JLK Inspection, a company specializing in world-class AI-based medical imaging solutions and a company of the Born2Global Centre, has developed JPC-01K, an AI-based prostate MR image analysis solution, and JBS-01K, which is used for quantitative analysis of brain MR images, and recently obtained European CE certification for such products, in accordance with the European Medical Device Directive (MDD).
“JBS-01K” AI-based automatic analysis of stroke using MR images (left) and “JPC-01K” AI-based automatic analysis of prostate using MR Images (right)
The CE MDD, a certification process that assesses quality, efficacy, effectiveness, durability, and safety, as suggested by the European Union, is essential for companies seeking to enter the European market and can be obtained only if highly strict requirements are met.
A representative of JLK Inspection explained, "It is noteworthy that our solutions have been acknowledged as products that meet world-class quality standards."
Having satisfied an international quality standard that encompasses all of Europe, JLK Inspection is now planning to enter the global market as soon as possible.
Meanwhile, last year, JLK Inspection released AIHuB, an all-in-one medical platform comprising 37 medical solutions, including JPC-01K and JBS-01K.
AIHuB is capable of detecting and monitoring 37 medical conditions in 14 different regions of the body. It can also conduct analysis based on multimodal images, including MRI, CT, X-ray, and mammogram images, using an AI-enabled technology that encompasses a wide variety of techniques for diagnosing illnesses, such as stroke, Alzheimer's, and cancer.
Having released AIHuB, JLK Inspection's action plan to enter the global market includes active participation in several leading international exhibitions and conferences, including RSNA (Radiological Society of North America) 2019, ECR (European Congress of Radiology) 2019, and CES (Consumer Electronics Show) 2020.
Now that it has received CE certification, JLK Inspection is expected to make preparations to engage in aggressive overseas marketing. A representative of the company stated, "Starting with CE certification, we are planning to obtain FDA approval and expand our market to the United States in the foreseeable future."
This month JLK Inspection, a member company of the K-ICT Born2Global Centre, will participate in the Radiological Society of North America (RSNA) 2018 in Chicago, presenting its latest AI-based medical image diagnosis system.
The South Korean startup's technology assists medical practitioners with detecting and monitoring more than 30 medical conditions, including strokes, Alzheimer's, prostate cancer, lung cancer thyroids cancer, breast cancer, and joint disease. JLK's AI-enabled image analysis include those conducted in MRI, CT, X-ray and mammography format, with its technology casting a wide net over various diagnostic techniques.
"We look forward to demonstrating our medical imaging system at RSNA," JLK Inspection CEO Won Tae Kim says. "We are excited to show how we are able to assist users with quantitative analysis of their medical images at their own convenience."
These include neural network solvers and libraries with an on-site AI platform providing a real time, seamless connection through a user-friendly interface. This also means the JLK system is stable and interlocks with all other in-hospital systems. They also provide state-of-the-art multi-contrast MRI and multi-modality images.
Not only are JLK's products simple to use, but they provide objectivity of medical care based on quantitative AI analysis in a streamlined, easy-to-analyze format. For this, JLK Inspection has also developed an AI medical all-in-one platform called AI HUB.
This month, JLK will debut the JBS-01K at RSNA 2018 which already received approval from the Korean FDA as a class III device. The system analyzes brain MRI images and clinical information to detect and present results of ischemic stroke diagnosis for users. The company's newest medical solution for stroke diagnosis is already in the process of gaining FDA and CE approvals in the U.S. and Europe, respectively.
As a multi-diagnosis solution, the JPC-01K also aims at detecting and diagnosing prostate cancer by automatically detecting the exact location of the cancer, then providing the user with a rapid response and prompt diagnosis. Furthermore, the JPC-01K will also give medical professionals the ability to perform an MR-targeted biopsy while helping reduce risks such as injection, pain, etc.
As a testament to its goals and efforts, JLK has raised over US$17 million in VC funding to date. The company has also worked hard to ensure numerous patents for their technology have been registered.
The imaging solutions company is planning on going public in the near future, with a set IPO on the KOSDAQ in the second half of 2019. Part of JLK's current global operations include marketing offices in Silicon Valley and R&D and manufacturing facilities in Seoul, South Korea.
Along with heading to RSNA this month, taking place from November 25-30, JLK Inspection will also be present at the International Security Expo (ISE) in London, UKfrom November 28-29. The company will be attending the conference on behalf of their imaging technology JSS-01K, a security solution that detects storage devices (USB, smartphone, external hdd, and tablet pcs) in security x-ray images.
JLK Inspection (CEO Wontae Kim), a member company of the K-ICT Born2Global Centre, announced that its ischemic stroke diagnosis-supporting software JBS-01K has been first approved by the Ministry of Food and Drug Safety (MFDS) of South Korea as an AI-based class III computer-aided diagnosis system.
Caused by a blood clot in patients' brain, ischemic stroke leads them to aftereffects and reduced performance in exercise ability. As South Korea has become an aged society, it is expected that the number of ischemic stroke patients will increase rapidly. Ischemic stroke has different treatments and prognosis by its occurrence subtypes, thus it is crucial to identify the stroke subtype. To analyze brain MR images of patients enables exact stroke subtype classification, quick and appropriate treatments, and a better prognosis.
