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.
Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. has had its hopes of entering the U.S. market dashed yet again following a second decision from the FDA that Febridx has not demonstrated substantial equivalence to the predicate device identified in its 510(k) application.
Japan’s Ministry of Health, Labour and Welfare (MHLW) has given Intuitive Surgical Inc. the green light for its Da Vinci SP surgical system. The surgical system has been cleared for use in general surgeries, thoracic surgeries (excluding cardiac procedures and intercostal approaches), urologic surgeries, gynecological surgeries, and trans-oral head and neck surgeries.
Novo Nordisk A/S received marketing approval from China’s NMPA for its smart insulin pen Novopen Six that automatically collects and stores the date and time of injections and the number of units of insulin that users take.
Koutech Medical Robotics (Shanghai) Co. Ltd. reported it has raised “hundreds of millions of yuan” in a series A round to support the development of its surgical robot. The round is led by Qiming Venture Partners.
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