According to the China Medical Device Innovation and Priority Approval Database, one innovative medical device has entered the special review process in a public announcement released by local drug regulatory authorities nationwide: the strong pulse light therapy device of Dayue Innovation (Suzhou) Medical Technology Co., Ltd. (hereinafter referred to as Dayue Medical).

Domestic brands are catching up
Intense pulsed light (IPL), also known as pulsed light, is one of the most widely used phototherapy techniques in clinical practice and plays a very important role in the field of skin beauty. Its wavelength is mostly between 500-1200nm. At present, IPL is widely used in the treatment of various skin diseases, especially those related to photodamage and photoaging, namely the classic Type I and Type II skin rejuvenation.

According to research, the theoretical basis for using strong pulsed light for skin treatment is mainly based on the principle of selective photothermal action. Due to its broad spectrum, IPL can cover various target color bases, such as melanin, oxygenated hemoglobin, water, etc., and has a wide range of clinical applications.

The principle of using strong pulsed light to treat dry eye related to meibomian gland dysfunction is not fully understood, mainly based on photothermal effects and reducing ocular inflammatory mediators. Usually, intense pulsed light therapy equipment consists of a main unit, treatment head (or treatment head and filter), foot switch (if any), and protective goggles (if any).

The strong pulse light therapy device, which is planned to be included in the priority approval by the Jiangsu Provincial Medical Products Administration, is a second-class medical device developed by Dayue Medical, including two specifications and models, T9 and T9 Pro. According to the public announcement, the product meets the requirements specified in Article 4, Item (4) of the "Jiangsu Province Second Class Medical Device Priority Registration Procedure (Trial)".

According to the data from the China Medical Device Screening System, there are currently 163 strong pulse light therapy devices on the market in China. It is worth mentioning that since 2022, the approval of strong pulse light therapy devices has officially entered the explosive stage, and the domestic optoelectronic market has undergone tremendous changes.

From the data, it can be seen that the approved number of strong pulse light therapy devices in China has entered explosive growth since 2022, and the approved number of such products has maintained an increasing trend year by year. In addition, it is worth noting that the number of domestic brands approved for this type of product has skyrocketed since then, with domestic brands accounting for 94.48% of the market and imported brands accounting for only 5.52%, greatly accelerating the process of domestic substitution. More and more enterprises focusing on strong pulse light therapy devices are entering the harvest period, and commercialization achievements are being implemented.

After domestic brands caught up, more and more strong pulse light therapy devices were approved, but this also represents a further increase in competition in the market. How to create differentiated features and establish a foothold in the track has become a question that equipment companies in this field need to consider.

Focus on women's health track
Dayue Medical was founded in 2016 and has been dedicated to women's health ever since. We have developed multiple products in the fields of female pelvic floor dysfunction, reproductive health, postpartum rehabilitation, etc. We are committed to providing high-end, professional, and serious home mobile medical solutions to patients.

According to the data from Yaozhi Medical Equipment - China Listed Device Screening System, Dayue Medical has launched a series of heavyweight medical devices. According to Yaozhi Patent Communication, Dayue Medical has authorized up to 55 patents and 6 patents are currently under review.

In the Dayue Medical Women's Health series products, the innovation of its pelvic floor muscle therapy device is remarkable. According to public information, the product has achieved miniaturization and home use through hardware innovation, and has transformed from a hospital setting to a home setting through intelligent and digital technology while ensuring safety and effectiveness.

It is worth mentioning that Dayue Medical is the first enterprise in China to achieve abdominal monitoring and dual channel electromyography signal acquisition on household devices. This design can effectively reduce interference, correct incorrect use, and improve treatment accuracy. This instrument mainly achieves active passive combination therapy through neuromuscular electrical stimulation and biological feedback technology.
Neuromuscular electrical stimulation is a passive training that can effectively induce passive muscle contractions, fundamentally improving female pelvic floor function. Biological feedback technology is an active training method that enables patients to perform corresponding actions based on the electromyographic signals collected by vaginal electrodes and the curves displayed on mobile apps while undergoing neuromuscular electrical stimulation, in order to exercise and strengthen pelvic floor nerve and muscle function.

This product also has an industry-leading algorithm combination that allows patients to independently perform pelvic floor assessments, and its evaluation standards and accuracy are also very accurate.

Conclusion
With the support of policies and the promotion of continuous technological development, the "gold content" of domestic medical devices is becoming increasingly high, and local medical devices are continuously shining with new brilliance.

Source: https://news.yaozh.com/archive/45202.html