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MDR Approval Announcement
OSTEOSYS ONE OF THE FIRST TO RECEIVE APPROVAL FOR DXA(Dual-energy X-ray Absorptimetry) SYSTEMS UNDER THE EU MEDICAL DEVICE REGULATION (MDR) CERTIFICATION
August 22, 2024 — SEOUL, KOREA. — OSTEOSYS CO., LTD, a company that manufactures BMD(Bone Mineral Densitometer)s and related software solutions, announced today that OsteoSys is approved under the European Union (EU) Medical Device Regulation 2017/745, commonly referred to as EU MDR.
EU MDR is the European Union Medical Device Regulation 2017/745 that was released in 2017 by the European Parliament and the Council of the European Union. The intent of the EU MDR is to ensure a high standard of safety and quality for medical devices that are produced in, or supplied to, member countries of the European Union.
OsteoSys has now obtained CE marking for all DXA systems (PRIMUS, EXCELLUS, DEXXUM T QUANTUM, DEXXUM T, EXA-3000) under the EU MDR.
“OsteoSys is very proud and pleased to have received MDR certification for DXA BMD systems” said Dr. Youngbok AHN, President of OsteoSys. “EU MDR is the strictest level of European medical regulation for a medical device and represents OsteoSys’s long-standing and outstanding commitment to product quality, safety, and efficacy.”
OsteoSys continues to work diligently toward achieving EU MDR approval and certification for OsteoSys’s full portfolio of products.
About OsteoSys
OsteoSys is a leading company with an 80% share in the domestic bone density DXA device diagnosis market and is expanding its expertise to overseas markets through 150 suppliers in more than 70 countries. From 2018 to 2023, OsteoSys succeeded in winning consecutive tenders for the whole body DXA device by the Turkish Ministry of Health supplying 150 units of whole body DXA system, Primus. As of 2024, the preclinical DXA, iNSiGHT, which had been launched in overseas markets since 2019, has been installed in renowned medical and research institutes such as Harvard Joslin Diabetes Center, National Institutes of Health (NIH), MD Anderson Cancer Center, and Mayo Clinic in the U.S.A. While leading the bone density diagnosis technology not only in Korea but also in overseas markets, OsteoSys is doing the best to achieve its core value ‘better products for better life’ in the medical and research field.
For more information, visit https://osteosys.com/en/
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OsteoSys pioneers bone densitometer market for lab animals
OsteoSys pioneers bone densitometer market for lab animals
The Korean bone densitometer maker aims to overtake GE as the world’s No. 1 player
OsteoSys CEO Ahn Young-bok South Korea-based OsteoSys Corp. aims to become the world’s leading player in the bone densitometry market backed by its portfolio of high-tech bone mineral density scan machines that are used to diagnose osteoporosis as well as scanning lab animals to help researchers study body composition.
Osteoporosis is often referred to as a ‘silent killer’ because it has no distinct symptoms. There are around 1 million patients in Korea and around 200 million patients worldwide suffering from the disease. Currently, the global bone densitometers market size stands at around 1 trillion won ($845.6 million), logging an annual 4% growth rate.
Unlike the general medical device market which is dominated by global companies, Korea’s OsteoSys is one of the top three manufacturers of bone densitometry products alongside US-based General Electric and Hologic. OsteoSys currently exports its products to around 98 countries.
Founded in 2000, OsteoSys has been committed to developing bone density machines for the past two decades. The company’s Chief Executive Ahn Young-bok was working as a professor at Konkuk University when he was approached by the late Medison Chairman Lee Min-hwa to develop bone mineral density machines. Lee and Ahn had been colleagues at the country’s top science and engineering university, Korea Advanced Institute of Science and Technology (KAIST)
Together, they worked to develop and produce bone densitometers, which were all imported at the time. In 2009, OsteoSys first released its dual-energy x-ray absorptiometry (DEXA) machine which offered higher precision than the previous ultrasound method.
In 2015, the company emerged as a competitor to bigger rivals GE and Hologic when it released a whole-body DXA machine offering body composition analysis. OsteoSys’ sold its products at a lower cost, credited with helping commercialize bone mineral density machines globally.
Next year, OsteoSys will unveil a new device that minimizes the X-ray exposure time. The company is hoping to overtake its rivals with its safer and speedier scan method given that the new device will be able to analyze bone mineral density, muscle mass and fat mass all in just three minutes, an impressive development considering that existing products take over 10 minutes.
PIONEERING A FRESH MARKET
Last year, OsteoSys pioneered a new market as it became the world’s first company to mass produce a bone densitometer for lab animals.
OsteoSys’ INSIGHT, a DXA machine for lab animals Animal models are used in preclinical trials which are mandatory in the development process of vaccines, treatments and pharmaceuticals. And often, preclinical testing requires animal dissection, which can be prevented through OsteoSys’ products. Due to this, OsteoSys has been lauded for introducing an animal-friendly product that minimizes the sacrifice of lab animals.
