Digital Health Roundup: Exec Chats With Illumina, Bloom, AngelMed; M&A, Funding; FDA Down-Classifies Apps
In this roundup feature focusing on new developments in digital health, Medtech Insight spotlights IBM Watson Health’s divestiture and other financing news, Exec Chats with Illumina, AngelMed and Bloom, Philips’ new hand-held ultrasound device and autonomous robotic surgery, as well as the latest FDA news on digital health.
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Digital neurotherapeutics company MindMaze plans to use the new funding to ramp up commercialization and expand its footprint in the US, also aided by a new partnership with the American Hospital Association.
US regulators have officially down-classified adjunctive predictive cardiovascular indicator software to class II as part of a trend to make it easier for sponsors to apply for premarket applications.
A recently published international cybersecurity standard goes beyond what regulators currently require of medtech manufacturers, say attorneys at King and Spalding. If adopted by the US FDA and others, it could add significant burden on medical software developers.