Experts: New Cybersecurity Standard Goes Beyond What US And Other Regulators Require
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.
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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.
The US FDA found more than 2,000 rats at an Arkansas Family Dollar distribution center, leadingto a six-state recall for products including feminine hygiene products, contact lens cleaners and face masks.
The US regulatory agency is looking for qualified independent contractors to help guide upgrades to its IT systems, make recommendations and report on how things are going.