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Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 FDA drafts surgical robot testing expectations and leaves autonomy out of scope Marani Health clears the M•care system for fetal and maternal monitoring at home FDA books December 2 and 3 for a workshop on robot autonomy and remote teleoperation Glytec wins Breakthrough designation for insulin dosing software in newborns Perfuze bench study puts Millipede88 first-pass success at 88 percent in MCA models Precision Neuroscience raises $250M Series D and takes total funding to $430M FDA calls BD's kit correction Class I over recalled saline ampules from a supplier FDA early alert flags a loose cable that reboots React Health VOCSN ventilators Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 FDA drafts surgical robot testing expectations and leaves autonomy out of scope Marani Health clears the M•care system for fetal and maternal monitoring at home FDA books December 2 and 3 for a workshop on robot autonomy and remote teleoperation Glytec wins Breakthrough designation for insulin dosing software in newborns Perfuze bench study puts Millipede88 first-pass success at 88 percent in MCA models Precision Neuroscience raises $250M Series D and takes total funding to $430M FDA calls BD's kit correction Class I over recalled saline ampules from a supplier FDA early alert flags a loose cable that reboots React Health VOCSN ventilators

The Directory / Regulatory, Quality & Testing Services

Regulatory, Quality & Testing Services Digital Health & SaMD

InSilicoTrials

Trieste, Italy · Series A · Not a regulated device

Runs a cloud platform for computational modeling and in silico trials, including credibility assessment of models and FDA-ready documentation. Joined the ARPA-H CIRCLE team in September 2026 to build validation infrastructure for critical illness digital twins.

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