The U.S. FDA has granted Datar Cancer Genetics Inc. a breakthrough device designation for Trinetra-Glio, a blood test to help in the diagnosis of brain tumors.
Skynor Medical (Shanghai) Co. Ltd. has raised ¥100 million (US$15 million) in a financing round to step up its efforts in product development and market expansion. More specifically, the Shanghai-based company intends to use the funds to develop its interventional treatment solutions for neuro and peripheral vascular diseases, as well as expand them to markets at home and abroad.
China has adjusted the tariff lines and rates for 37 medical devices, including surgical robots, in its newly released Import and export tax rules of the PRC (2023).
Sonoscape Medical Corp. obtained marketing approval in China for its intravascular ultrasound (IVUS) diagnostic device and intravascular ultrasound diagnostic catheter.
Zylox-Tonbridge Medical Technology Co. Ltd. has obtained marketing approval for its retrievable inferior vena cava (IVC) filter Zylox Octoplus in China. “Zylox Octoplus is approved for the prevention of pulmonary embolism (PE) and deep vein thrombosis (DVT) in the peripheral vasculature,” a spokesperson at Zylox-Tonbridge told BioWorld. The approval is based on a multi-center, randomized and positive control clinical trial in China. The trial was conducted in nine peripheral vascular intervention centers in China.
Perception Vision Medical Technologies Co. Ltd. (Pvmed) raised around $14 million in a series A financing round, to further develop artificial intelligence (AI) cancer treatment solutions for the two major tumor treatment methods, radiotherapy, and surgery.
Seekin Inc.’s cancer mutation detection kit Pancanseek for leukemia patients has received a CE-IVD mark, expanding the company’s reach in the testing space.
Prenetics Global Ltd. agreed to acquire a majority stake in Act Genomics Holdings Co. Ltd. as part of a move to target the precision oncology market. Prenetics will issue 19.9 million class A ordinary shares and pay $20 million in cash to complete the acquisition.
Medical technology company Synchron Inc. completed an AU$110 million (US$73.9 million) series C round that will allow the company to conduct a feasibility study and pivotal trial of its implantable brain computer interface that can interpret and stimulate parts of the brain.
Gaush Meditech Ltd. raised HK$672 million (US$86.4 million) on a Hong Kong Stock Exchange listing. The company plans to use 38.2% of the funds to improve its research and development capability and speed up the commercialization of its patents in two years.
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