JBS-01K is developed by JLK Inspection's own AI technology. It is an AI-based medical image diagnosis-supporting system which assists medical specialists in diagnosing the cause of ischemic stroke more than detecting brain lesions. When brain MR images and atrial fibrillation presence of patients are entered into JBS-01K, this software shows the probability of four ischemic stroke subtypes to support the physicians and their diagnosis.
The MFDS of South Korea uses a four-class classification of medical devices by their intended use and potential hazard to human. More specifically, an AI-based medical device is classified according to how the device shows the diagnosis results. 'Computer aided diagnosis software,' which analyzes medical images and automatically shows the probability of presence, severity, or condition of the diseases, is classified as class III, while class II includes 'analyzer, medical image, software' and 'computer aided detection system' which shows the area of medical images.
JBS-01K is currently the only medical device classified as 'computer aided diagnosis software' (A26430.14) and approved by the MFDS through a large-scale and multi-center clinical trial for safeness and effectiveness.
In 2017, the first investigation application of AI-based medical device in class III for JBS-01K was approved by the MFDS. The multi-center clinical trial was conducted for five months at Dongguk University Ilsan Hospital and Seoul National University Bundang Hospital, and it used the medical data of 1,089 subjects, which was a large-scale clinical trial the world had never seen before regarding AI-based medical device.
The clinical trial was conducted to compare neurologists and JBS-01K independently in terms of the diagnosis results of ischemic stroke subtypes. Assuming JBS-01K as the medical specialist level, an evaluation of the results to check the agreement between JBS-01K and neurologists did prove that performance of the AI-based software is as high as the level of medical specialists according to the multi-center clinical trial with 1,089 subjects.
Made by using big data of brain MR images and clinical information together with the team of neurology professor Dong-Eog Kim of Dongguk University Ilsan Hospital, JBS-01K can provide a data-based quantitative analysis of ischemic stroke subtypes and help the physicians to give patients personalized diagnoses and proper treatments. The use of JBS-01K is expected to improve the prognosis and the life of each patient and reduce the social cost of a nation. In the case of South Korea, the number of MRI units per each million people is 26.3, which ranks fourth according to the OECD data in 2015. This is why JBS-01K is expected to be widely used in not only big hospitals but many medical institutions with MRI units in South Korea.
Meanwhile, JLK Inspection has applied for FDA Approval Submission for JBS-01K and is looking for various ways to enter the overseas market such as China and Europe with its international partners.
In addition to JBS-01K, JLK Inspection has built CT-based and MRI-based solutions which cover the whole range of hyperacute and acute cerebrovascular diseases. An AI-based dementia diagnosis platform is currently in development and it will be released in the market to treat the patients as soon as possible. JLK Inspection becomes a global leader in the medical industry with their own AI technology development to save people against varied diseases professionally.
For more detailed information on JLK INSPECTION, visit www.jlk-inspection.com
JLK Inspection (JLK), the Seoul-based deep learning and artificial intelligence company, announced that after extensive research and development, it has achieved a major milestone in the development of a technology for assisting in the diagnosis of ischemic strokes, which can provide key information to determine treatment. JLK is a member company of the K-ICT Born2Global Centre.
JLK Inspection recently completed clinical trials for its AI-based stroke diagnosis platform,
which is designed to assist doctors in quickly classifying the cause of a stroke.
When a patient comes to the hospital with a suspected stroke, the very first step doctors need to tackle is to determine what kind of stroke they are seeing: is there bleeding in the brain or a blockage that prevents blood flowing to the brain? Most cases are identified as ischemic strokes, which occurs when a blood vessel is blocked by a clot, obstructing the blood flow in the brain. Treatment of ischemic strokes starts with classifying the cause of the stroke, which is not only difficult task but also carries the risk of causing serious damage or even death to the patient if the stroke's cause is misclassified by thephysician.
Approximately one in six people are at risk of suffering from a stroke, but it is a predicable condition which can be cured with appropriate treatment following proper diagnosis,which is highly dependent on analysis of image data. According to Wontae Kim, CEO of JLK Inspection, this is why the company chose to specialize in this area.
JLK recently completed clinical trials for its AI-based stroke diagnosis platform, which is designed to assist doctors in quickly classifying the cause of a stroke. According to Kim, "It is inspiring in that, JLK Inspection has a platform for CT-based hemorrhagic stroke detection as well as for MRI-based ischemic stroke diagnosis at a time when its peers areonly working in the hemorrhagic stroke detection area." He also added that "fast diagnosis using our solution is essential in treating strokes, helping provide more time for faster treatment, while potentially saving lives and millions in medical expenses."
JLK utilizes artificial intelligence and deep learning technologies to analyze MRI images of stroke patients to help classify the cause of a stroke. To train the AI platform, JLK has secured billions of pieces of data from millions of cases via collaborations with hospitals in Korea, including Seoul National University Hospital and Dongkuk University Hospital. JLK's experts are working with these institutions to help train the software to analyze the provided data correctly.
It is expected that JLK technology will assist physicians in classifying strokes more quickly, leading to faster and more-precise decision-making for the patient while working as a virtual "skilled assistant" to help physicians assess medical images as accurately as possible.
For more detailed information on JLK INSPECTION, visit www.jlk-inspection.com