BewinTech Advances in Medical Fiber Optic Sensing with World-Leading 0.23mm MEMS-Based Sensors

Early fiber optic sensors were primarily used in the telecommunications sector. Later, with advancements in fiber optic sensing technology, fiber optic temperature, pressure, and displacement sensors gradually gained widespread application in fields such as chemical engineering, bridge monitoring, and military operations. According to forecasts by ElectroniCast, the global market size for fiber optic sensors is projected to grow rapidly from $5.48 billion in 2019 to $9.6 billion in 2027. However, in the healthcare industry, fiber optic sensors remain a relatively “newcomer.”

Across the entire healthcare market, fiber optic sensors have found applications in numerous fields, including intracranial pressure monitoring, urology, pulmonary artery pressure measurement, portal vein pressure assessment, respiratory care, nephrology, and intraocular pressure monitoring. Intracranial pressure (ICP) is a critical monitoring parameter in neurosurgery, frequently used to assess the intracranial status of patients with severe traumatic brain injury and to guide subsequent treatment decisions. Consequently, pressure sensors are commonly employed in neurosurgical practice. Furthermore, sensors are utilized for laser lithotripsy procedures in nephrology, dynamic urine monitoring in urology, and intraocular pressure measurement in ophthalmology. There is substantial demand for sensors across multiple hospital departments.

In practical applications, fiber optic sensors are often integrated into pressure guidewires to measure parameters such as intracorporeal pressure and temperature, providing specific data for clinical diagnosis. Meanwhile, companies also utilize MEMS technology to fabricate miniature sensors, which reduces sensor size while enhancing measurement accuracy. China’s MEMS sensor industry ranks first globally in sales volume, accounting for over 50% of the global market share. However, the development of domestic MEMS fiber optic sensors started relatively late, with Chinese manufacturers being fragmented and market concentration remaining low.

AsThe first and currently only domestic enterprise in China to possess both MEMS fiber-optic sensor and FFR pressure guidewire technologies, Bywave Sensing has positioned itself at the forefront of the FFR market. Globally, only two companies possess both of these technologies.

The company utilizes white-light interferometry and scanning spectroscopy-based fiber optic sensing demodulation technologies, employing MEMS processes to manufacture ultra-miniature point fiber optic sensors with a size of only 0.23 mm.In the FFR market, Bywave Sensing has taken a leading step, becoming the first company in China to offer a miniature fiber-optic FFR system, which had previously received FDA clearance. Leveraging its mastery of core MEMS fiber-optic sensor and FFR pressure guidewire technologies,The FFR pressure guidewires manufactured by Bywave Sensing adopt an integrated design, minimizing production costs.。

Given the wide application of micro fiber-optic sensors in the medical and industrial sectors, why are there so few participants in the Chinese market? First, fiber-optic sensors have only emerged over the past one to two decades, resulting in insufficient technological accumulation among domestic players. Second, MEMS fabrication is a capital-intensive “money pit”; without substantial financial resources and time for accumulation, companies are hesitant to enter the market casually.

Bywave Sensing meets both of these criteria,The company’s founder, Zhang Lizhe, has dedicated 15 years to the field of fiber-optic sensors, leading a team of experts in fiber-optic sensing and MEMS sensing processes from Xiamen University, Nankai University, and Imperial College London.. Moreover, the company has completed a Pre-A financing round worth tens of millions of yuan. Therefore, leveraging its accumulated technology and resources, the ultra-miniature fiber optic sensors developed by Bywave Sensing are world-leading, featuring compact size, high precision, excellent stability, and immunity to electromagnetic interference.

After decades of development, electromechanical sensors based on electrical signals have become relatively mature. However, such sensors are significantly limited in environments with strong electromagnetic interference or where flammable and explosive hazards exist. Furthermore, these electromechanical sensors may require more than a dozen different materials, resulting in complex manufacturing processes. In contrast, Bywave’s miniature fiber-optic sensors are not only compact and easy to integrate into various medical devices, but also offer customizable temperature ranges to maximize the elimination of thermal interference. Meanwhile, the primary materials of fiber-optic sensors are silicon and quartz, both of which exhibit stable physical and chemical properties, good biocompatibility, and high safety for use within the human body.