OsteoSys’ products were also used for the National Aeronautics and Space Administration (NASA) project which measured bone mineral density and muscle mass of lab rats in space.
The company has exported its products to the Mount Sinai Hospital in New York, the University of Tokyo and New York University. OsteoSys is also set to supply its products to Harvard University and Kyoto University.
“We expect our machines to become essential in labs, pharmaceutical companies and universities,” said CEO Ahn, adding that the company aims to be the No. 1 player in the global bone densitometer market for humans as well as preclinical studies and veterinary use.
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Medimaps Group Announces Partnership With OsteoSys to Bring Trabecular Bone Score to Korea’s Leading Bone Densitometry Platform
GENEVA, November 14, 2022–(BUSINESS WIRE)–MEDIMAPS GROUP (www.medimapsgroup.com), a Swiss/Global med-tech company specializing in image processing software for assessing bone health, today announced that its novel method for enhancing osteoporotic fracture risk assessment, Trabecular Bone Score (TBS iNsight™), a surrogate of bone microarchitecture boosted by AI, is now available on diagnostic platforms from OsteoSys Co., Ltd. OsteoSys is the leading Bone Mineral Densitometer brand in Korea and the third largest supplier of DXA scanning equipment worldwide.
TBS iNsight™ is available on OsteoSys’ Primus Whole Body DXA, their high-end DXA scanning product. The agreement expands worldwide access to Medimaps’ technology to clinicians in countries throughout southeast Asia, Europe, and South America. Financial terms were not disclosed.
Medimaps has obtained a CE 2797 mark for TBS iNsight™, an FDA 510(k) clearance in the US, and it is cleared in more than 60 countries worldwide, including Japan and South Korea. TBS is also now reimbursable in the US and some European countries and is working towards reimbursement in Japan and Korea. TBS is recommended for use by many local, national, and international medical societies such as in Switzerland, France, Italy, Germany, Spain, as well as in the United States, China, and Japan.
“Bone structure is just as important as bone mineral density (BMD) when diagnosing and treating osteoporosis,” said Dr. Young-bok AHN, CEO and founder of OsteoSys. “Along with BMD, Medimaps TBS iNsight™ provides a more complete picture of patient fracture risk. We see TBS iNsight as a viable option integrated into our DXA scanners to address osteoporosis, a health concern that is growing rapidly as the worldwide population ages.”
“Our proprietary and patented technology is empowered by a deep learning multi-layer approach, which makes it applicable for a wide spectrum of image modalities and resolutions,” said Prof Didier Hans, CEO and co-founder of Medimaps Group. “TBS is demonstrating diagnostic accuracy improvement for primary and secondary osteoporosis and in both females and males, and it appears sensitive to changes over time that result from effective treatment (with TBS increasing) or continued bone loss in the absence of effective treatment (with TBS decreasing). Because it is seamlessly integrated into BMD assessment, TBS will be able to be applied in a number of clinical settings, ranging from opportunistic X-ray based screening, to patient risk profiling, and presurgical evaluations.”
Osteoporosis is a condition of primary concern among aging patient populations. Patients at risk for osteoporotic fractures often receive a BMD assessment, which only measures the quantity of bone but not the quality of bone. Medimaps Group’s TBS iNsight works alongside BMD and clinical risk factors to analyze bone micro-architecture as an assessment of bone quality. Within moments, the software application provides practitioners with an easy-to-interpret score to quickly identify and classify patients’ fracture risk and implement a course of intervention. Medimaps technology utilizes the same images acquired for BMD assessment (but also digital x-ray or projected CT images). Patients are not exposed to additional radiation, and TBS integrates seamlessly into a physician’s clinical workflow to provide a completed structured report.
About OsteoSys Co. Ltd.
Founded in 2000 and based in Seoul, South Korea, OsteoSys manufactures bone densitometer devices to treat and diagnose osteoporosis through a wide range of body and peripheral DXA scanning offerings. Learn more at https://osteosys.com/englsh/.
About Medimaps Group
Medimaps Group’s medical imaging software applications based on patented multi-purpose technology with artificial intelligence capabilities provide healthcare solutions that fit seamlessly into the workflow for the benefit of the patient. TBS iNsight™ (Osteo) has been used for years in clinical practice worldwide in the field of osteoporosis. It has become the new gold standard for bone texture assessment in routine clinical practice. TBS has gained international recognition with more than 900 peer-reviewed scientific publications and is included in many guidelines and used by more than 30,000 physicians worldwide including leading healthcare institutions. Learn more at https://www.medimapsgroup.com/.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221113005059/en/
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Call For OsteoSys Research Award(ORA 2019)
Osteosys
2019 research award1. Call for 2019 OsteoSys Research Award
As part of one of the world’s most innovative and recognizable Bone Mineral Densitometry brands, OsteoSys is committed to supporting medical researchers for technical innovation. OsteoSys Research Award Program provides funding for cutting-edge medical research and helps a collaborative relationship between faculty and OsteoSys researchers. With awards up to $3,000 per year for each selected paper, OsteoSys Research Award creates new opportunities for researchers to engage in a pioneering pursuit that will bring better technologies for better lives.
