Press

Will it be possible to introduce domestic development AI medical device this year?

This year, there is a growing interest in the birth of AI (artificial intelligence) medical devices developed by Korean companies.

AI medical devices refer to products that analyze, diagnose, and predict medical information collected from patients, such as patient medical records, biometric information, and medical images.

It analyzes the medical information collected and provides the information (quantitative value for the specific site) applied to the diagnosis and treatment of the disease, or automatically diagnoses or predicts the possibility of the presence or absence of the disease, and provides it to the medical staff.

Currently, there are four medical devices in Korea that are commercialized using AI technology.

JLK Inspection, Buno, Lounette and Silicon Sapien are in clinical trials to receive approval for medical devices.

JLK Inspection and Viewo were approved in September 2017, and LoNit and Silicon Sapien were approved for clinical trials in October of the same year.

These companies are validating artificial intelligence diagnostic algorithms based on MRI, CT, and X-ray images through clinical trials.

The JLK Inspection is based on MRI, which is based on the medical imaging analysis software, the Bone Scale X-ray image-based bone age measurement (medical image analysis software) Medical image detection assistant software) and Silicon Sapien is developing coronary artery prediction system (medical imaging diagnostic assistant software) based on coronary CT image.

Artificial intelligence-based infarction diagnostic software, developed by JK Leke Inspection, aims to provide medical staff with information on the causes of cerebral infarction. The company said that it will make diagnosis and proper prescription for each patient. Research is being conducted at the Ilsan Hospital of Dongguk University and the Seoul National University Hospital of Bundang.

Vuno is conducting clinical trials of 'VUNOmed-BoneAge' to measure the bone age of growing children. The accuracy of bone age measurement is evaluated by using X-ray image for growing men and women in Korea University Hospital. In the case of bone age measurement, a lot is done at a university hospital, but it is a field that can not be practiced well at a clinic.

VNO is developing the VUNOmed-BoneAge, which learns bone age measurement data from university hospitals, at the opening of the clinic. In addition, early detection technology for lung disease is under development.

Lunit is developing medical image detection assistant software called 'Lunit sight for Chest Radiography'. The safety and efficacy of pulmonary nodule diagnosis using chest X-ray imaging are evaluated at Seoul National University Hospital and Boramae Hospital.

The company is developing the world's first cloud-based real-time X-ray reading service and opened its 'Louvre Insight' in November last year for simple testing and research purposes. According to the Lunet side, the accuracy of the readings can be improved up to 20%.

Silicon Sapien is developing HeartMedi 1.0, which measures the degree of stenosis through fractionated flow reserve (FFR) measured based on coronary CT images. It was developed by the Kangwon National University Project Team and was founded in 2014 by Silicon Sapien. They are recruiting patients at Seoul National University Hospital in Bundang and conducting clinical trials.

In the case of coronary artery disease, medical personnel perform myocardial fractionation blood flow reserve, an invasive test to determine the degree of stenosis to determine stenting. 'HeartMedi 1.0' is a non-invasive test that uses coronary CT to confirm the degree of stenosis. It is expected that the inconvenience that sufferers with coronary artery disease should suffer.

AI medical devices being developed by Korean companies are being conducted as retrospective clinical trials to confirm the validity of software using existing medical data except for Silicon Sapien.

Retrospective clinical trials are shorter than prospective clinical trials in which patients must be recruited. It is known that it usually takes two to three months for data collection and three months for analysis. In about six months, clinical trials of AI medical devices are concluded.

The Food and Drug Administration will review and give final approval within 85 days of receipt of a medical device license application.

It is expected that the first AI medical device will be born in the first half of this year as soon as J-ELK Inspection and BUENO approved the clinical trial plan in Oct. last month by Lounet and Silicon Sapien.

Of course, due to problems such as how much data can be secured in this process, the duration of clinical trials may be long, and precise timing can not be predicted because supplementary instructions may be issued for insufficient data during the period of review of the drug store. However, there is no doubt that this year's first AI medical device will be born.

