Beijing Tinavi Medical Technologies Co. Ltd.’s surgical robot received approval from China’s National Medical Products Administration (NMPA) for total knee replacement, expanding its product portfolio to cover spine, trauma and joints in orthopedic surgery. The new product, named Tirobot Recon, provides support for surgeons in total knee arthroplasty.
Australia’s Therapeutic Goods Administration (TGA) has issued a regulatory proposal regarding the agency’s approach to audits for devices, a proposal that might reduce the number of these audits. TGA said it may limit audits to the highest-risk devices and may eliminate them for devices that have been granted market access in other regulatory jurisdictions.
Australia’s Therapeutic Goods Administration (TGA) is reconsidering its approach to regulating devices that bear materials of animal, microbial or recombinant origin, a broad class of products that includes transcatheter aortic valve replacement (TAVR) devices.
Mediwhale Inc. and Yonsei University College of Medicine, Seoul, Republic of Korea, are developing a new predicting tool combining artificial intelligence (AI) and non-invasive retinal eye examination capable of accurately predicting chronic kidney diseases before symptoms appears.
Shineco Inc.’s subsidiary Changzhou Biowin Pharma received marketing approval from China’s NMPA for its test device that can complete a diagnosis of acute myocardial infarction in five minutes. The five-minute cardiac test relies on a combination of three major cardiac markers that can detect cardiac troponin I, myoglobin and heart fatty acid binding protein in a single test.
Tissue regeneration company Osteopore Ltd. is on the cusp of dramatically changing the way orthopedic surgery is conducted globally, with Australia playing a crucial role. Osteopore was the first company to successfully develop and commercialize 3D-printed bioresorbable implants for surgical use, reducing post-surgery complications compared to permanent implants.
Lifetech Scientific Corp.’s fully degradable iron-based absorbable coronary scaffold showed its safety and efficacy to treat non-complex coronary lesions that have not been previously treated with an interventional device during a three-year, first-in-humans trial.
Awak Technologies Pte Ltd. and Singapore General Hospital (SGH) plan to launch a pre-pivotal clinical trial for their automated wearable artificial kidney peritoneal dialysis (Awak PD) device. Awak PD is a wearable and portable PD device designed for patients with end-stage kidney disease to have dialysis on the go. The research team is now recruiting subjects for the single-site, prospective, single-arm study.
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.
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