Shinva Medical Secures Class II and III Device Approvals for Advanced Radiotherapy and Thoracoscopic Systems

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Shinva Medical Instrument Co.,Ltd. (600587.SH) has announced that it recently received the Medical Device Registration Certificate from China's National Medical Products Administration, while its subsidiary, Shinva Surgical Instruments Co., Ltd., obtained a separate certificate from the Shandong Medical Products Administration.

The newly approved Class III device is the Respiratory Gating System, while the Class II device encompasses Thoracoscopic Surgical Instruments. As a cornerstone product in the field of precision radiotherapy, the Respiratory Gating System leverages real-time dynamic management of patients' respiratory motion to markedly improve targeting accuracy and therapeutic outcomes.

This system works in seamless tandem with the company's existing large-bore CT positioning equipment, enabling precise matching from initial localization through to treatment delivery, thereby reinforcing the firm's technological edge in comprehensive precision radiotherapy solutions. Thoracoscopic surgical instruments, which serve as fundamental and frequently utilized tools in thoracic surgery, complement the company's current medical endoscope camera systems and thoracoabdominal endoscopes, helping to round out its minimally invasive endoscopic surgery portfolio.

Upon obtaining these registrations, the company not only broadens its product lineup within the minimally invasive endoscopic arena but also elevates its overall competitiveness in thoracoscopic procedures, supporting expanded market reach and enhanced brand recognition.

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