A device "that doesn't meet the rigors of good clinical evidence" should not be approved, voting panel consultant Russell Snyder (University of Texas Medical Branch at Galveston) remarked.
By FDA Advisory Committe, [RxPG] MediSpectra's Luma cervical imager will require further study prior to marketing, FDA's Obstetrics & Gynecology Devices Panel agreed at its May 17 meeting.
The Luma device failed to meet certain efficacy endpoints in two pivotal studies.
The panel found that Luma did not achieve statistical significance, and because of study design it is unclear whether there is a clinical benefit from the device. The panel voted 9-2 against approval.
A device "that doesn't meet the rigors of good clinical evidence" should not be approved, voting panel consultant Russell Snyder (University of Texas Medical Branch at Galveston) remarked.
The firm is seeking an indication for the spectroscopy-based cervical imaging system as an adjunct to colposcopy in identifying high-grade disease with abnormal Pap results.
MediSpectra had failed to complete its second pivotal study, recruiting 228 out of a total of 788 planned subjects for the single-arm design. The first pivotal study, a randomized, controlled design, enrolled 2,299 subjects.
At the meeting, panelists debated whether MediSpectra should conduct another trial or finish its second pivotal study, assuming the firm continues with its quest to gain FDA approval.
Publication:
FDA's Obstetrics & Gynecology Devices Panel
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