So can AI medical devices be used right away in real medical practice?

Industry experts and experts should keep an eye on this.

The KFDA is working to develop guidelines for AI medical device approval screening and clinical trial validation, and Ryu Young-jin, the chief of the KFDA, has said that it will be able to quickly release advanced medical devices into the market through quick approval through New Year's Day. Evaluation, payroll, and practical use in the clinical field.

Choi Yoon-sup, CEO of Digital Healthcare Partners (DHP), a specialist in accelerating the start-up of healthcare, said, "AI medical devices under development can not be used without physicians in the field and assist physicians. Therefore, it should be observed whether it will be introduced to hospitals after permission. It was developed in line with the needs of doctors, but it has to be well integrated into the clinic and the treatment process. "

"We need to demonstrate the value of AI medical devices without interfering with existing practices and procedures. For this purpose, convenience of treatment, clarification of treatment, efficiency of treatment, and safety should be improved. This year, AI medical devices will be licensed and introduced. The need for AI medical devices and the needs of doctors may be different for hospitals. The spread to other hospitals can be expected when the needs of hospitals and doctors are well-matched. "

The number of start-ups to develop AI medical devices in Korea is about 10, and the number of large-scale companies including Samsung Electronics, which declared development, is increased.

According to the Ministry of Food and Drug Administration, no clinical trials have yet been received or approved, except for four sites that have received and approved the current protocol.

Although it is not possible to predict how much it will be used in actual medical field, it is expected that the development of advanced medical devices such as AI medical devices will become active.

Many global companies, including Google, IBM, Microsoft, and Johnson & Johnson, are developing and launching products that combine AI technology. Google Streams, Deep Mind Health, and IBM Watson. We are in the midst of product development with leading brands such as BUNO and ROUNET, which are recognized overseas.

The KFDA is also in the position to actively support product development. The KFDA has already organized a specialist consultation body last year to collect opinions from industry and academia, and announced guidelines on the approval of AI technology-based medical device licensing and guidelines for evaluating clinical trial efficacy. We will continue to do this in the future.

"We already have discussions with the industry and published the Guideline for Guideline for Approval of Medical Device Applicable to AI Technology and Guideline for Validity of Clinical Trial Evaluation. "This year, we are holding a briefing session for related industries and holding a briefing session if requested by companies, medical institutions, educational institutions, academia, etc. This year, I will try hard. "

Young doctor
http://www.docdocdoc.co.kr/news/articleView.html?idxno=1050903

Press

What about clinical trials for AI medical devices?

Following guidelines for software licensing with Big Data and AI technology, guidelines have been drawn up to guide how to evaluate the effectiveness of AI tests in medical devices.

Medical devices with big data and artificial intelligence (AI) technology analyze medical big images such as medical records, electrocardiogram, blood pressure blood, and medical images such as CT and MRI to diagnose or predict diseases by medical device .

The Korea Food and Drug Administration (KFDA) published the Guideline for Evaluation of Clinical Validity of Artificial Intelligence-Based Medical Devices (Civilian Guide).

The guideline should include factors to consider when designing retrospective clinical trials, how to set up efficacy parameters, and how to evaluate efficacy.

According to the guidelines, clinical trials of artificial intelligence devices not only recognize prospective clinical trials that recruit patients and conduct clinical trials, but also retrospective clinical trials that validate efficacy through collected medical data.

For prospective clinical trials, the selection of data for clinical trial subjects should reflect the target population, including disease group, frequency of disease, and gender, depending on the indication of the medical device. The clinical trial subject data should remain independent of the training data used during the development of the device.

The drug store also recommends random sampling from extracted data sets to avoid bias.

In the case of retrospective clinical trials using Big Data, it differs slightly from clinical trials because it uses existing information. First, retrospective clinical studies may be waived for clinical trial subjects.

