FDA News

Technology to reduce radiation exposure during fluoroscopic procedures receives FDA clearance

ControlRad announced that its radiation reduction technology for use during any fluoroscopic imaging procedure such as atrial fibrillation ablation and PCI has been granted 510(k) clearance from the FDA.

The technology (Trace) can be integrated into existing mobile C-arms, according to a press release from the company. The solution includes a semitransparent filter, imaging processing technology and a tablet to reduce radiation exposure by up to 89% without affecting image quality.

“Radiologists and our teams have grave concerns about the long-term effects from radiation exposure,” John A. Carrino, MD, MPH, vice chairman of radiology at the Hospital for Special Surgery in New York City, said in the release. “I am excited that new technology for mobile C-arms is now available because it has the potential to drastically improve our radiation safety while maintaining image quality so we can continue to effectively diagnose and treat our patients. I believe these new products should become the standard of care for fluoroscopic procedures.”

ControlRad announced that its radiation reduction technology for use during any fluoroscopic imaging procedure such as atrial fibrillation ablation and PCI has been granted 510(k) clearance from the FDA.
Source: Adobe Stock

The commercial launch of this system has been initiated by ControlRad, according to the release.

Disclosure: Carrino reports no relevant financial disclosures.

ControlRad announced that its radiation reduction technology for use during any fluoroscopic imaging procedure such as atrial fibrillation ablation and PCI has been granted 510(k) clearance from the FDA.

The technology (Trace) can be integrated into existing mobile C-arms, according to a press release from the company. The solution includes a semitransparent filter, imaging processing technology and a tablet to reduce radiation exposure by up to 89% without affecting image quality.

“Radiologists and our teams have grave concerns about the long-term effects from radiation exposure,” John A. Carrino, MD, MPH, vice chairman of radiology at the Hospital for Special Surgery in New York City, said in the release. “I am excited that new technology for mobile C-arms is now available because it has the potential to drastically improve our radiation safety while maintaining image quality so we can continue to effectively diagnose and treat our patients. I believe these new products should become the standard of care for fluoroscopic procedures.”

ControlRad announced that its radiation reduction technology for use during any fluoroscopic imaging procedure such as atrial fibrillation ablation and PCI has been granted 510(k) clearance from the FDA.
Source: Adobe Stock

The commercial launch of this system has been initiated by ControlRad, according to the release.

Disclosure: Carrino reports no relevant financial disclosures.