When China’s e-commerce giant Alibaba flexes its muscles, this time in personalized healthcare using artificial intelligence, everyone takes note.
Armed with big data and deep learning capabilities, Alibaba is decisively venturing into personalized healthcare, a fast-growing area in China.
Alibaba may be years behind established personalized healthcare players such as [PatientsLikeMe Inc.] and IBM’s Watson, but the Chinese tech...
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A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.
After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.
From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.
Pending legislation seeks to address what the sponsors argue is a lack of transparency in medical billing. If enacted, the bill would provide patients with the costs of procedures and medications before receiving them. A data collection expert discusses what the bill could mean for patients.
Notified bodies are calling for their key role, as the technical, regulatory and clinical ‘extended arm’ of regulatory authorities, to remain central to the EU medtech conformity assessment process.
The US FDA has announced its user fees for fiscal 2026, which are based on a figure of $455,000 for a PMA.
