Cardiovascular device developer BioStable Science & Engineering said today it completed a de novo application to the FDA as it seeks Class II designation for its Haart 300 aortic annuloplasty device. The Austin, Texas-based company said its Haart 300 is an internal aortic annuloplasty ring designed to replicate the anatomy of the aortic valve and […]
Food & Drug Administration (FDA)
St. Jude wins FDA nod, launches PressureWire X FFR system
St. Jude Medical (NYSE:STJ) said today that it won 510(k) clearance from the FDA for its PressureWire X guidewire fractional flow reserve measurement system and launched the device in the U.S. The PressureWire guidewire system is designed to measure arterial blood pressure by calculating fractional flow reserve associated with stenosis in patients with coronary artery disease. The next-gen version of the device […]
Gamida Cell wins FDA breakthrough therapy designation for NiCord cell graft
Gamida Cell said today that it won breakthrough therapy designation from the FDA for its lead product candidate, NiCord. The Jerusalem-based company’s expanded cell graft is designed to be an alternative to bone marrow transplantation for patients with high-risk hematological cancers. Gamida Cell said it plans to launch an international Phase III registration study of the […]
Fresenius Kabi wins FDA nod for Aurora Xi plasmapheresis system
Fresenius Kabi (NYSE:FMS) said today that it won FDA 510(k) clearance for its Aurora Xi plasmapheresis system. Plasma, a component of blood that contains proteins, is used in therapies to treat burn victims, bleeding disorders, and other chronic and genetic problems. Patients who require plasma infusions or injections have to get them regularly and often […]
Viveve wins FDA 510(k) for its Viveve System
Viveve (NSDQ:VIVE) said today it won FDA 510(k) clearance for its Viveve System, now cleared for use in general surgical procedures for electrocoagulation and hemostasis. The company’s Viveve System is designed as a non-surgical treatment for post-partum laxity of the vaginal introitus. “FDA 510(k) clearance for the Viveve System represents a major milestone in our efforts to […]
Baxter recalls select IV fluid filters
Baxter (NYSE:BAX) is recalling its 50mm 0.2 micron filter used to filter water-based intravenous solutions due to the presence of particulate matter and the potential absence of filter layers. The FDA has labeled the recall as Class 1, indicating “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to […]
FDA approves St. Jude Medical’s Infinity DBS and directional leads
St. Jude Medical (NYSE:STJ) said today that the FDA approved its Infinity deep-brain stimulation device, including its DBS directional leads, to treat Parkinson’s disease and essential tremor. The Infinity system is designed so that Apple (NSDQ:AAPL) mobile devices can be used as wireless controllers, via a Bluetooth connection; St. Jude claims the system as the only upgradable DBS platform for […]
Vascular Solutions recalls Twin-Pass dual access caths
Vascular Solutions (NSDQ:VASC) said yesterday it initiated a nationwide recall of its Twin-Pass dual access catheters due to a potential for excess material in the catheter that could dislodge and pose a risk for embolism. The FDA has labeled the recall as Class 1, indicating “a reasonable probability that use of these products will cause serious adverse […]
FDA approves St. Jude Medical’s BurstDR spinal cord stimulation for chronic pain
St. Jude Medical (NYSE:STJ) said today that the FDA granted pre-market approval for its BurstDR spinal cord stimulation technology, which is designed to mimic the body’s natural nerve-firing patterns to optimize SCS treatment for chronic pain. The BurstDR technology is available with new implantations of St. Jude’s Proclaim Elite and Prodigy MRI SCS devices; it will also […]
FDA approves Valencia’s eCoin neurostim trial
Valencia Technologies said today it won investigational device exemption approval from the FDA to begin a trial of its eCoin neurostimulator for treating drug-resistant hypertension. The company is slated to pick up 300 patients on at least 3 antihypertensive drugs for a trial of the coin-sized device, which is designed to be placed in the forearm […]
Medtronic’s HeartWare faces 2 Class I FDA recalls
Medtronic (NYSE:MDT) said today the FDA labeled 2 outstanding global voluntary recalls related to subsidiary HeartWare International‘s HVAD system as Class 1. A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency. The voluntary recall is related […]