PERTH, Australia – Medical device stakeholders generally opposed the Therapeutic Goods Administration’s (TGA) proposal to refine regulation of devices that consist of substances introduced into the human body via a body orifice or applied to the skin. The agency received 45 comments, 17 of which came from medical device manufacturers or associations representing device manufacturers or sponsors, and most of those comments did not support the proposal to refine the regulations.

Peking Jabrehoo Med Tech Co. Ltd.’s genetic testing kit won marketing approval from China’s NMPA. It is the first preimplantation genetic testing for aneuploidy (PGT-A) that uses the reversible termination sequencing method in China, according to the company.

A successful fundraising round by a Chinese surgical robot developer last week underscored the potentially fast growth of a sector that remains underdeveloped in China. Chinese surgical robot company Edge Medical Robotics Co. Ltd. raised $200 million in a series C round, and plans to use the funds for the commercialization of its core products.

Beijing Airdoc Technology Co. Ltd. raised HK$1.67 billion (US$214.8 million) with its IPO on the Hong Kong Exchange (HKEX) on Nov. 5, falling below its expectations of a $500 million raise. Share prices for the artificial intelligence-based (AI) medical imaging firm were priced at HK$75.10 apiece and dropped 3.5% to HK$72.50.

Fapon Biotech Inc. expanded its presence in the global next-generation sequencing (NGS) market by acquiring all of the shares in U.S. firm Sequlite Genomics US Inc. With the acquisition, the Dongguan, China-based Fapon Biotech will manage Sequlite’s product development and business operation.

Jubliee Biotech Co. Ltd. is hoping to get FDA clearance with Jubiwatch, its smartwatch and medication management platform. “We aim to obtain FDA pre-submission between April and June 2022, and hopefully hit the U.S. market at the end of 2023,” Sung Kyoung Lee, CEO at Jubliee Biotech, told BioWorld.

Shanghai Microport Medbot (Group) Co. Ltd. started trading its shares on the Hong Kong Stock Exchange on Nov. 2, with shares increasing over 6% in the middle of the day. It raised HK$1.56 billion ($201 million) with shares going at HK$43.2 apiece in an initial public offering. The firm plans to use 35% of the proceeds for the development and commercialization of its core product, the laparoscopic surgical robot Toumai.

Asahi Intecc Co. Ltd. is tapping Hexagon Manufacturing Intelligence Inc.’s non-linear structural analysis software, Marc, to develop delivery devices that carry markers to the vicinity of cancers in preparation for endoscopic surgery.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking comments from industry on mandatory reporting of medical device averse events by health care facilities, and the agency also published comments on a consultation on patient information to be provided with devices. As part of the recent overhaul of Australia’s medical device regulations, the TGA released an action plan for medical devices in 2019 that explored whether it should be mandatory for health care facilities to report adverse events and safety problems with devices to the TGA.