Intraluminal ultrasounddeveloper Endosonics announced this month that the Food and DrugAdministration has cleared its Oracle-Micro catheter, which combinescoronary balloon angioplasty with ultrasound imaging. Endosonicsclaims that the product is the only
Intraluminal ultrasounddeveloper Endosonics announced this month that the Food and DrugAdministration has cleared its Oracle-Micro catheter, which combinescoronary balloon angioplasty with ultrasound imaging. Endosonicsclaims that the product is the only device that can perform bothpercutaneous transluminal coronary angioplasty (PTCA) and intravascularultrasound on the same catheter.
In clinical studies the company submitted to the FDA, cardiologistsusing Oracle-Micro had different impressions of treatment successand in some cases changed therapy decisions compared to cardiologistswho used conventional angiographic imaging.
Gaining FDA approval for Oracle-Micro was not a cake walk,however. The agency earlier this year asked Endosonics to revisethe data in the application (SCAN 8/31/94). Endosonics won theagency's go-ahead within weeks of resubmitting the application,the company reported.
Endosonics plans limited shipments of the current version ofOracle-Micro to U.S. customers while it submits a series of PMAsupplements for the latest version of the product.
Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.
Study Shows Enhanced Diagnosis of Coronary Artery Stenosis with Photon-Counting CTA
July 10th 2025In a new study comparing standard resolution and ultra-high resolution modes for patients undergoing coronary CTA with photon-counting detector CT, researchers found that segment-level sensitivity and accuracy rates for diagnosing coronary artery stenosis were consistently > 89.6 percent.
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.