Meanwhile, the key to miniaturizing fiber optic sensors lies in Bywave’s unique MEMS process. “Even with the same manufacturer and the same equipment, different operators may produce sensors with varying performance.” In developing pressure sensors, Bywave did not merely adhere to the 100,000-cycle fatigue test required by the Chinese National Military Standard; instead, it completed 1 million cycles in accordance with the U.S. Military Standard. Through repeated testing, optimization, and re-testing—aimed at reducing sensor size, enhancing temperature performance, and improving sensitivity and accuracy—this persistent refinement has culminated in a distinctive MEMS process, enabling Bywave to produce ultra-miniature sensors measuring just 0.23 mm in size.

Furthermore, stability is also a critical metric for evaluating fiber optic sensors, which constitutes a key advantage of Bywave’s miniature fiber optic sensors. Previously, Bywave’s customers conducted measurements,The company's ultra-micro sensors exhibit a drift of less than 4 mmHg over 7 or 14 days.。

For its first step in the medical field, Bywave Sensing chose the FFR (Fractional Flow Reserve) market.

As the gold standard for functional diagnosis of coronary artery disease, fractional flow reserve (FFR) can be used to assess whether vascular stenosis induces myocardial ischemia, thereby helping physicians determine whether patients require stent implantation. According to Frost & Sullivan data, the penetration rates of FFR in the United States, Japan, and China in 2020 were 16.1%, 15.7%, and 0.6%, respectively. The penetration rate of FFR in China remains significantly low, partly due to inadequate market education and partly due to the strategic monopoly held by overseas giants over pressure wire technology. In China, the high cost of imported wires, often reaching RMB 10,000 per wire, has greatly constrained the development of FFR.

In addition to the technological monopoly on pressure guidewires, the high entry barriers associated with MEMS fiber-optic sensors have excluded certain companies from the market. The few foreign enterprises that hold a monopolistic position in China’s FFR market all source their MEMS fiber-optic sensors externally.Globally, only a handful of companies are capable of independently manufacturing MEMS fiber-optic sensors and pressure guidewires, with Bywave Sensing being the first in China.。

The operating temperature range of Bywave’s sensor products is customizable, with a measurement accuracy better than 1 mmHg. In terms of manufacturing, all of Bywave’s pressure guidewires are fabricated using laser welding exclusively, without employing other welding techniques or introducing additional materials, thereby ensuring superior overall tensile strength. These pressure guidewires also feature a unique structural design that enhances their trackability and maneuverability. Furthermore, the cost of Bywave’s miniature optical fiber FFR products is significantly lower than that of comparable international products, offering substantial advantages for clinical adoption.

Previously,Micro-fiber optic FFR product receives FDA clearance; Bywave becomes the first Chinese manufacturer to obtain FDA clearance in the FFR field.

By possessing both MEMS fiber-optic sensor technology and pressure guidewire technology, Beijing Bywave Sensing Technology Co., Ltd. has secured the initiative in research and development as well as production. On one hand, this enables the company to enhance guidewire production efficiency and reduce manufacturing costs. On the other hand, leveraging its proprietary guidewire manufacturing capabilities and extensive network of physician resources, the company is well-positioned to meet clinicians’ needs for product modifications.

“We can respond quickly to physicians’ needs and improve and optimize our products. For example, after using the FFR product, physicians may request higher sensor sensitivity or ask whether temperature effects can be eliminated. We can readily implement improvements for such issues.”

In addition to cardiology, Bywave has developed pressure sensors with varying measurement ranges to meet the needs of different medical specialties. These include miniature sensors with a range of only 10 mmHg for intracranial pressure monitoring, as well as pressure sensors with a range of 100 MPa. Its products are widely used in urology, nephrology, neurosurgery, and other departments. When supplying sensors to hospital clients, Bywave also assists with coagulation testing, stability testing, and sensor accuracy validation.

