EaseMed Participates in National Ultrasound Scalpel Standard Development Ahead of IPO Filing

Zhangtong News Agency, April 15 — On April 11,The Subcommittee on Medical Ultrasound Equipment of the National Technical Committee for Standardization of Medical Electrical Appliances convened a seminar in Beijing to discuss the standard for "Ultrasonic Soft Tissue Cutting and Hemostatic Surgical Devices," with Yisi Medical participating in the discussion.。

At the meeting, industry experts from institutions such as the Hubei Provincial Institute for Medical Device Quality Supervision and Inspection, along with technical expert representatives from 12 domestic and foreign ultrasound equipment enterprises, including Yisi Medical, Johnson & Johnson, and Medtronic, clarified the scope of the standards and applicable products. Subsequently, they conducted professional analyses and objective discussions on the formulation of key technical indicators and test methods outlined in the draft.

During the on-site discussion, Yisi Medical provided suggestions on the wording of certain technical terms in the draft. For instance, it was noted that “clamping force” and “holding force” could not be clearly distinguished in terms of their specific clinical value based on literal interpretation alone. The attending experts unanimously agreed to revise “holding force” to “grasping force.” Additionally, regarding the test methods for lateral amplitude at the device tip and maximum clamping force, Yisi Medical proposed adding new test methods to the existing ones to better meet clinical needs related to product safety performance, which also resonated with the experts present.

Regarding the draft’s lack of objective, reproducible measurement methods and the inclusion of outdated or inappropriate test items, Yisi Medical proposed corresponding deletions. For instance, the draft listed burst pressure testing—already conducted during animal experimental studies—as a standard requirement, resulting in redundant testing. Furthermore, measurement items irrelevant to safety and efficacy, such as output acoustic power, should be re-evaluated for deletion or revision from the perspective of deregulating enterprise development and accelerating product market approval processes. All these suggestions were incorporated into subsequent revisions of the draft.

Group Photo at the Seminar

The formulation of industry standards for medical devices not only pertains to product manufacturing specifications but also directly impacts public safety and vital interests. In recent years, Yisi Medical has seized the opportunity to enhance product performance and reduce surgical costs by making substantial efforts in technological innovation within its ultrasound product line. The core technical indicators of its independently developed ultrasonic hemostatic scalpel, including cutting speed and vessel burst pressure, surpass those of comparable imported products. Meanwhile, the company looks forward to leveraging its practical experience in research, development, and manufacturing to actively participate in the formulation and discussion of relevant domestic standards, accelerate alignment with international standards, and continuously promote product quality improvement and overall industry upgrading.