1. Medtech Insight

Mela Sciences Cites Binding Study Protocol Pact As Key To FDA Reversal On MelaFind PMA

A rare binding study protocol agreement with FDA was a crucial factor in Mela Sciences’ successful campaign to reverse an initial “not approvable” determination for the firm’s melanoma detection device, according to CEO Joseph Gulfo.

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More from Medtech Insight

Opportunity For Medtech To Contribute To EU Cybersecurity Recommendations

 
• By Amanda Maxwell

The deadline for comments is 30 June 2025

Dexcom Wins FDA Nod For 15-Day G7 CGM, Closing Gap With Abbott’s 14-Day FreeStyle Libre

 
• By Marion Webb

Dexcom announced it received US clearance for its 15-day CGM, which has a MARD of 8.0% and is expected to launch in the second half of 2025 to allow for integration with insulin pumps.

Diagnostics Are Essential, But How Can Companies Ensure A Fair Price?

 
• By Barnaby Pickering

Biotech and pharma are increasingly clear about one thing: They need diagnostics. But with prices suppressed, how have diagnostics companies proven their utility without going under?