An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
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Biolinq plans to use the proceeds of its new venture funding to support US FDA de novo review, automation engineering and commercialization efforts with partners, CEO Rich Yang told Medtech Insight.
OneCell Diagnostics, the Mumbai-based startup backed with $16m in series A funding, is rebranding to 1Cell.Ai to represent the firm's focus on combining deep science with AI-powered capabilities.
OneCell’s co-founder Uttarwar discusses clinical validation milestones, CLIA certification, and the startup’s strategic roadmap – from hospital partnerships in India to biopharma collaborations in the US.
Reimagine Care teamed up with MedStar Health to support cancer patients at home via an AI assistant and clinical support. Reimagine Care’s data suggests its platform can save cancer centers up to $1m annually per full-time oncologist panel and reduce ED visits by 30%.
In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.
The US FDA continues to issue early alerts as part of its communications pilot aimed at improving how the agency manages recalls. This time, the agency is notifying users about two separate intravascular catheters.
The US Medicare agency will hold three public meetings in June and July addressing tremor treatment devices and clinical diagnostic lab tests. The first meeting on June 25 will focus on endpoints for Parkinson’s device trials, while subsequent meetings will address payment rates and codes for laboratory tests.
