slam" of authoritative certifications in major global medical markets[1]. The steep pulse ablation series products are minimally invasive interventional non-thermal ablation devices for tumors based on nanosecond-pulsed electric field (nsPEF) technology. Both their underlying hardware and algorithms are 100% developed in China, holding over 300 international patents. The product utilizes ultra-short high-voltage pulses lasting one billionth of a second, with an electric field intensity reaching up to 30,000 volts per centimeter. It can penetrate the cell membrane to directly act on the cell nucleus, inducing tumor cell apoptosis through irreversible electroporation, thereby achieving "non-thermal ablation." This technical approach can precisely preserve key structural tissues such as blood vessels, bile ducts, and nerves, making it particularly suitable for "no-go" areas difficult to treat with traditional ablation methods, and providing a new treatment option for patients with late-stage or complex-location tumors who are not candidates for surgery.

In the FDA 510(k) registration submission for the pulse ablation therapy system, Tigermed-Jyton demonstrated exceptional professional expertise and efficient execution. Facing the rigorous challenges of formal review, technical evaluation, pre-submission meetings, and multiple rounds of interactive review, the Tigermed-Jyton team achieved timely and precise rapid responses, particularly during the interactive review phase where the response time was limited to only 2 to 3 days per round. Regarding the additional information requests raised by the reviewers, the team maintained close communication with FDA reviewers through various channels, including conference calls and emails, accurately grasping the reviewers' key concerns, and efficiently completing the preparation and submission of the supplementary materials. Ultimately, we successfully assisted the client in obtaining FDA approval. After the project concluded, an FDA reviewer specifically sent a letter of commendation, highly recognizing the Tigermed-Jyton team for their "timely responses, well-organized evidence, and collaborative spirit throughout the process."

This approval is not only a significant milestone for RuiDi Bio in the field of minimally invasive tumor therapy but also further evidence of Tigermed-Jyton's continuous deepening of its global service capabilities in medical devices. In the future, Tigermed-Jyton will continue to provide professional and efficient services to help more innovative medical devices enter the global market, jointly building a healthier future worldwide.

About Ruidi

Hangzhou Ruidi Biotechnology Co., Ltd., founded in 2014, is a National High-Tech Enterprise dedicated to advancing a pulsed electric field (PEF) energy platform and pioneering innovation in high-end minimally invasive interventional medical devices, while driving the translational application of PEF technology in biomedicine. The company has built a diversified pipeline across oncology, atrial fibrillation, and chronic encephalopathy, with multiple products designated under the Innovative Medical Device Special Review channel. Its R&D and manufacturing facility in Hangzhou Future Sci-Tech City Haichuang Park houses a GMP-compliant Class 10,000 cleanroom, a high-standard assembly workshop, and a fully equipped testing laboratory, and is certified to ISO 13485.