babyLance™ Safety Heelsticks

Examines babyLance Safety Heelstick’s Activation, Ease of Use, Incision Quality and Safety

Analyzes End-Users Expectations, Clinical Studies, and FDA Guidance Documents and 510(k) with Sharps Safety Indication Application

Trademark registration with the Canadian Intellectual Property Office protects both the word "babyLance" and the neonatal heelstick's unique blue and green logo.

Reflects U.S. FDA 510(k) Clearance for Marketing Neonatal Heelstick Device with a Sharps Prevention...

Examines Additional Considerations for Sharps Prevention Features and Submissions for a Modified Medical Device with Existing 510(k)...

Clinical Use Studies Also Show 94-Percent Score for Ease-of-Use, Ergonomics and Performance Tests

Only Infant Heelstick to Have FDA 510(k) Clearance for Sharps Prevention Indication

Results From Simulated and Clinical Use Survey at Citrus Valley Medical Center

1900 cases of babyLance(tm) infant heelsticks donated to international humanitarian aid and disaster relief organization

babyLance Heelstick Reinvention Process Prioritized Harmony Between End-User Ergonomic Requirements and Design Team Innovation