Eight Neurosurgical Devices and Software Receive NMPA Approval (June 1–30, 2026); Related IPO Filing Submitted

Registrant Name:Shanghai United Imaging Healthcare Co., Ltd.

Registration Certificate No.:NMPA Registration No. 20263051141

Structure and Composition / Main Components:The product consists of a beam module, gantry, multi-leaf collimator (MLC), treatment couch, flat-panel detector, hand control box, gating components (VSM), RT power cabinet, SCCU, ACBU, treatment control workstation (TCC), treatment delivery application workstation (TAC), application server (APC), Monitor 1, Monitor 2, control box, and accessories (imaging crosshair plate, light field crosshair plate, front pointer, beam block tray, and electron applicators).

Scope of Application/Intended Use:This product is indicated for image-guided radiation therapy of primary or secondary tumors throughout the whole body, including the head, neck, thorax, abdomen, pelvis, spine, and extremities.

Registrant Name:Double Medical Technology Co., Ltd.

Registration Certificate No.:NMPA Registration No. 20263131251

Structure and Composition / Main Components:The product is made of polyether ether ketone (PEEK-OPTIMA LT1) material that complies with the requirements of the YY/T 0660 standard. It is available in two delivery states: sterile and non-sterile. Sterile products are sterilized using ethylene oxide, with a sterilization validity period of 5 years.

Scope of Application/Intended Use:It is used in conjunction with PEEK cranial bone plates, cranial repair mesh plates, and connecting plates of the same system, and is suitable for internal fixation of cranial fractures and repair of defective areas.

Registrant Name:Jingmeide (Shenzhen) Medical Technology Co., Ltd.

Registration Certificate No.:National Medical Device Registration Approval No. 20263071275

Structure and Composition / Main Components:This product consists of the main unit, power adapter, and probe connection cable.

Scope of Application / Intended Use:This product is used in conjunction with the intracranial pressure sensor kit manufactured by our company to monitor intracranial pressure and intracranial temperature in patients over one year of age, for use by qualified licensed healthcare professionals in medical institutions.

Registrant Name:Suzhou Xinhang Intelligent Medical Technology Co., Ltd.

Registration Certificate No.:National Medical Device Registration No. 20263011306

Structure and Composition / Main Components:It consists of a workstation (host, monitor wall mount and tripod/or trolley, power adapter), a depth camera, a depth camera bracket, preoperative planning software (PPS, V1), and a single-use auxiliary positioning probe (XH-TZ-01).

Scope of Application / Intended Use:Intended for use in conjunction with a specific head frame to navigate disposable auxiliary localization probes during adult neurosurgical procedures.

Registrant Name:Jiangsu Baining Yingchuang Medical Technology Co., Ltd.

Registration Certificate Number:NMPA Registration No. 20263071387

Structure and Composition / Main Components:The product consists of the main unit, patient interface box, silent detector, patient simulator (optional accessory), and stimulation probe.

Scope of Application/Intended Use:This product, when used in conjunction with specific accessories manufactured by our company, is intended for the intraoperative identification, localization, and monitoring of the facial nerve, vagus nerve, and recurrent laryngeal nerve. In open thyroid surgery in adults, it assists in providing reference cues for parathyroid glands by inducing autofluorescence in parathyroid tissue, thereby aiding in the assessment of tissues where visual identification by the surgeon is uncertain. This product shall not be used independently for the identification or determination of parathyroid glands and cannot replace pathological examination.

Registrant Name:Nanjing Zhuwei Medical Technology Co., Ltd.

Registration Certificate Number:NMPA Registration No. 20263211382

Structure and Composition / Main Components:The product consists of a software installation program and authorization files. Its functional modules include basic functions, fusion, registration, segmentation, manual measurement, visualization, fiber tractography, and path planning.

Scope of Application/Intended Use:This product is used for planning neurosurgical procedures.

Registrant Name:Chengdu Meiyida Medical Technology Co., Ltd.

Registration Certificate No.:National Medical Device Registration No. 20263131353

Structure and Composition / Main Components:Patient-matched polyether ether ketone (PEEK) cranial repair implants are made of PEEK materials (PEEK-OPTIMA-LT1 or PEEK-LISCIEX-ZR7) that comply with the requirements of YY/T 0660 standard, and are packaged non-sterile.

Scope of Application/Intended Use:Used in conjunction with the same system components, suitable for surgical treatment of skull defect repair and reconstruction.

Registrant Name:Boston Scientific Neuromodulation Corporation

Agent Name:Boston Scientific International Medical Trading (Shanghai) Co., Ltd.

Registration Certificate No.:NMPA Import Registration No. 20263120231

Structure and Composition / Main Components:This product consists of an implantable spinal cord neurostimulator, port plug, stimulator mold, and torque wrench.

Scope of Application/Intended Use:This product is used in conjunction with compatible implantable spinal cord stimulation electrodes for the adjunctive treatment of chronic, intractable pain in the trunk and limbs in patients aged 18 years and older (excluding pregnant women). This product is classified as an MR Conditional medical device. Under specified conditions and with special precautions taken to protect the patient and the implanted device, patients may undergo clinical magnetic resonance imaging (MRI) scans at a field strength of 1.5T. For specific requirements regarding MRI examinations, please refer to the product instructions for use.