Japan’s Ministry of Health, Labor and Welfare (MHLW) released a number of new guidelines and clarifications on medical device regulatory issues including cybersecurity, remanufactured single-use devices (SUDs) and the Medical Device Single Audit Program (MDSAP).

India’s health care industry stakeholders have been left scratching their head as authorities, who have championed self-reliance and increased supplies, provided mixed signals in recent notices.

The Chinese government has launched a series of regulations regarding intellectual property (IP) to improve the quality of patent applications. “These new IP rules reflect the Chinese government's continuous effort in fighting the long-existing and more severe ‘abnormal patent filing activities’ and ensuring the quality of patent applications with practical restriction measures,” Binxin Li, an IP partner in Fenxun Partners, Baker McKenzie's joint operation platform partner in China, told BioWorld.

Japanese researchers have created complex 3D kidney organoids that could lead the way to better kidney research and even artificial kidneys for human transplant.

South Korea’s Gwangju Institute of Science and Technology (GIST) has completed a preclinical study for a noninvasive therapy for Alzheimer’s disease. The "ultrasound-based gamma entrainment” technique involves syncing up gamma waves, or brain waves above 30 Hz, with an external oscillation of a given frequency. This happens naturally by exposing a subject to a repetitive stimulus, such as sound, light, or mechanical vibrations.

Beijing Microkpro Medical Instrument Co. Ltd. has received marketing approval for its artificial cornea from China’s NMPA. Miok Keratoprosthesis is the world’s first artificial cornea made of 100% non-biological materials and does not require co-implantation of donor corneas, according to Microkpro Medical.

Targetingone Corp. Ltd.’s new testing kit based on digital polymerase chain reaction (dPCR) techniques has received approval from China’s NMPA. It is the first dCPR-based testing kit to receive the country’s class III medical device registration certificate. The Beijing-based company collaborated with Tsinghua University, several hospitals and the Chinese Center for Disease Control and Prevention (CDC) participated to research and develop the testing kit.

Peijia Medical Ltd. has acquired exclusive rights to Jenavalve Technology Inc.’s transcatheter aortic valve replacement (TAVR) products for the treatment of aortic regurgitation (AR) and aortic stenosis (AS). Suzhou, China-based Peijia is now able to develop, manufacture, and commercialize the TAVR products in Greater China.

A study by researchers led by David James from the University of Sydney showcases the diversity in metabolic responses observed across different mouse strains exposed to two different diets that demonstrates the heritability of metabolic traits.

Digital health company Connectedhealth Pte. Ltd. launched its Sugosure system to offer care management to type 2 diabetes patients in Singapore. The system is aiming to tackle the “poor management” of type 2 diabetes with technology and to reduce the risk of long-term complications, said Ronald Ling, the CEO of Connectedhealth.