The Food and Drug Administration has put the final pieces togetherfor 3-D ultrasound developer TomTec Imaging Systems. The Boulder,CO, company received 510(k) clearance from the agency for EchoScan,the image acquisition portion of its 3-D and 4-D
The Food and Drug Administration has put the final pieces togetherfor 3-D ultrasound developer TomTec Imaging Systems. The Boulder,CO, company received 510(k) clearance from the agency for EchoScan,the image acquisition portion of its 3-D and 4-D ultrasound workstation.TomTec won marketing clearance earlier this year for EchoView,the workstation's image reconstruction component (SCAN 3/15/95).TomTec may now begin marketing the system to routine clinicalsites.
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FDA Expands Approval of MRI-Guided Ultrasound Treatment for Patients with Parkinson’s Disease
July 9th 2025For patients with advanced Parkinson’s disease, the expanded FDA approval of the Exablate Neuro platform allows for the use of MRI-guided focused ultrasound in performing staged bilateral pallidothalamic tractotomy.