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More Remote Monitoring Devices Added to FDA’s EUA and a Step Forward for Digital Therapeutics Reimbursement
Regulatory News FDA expands guidance on remote monitoring devices for COVID-19 Device categories covered by the guidance now include both diagnostic and monitoring spirometers and peak-flow [...]
International Regulators Talk of Phased Implementation & Telehealth Coverage Extends, But Usage Still Falters
The Simbex Regulatory and Reimbursement Recap is a monthly briefing for news in the regulatory and healthcare reimbursement space relevant to Simbex areas of expertise. The briefing is curated by [...]
Regulatory News MDR delay official as industry calls to push back IVDR The European Council voted 27-0 to adopt an amendment to delay the application of the Medical Devices Regulation by one year [...]
Regulatory News FDA allows expanded use of devices to monitor patients’ vital signs remotely FDA does not intend to object to limited modifications to the indications, claims, functionality, or [...]