{"id":10560,"date":"2024-10-16T16:34:54","date_gmt":"2024-10-16T09:34:54","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=10560"},"modified":"2024-10-16T16:34:54","modified_gmt":"2024-10-16T09:34:54","slug":"sonires-hifu-therapy-system-designated-as-breakthrough-device-by-fda","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=10560","title":{"rendered":"SONIRE’s HIFU Therapy System Designated as Breakthrough Device by FDA"},"content":{"rendered":"

TOKYO<\/span><\/span>, Oct. 16, 2024<\/span><\/span> \/PRNewswire\/ — SONIRE Therapeutics Inc.\u00a0(hereinafter referred to as “SONIRE”), based in Tokyo, Japan<\/span>, announces that its self-developed next-generation HIFU (High-Intensity Focused Ultrasound) therapy system (development code: Suizenji) has been designated as a breakthrough device by the U.S. Food and Drug Administration (hereinafter referred to as “the FDA”) for the treatment of pancreatic cancer.<\/p>\n

Logo: https:\/\/cdn.kyodonewsprwire.jp\/prwfile\/release\/M107547\/202410107892\/_prw_PI1fl_w3RY8a4h.jpg<\/a><\/p>\n

Image: https:\/\/cdn.kyodonewsprwire.jp\/prwfile\/release\/M107547\/202410107892\/_prw_PI2fl_8yiEY846.jpg<\/a><\/p>\n

The FDA’s Breakthrough Device Program supports the development of medical devices that provide more effective treatment or diagnostic of life-threatening or irreversible human diseases. Through the program, SONIRE will receive an opportunity to interact with FDA experts through different program options to efficiently address topics as they arise during a premarket review phase. Therefore, it is expected that the program will prompt patients to access the new treatment provided by Suizenji as soon as possible.<\/p>\n

For more information about the Breakthrough Device Program, please refer to the FDA website:
https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/breakthrough-devices-program<\/a><\/p>\n

SONIRE will continue to promote its business in order to realize the wish put in its company name at the time of its foundation: “Sonics brings new future full of hope to many cancer patients and their families as possible.”<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n

TOKYO<\/span><\/span>, Oct. 16, 2024<\/span><\/span> \/PRNewswire\/ — SONIRE Therapeutics Inc.\u00a0(hereinafter referred to as “SONIRE”), based in Tokyo, Japan<\/span>, announces that its self-developed next-generation HIFU (High-Intensity Focused Ultrasound) therapy system (development code: Suizenji) has been designated as a breakthrough device by the U.S. Food and Drug Administration (hereinafter referred to as “the FDA”) for the treatment of pancreatic cancer.<\/p>\n

Logo: https:\/\/cdn.kyodonewsprwire.jp\/prwfile\/release\/M107547\/202410107892\/_prw_PI1fl_w3RY8a4h.jpg<\/a><\/p>\n

Image: https:\/\/cdn.kyodonewsprwire.jp\/prwfile\/release\/M107547\/202410107892\/_prw_PI2fl_8yiEY846.jpg<\/a><\/p>\n

The FDA’s Breakthrough Device Program supports the development of medical devices that provide more effective treatment or diagnostic of life-threatening or irreversible human diseases. Through the program, SONIRE will receive an opportunity to interact with FDA experts through different program options to efficiently address topics as they arise during a premarket review phase. Therefore, it is expected that the program will prompt patients to access the new treatment provided by Suizenji as soon as possible.<\/p>\n

For more information about the Breakthrough Device Program, please refer to the FDA website:
https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/breakthrough-devices-program<\/a><\/p>\n

SONIRE will continue to promote its business in order to realize the wish put in its company name at the time of its foundation: “Sonics brings new future full of hope to many cancer patients and their families as possible.”<\/p>\n

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