Tianjin Usights Ophthalmology Technology Co. Ltd.’s ophthalmic fiberoptic microcatheter system has been approved by the NMPA for marketing for minimally invasive glaucoma surgery (MIGS) in China. Tianjin, China-based Usights claims this is the first homegrown products for MIGS in China that has been approved.
Rainmed Medical Ltd.'s coronary angiography-derived fractional flow reserve system (caFFR system) was approved by Australia’s TGA for precision diagnosis of coronary artery diseases.
Sino Medical Sciences Technology Inc. received marketing approval from China’s NMPA for its drug eluting stent system to improve vascular stenosis in patients with localized ischemic heart disease. The product is designed to improve the speed of wound healing and accelerate the recovery of vascular endothelium after stent implantation. It fits vessels with a diameter of 2.25 mm to 4.00 mm and a lesion length of less than or equal to 40 mm.
Aim Biotech Pte. Ltd. has launched a lab tool that can closely model human disease. The organic system can add vascularization and immune competence to organoids, spheroids and tumor biopsies. This allows for the creation of a more defined and tunable microenvironment that more closely emulates the complexity of human physiology.
Shenzhen Proxinse Medical Technology Co. Ltd. raised an undisclosed amount in a series A financing to develop endoscope-related products. This round of financing was led by Guangdong Technology Financial Group Co. Ltd.
Pharus Diagnostics Inc. emerged from stealth mode to streamline precision medicine-based cancer screening with its new multi-cancer early detection liquid biopsy test. Spun out from Hsinchu, Taiwan-based Quark Biosciences Taiwan Inc. in July 2022, Pharus is developing solutions to detect cancer early via Oncosweep, its multi-cancer early detection (MCED) liquid biopsy test that evaluates microRNA (miRNA) within the body.
Jenscare Scientific Co. Ltd. has raised HK$225 million (US$29 million) in an initial public offering on the Stock Exchange of Hong Kong. Its shares opened at HK$28 per share, increased by over 9% in the middle of the day and closed at HK$28.25 on the first trading day of Oct. 10.
Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination products may not fit within existing definitions for drugs, biologicals or medical devices.
Guangdong Pulse Medical Technology Co. Ltd. received marketing approval from China’s NMPA for its left atrial appendage (LAA) closure product called the Leftear occluder system.
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