The Taiwan Bone King's OOOPDS 3D Reconstruction and Surgical Planning Medical Software has obtained TFDA (Taiwan Food and Drug Administration) medical device certification.

The Taiwan Bone King's OOOPDS 3D Reconstruction and Surgical Planning Medical Software has obtained TFDA (Taiwan Food and Drug Administration) medical device certification.

Taipei, Taiwan, April 12, 2021 /PRNewswire/ — SURGLASSES announced today that its "OOOPDS 3D Reconstruction and Surgical Planning Medical Software" has recently obtained certification from Taiwan's Ministry of Health and Welfare TFDA (Taiwan Food and Drug Administration) and is qualified for product launch. It has become the most comprehensive 3D medical surgical planning software domestically. The next step for Taiwan Bone King is to apply for FDA certification in the United States, aiming to enter the global market for 3D printed medical materials.

SURGLASSES's OOOPDS has obtained TFDA CLASS II certification as a medical surgical planning software.

SURGLASSES announced today that its "OOOPDS 3D Reconstruction and Surgical Planning Medical Software" recently passed certification from Taiwan's Ministry of Health and Welfare TFDA (Taiwan Food and Drug Administration) and is now qualified for product launch.

In recent years, international 3D printing technology has gradually matured and been applied in various medical fields, including orthopedics, spine, and dentistry. However, due to limited regulatory support, the availability of 3D surgical planning medical software that supports 3D printing remains relatively scarce. The primary reasons include the difficulty and time-consuming nature of developing medical software, as well as insufficient regulatory knowledge. As many of us understand, utilizing 3D printing to convert files from computed tomography (CT) and magnetic resonance imaging (MRI) scans into surgical plans, and even designing reference models and implants, creates customized implants directly tailored to patients' needs. This approach is considered the optimal solution as it is both economical and efficient. It significantly reduces surgical time, enhances patient satisfaction, and accelerates patient recovery. For more information, please visit the SURGLASSES official website at www.surglasses.com.

CEO Wang Minliang stated that SURGLASSES is renowned for developing the world's first smart surgical glasses. Currently, these smart surgical glasses have obtained CE certification from the European Union, and the product has been deployed in regions including the United Kingdom, Europe, the Middle East, India, and Russia. However, Wang emphasized that SURGLASSES‘s innovative research and development stem from its complete mastery of medical software. After extensive patent layouts, various products are currently undergoing certification processes in different countries.


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