When conducting clinical trials, the subject must obtain consent from the subject and be approved by the Clinical Trials Review Board (IRB). However, retrospective clinical trials using existing medical data are unlikely to be realistic. Therefore, in retrospective clinical trials, exemption from subject consent may be considered, subject to IRB approval.

For clinical trials comparing clinical instrument reading accuracy with medical instrument readings, the clinician may participate as a control. However, the agency recommended that clinicians participating in the control assessment should be independent of the clinical expert group involved in establishing the reference standard.

A reference standard is a standard used to identify the presence or absence of a disease or a specific condition to diagnose or predict. You can build reference standards using data validated by a group of clinical experts.

The most important validity parameters are diagnosis sensitivity, specificity, positive predictive value, negative predictive value, ROC (Receiver Operating Characteristic) Curve, Area Under the Curve (AUC), positive agreement rate and voice agreement rate.

In retrospective clinical trials, the primary efficacy variables were sensitivity, specificity, sensitivity and specificity of AUC output or software readings, sensitivity, specificity and AUC change before and after use of the software.

The criteria for the success of clinical trials can be set by the manufacturer autonomously. Instead, they should be able to give reasons and reasons for setting success criteria. In addition, these criteria are described in the performance and usage method when the product is licensed, and it is specified in the user manual so that the user can confirm it.

"This guideline details the clinical trial method that reflects the characteristics of the products that utilize the medical data measured and collected, such as patient's medical records, medical image data, biometric information, etc." I hope you can help me. "

On the other hand, JICA Inspection, BUNNO Korea, Lunet and Silicon Sapien have been approved for clinical testing of AI medical device software in Korea.


Young doctor
http://www.docdocdoc.co.kr/news/articleView.html?idxno=1050652

Press

Prediction of coronary artery disease without drug insertion or wire insertion

[August 17, 2016]



▲ Coronary artery disease prediction analysis service process

The future creation science department said that the Kangwon University team (professor Shim Eun-Boo) who carried out the "New Industry Creation Project" succeeded in developing a service that predicts coronary artery disease by computer simulation without the need to insert drugs or insert guide wires.

This is a SW-based simulation method that utilizes images taken by CT (Computerized Tomography) equipment, and is expected to pioneer new medical image SW market in rapidly growing domestic and overseas cardiac diagnosis market.

The most common cause of death in Koreans is coronary artery disease, such as angina pectoris and myocardial infarction. Currently, stent-based intervention is being performed in the clinic to treat this disease.

The FFR (Myocardial Fraction Retention Reservoir) test is used to determine whether the stent is inserted or not. The patient injects a drug called adenosine to make the heart move, then inserts a guide wire with a pressure sensor into the blood vessel Measure the pressure before and after the site where the stenosis of the sun appears.

This method has a problem of using a wire insertion method (injury to a living body) and a side effect due to a drug, and costs about 150 ~ 2,000,000 won.

The medical imaging service (CT-FFR simulation model) using cardiovascular simulation developed by Kangwon National University is a non-invasive FFR that analyzes coronary artery CT images and simple physiological data (blood pressure, heart rate, etc.) Prediction method.

The advantage of the existing invasive method is that it does not require drug administration or insertion of a guide wire, which can reduce patient pain and cost.

Heartflow, Inc., a leading company in the field, used the myocardial mass to calculate the peripheral resistance of the heart. On the other hand, Kangwon National University used the blood vessel length to shorten the calculation time and the calculation amount. We have implemented a system that can be analyzed in about three hours per case on a regular PC, not a high-performance cluster computer.

In addition, the project team evaluated the clinical usefulness of CT-FFR simulations with Ulsan University, Seoul National University, Inje University, Keimyung University, Pusan ​​National University, Kangwon National University, and other clinics with 189 patients and 323 blood vessels. .

Following the establishment of Silicon Sapien Co., Ltd. in 2014 for the early commercialization of research results, in June of this year, the company obtained GMP (Good Manufacturing Practice) for medical device manufacturing approval for CT-FFR product export and CT-FFR service from KFDA did.

