Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: CA Healthcare Acquisition, Dasa, Dentatechnica, Electrocore, Encision, Fujifilm Medical Systems U.S.A., Lumiradx, Mind Medicine, Neurovision Imaging, Red One Medical Devices, Sophia Genetics, Velico Medical.
As many lower and middle-income countries continue to scramble for COVID-19 vaccine doses, which are largely being manufactured in Europe and the U.S., their own regulatory rules may be getting in the way in some instances.
Shanghai Heartcare Medical Technology Co. Ltd. shares took a hard fall in their Aug. 20 debut on the Hong Kong Stock Exchange (HKSE), closing at HK$129 (US$107.47) after tumbling all the way down to HK$127.8 earlier in the day.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Shoulder Innovations.
Medicare coverage does not necessarily mean appropriate reimbursement levels, a point pressed by Inspire Medical Systems Inc. at the Aug. 23 Medicare outpatient advisory panel hearing. The panel agreed that the company’s hypoglossal nerve stimulation (HNS) device for sleep apnea was subject to an inappropriate device offset figure, which could lead to a Medicare rate increase of more than $7,000 and a significant boost of sales of the company’s flagship Inspire HNS device.
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