St. Jude Medical Inc. (NYSE:STJ) got the FDA’s green light for the U.S. market’s first combined FFR/OCT blood vessel imaging system for diagnosis and treatment of coronary artery disease.
The Ilumien system combines St. Jude’s PressureWire Aeris wireless fractional flow reserve imaging technology, which allows physicians to visualize blood vessel characteristics, and its Extreme Resolution optical coherence tomography, which helps evaluate the severity of blood flow blockages in coronary arteries.
Together they can help physicians identify culprit blood vessel lesions responsible for ischemia, the narrowing of arteries that can result in reduced blood flow to heart muscles.
"The key to optimizing treatment of coronary artery disease is knowing which vessel needs treatment and how to treat it," cardiovascular division president Frank Callaghan said in prepared remarks. "By integrating FFR and OCT technologies, we are providing physicians with innovative technology that gives them the information they need to accurately diagnose and optimize therapy for their patients."
The Ilumien system won CE Mark approval in the European Union in July.
Solta Medical, Inc. (NSDQ:SLTM) subsidiary Medicis Technologies Corp. received U.S. Food & Drug Administration clearance of the second generation LipoSonix system specifically indicated for non-invasive waist circumference reduction.
Accuray Inc. (NSDQ:ARAY) won FDA clearance to market the Dose Control System (DCS), a new feature for Accuray’s TomoTherapy system that improves system performance.
Canon U.S.A. Inc.’s TX-20 Full Auto Tonometer received 510(k) clearance from the U.S. Food and Drug Administration and is now commercially available for sale.
Hologic (NSDQ:HOLX) announced today that the FDA cleared the Company’s Trident specimen radiography system.
Ventana Medical Systems Inc., a member of the Roche Group, received 510(k) clearance from the FDA for the Ventana Companion Algorithm HER2 (4B5) for image analysis applications with associated VIRTUOSO software and iScan Coreo Au scanner.