2. What is OsteoSys Research Award?
OsteoSys believes that innovative research is the key driving force to bring life to the industry. The OsteoSys Research Award provides an opportunity for university faculty, medical researchers, doctors and OsteoSys to conduct a collaborative research network. If your paper 1) is written in English, 2) is scheduled to be published in 2019 by a notable academic journal, 3) whose contents include any device manufactured by OsteoSys device (SONOST-2000, SONOST-3000, BeeTLe, EXA-3000, Presto, Dexxum T, Excellus, Primus, iNSiGHT), your paper is welcome to participate in OsteoSys Research Award. The award provides up to $3,000 in funds.
3. Submission Guidelines
Eligible Applicants:
²We accept applications from professors (full, associate, and assistant), doctors, and medical researchers from all over the world.
Co-PI(s):
²We accept applications that have a PI (Principal Investigator) and one or more co-PIs for the same proposal. However, only one award is granted to the primary PI and the primary PI’s university/institution if the proposal is selected.
4. Requirements
Target Research Topic
Please check whether your paper directly deals with OsteoSys’ device. If so, please check whether your paper is engaged with one of the target research topics as below.
² Cross-sectional study for acquiring BMD of a group of people who can represent the whole population.
² Cross-sectional study for acquiring body composition (Fat Mass, Lean Mass, Bone Mass) of a group of people who can represent the whole population.
² Comparison assessment between OsteoSys’ device and those of major competitors (GE, Hologic, DMS, etc).
² Evaluation of a device(and its application) for (pre) clinical trial of a new medication and for follow-up studies of a group of patients:
Device/Model Application/Function Possible Research Theme Primus BMD, Body Composition Analysis(Lean Mass) The relationship between bone mineral density and body composition with vertebral fragility fractures. Primus Body Composition Analysis(Lean Mass) Sarcopenia and frailty guidelines update. Primus Body Composition Analysis(Lean Mass) The relationship between t-cell responses to cytomegalovirus (cmv) and onset of frailty in HIV- and HIV+ men in the multicenter aids cohort study. Primus/Excellus Body Composition Analysis(Lean Mass) The effects a multimodal intervention in older frail/prefrail people with diabetes mellitus from a functional perspective. iNSiGHT Body Composition Analysis for a lab animal(Bone Mass, Fat Mass, Lean Mass) Phase 1 Clinical Trial for Anti-Sarcopenia/Anti-Osteoporosis/Anti-Obesity Medication. * Abovementioned research themes are presented for the purpose of suggestion only. You are welcome to dive in your own research theme.
5. Confidentiality and Intellectual Property Rights
Confidentiality
Authors or universities/institutions must ensure that no confidential or proprietary information is included in submitted papers. OsteoSys will treat all information submitted in proposals as non-confidential and non-proprietary.
Intellectual Property (IP) Rights
OsteoSys requires the right to utilize the results of the research that it sponsors.
6. Submission
Submission Protocol
Submission of a paper must be done through the online submission form (Click below to open the on-line application page)
https://goo.gl/forms/PVV8VUH5mjMPK1wv2
Submissions by email will not be accepted. Submitters will receive a confirmation email once they complete the online submission form and process.
Deadline
Submission must be completed by 11:59 pm PDT on October 15, 2019.
Required Information for the Online Submission Form
The following information will be required in order to complete the online submission form for each Paper submitted.
² Paper information: Written Proof for Paper’s publication in 2019, 1-page summary, Script of the Paper.
² PI’s Information; Full name, Nationality, Email address, Mobile number, Position and Name of Institution/Hospital/University.
7. Award Candidates
Funding
Award will be available only after you have agreed to the terms of confidentiality and intellectual property rights presented above. If you cannot agree on the term, do not apply for the award. The fund can be granted up to $ 3,000 and the amount of grant for each accepted paper will be settled by OsteoSys Research Award Review Committee based on their in-depth evaluation.
8. Inquiry
Inquiries Related to the 2019 OsteoSys Research Award Program
Please send an email to the Research Award Program Administration Office at (wooseeam@osteosys.com) if you have a question regarding the 2019 OsteoSys Research Award Program. The Research Award Program Administration Office is the only resource that can officially answer your question(s).
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Africa Health 2017, June 6~9th in Johannesburg, South Africa)
I.H. Kim, the deputy general manager of overseas division, participated in 2017 African Health from June 6~9th, in Johannesburg, South Africa.
It was meangful time for OsteoSys to get connected to our new distributor in Zambia, Onyx Techologies, and its president John. Welcome to OsteoSys, Zambia!
