OOOPDS – a surgical planning software received TFDA Class-II medical device certification developed by Taiwan Main Orthopaedic Biotechnology Co., Ltd.


OOOPDS – a surgical planning software received TFDA Class-II medical device certification developed by Taiwan Main Orthopaedic Biotechnology Co., Ltd.
OOOPDS medical used surgical planning software received TFDA Class II

Taiwan Main Orthopaedic Biotechnology announced today (12) that their OOOPDS 3D medical image reconstruction and surgical planning medical software has received TFDA Class-II certification. OOOPDS is the most comprehensive 3D surgical planning software in Taiwan. It is easy to combine medical-grade 3D printers. The next step is to submit for the USFDA to enter the US and worldwide 3D medical printing markets.

In recent years, 3D printing technology has gradually matured and has been applied in various related medical fields such as orthopedics, spine, dentistry, etc. However, the certified 3D medical imaging surgical planning is the key point that the printed 3D materials transfer into actual medical products. There is very few software like OOOPDS that offered easy-to-use functions the support not only the ultrafast conversion of DICOM into accurate 3D objects but also the one-touch segmentation for the surgical planning to simulate the surgical outcome. It is compatible to connect with 3D printers to print medical implants including metallic materials. 

Patient-specific implants using 3D printers have proved their advantages in many research papers in recent decades. Using the patient’s CT and MRI scans to convert into doctors’ surgical plans and through 3D printing to generate custom implants is the best solution for implants. The main part is a key certificated medical software for the applications. OOOPDS is now ready to go into the market with TFDA in Taiwan. For more information, please refer to our official website on www.surglasses.com.

The CEO Wang Min-Liang said Taiwan Main Orthopaedic Biotechnology is well-known innovative medical device company that developed the world’s first smart surgical glasses with Augmented Reality technology. Our smart surgical glasses products obtained the CE mark, and the product has been deployed in the UK, Europe, the Middle East, India, Russia, and other regions. The company is very innovative when it comes to medical software and algorithms. The OOOPDS software is one of our key projects while the company startup. We are very happy to announce the TFDA certification for OOOPDS and we welcome any kind of cooperation.

Keywords: 3D medical software, 3D orthopedics printing, 3D printing medical, medical 3D reconstruction

SOURCE Taiwan Main Orthopaedic Biotechnology Co., Ltd.

Ties up with Thai mega-star Ms. Araya ‘Chompoo’ A. Hargate to introduce health benefits of curcumin to Thai consumers

Targets sale of 1,000,000 bottles a month during 2021

Four months after its launch in Thailand, an innovative health drink fortified with curcumin extracted from the turmeric plant’s rootstalks, has found its way on to the shelves of more than 15,000 modern trade retail outlets and almost 500,000 mom and pop stores, nationwide, offering liver function and other benefits attributed to curcumin.

OOOPDS – a surgical planning software received TFDA Class-II medical device certification developed by Taiwan Main Orthopaedic Biotechnology Co., Ltd.
New Thai health drink ‘QminC’ surges during COVID-19 pandemic. Ties up with Thai mega-star Ms. Araya ‘Chompoo’ A. Hargate to introduce health benefits of curcumin to Thai consumers

Branded as ‘QminC’, the preservative-free health drink has a pleasant flavour and is sold in 150 ml glass bottles with a retail price of Baht 25 (approximately US$ 0.83) per bottle.

Mr. Thanthit Yuenyongtechahiran, President of Tera Food and Beverage Company Limited, the producer and marketer of QminC health drink, said, “We’ve introduced to Thailand an innovative health drink that is both tasty and has important functional attributes, and with the key ingredients imported from Japan. It has proven exceptionally popular at this time when people are particularly concerned about their health and immunity as a result of the COVID-19 pandemic.”

He said that, during 2021, the company expects to sell “close to a million bottles a month” of the health drink, which also contains nano-liposomal natural curcumin extracts (using proprietary technology from Japan), L-Glutathione, 20% lemon juice, as well as vitamins B6, B12 and C.

Ms. Araya ‘Chompoo’ A. Hargate, one of Thailand’s highest-ranked ‘A-list’ celebrity actresses, has been enrolled as a product ambassador to present the yellow-coloured drink. The mother of two children commands some of the country’s highest endorsement fees and is known for her healthy lifestyle. She has dominated the A-list celebrity rankings in Thailand for almost twenty years and boasts an Instagram account with more than 10 million followers.

Billboard, television, and digital advertising for the drink has blanketed Bangkok as well as towns and cities across Thailand’s 77 provinces.

QminC is being retailed at more than 2,100 branches of Tesco Lotus hypermarkets and supermarkets, and at over 10,000 branches of 7-Eleven (Thailand’s leading convenience store chain), as well as at other outlets.  The modern trade accounts for around 60% of Thailand’s grocery sales, or around US$ 50 billion.

SOURCE QminC

Cost effective option compared with existing diagnostic tools expected to contribute immensely in early diagnosis of gastric cancer

After eight years of discovery research, product development and clinical validation involving 5,248 subjects from Singapore and South Korea, a team of clinicians and scientists from Singapore has developed a non-invasive blood-based diagnostic test for gastric cancer (also known as stomach cancer). The test can potentially be used as a cost effective screening test for the early detection of gastric cancer.

