Newly FDA-Cleared Stereotactic System Can be Utilized with Pre-Op MRI or CT
Utilized for neurological procedures including biopsies, catheter placement and electrode introduction, the SmartFrame OR Stereotactic System can be combined with preoperative MRI or CT to ensure optimal placement of devices and instruments.
The Food and Drug Adminstration (FDA) has granted 510(k) clearance for the SmartFrame OR Stereotactic System, which reportedly facilitates optimal preoperative placement of instruments and devices for neurological procedures.
Comprised of the SmartFrame OR and the ClearPointer™ Optical Navigation Wand, the SmartFrame OR Stereotactic System can enhance preoperative planning for electrode introduction, catheter placement and brain biopsy procedures, according to ClearPoint Neuro, the manufacturer of the system. The company noted the SmartFrame OR can be combined with preoperative magnetic resonance imaging (MRI) or computed tomography (CT).
Utilized in combination with the SmartFrame OR and a compatible stereotactic optical navigation system, the ClearPointer Optical Navigation Wand facilitates patient registration and navigation, according to ClearPoint Neuro.
“SmartFrame OR embodies over a decade of accumulated expertise in MRI-guided navigation, now enhanced with the latest OR imaging technology,” said Rob Rubio, a segment leader for neuromodulation at ClearPoint Neuro. “It offers surgeons flexible workflows, including iCT forward projection, enabling precise image-based corrections to achieve sub-millimetric accuracy.”
FDA Clears Virtually Helium-Free 1.5T MRI System from Siemens Healthineers
June 26th 2025Offering a cost- and resource-saving DryCool magnet technology, the Magnetom Flow.Ace MRI system reportedly requires 0.7 liters of liquid helium for cooling over the lifetime of the device in contrast to over 1,000 liters commonly utilized with conventional MRI platforms.
Can Contrast-Enhanced Mammography be a Viable Screening Alternative to Breast MRI?
June 17th 2025While the addition of contrast-enhanced mammography (CEM) to digital breast tomosynthesis (DBT) led to over a 13 percent increase in false positive cases, researchers also noted over double the cancer yield per 1,000 women in comparison to DBT alone.
Multinational Study Reaffirms Value of Adjunctive AI for Prostate MRI
June 16th 2025The use of adjunctive AI in biparametric prostate MRI exams led to 3.3 percent and 3.4 percent increases in the AUC and specificity, respectively, for clinically significant prostate cancer (csPCa) in a 360-person cohort drawn from 53 facilities.
