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FDA clears Siemens IV-MRI package
Siemens Medical Systems has received 510(k) marketing clearancefor an upgrade package for its Magnetom Open MRI scanner thatenables clinicians to perform MRI-guided procedures with the scanner.The FDA's move also allows the Iselin, NJ, vendor to promote
Siemens Medical Systems has received 510(k) marketing clearancefor an upgrade package for its Magnetom Open MRI scanner thatenables clinicians to perform MRI-guided procedures with the scanner.The FDA's move also allows the Iselin, NJ, vendor to promote theuse of Open for interventional imaging, which was not includedin Open's original 510(k) clearance document (SCAN 4/6/94).
Siemens' MR-Guided Procedures Package includes hardware suchas a bore light, ergonomic chair, foot pedal to initiate scans,multipurpose 35-cm coil, auto-display of images as they are acquired,and an optional in-room monitor. It also includes fast imagingsequences, according to Anne Deery Sheehan, Open product manager.
The package was designed to allow clinicians to conduct MR-guidedbiopsies and drainages on a range of anatomyfrom the head andneck to the spine, abdomen, and extremities. The package has beenunder evaluation at University Hospitals of Cleveland and at sevensites in Europe.
Siemens believes that the option is the first clinically availableMR-guided surgery package. Siemens will offer the package as anoption for installed Open scanners, with a list price of $155,000including in-room monitor. A new Open with the package will probablylist for around $1 million.
New Study Assesses Long-Term Outcomes of PSMA PET Use in PCa Recurrence Cases
October 24th 2024For patients with biochemical recurrence of prostate cancer, PSMA PET imaging may facilitate a 12.8 percent lower incidence of prostate cancer mortality in contrast to the combination of CT and bone scan, according to long-term outcome estimates from a new decision-analytic modeling study.
Can Diffusion MRI Predict Patient Response to Neoadjuvant Chemotherapy for Breast Cancer?
October 23rd 2024A model emphasizing time-dependent diffusion MRI was 15 percent more effective than apparent diffusion coefficient (ADC) measurements at predicting pathologic complete response to neoadjuvant chemotherapy for women with breast cancer, according to new research.