OOOPDS – a surgical planning software received TFDA Class-II medical device certification developed by Taiwan Main Orthopaedic Biotechnology Co., Ltd.
Members of the team involved in the development of a non-invasive blood-based test for gastric cancer (from right): Professor Jimmy So, Head and Senior Consultant with the NUH Division of General Surgery (Upper Gastrointestinal Surgery), Dr Calvin Koh, Consultant with the NUH Division of Gastroenterology and Hepatology and Dr Zhou Lihan, Co-founder & CEO of MiRXES. (PRNewsfoto/National University Health System (NUHS))

Gastric cancer is the third leading cause of cancer deaths worldwide according to World Health Organization (WHO) statistics. In Singapore, it is the fifth and sixth cause of cancer deaths in males and females respectively, causing approximately 300 deaths every year. Gastric cancer mortality is high due to late presentation. Endoscopy is currently the standard diagnostic test for gastric cancer. However, it is perceived as invasive and expensive, hence many patients are reluctant to undergo endoscopy even if they have gastric symptoms.

Led by Professor Jimmy So, Head and Senior Consultant with the National University Hospital’s (NUH) Division of General Surgery (Upper Gastrointestinal Surgery), Professor Yeoh Khay Guan, Senior Consultant with the NUH Division of Gastroenterology and Hepatology, and Associate Professor Too Heng-Phon from the National University of Singapore Yong Loo Lin School of Medicine’s Department of Biochemistry, the team included clinicians and scientists from the National University Health System (NUHS),the Bioprocessing Technology Institute (BTI) of the Agency for Science, Technology and Research (A*STAR), national platform Diagnostics Development (DxD) Hub, and MiRXES Pte Ltd, a Singapore headquartered molecular diagnostic company which was spunoff from A*STAR’s BTI.

The team started this project in 2012 by first examining 578 microRNA[1] candidates in 682 patients. They discovered a panel of 12-microRNA biomarkers that can differentiate gastric cancer patients from normal patients with an accuracy over 92%. Based on this panel of 12-microRNA biomarkers, the team created a clinical assay (or test kit) which was manufactured to clinical standards. From year 2013 to 2018, the team validated this blood panel in a multicentre cohort involving more than 5,000 subjects from Singapore[2], making this study the most extensive evaluation of circulating microRNAs as biomarkers for gastric cancer detection to date worldwide.

“The majority of gastric cancer patients are diagnosed at advanced stages, for which the five-year survival rate is lower than 5%. Early detection is thus the key to reducing death from gastric cancer. To bring about a meaningful fall in the gastric cancer mortality rate, an effective strategy that would detect gastric cancer early so as to enable prompt intervention is required. This non-invasive blood test is a breakthrough in gastric cancer diagnosis and it may potentially be used as an effective screening test for the early diagnosis of gastric cancer,” explained Professor So, who is also the Head and Senior Consultant with the Division of Surgical Oncology, National University Cancer Institute, Singapore.

Outperforms conventional blood-based biomarkers

The performance of this test was confirmed with endoscopies and biopsies and was shown to detect gastric cancer with high sensitivity across age groups, genders, ethnicities and tumour stages. The test is able to detect 87% of all gastric cancers, including 87.5% of patients with stage I cancers.

In addition, the results showed that this blood-based test was more accurate than any of the existing conventional blood-based biomarker tests for gastric cancer detection. The findings were published in Gut, a leading international medical journal in October 2020[3].

Cost-effective risk assessment tool for gastric cancer before endoscopy

Based on a cost-effectiveness analysis to explore the economic and health impact of using the test in a hypothetical national screening programme in Singapore, the team has found that it may be a cost-effective screening tool for gastric cancer in high-risk groups[4] as it costs much less[5] than endoscopy.

This test thus provides an alternative solution for those who would like a better understanding of their risk of contracting gastric cancer in evaluating their need for endoscopy. Results from this test would help to identify patients who are at high risk of stomach cancer to undergo endoscopy, thereby reducing the reliance on endoscopy[6].

“With further health technology assessment to demonstrate the effectiveness of this assay as a screening tool in the Singapore population, we are hopeful that the assay will be implemented as a screening test for gastric cancer when used in combination with follow-up endoscopy for high-risk patients,” shared Professor So.

Associate Professor Too however emphasised that, “The test does not replace endoscopic evaluation. We believe this assay provides an option for patients who might not be keen on initial endoscopic screening and adds to the current cancer detection tool armamentarium, just as the stool DNA test is an option for colon cancer screening. Furthermore, the convenience and non-invasiveness of this test allows the public to have access to better health-care.”

Future plans

The research team is planning to evaluate the feasibility of utilising this test in the primary care setting to identify people who are at risk of contracting stomach cancer. Additionally, further research on improving the usability of test kit is also currently underway.

This non-invasive blood-based assay was co-developed with MiRXES Pte Ltd and the DxD Hub, which led the assay optimisation, analytical verification and clinical validation of the product. The assay has been commercialised as GASTROClear™ and has successfully attained European CE mark[7] in 2017 and gained the Health Sciences Authority’s approval in 2019. MiRXES is also conducting local clinical studies to seek regulatory approval of GASTROClear™ in China and Japan, which have the highest numbers of new stomach cancer cases per year globally. The test takes about three hours to run in a clinical lab and the test report can be delivered to the patient’s doctor within a week.

The research was supported by Singapore Ministry of Health’s National Medical Research Council under its Bedside & Bench grant (NMRC/ BnB/0014b/2014), the Translational and Clinical Research grant (TCR/009-NUHS/2013), and the Technology Development Grants from A*STAR. The study was supported by the Singapore Gastric Cancer Consortium (SGCC), a national translational research group comprising clinicians and scientists working in stomach cancer research from academic medical centres, universities, hospitals and research institutes across Singapore.

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