Silicon Sapien plans to launch commercialization of 'HeartMediTM', 'Coronary Artery Disease Prediction Analysis Service', and MOU for service promotion with Pusan ​​National University Hospital based on the technology.

"With the support of the New Industrial Creation Project Technology Commercialization Expert Group, we have been able to realize original technology and marketable services that go beyond the patent barriers of foreign leading companies." "If the service is applied to the medical field in earnest, I hope that it will contribute greatly to the improvement of the convenience of the people, such as the convenient and quick diagnosis of arterial disease and the reduction of medical expenses. "



doctorW Cho Hyung Yeon reporter

http://www.doctorw.co.kr/news/articleView.html?idxno=55888

Press

Predictions with Coronary Artery Disease Computer Simulation

[August 10, 2016]

Coronary artery disease such as angina pectoris or myocardial infarction can be predicted only by computer simulation.

According to the Ministry of Science & Technology, the Kangwon National University, which implemented the 'New Industry Creation Project', developed software that predicts coronary artery disease by computer simulation without the need for insertion of a guide-wire.

Utilizing images taken with CT (Computerized Tomography) equipment, the technology is expected to open up a new market for medical imaging software in the fast-growing domestic and overseas cardiac diagnosis market.

Angina pectoris and myocardial infarction are usually treated with stent intervention.

At this time, the patient is injected with a drug called adenosine, putting the heart into motion, and then insert a guide wire with a pressure sensor into the blood vessel to measure the pressure at the stenosis.

Although it is a mandatory test, it is an invasive way to injure the living body, so the suffering of the patient is followed and the side effects of the drug are concerned. Moreover, up to 2,000,000 won is also a burden.

The software we have developed solves all of this. In particular, the calculation of the peripheral resistance of the heart is based on the use of blood vessel length rather than the US Heartflow, a leading company in the field of using myocardial mass.

Another advantage is that it can be analyzed for about three hours per case in a general personal computer rather than a high-performance computer.

According to the project team, 189 patients and 323 blood vessels were confirmed to be at the highest technology level in clinical usability evaluation of simulations conducted with Ulsan University, Seoul National University, Inje University, Keimyung University, Pusan ​​National University, Kangwon National University and others. The results were also published in the International Journal of Cardiology.

In early 2014, the company founded Silicon Sapien Co., Ltd. in order to conduct the research results early. In June of this year, GMP was obtained from the Korea Food and Drug Administration (KFDA) for CT-FFR product export medical device manufacturing approval and CT-FFR service.

table. Technology comparison between Silicon Sapien and Mihat Flow



▲ LPM (Lumped parameter model): Physiological electrical circuit model of coronary circulatory system



MEDICAL TRIBUNE

http://www.medical-tribune.co.kr/news/articleView.html?idxno=68751

Press

Development of coronary artery disease prediction service

[August 12, 2016]

□ The future creation science department (minister Choi, Yang-hee, hereinafter referred to as the future department) is a computer simulation of the coronary artery without the need of drug insertion or guide-wire insertion. And has successfully developed a disease prediction service.

* Supporting the convergence of basic and original technology and supporting simultaneous R & D and technology commercialization, leading to rapid market entry and creation of new industry and market (creation of foundation for creation economy through science and technology)

This is a SW-based simulation method that utilizes images taken by CT (Computerized Tomography) equipment and is expected to open up a new medical image SW market in the fast growing domestic and overseas cardiac disease diagnosis market *.

* Market forecast for cardiac disease diagnosis (2013 SME Technology Roadmap, Small and Medium Business Administration): 9.7 trillion won ('12) → 13.6 trillion won ('16), 40.5 billion won ('12) → 59.7 billion won (16 dollars) , Growth of 10.2% per year

The most common cause of death is coronary artery disease, such as angina pectoris and myocardial infarction. Currently, stent-based intervention is being performed in the clinic to treat this disease.

