Shenzhen Xzing Technology Co. Ltd.’s Endofresh disposable upper gastrointestinal (GI) endoscope has granted the NMPA’s class II approval. The company said the approved product is used for upper gastrointestinal GI endoscopy, diagnosis and treatment.
SK Biopharmaceuticals Co. Ltd.'s three-pronged plan for tackling epilepsy is going strong, with lead drug cenobamate for drug-resistant focal-onset seizures nearing the finish line, and earlier-stage programs for a mRNA-based approach and a digital therapeutic in the works.
Resapp Health Ltd. saw its stock shoot up 35% on the heels of positive clinical results for its new smartphone-based COVID-19 screening test. In a pilot clinical trial of 741 patients recruited in the U.S. and India, digital health company Resapp’s screening test, which uses machine learning to analyze the sound of a patient’s cough, correctly detected COVID-19 in 92% of people with the infection.
Sihuan Pharmaceutical Holdings Group Ltd.’s subsidiary Beijing Meiyan Kongjian Biology Medicine Co. Ltd. has acquired an 80% equity stake in Shenzhen Yimei Medical Technology Co. The deal is to be completed via a mix of capital and equity transfers. Sihuan Pharmaceutical is interested in Shenzhen Yimei’s two-in-one patented technology of collimated ultrasound and superficial focused ultrasound.
Australia’s Therapeutics Goods Administration (TGA) cleared Orthocell Ltd.’s regenerative nerve repair device, Remplir, a biological scaffold that mimics the outer layer of the peripheral nerve to facilitate nerve repair.
Pear Therapeutics Inc. partnered with Softbank Corp. to bring a digital therapy for sleep/wake disorders to the Japanese market. Pear will develop the app, while Softbank will evaluate Japanese market potential with an option to negotiate an exclusive license for Pear’s Japanese sleep/wake disorder therapeutics.
China’s NMPA has given 10 of Sihuan Pharmaceutical Holdings Group Ltd.’s skin repair products medical device registration certificates. The products are developed by its medical aesthetics platform Beijing Meiyan Kongjian Biology Medicine Co. Ltd. The certification is for three scar repair products, four medical dressing and patch products, as well as three skin repair products.
A smart contacts lens that detects diabetes and treats diabetic retinopathy could provide patients with a more comfortable alternative to insulin shots and monitoring blood glucose levels. The product was developed by a research team at the Pohang University of Science & Technology (POSTECH) that includes Sei Kwang Hahn, the CEO of Seoul, South Korea-based Phi Biomed Co. Ltd.
China’s NMPA has approved 12 antigen self-test kits between March 12 and 16 amid COVID-19 outbreaks in many parts of the country. The regulator claims that there will soon be more test kits approved. The number of COVID-19 infectious cases in China surged rapidly over the first half of March.
By using roughly 400 data points, from molecular to physical fitness, researchers have gained new insights into how organs such as the heart vs. the skin, and systems such as the immune and metabolic systems, age at different rates within individuals.