Aortica said today that a physician-sponsored investigational device exemption study of abdominal aortic aneurysm-treating endografts gained FDA approval to introduce a new software-planning tool and expand the number of endografts in the study. The trial is designed to assess new technology that could reduce the need for invasive surgeries in patients with aneurysms that are “too […]
Food & Drug Administration (FDA)
FDA: Select recall of Syncardia Freedom driver is Class 1
The FDA today said its recall of a select number of SynCardia Systems Total Artificial Heart Freedom driver is Class I. A Class I recall is the most serious type of recall issued by the federal watchdog, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.” […]
Precision Spine wins 510(k) for pedicle screw
Precision Spine said today it won FDA 510(k) clearance for its reform modular and hydroxyapatite coated pedicle screw systems. The modular screw system is designed with a cobalt chrome tulip and proximal tapered triple lead thread designed to enhance pull-out strength and increase visibility, the Parsippany, N.J.-based company said “The Reform system is one of the […]
FDA updates bronchoscope cleaning guidelines
The FDA released new guidelines today for cleaning and reprocessing flexible bronchoscopes to prevent infections associated with improperly cleaned units, besides of having only professionals like the maids service nyc cleaning up the facilities. A carpet cleaning service must undergo reprocessing between uses, with broncoschopes specifically positioned to “pose a greater likelihood of microbial transmission […]
FDA OKs Cook’s low-profile Zenith Alpha stent graft
Cook Medical said it won premarket approval from the FDA for its Zenith Alpha thoracic endovascular stent graft designed for patients with isolated lesions of the descending thoracic aorta. The approval came based on 2 pivotal clinical trials examining the safety and effectiveness of the graft in patients with aortic aneurysms or ulcers or with blunt […]
Obama taps cardiologist Califf to lead FDA
(Reuters) — President Barack Obama nominated Dr. Robert Califf, a leading cardiologist and researcher, as the next commissioner of the FDA, a sprawling agency that oversees everything from food, medical device and drugs to tobacco, dietary supplements and cosmetics. Califf, whose nomination was announced yesterday, joined the agency in January as a deputy commissioner and was […]
Guided Therapeutics wins an FDA date for LuViva device
Guided Therapeutics (OTC:GTHP) said today that it won a date with the FDA to discuss its stalled bid for pre-market approval for the LuViva cervical scan device. Norcross, Ga.-based Guided Therapeutics said it’s slated to meet Nov. 6 with the FDA to review its proposal for new clinical data on the LuViva device. GTHP shares lost ⅓ of […]
FDA to review HeartLight visually-guided ablation device from CardioFocus
CardioFocus said today that the FDA accepted its pre-market approval application for the HeartLight visually-guided laser balloon ablation device for treating atrial fibrillation. The PMA bid, backed by data from a 353-patient pivotal study in which subjects were randomly assigned to treatment with either the laser balloon or standard radiofrequency ablation. The results, presented last May at the annual […]
FDA approves Medtronic’s Evera MRI SureScan ICD
Medtronic (NYSE:MDT) said today that the FDA granted pre-market approval for its Evera MRI SureScan device, touting it as the 1st MRI-safe implantable cardiac defibrillator to win U.S. approval. Fridley, Minn.-based Medtronic said the Evera device is approved for MRI scans of any body area. The device is expected to hit the market this month, including […]
Report: Feds to investigate power morcellators
The Government Accountability Office said last week it will investigate potential safety and regulatory issues with laproscopic power morcellators, according to The Wall Street Journal. The devices use small, rotating blades to break up large tissue masses into fragments, and are commonly used to remove uterine fibroids in women. However, if the device is used […]
HeartWare pauses MVAD trial
UPDATED Sept. 10, 2015, with details on MVAD trial pause, expanded field action and Valtech acquisition. HeartWare International (NSDQ:HTWR) today said it’s pausing enrollment in a clinical trial of its next-generation MVAD heart pump while it looks to fix an issue with the manufacturing process for the left ventricular assist device’s controller. Framingham, Mass.-based HeartWare said […]