The first Chinese manufacturer of intracardiac ultrasound (ICE) to conduct exploratory human clinical trials, the first manufacturer of intracardiac ultrasound products to be approved for marketing by the State Drug Administration (SDA), the first Chinese manufacturer to complete a human clinical study of 4D ICE, and the first Chinese manufacturer of ICE diagnostic systems to be certified for approval by the U.S. Drug Enforcement Administration (DEA) ......
So many "first", all from a new area enterprises - Jiangsu Ting Sheng Technology Co.
This leading team in intracardiac ultrasound in the country and theAfter Philips and Johnson & Johnson, the world's third company to complete the development of ASIC-integrated 4D intracardiac ultrasound products and enter the clinical stageThe
The first in the country, the third in the world, how is it "made"?
"Make our own ICE products."
Before we introduce Timing Rise Technology, let's understand a little bit about intracardiac ultrasound (ICE).
As we all know, the heart is the "powerhouse" of the human body, and its structure is so precise that it is like a maze that is always beating. But during surgery, doctors are often faced with a huge challenge: how to safely and accurately complete the repair without being able to see or feel it?
This is where intracardiac ultrasound comes in handy - it's theA novel ultrasound imaging techniqueThe tip of the catheter hides a miniature probe, like a thin "hairline" that can "drift" along the blood vessels all the way to the inside of the heart.have sb do sthsurgeonreal time andaccurate"examine by fluoroscopy (i.e. X-ray)"Heart. This has not only become a powerful adjunct to interventional procedures, but has also given new hope to patients with emphysema, contrast allergies, and other difficulties with conventional ultrasound imaging.
The technology is advanced enough, but the threshold is also high. For a long time in the past, the domestic intracardiac ultrasound market was almost dominated by multinational giants.
"Why can't we make our own ICE products?"
In 2019, the startup team of Timing Rise Technology began to gather: five partners, including senior scientists in ultrasound, cardiologists, and serial entrepreneurs, to start the road of innovation together.
Since then, the story of "First" has been written.3 years of research and development to break the monopoly
To break the monopoly of technology is not an overnight task. Like all "breakers", Nicholson team also experienced a long period of exploration.
transducer, chip design, bonding process, ultrasound imaging algorithms, ultrasound modeling and navigation algorithms ...... an ICE conduit, integrating many technologies thatHundreds of trials behind every step.The
Take the transducer in the 2D ICE product probe as an example, this 8mm long and 2mm wide part may seem insignificant, but in fact, it is equipped with more than 60 micron-level array elements. To ensure that the real-time picture is clear and stable, the array element should transmit and receive signals uniformly and stably, which is extremely demanding on the processing technology. Because no one has ever done it in China.The team could only feel their way across the river, trying more than a hundred different kinds ofThe
After more than three years of attack and countless process validations, the
In 2022, TingSheng Technology fired the industry's "first shot" - the team independently developed two-dimensional intracardiac ultrasound products to complete the first case of exploratory clinical trials in humans, successfully treating a case of oval foramen not closed patients.Throughout the surgery, not only is the imaging clear, the doctor can monitor the entire surgical process in real time; most importantly, the patient does not need general anesthesia, and there is no radiation during the operation.
Since then, the development of Nicholson has pressed the "accelerator button", quickly completed the registration of clinical trials, and entered the special approval channel for innovative medical devices.
In November 2023, TINGSN Sonic Eyes 10 was approved for marketing. As the team expected when they started the business, this is the first self-developed and approved intracardiac ultrasound diagnostic catheter in China, breaking the monopoly of imported products for a long time. Currently, this product has been used in nearly 500 hospitals nationwide, covering 31 provincial administrative regions.
At the same time, the intracardiac ultrasound diagnostic system independently developed by TingSheng Technology has also successfully passed the approval of the U.S. Food and Drug Administration (FDA). FDA certification has long been known as the "passport" to the global medical device market due to its stringent standards. As the first Chinese "player" in the field of intracardiac ultrasound to be allowed to enter the market, the technical strength, safety and effectiveness of TingSheng's products are self-evident.From "followers" to "parallel runners"
Nowadays, intracardiac ultrasound products have been formally included in the collection and procurement catalog. The latest data show that six domestic enterprises have been approved nine registration certificates, of which, Nicholson Technology holds four registration certificates, occupying nearly half of the share.
Despite being the "No. 1 in the country," the team didn't stop there.Continue to4D intracardiac ultrasound products step forwardThis is described as the "ceiling" in the field. According to reports, this is the field of "ceiling", higher technical barriers. For example, 4D product transducer internal configuration of nearly 1,000 array elements, need to be controlled through the ASIC chip. This chip, the same to independent development.
At present, the world really completed the ASIC integrated 4D ICE research and development and entered the clinical trial stage of the enterprise only two: Philips, Johnson & Johnson, are the medical industry giant. Until April this year.TingSheng Technology's self-developedTINGSN 4D ICE Successfully Completed the First Human Clinical Study in China, an innovative force from the new district, has once again torn apart the monopoly pattern.
From "running with" to "running with", Nicholson's "global third" is also a key leap in the field of cardiovascular interventional imaging.
This innovative team will continue to take root in Jiangbei and write more stories about "first".
