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BioWorld - Sunday, January 4, 2026
Home » Topics » Asia-Pacific, BioWorld MedTech

Asia-Pacific, BioWorld MedTech
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Device in heart

UK’s NICE wary of routine use of Ozaki procedure for aortic valve reconstruction

Aug. 14, 2023
By Mark McCarty
Transcatheter aortic valve replacement (TAVR) devices are all the rage for treatment of aortic valve disease, but that doesn’t mean valve reconstruction via the so-called Ozaki procedure has been consigned to the pages of medical history. The U.K.’s National Institute for Health and Care Excellence has recommended that trusts in the U.K. health system use this procedure only in clinical trials at least for the time being, although the agency noted that the Ozaki procedure allows the patient to sidestep the need for long-term antithrombotic therapy, a big selling point for patients and clinicians alike.
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Photomicrograph of hepatocellular carcinoma

China approves world’s first methylation test for liver cancer

Aug. 9, 2023
By Doris Yu
Laboratory for Advanced Medicine & Health Group (LAMH)’s subsidiary Guangzhou Youze Biotechnology Co. Ltd. received marketing approval in China for its methylation test, which the company says is the first methylation test kit for liver cancer on the market in the world.
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Mirxes stomach cancer blood test Gastroclear

Mirxes raises $50M in series D round for cancer early detection

Aug. 7, 2023
By Doris Yu
Mirxes Holding Company Ltd. raised $50 million in a series D funding round to expand its cancer early detection blood tests, including its lead product stomach cancer blood test Gastroclear, in the Asia Pacific region. Mirxes uses RNA technology to develop diagnostic solutions for the early detection of diseases.
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Genesis Medtech's Artisential aparoscopic surgical device

Genesis has promising start in China with laparoscopic surgical device clearance

Aug. 3, 2023
By Doris Yu
Genesis Medtech Group received marketing approval from China’s National Medical Products Administration for its laparoscopic surgical device called Artisential, which helps surgeons in precision surgery. The approval not only adds another market in which the device is available but will allow Genesis to expand its reach in China.
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3D illustration of thyroid in human body with parathyroid glands highlighted

Baird Medical’s microwave ablation needle approved for thyroid nodules

July 31, 2023
By Doris Yu
Baird Medical Investment Holdings Ltd.’s disposable microwave ablation (MWA) needle was approved by China’s National Medical Products Administration for treatment of benign thyroid nodules, which will help the company build a portfolio of products for thyroid diseases.
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Abstract molecules illustration

Advanced wearable patch sensor detects dopamine and glucose in Sweat

July 28, 2023
By Bernard Banga
Researchers from the University of Shanghai for Science and Technology have developed an electrotechnical patch, printed on a wearable substrate, capable of detecting dopamine and glucose levels in real-time. They published their work in Analytica.
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Surgeons using Tirobot Recon to conduct total knee replacement

Tinavi’s surgical robot is approved for knee replacement in China

July 27, 2023
By Doris Yu
Beijing Tinavi Medical Technologies Co. Ltd.’s surgical robot received approval from China’s National Medical Products Administration (NMPA) for total knee replacement, expanding its product portfolio to cover spine, trauma and joints in orthopedic surgery. The new product, named Tirobot Recon, provides support for surgeons in total knee arthroplasty.
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TGA revisits framework for audits for devices entering Australian market

July 26, 2023
By Mark McCarty
Australia’s Therapeutic Goods Administration (TGA) has issued a regulatory proposal regarding the agency’s approach to audits for devices, a proposal that might reduce the number of these audits. TGA said it may limit audits to the highest-risk devices and may eliminate them for devices that have been granted market access in other regulatory jurisdictions.
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Flag of Australia, sky background

TGA eyes revamp of regulations for devices with biological tissues

July 24, 2023
By Mark McCarty
Australia’s Therapeutic Goods Administration (TGA) is reconsidering its approach to regulating devices that bear materials of animal, microbial or recombinant origin, a broad class of products that includes transcatheter aortic valve replacement (TAVR) devices.
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Mediwhale utilizes AI and retinal scans to develop precise non-invasive test for CKD risk

July 24, 2023
By Bernard Banga
Mediwhale Inc. and Yonsei University College of Medicine, Seoul, Republic of Korea, are developing a new predicting tool combining artificial intelligence (AI) and non-invasive retinal eye examination capable of accurately predicting chronic kidney diseases before symptoms appears.
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