Application could receive clearance this yearUltrasound vendor ATL announced this month that its premarketapproval (PMA) application for using ultrasound to differentiatesolid breast lesions has received expedited review from the Foodand Drug
Ultrasound vendor ATL announced this month that its premarketapproval (PMA) application for using ultrasound to differentiatesolid breast lesions has received expedited review from the Foodand Drug Administration. The FDA's action gives ATL a good chanceat having its PMA cleared by the end of this year.
ATL filed the PMA in February for using its HDI (high-definitionimaging) technology to differentiate malignant from benign solidbreast masses (SCAN 1/19/94). The Bothell, WA, company sponsoreda two-year clinical study to support its claim that cliniciansusing ATL's Ultramark 9 HDI scanners can acquire enough data abouta lesion's structural characteristics to determine whether itis malignant or benign.
In submitting its PMA application, ATL requested fast-trackreview of the technology. Fast-track review is one of severalreforms implemented by the FDA last year in an effort to speedup review of medical devices in the agency's Center for Devicesand Radiological Health (SCAN 7/14/93).
The FDA granted ATL's request because the technique could havea specific public health benefit, one of four criteria the FDAuses to grant expedited review. The agency found that HDI forlesion differentiation "has the potential for clinicallymeaningful public health benefit as an adjunct to mammographyand/or physical examination of the breast," according toTerry Sweeney, ATL's director of worldwide regulatory affairs.
By receiving expedited review, ATL's application will be sentto the head of the PMA queue at the Office of Device Evaluation,ahead of other medical devices awaiting review. Nine medical deviceshave received expedited review to date, according to Sweeney.ATL does not know of any other medical imaging devices that havebeen granted fast-track review.
While ATL did not receive a specific time frame from the FDAfor review of its application, it is believed that the reviewshould be completed in about 11 months, as opposed to the two-yearreview times common for most PMAs. The application was filed bythe FDA on Feb. 17, meaning that ATL could get the applicationcleared this year if all goes well.
The FDA's recent burst of energy in clearing 510(k)s bodeswell for the application and is a sign that the reforms implementedlast year are beginning to work, according to Sweeney.
"They've shortened the time frame (for reviewing applications)and their backlog is dropping fairly rapidly," Sweeney said."They've really cranked it up."
If the FDA grants ATL's PMA, the vendor will be able to promoteHDI's ability to conduct differentiation of solid breast lesions.ATL is hoping that the technique will serve as an adjunct to mammographyby enabling clinicians to differentiate solid breast lesions withoutrequiring biopsy. The technique does not require any new hardwareor software for HDI systems, according to the company.
ATL is sponsoring a study of the economic impact of the techniqueon the clinical management of patients with suspicious breastmasses. ATL will use the results of the study to promote the costsavings of the technique over other methods of performing breastbiopsy.