* The cause of death in Korea (National Statistical Office, 2014): 1st place cancer (146.5 people per 100,000 people), 2nd place heart disease (52.5 people per 100,000 people), 3 cerebellar vascular disease (51.5 people per 100,000 people)

The FFR (Fractional Flow Reserve) test is used to determine whether the stent is used or not. The patient is given a drug called adenosine, The wire is inserted into the blood vessel to measure the pressure before and after the site where the stenosis has occurred.

ㅇ In this method, there is a problem of using a wire insertion method (injury to a living body) and a side effect due to a drug, and it costs about 150 ~ 2,000,000 won.

□ The medical image service (CT-FFR simulation model) using cardiovascular simulation developed by Kangwon National University is a non-invasive method for analyzing coronary artery CT images and simple physiological data (blood pressure, heart rate, etc.) FFR prediction method.

ㅇ It is a merit that the existing invasive method does not require drug administration or insertion of guide wire, so there is no pain and the cost can be greatly reduced.

ㅇ Heartflow, Inc., a leading company in the field, used the myocardial mass to calculate the peripheral resistance of the heart. However, Kangwon National University achieved a performance * that shortens the calculation time and calculation time by simply using the blood vessel length,

* Published in the June 16 issue of Pflugers Archiv-European Journal of Physiology, International SCI Journal

ㅇ We implemented a system that can analyze in 3 hours per case in a general PC, not a high-performance cluster computer used for simulation.

In addition, the project conducted clinical evaluation of the CT-FFR simulation with Ulsan University, Seoul National University, Inje University, Keimyung University, Pusan ​​National University, Kangwon National University, and the like for 189 patients and 323 blood vessels. Results * were obtained.

* Some of the clinical results are published online in the International Journal of Cardiology, June 16, 2008, the international SCI journal.

□ The project team established Silicon Sapien Co., Ltd. in 2014 for the early commercialization of research results. In June of this year, we obtained GMP (Good Manufacturing Practice) for CT-FFR service, I got it.

ㅇ Based on the technology, Silicon Sapien plans to launch commercialization of 'HeartMediTM' and 'MOU for promotion of services with Pusan ​​National University Hospital'.

□ Thanks to the support of the New Industrial Creation Project Technology Commercialization Expert Group, Shimyeongbo Project Team Manager was able to implement original technology and marketable service that surpasses the patent barriers of overseas leading companies. "If the service is applied to the medical field in earnest "I am expecting that it will contribute greatly to the benefit of the people, such as the convenient and quick diagnosis of coronary artery disease, and medical cost reduction."

□ Future Creation Science Department (Minister of the Future) will be a member of the Kangwon University Project Team (Director Shim Eun-Boo) who performed the "New Industry Creation Project" ) Has successfully developed a service that predicts coronary artery disease by computer simulation without the need for insertion.

* Supporting the convergence of basic and original technology and supporting simultaneous R & D and technology commercialization, leading to rapid market entry and creation of new industry and market (creation of foundation for creation economy through science and technology)

This is a SW-based simulation method that utilizes images taken by CT (Computerized Tomography) equipment and is expected to open up a new medical image SW market in the fast growing domestic and overseas cardiac disease diagnosis market *.

* Market forecast for cardiac disease diagnosis (2013 SME Technology Roadmap, Small and Medium Business Administration): 9.7 trillion won ('12) → 13.6 trillion won ('16), 40.5 billion won ('12) → 59.7 billion won (16 dollars) , Growth of 10.2% per year

The most common cause of death is coronary artery disease, such as angina pectoris and myocardial infarction. Currently, stent-based intervention is being performed in the clinic to treat this disease.

