Protected: How to Conduct a Technology & Intellectual Property Review for Medical Devices
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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 [...]
MDR Officially Delayed and Telehealth is Here to Stay
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 [...]
Global Medical Device Regulators and Payors Adapt in Response to Pandemic
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 [...]