MedDevice Startups, a Regulatory Newsroom for Medical-Device Builders

Field notes

The site divides its coverage according to a device company’s operating stage, from concept and pre-submission through postmarket security, while maintaining a news archive and FDA clearance tracker. The tracker states that it matches decisions against a startup directory and covers every 510(k) clearance and original PMA approval from the prior 12 months. At the time shown, it contained 3,145 decisions, with 65 510(k)s and one PMA recorded in the last 30 days.