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Home » Authors » Doris Yu

Articles by Doris Yu

Magassist wins FDA breakthrough nod for ventricular assist device

Sep. 1, 2023
By Doris Yu
Magassist Co. Ltd. has been granted a breakthrough device designation by the U.S. FDA for its interventional ventricular assist device (VAD), which is expected to accelerate the development and approval of the product.
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China in red on globe

China issues draft rules to enhance device classification and ensure quality and safety

Aug. 28, 2023
By Doris Yu
Two new sets of draft guidelines in China aim to strengthen and streamline registration systems while clearly spelling out additional rules for device makers to ensure quality management and controls, including strengthening controls over any outsourced manufacturing and calling of makers of implantable devices to manufacture in house.
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Digital brain and silhouette

Brainaurora files for Hong Kong IPO to develop digital therapeutics

Aug. 22, 2023
By Doris Yu
Brainaurora Medical Technology Ltd. has filed for an initial public offering (IPO) in Hong Kong to develop its digital therapeutics for the treatment of cognitive impairment diseases. The company claims to be the first in China to launch a digital therapeutics (DTx) product for cognitive impairment, as well as the largest company in China in terms of revenue from the commercialization of cognitive impairment DTx products in 2022.
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Lung cancer illustration

Broncus achieves positive data from study of radiofrequency ablation for lung cancer

Aug. 16, 2023
By Doris Yu
Broncus Holding Corp. successfully completed a clinical study of the world’s first transbronchial radiofrequency ablation system for lung cancer treatment.
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Peijia Taurustrio transcatheter aerotic valve replacement system

Peijia admits first patient in trial of Taurustrio TAVR system

Aug. 15, 2023
By Doris Yu
Peijia Medical Co. Ltd. reported the implant of its Taurustrio transcatheter aortic valve replacement (TAVR) system in a first patient as part of a multi-center trial getting one step closer to launching the first TAVR system for aortic regurgitation (AR) in China.
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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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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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