South Korea is making progress towards incorporating digital medical devices into its health care system and facilitating reimbursements, but these efforts may require giving up some entrenched practices. “Digital medical devices” covers a broad range of products, including software and technologies used in therapeutic interventions. They are usually supported by technologies like the Internet of Things (IoT), artificial intelligence (AI), cloud computing, machine learning, sensors and wearables, data analytics and others that can facilitate the shift from traditional health care into the digital world.
Adicon Holdings Ltd. raised HK$409 million (US$52 million) in an initial public offering on the Hong Kong stock market. Its shares opened at HK$12.32, jumped 12% and closed at HK$13.8 on the first trading day. Hangzhou, China-based Adicon is among the top three independent clinical laboratory (ICL) service providers in China by total revenues. It offers testing services to hospitals and health check centres through a network of 33 self-operated laboratories across China.
A non-invasive retinal exam may soon enable clinicians to visualize the future for patients at risk of chronic kidney disease (CKD). When combined with an artificial intelligence algorithm, an exam accurately predicted CKD prior to symptom onset in a study published in Digital Medicine.
Cerevasc Inc. has formed a partnership with Lianmedical Co. Ltd. to introduce Cerevasc’s medical devices for neurological diseases in the Asian market. Shanghai-based Lianmedical will help market Cerevasc's eshunt system and related products in mainland China, Hong Kong, Taiwan, and Macau. It’s eshunt system provides percutaneous transvenous-transdural access to the central nervous system.
Precision diagnostics company Inoviq Ltd.’s stock soared 44% on the news that its breast cancer diagnostic, SubB2M/CA15-3, detected all stages of breast cancer with 87% accuracy, 81% sensitivity and 93% specificity. The clinical validation study that included 483 samples outperformed the standard of care CAS15-3 test, demonstrating an area under the curve (AUC) of .93 compared to .70.
With a new medical device policy, India is laying the groundwork for a spurt in domestic manufacturing and to emerge as an innovative and globally competitive in the space, which is currently heavily reliant on imports. The new National Medical Devices Policy 2023, approved by the government at the end of April and notified in May, aims to place the Indian medical devices sector on an accelerated growth path.
After a licensing deal with Galvanize Therapeutics Inc., Energenx Medical Ltd. will develop and commercialize pulsed electric field therapies for chronic obstructive pulmonary disease (COPD) in Mainland China, Hong Kong, Taiwan and Macau, where there is a significant need. The deal could also be the basis for future exports out of China as Energenx develops its own products.
General Stim Inc.’s implanted sacral nerve stimulation (SNS) system was approved in China to treat individuals with certain bladder and bowel conditions. Hangzhou-based General Stim’s SNS system consists of a sacral nerve stimulator, an extension lead and an electrode.
Pulse Medical Technology Inc. obtained breakthrough device designation from the FDA for its fourth generation μFR system, which would accelerate the commercialization of the device. “The fourth generation μFR system is currently not available on the market, but Pulse Medical is preparing for the marketing approval of the product in the U.S.,” Jingfeng Han, director of science division at Pulse Medical, told BioWorld.
Recent regulatory reforms to Australia’s medical device framework have shown Australia’s Therapeutic Goods Administration (TGA) a new way of collaborating with industry to make improvements and ensure patient safety, said Tracey Duffy, deputy secretary for the TGA’s Medical Devices and Product Quality Division, during the recent Ausmedtech conference in Adelaide.
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