Picker MSI unit gains FDA clearance

Picker International’s campaign to make magnetic source imaging (MSI) a tool for routine clinical imaging received a boost last month when the Food and Drug Administration cleared the company’s Vectorview scanner. Picker hopes the FDA’s move will improve the reimbursement situation for MSI, thus making it economically viable for hospitals.

Picker introduced Vectorview at the 1996 RSNA meeting as the successor to the company’s Neuromag-122 system. The system features 300 channels, which increase the sensitivity of the unit and make it able to image deeper in the brain.

Unlike most medical imaging products, 510(k) clearance is not crucial for MSI scanners because they are usually acquired by research sites. Vectorview’s clearance is important, however, because these sites often do some clinical work, and now it will be easier for them to gain reimbursement for this work, according to John Patrick, general manager of image-guided surgery at Picker.

With the FDA’s imprimatur in hand, Picker plans to push for increased awareness and reimbursement of MSI by sponsoring studies on the technology’s clinical applications. The reimbursement situation for MSI is still fragile: While many private insurers will pay for studies, there are no CPT codes for MSI, and the federal government still will not pay for MSI exams under Medicare or Medicaid. Getting paid for their work is crucial if hospitals are to begin using MSI on a routine clinical basis. The list price of a Vectorview unit, including installation costs, is $2.5 million, according to Patrick.

Picker began shipping Vectorview in July and has installed units at hospitals in Finland, Japan, and Utah. The company has two back orders from hospitals in Japan, Patrick said.