Fischer Imaging's hopes for a relatively quick turnaround of its March 12 PMA submission for the SenoScan digital mammography system could be boosted by the possibility that the device will not have to go before an FDA advisory panel, the Denver-based firm said.

Preliminary talks with FDA suggest that the agency will not seek panel review of the SenoScan, Fischer said. A final determination will be made after evaluation of the firm's clinical data.

The need for rapid review of digital mammography devices was highlighted in a recent Institute of Medicine report on mammography.

The report urged FDA to resolve regulatory difficulties experienced by device manufacturers. Among other suggestions, IoM recommended that the agency increase the number of statistical experts on its radiological devices advisory panel (¹ Also see "Mammography Device Review Warrants More Statisticians On Panel - IoM" - Medtech Insight, 12 March, 2001.).

Fischer suggested that FDA may be looking to match its 91-day turnaround of GE Medical Systems' PMA for the Senographe 2000D, the first digital mammography system approved in the U.S. That device, moreover, did have to undergo an advisory panel review.

Fischer's premarket approval application is based on clinical data from a six-center, 1,500-patient trial.

Employing a narrow charged-coupled device scanner, SenoScan offers two sizes of digital images: a 50 micron pixel size standard mode with a full-field view, and a 25 micron pixel high-resolution mode with a reduced field of view.

"SenoScan's directly captured digital images have the potential for offering greater speed and accuracy in the application of computer-aided detection and will also enable rapid access to second opinions via the Internet," Ken Crocker, Fischer's director of marketing, said in a March 14 release.

Crocker also noted that market penetration of the SenoScan would be facilitated by increased Medicare reimbursement rates.

Effective April 1, the Health Care Financing Administration will reimburse digital mammography screening at 150% of what would otherwise be paid for bilateral diagnostic mammography, based on provisions in the Medicare Benefits Improvement and Protection Act.

Fischer has been a prominent player in lobbying Congress for increases in digital mammography reimbursement levels.

At an October 2000 meeting of the Medical Device Manufacturers Association and the National Electrical Manufacturers Association, CEO Morgan Nields cited high capital costs of the equipment and drainage of costs to academic medical centers as reasons for higher reimbursement levels (² [A#01260460000]).

The IoM report advocated flexibility on the part of HCFA for new breast cancer screening technologies such as digital mammography. The report recommended the agency consider implementing a conditional coverage policy for patients enrolled in large screening trials.

Studies that would qualify include National Cancer Institute's 49,500-patient screening trial comparing digital to film mammography.

In addition to gauging whether digital mammography is better able to detect cancer than film screening, the trial would provide much needed data on the overall sensitivity of film mammography, Fischer said.

The SenoScan is featured in the trial, which will also include devices from GEMS, Trex Medical (Lorad) and Fuji (FCR 5000).

In its report, the IoM also suggested the need for evaluating film-based screening. The report states that NCI should sponsor large randomized trials every 10 to 15 years to "reassess the effects of accepted screening modalities on clinical outcome."

Meanwhile, Senator Tom Harkin (D-Iowa) introduced a bill with Sen. Olympia Snowe (R-Maine) March 15 seeking to increase the Medicare reimbursement rates for film-based mammography to $90 for 2002 from $67.

Fischer Angling For Swift Mammography Device Review Following IoM Report

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