US Original PMAs and Panel-Track Supplements
Class III devices and panel-track supplements approved by US FDA’s Center for Devices and Radiological Health. Data derived from FDA.gov. Updated weekly.
Medtech Insight Data Trackers
Keep tabs on device approvals in the US and abroad, US Breakthrough Device designations, warning letters, guidances, M&A and more.
Approvals
US PMA Supplements
PMA supplements approved by US FDA’s Center for Devices and Radiological Health. Data derived from FDA.gov. Updated weekly.
US 510(k) Clearances
Devices cleared for market via US FDA’s 510(k) pathway. Data derived from FDA.gov. Updated weekly.
US De Novo Classifications
Devices granted De Novo marketing authorization by the US FDA. Data derived from FDA.gov Updated weekly.
Non-US Approvals
Devices authorized for marketing outside the US. Data derived from Citeline’s Meddevicetracker. Updated weekly.
Compliance
US FDA Warning Letters
A comprehensive listing of FDA warning letters since 2016, sortable by CFR citation number. Updated monthly.
Global Medtech Guidance Tracker
Comprehensively tracks regulatory guidance documents issued by medtech authorities worldwide. Updated monthly.
Commercial
Medtech Company Financing
Financings, M&A and alliances across the medical device, diagnostics and digital health sectors. Data derived from Citeline’s Meddevicetracker.
Mergers and Acquisitions
Mergers and acquisitions in the medical device, diagnostics and digital health sectors. Data derived from Citeline’s Meddevicetracker.
US Breakthrough Devices
Details and status updates on devices that have been accepted into the US Food and Drug Administration’s Breakthrough Devices program, based on company announcements and media coverage. Updated biweekly.