Bywave’s fiber-optic sensing technology originated from military projects and meets military-grade quality standards, with applications extending well beyond the medical field.In the oil and gas sector, Bywave’s sensors enable continuous, real-time monitoring of downhole pressure and temperature, with an operating temperature of up to 300°C, representing the industry’s highest standard. In the transportation sector, the company’s accelerometers provide real-time vibration monitoring at various locations, including high-speed rail tracks and pantographs. In the power generation sector, Bywave is developing sensor products for temperature measurement in aluminum electrolysis. In the military domain, the company is also developing sensors for rapid, dynamic pressure testing.

Despite Bywave’s extensive presence across multiple sectors, the company’s core focus remains on a select range of products: temperature sensors, pressure sensors, accelerometers, and displacement sensors. Leveraging its proprietary fiber-optic sensing technology and MEMS fabrication processes, Bywave continues to expand the application scope of its fiber-optic sensor offerings, thereby serving a broader base of medical and industrial clients.

Identifying needs, solving problems, and fulfilling demands marked the beginning of Zhang Lizhe’s establishment of Bywave.

Through long-term engagement with physicians across various departments, founder Zhang Lizhe identified a significant demand in hospitals for precision interventional therapy. For instance, clinicians sought to measure the frequency, velocity, and direction of finger tremors in Parkinson’s disease patients, enabling timely notification for hospitalization when predefined thresholds were reached. Leveraging existing fiber-optic sensing technology, Zhang Lizhe designed two systems that facilitated the acquisition of quantitative data for physicians.

Moreover, we previously perceived little relevance between fiber optic sensors and orthopedics. However, during the Wenchuan Earthquake, some patients extracted from the rubble initially appeared stable, yet their condition deteriorated rapidly within just half an hour. Physicians observed that upon removal of the objects compressing the patients’ bodies, toxins released from the compressed tissues would attack vital organs, often leading to organ failure within 30 minutes. In such scenarios, clinicians sought a device capable of monitoring pressure levels and blood flow at the injury sites. To address this need, Zhang Lizhe integrated fiber optic sensors into indwelling needles to measure pressure values and assisted physicians in conducting experiments on more than 200 mice.

“Physicians may struggle with the lack of channels to meet the demand for such quantitative measurements, but fiber optic sensors can easily accomplish this. Later, I successively engaged with doctors from other departments, including peripheral vascular, otolaryngology, neurosurgery, obstetrics and gynecology, and nephrology, who also favored sensor products capable of quantitatively measuring internal human body pressures. Given the promising prospects of fiber optic sensors in the medical field, we decided to develop medical-grade sensors.”

Having first engaged with fiber optic sensors in 2006 and cultivated deep expertise in the sensor field for nearly 15 years, Zhang Lizhe has led a team of professionals from Imperial College London, Nankai University, and Xiamen University to establish Bywave’s renowned technological reputation. Globally,Bywave has gradually established a sales network with major hospitals and various departments. In addition to collaborating with hospitals on scientific research projects or clinical preliminary studies, Bywave works with leading physicians across specialties to expand the application scenarios of its sensor products, explore emerging markets, and develop innovative products.. From cardiology to urology, gynecology, and intracranial markets, ranging from micro fiber-optic FFR systems to radiofrequency ablation catheters. Meanwhile, in the process of laying out various industrial sectors, Bywave has gradually established partnerships with leading enterprises in fields such as petroleum, wind power, hydropower, thermal power, and coal.

In its future development, Bywave will continue to exert efforts in the medical and industrial fields,Accelerate the NMPA certification of FFR guidewires and the clinical trials of intrarenal pressure guidewires in the medical sector.Moreover, the company plans to launch a Series A financing round to fund product research and development, commercialization, and production line expansion.

“One day, fiber optic sensors will be widely adopted across major sectors, replacing some traditional electromechanical sensors while opening up emerging markets. With the rise of the Internet of Things (IoT) and smart networks, fiber optic sensors could enter a trillion-dollar market. Bywave aims to root itself in core technologies, continuously optimize and iterate, and become a century-old enterprise.”