* The cause of death in Korea (National Statistical Office, 2014): 1st place cancer (146.5 people per 100,000 people), 2nd place heart disease (52.5 people per 100,000 people), 3 cerebellar vascular disease (51.5 people per 100,000 people)

The FFR (Fractional Flow Reserve) test is used to determine whether the stent is used or not. The patient is given a drug called adenosine, The wire is inserted into the blood vessel to measure the pressure before and after the site where the stenosis has occurred.

ㅇ In this method, there is a problem of using a wire insertion method (injury to a living body) and a side effect due to a drug, and it costs about 150 ~ 2,000,000 won.

□ The medical image service (CT-FFR simulation model) using cardiovascular simulation developed by Kangwon National University is a non-invasive method for analyzing coronary artery CT images and simple physiological data (blood pressure, heart rate, etc.) FFR prediction method.

ㅇ It is a merit that the existing invasive method does not require drug administration or insertion of guide wire, so there is no pain and the cost can be greatly reduced.

ㅇ Heartflow, Inc., a leading company in the field, used the myocardial mass to calculate the peripheral resistance of the heart. However, Kangwon National University achieved a performance * that shortens the calculation time and calculation time by simply using the blood vessel length,

* Published in the June 16 issue of Pflugers Archiv-European Journal of Physiology, International SCI Journal

ㅇ We implemented a system that can analyze in 3 hours per case in a general PC, not a high-performance cluster computer used for simulation.

In addition, the project conducted clinical evaluation of the CT-FFR simulation with Ulsan University, Seoul National University, Inje University, Keimyung University, Pusan ​​National University, Kangwon National University, and the like for 189 patients and 323 blood vessels. Results * were obtained.

* Some of the clinical results are published online in the International Journal of Cardiology, June 16, 2008, the international SCI journal.

□ The project team established Silicon Sapien Co., Ltd. in 2014 for the early commercialization of research results. In June of this year, we obtained GMP (Good Manufacturing Practice) for CT-FFR service, I got it.

ㅇ Based on the technology, Silicon Sapien plans to launch commercialization of 'HeartMediTM' and 'MOU for promotion of services with Pusan ​​National University Hospital'.

□ Thanks to the support of the New Industrial Creation Project Technology Commercialization Expert Group, Shimyeongbo Project Team Manager was able to implement original technology and marketable service that surpasses the patent barriers of overseas leading companies. "If the service is applied to the medical field in earnest "I am expecting that it will contribute greatly to the benefit of the people, such as the convenient and quick diagnosis of coronary artery disease, and medical cost reduction."

o For more information, please refer to Appendix.



Future Creation Science Division

http://www.korea.kr/policy/pressReleaseView.do?newsId=156146928

Press

Prediction of coronary artery disease without drug insertion or wire insertion

[August 10, 2016]

The Kangwon National University project, which carried out the new industry creation project, developed a service that predicts coronary artery disease by computer simulation. Shim Eun-bae, a professor at Kangwon University, said on October 10 that it developed a service that predicts coronary artery disease by computer simulation without the need for drug injection or guide-wire insertion. It is a SW-based simulation method that utilizes images taken by CT (computerized tomography) equipment.

According to the National Statistical Office (KNSO) data for 2014, the second leading cause of death in Korea is heart disease, most of which are coronary artery diseases such as angina and myocardial infarction. To treat this, intervention using stent is being performed in clinical practice.

FFR (myocardial perfusion reserve) test is the clinical indicator used to determine the stenting procedure. After injecting a drug called adenosine into the patient, the heart is put into motion, and a guide wire with a pressure sensor is inserted into the blood vessel to measure the pressure before and after the site of the stenosis.

This method has the problem of using an invasive method of wire insertion and the side effects of drugs. It costs between 1.5 and 2 million won.

The medical imaging service (CT-FFR simulation model) using cardiovascular simulation developed by the project team is a non-invasive FFR prediction that analyzes coronary artery CT images and simple physiological data (blood pressure, heart rate, etc.) Method.

