CDRH Priorities for 2021 and Strategies for Digital Health Companies
A new digital health Center of Excellence within the FDA aims to boost digital health innovation by fostering partnerships and connections among digital health stakeholders.
FDA releases new EMC draft guidance and CMS increases home health reimbursement for 2021
A new digital health Center of Excellence within the FDA aims to boost digital health innovation by fostering partnerships and connections among digital health stakeholders.
Innovation at Simbex Highlighted by New Hampshire Union Leader
Researchers and engineers with great ideas sometimes need help getting their innovations from the concept stage to being a fully marketed product, and that’s where Lebanon’s Simbex comes into [...]
FDA Releases New Biocompatibility Draft Guidance and CMS provides further comment on “reasonable and necessary”
A new digital health Center of Excellence within the FDA aims to boost digital health innovation by fostering partnerships and connections among digital health stakeholders.
New Digital Health Center of Excellence & Coverage for “Breakthrough” Devices
A new digital health Center of Excellence within the FDA aims to boost digital health innovation by fostering partnerships and connections among digital health stakeholders.
FDA Issues Pandemic Inspections Guidance & CMS Announces New Payment Rates
FDA issued an immediately effective frequently asked questions guidance explaining its approach to inspections and manufacturing and supply chain changes during the coronavirus disease (COVID-19) [...]
How to Conduct a Technology & Intellectual Property Review for Medical Devices
A Technology Review often begins with early assessment of the technology solution, which entails confirming that the technology is feasible and has not already been developed.
Rx Rehab Exercise Devices Now 510(k) Exempt & First CMS Code for Exoskeletons
Read the latest regulatory and healthcare reimbursement news, including the FDA exempts additional Class II devices from 510(k) requirements.
More Remote Monitoring Devices Added to FDA’s EUA and a Step Forward for Digital Therapeutics Reimbursement
Read the June, 2020 regulatory and healthcare reimbursement recap from Simbex, including the FDA expands guidance on remote monitoring devices for COVID-19.
