Sousonic Biotech Secures First-Ever FDA 510(k) Clearance for Endoscopic Ultrasound System with Disposable Sterile Probe
Recently, Shengsuo Biotechnology (Shanghai) Co., Ltd.'s"Endoscopic Ultrasound Diagnostic Equipment and Disposable Sterile Endoscopic Ultrasound Probes"The product has received U.S. FDA 510(k) clearance. The company has become the first manufacturer to offer disposable endoscopic ultrasound probes for use with endoscopic ultrasound diagnostic systems, specifically for the clinical diagnosis of tumors in the upper respiratory tract and bronchi, as well as in the gastrointestinal tract and hepatobiliary-pancreatic lumen.
Currently, all ultrasound probes used in clinical practice are reusable devices that require cumbersome and time-consuming re-sterilization and disinfection after each use. This process reduces the convenience and reliability of these products in clinical settings, increases potential risks, and has drawn significant criticism from clinicians and medical device regulatory authorities, particularly due to the persistent concern of cross-infection between patients. In response, the U.S. Food and Drug Administration (FDA) has issued multiple warning letters to manufacturers currently on the market and has imposed stricter requirements on re-sterilization and disinfection procedures. These measures have resulted in higher usage costs and increased uncertainty regarding risks for clinical users.
Addressing the current pain points in clinical applications, Shengsuo Biotechnology (Shanghai) Co., Ltd. has successfully developed this new product by leveraging years of technological accumulation and extensive experience in the research and development of high-performance, high-frequency medical ultrasound imaging products. As a result of fully independent research and development, the company possesses complete core technologies. The application of high-performance materials and innovative manufacturing processes further ensure the product’s high quality and reliability. Furthermore, the in-house production of key core components facilitates quality management and cost control, making single-use high-performance ultrasound probes feasible and positioning them as a future trend in clinical applications.
As the first disposable endoscopic ultrasound probe and endoscopic ultrasound diagnostic system, this product consists of main functional modules, including the main unit, probe driver, and disposable fiber-optic endoscopic ultrasound probe, as well as auxiliary modules such as a display screen, control panel, foot switch, and cart. Endoscopic ultrasound has become an important tool in early tumor screening procedures; it can be used to confirm the specific location of tumors to assist in biopsy sampling and to make preliminary assessments of tumor characteristics through high-quality ultrasound imaging, demonstrating significant clinical value.
This product is a fully independent system designed to be used in conjunction with optical endoscopes as an accessory for endoscopic ultrasound diagnostic equipment. It is intended for ultrasound diagnostic examinations within the upper respiratory tract and bronchi, as well as the gastrointestinal tract and hepatobiliary-pancreatic cavities. The device is compatible with a broader range of ultrasound frequencies and various ultrasound probes. In addition to the most commonly used 1.4 mm outer diameter ultrasound probe recently approved, Sonso Biotech (Shanghai) Co., Ltd. will soon launch the smallest ultrasound probe in this clinical application field, with an outer diameter of only 1.1 mm. This probe can be used with the current thinnest optical endoscopes (with a working channel of just 1.2 mm), enabling imaging of more distal peripheral lung regions and further expanding the clinical applications of this technology. Meanwhile, Sonso Biotech (Shanghai) Co., Ltd. is also applying for domestic production licensing for this product. We look forward to this product benefiting patients at the earliest possible date.
Shengsuo Biotechnology (Shanghai) Co., Ltd., established in 2017, is a wholly-owned subsidiary of Ultrasound Wondering, Inc., which is headquartered in Los Angeles, California, USA. The company specializes in comprehensive diagnostic and therapeutic solutions guided by high-frequency ultrasound.
Since its inception, the company has been dedicated to the research and development of high-frequency ultrasound probes, ultrasound diagnostic imaging systems, endoscopic biopsy and radiofrequency ablation devices, and navigation guidance systems. By combining independent R&D with clinical application collaborations, we strive to meet domestic and international market demands and provide more comprehensive integrated solutions for diagnosis and treatment under high-frequency ultrasound guidance.