The advantage of the existing invasive method is that it does not require drug administration or insertion of a guide wire, which can reduce patient pain and cost. We implemented a system that can be analyzed in about 3 hours per case on a regular PC, not a high-performance cluster computer used for simulation.

The results of the CT-FFR simulation with Ulsan University, Seoul National University, Inje University, Keimyung University, Pusan ​​National University, and Kangwon National University were evaluated for the clinical usefulness of 189 patients and 323 blood vessels.

The project team founded Silicon Sapien in 2014 to promote research and commercialization. In June of this year, KFDA obtained medical device manufacturing approval for CT-FFR products and GMP (Good Manufacturing Practice) for CT-FFR service. Silicon Sapien plans to launch commercialization of 'HeartMediTM' and 'MOU for promotion of coronary artery disease prediction service' with Busan University Hospital based on the technology.



etnews Song Hye-young

http://www.etnews.com/20160810000347

Press

Development of coronary artery disease prediction service

[August 16, 2016]



Kangwon National University (Director Shim Eunbo) succeeded in developing a service to predict coronary artery disease by computer simulation. This achievement was derived through the project of creation of new industry in the future creation science department.

The developed technology is SW-based simulation method that utilizes images taken by CT (Computerized Tomography) equipment, and is expected to open up a new medical image SW market in the fast growing domestic and foreign heart disease diagnosis market.

Most of the heart diseases known as the cause of death in Korea are coronary artery diseases such as angina pectoris and myocardial infarction. Currently, stent-based intervention is performed in the clinic to treat this disease.

The FFR (Fractional Flow Reserve) test is used to determine whether a stent is used. The injected drug, adenosine, is used to move the heart into motion. A guidewire with a pressure sensor is inserted into the blood vessel The pressure is measured before and after the site where the stenosis is inserted.

This method has the problem of using an invasive method of wire insertion and the side effect due to the drug is worried, and the cost is about 150 ~ 2,000,000 won.

A medical image service (CT-FFR simulation model) using cardiovascular simulation developed by Kangwon National University is a noninvasive FFR prediction method that analyzes coronary artery CT images and simple physiological data using computer simulation technology.

The advantage of the existing invasive method is that there is no need for medication or insertion of guide wire, and there is no patient suffering and the cost can be greatly reduced.

Heartflow, the leading company in the field, calculated the heart 's peripheral resistance using myocardial mass, while the Kangwon National University team was able to shorten the computation time and calculation time by simply using the blood vessel length.

In addition, we implemented a system that can be analyzed in about three hours per case on a conventional PC, rather than a high-performance cluster computer used for simulation.

In addition, the project conducted clinical evaluation of the CT-FFR simulation with Ulsan University, Seoul National University, Inje University, Keimyung University, Pusan ​​National University, Kangwon National University, and 189 patients and 323 blood vessels. I got it.

Following the establishment of Silicon Sapien Co., Ltd. in 2014 for the early commercialization of research results, in June of this year, the company obtained GMP (Good Manufacturing Practice) for medical device manufacturing approval for CT-FFR product export and CT-FFR service from KFDA did.

Silicon Sapien plans to launch commercialization of 'HeartMediTM', 'Coronary Artery Disease Prediction Analysis Service', and MOU for service promotion with Pusan ​​National University Hospital based on the technology.

"If the service is applied to the medical field in earnest, we expect that it will contribute greatly to the improvement of the convenience of the people, such as convenient and quick diagnosis of coronary artery disease and reduction of medical expenses".





Dailymedi Youngmin Reporter

http://www.dailymedi.com/detail.php?number=809243&thread=22r06

Press

HELLO SiliconSapiens

Silicone Sapien Co., Ltd. provides CT-FFR, which presents the risk related to cardiovascular disease through CT imaging only to examinees and patients, in conjunction with health check-up centers and hospitals, as well as targeted anticancer drug simulation technology to increase efficiency in prescribing anticancer drugs. In addition, we have developed a virtual exercise load test system to provide a service that shows the risk of cardiovascular system during exercise.

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