Medical device company Kalypto Medical has asked the Food and Drug Administration not to grant Smith & Nephew clearance for the PICO single-use negative pressure wound therapy device, according to a Medical Device and Diagnostic Industry report.
The company has collected a citizen petition stating that PICO is second-in-class compared to Kalypto's first-in-class NPD, although Kalypto's attorneys have said that they don't know specifics of Smith & Nephew's clearance submission.
Kalypto has asked the FDA to ensure a thorough review of Smith & Nephew's process, standards and performance data, including that PICO is compared to NPD.
Related Articles on Smith & Nephew:
Smith & Nephew Signs Distribution Agreement With Injectable Bone Void Filler Company
Smith & Nephew Acquires TENET Medical Engineering
Smith & Nephew Patent Dispute With Arthrex Continues in Oregon
Kalypto has asked the FDA to ensure a thorough review of Smith & Nephew's process, standards and performance data, including that PICO is compared to NPD.
Related Articles on Smith & Nephew:
Smith & Nephew Signs Distribution Agreement With Injectable Bone Void Filler Company
Smith & Nephew Acquires TENET Medical Engineering
Smith & Nephew Patent Dispute With Arthrex Continues in Oregon