Nearly a third of the 25 radiology-related applications passing FDA muster in April address radiation oncology. The rest were split among MRI, ultrasound, image management, and nuclear medicine. Standouts included two ultrasound systems, an x-ray
Nearly a third of the 25 radiology-related applications passing FDA muster in April address radiation oncology. The rest were split among MRI, ultrasound, image management, and nuclear medicine. Standouts included two ultrasound systems, an x-ray fluoroscope dedicated to urology, and an MRI upgrade.
Pentax Precision Instrument of Orangeburg, NY, gained 510(k) clearance April 17 for its Fiber Ultrasound Gastroscope, an endoscope that combines optical and ultrasonographic visualization. The system, designated FG-36UX, is designed for use in the upper gastrointestinal tract: esophagus, stomach, duodenum, small bowel, and underlying areas. One point of the bifurcated umbilicus is connected to an ultrasound scanner, and the other to a light source with air/water and suction controls. The branch dedicated to optical imaging contains fiber bundles for illuminating the body cavity and then optically visualizing the anatomy. A convex linear transducer provides ultrasonic data. The instrument is also equipped with two biopsy forceps. The control body allows up and down and left and right angulation, accessory elevator control, and delivery of air and water, as well as the modulation of suction.
Type 2102 from B-K Medical of Denmark is a shared services ultrasound product designed for applications in urology, cardiology, and ob/gyn. The system, which offers B-mode, M-mode, color Doppler, pulsed-wave Doppler, and harmonic imaging, cleared the FDA April 3. It can be used diagnostically and to guide biopsy. Transducers feature linear and convex arrays, as well as a mechanical sector.
The FDA granted permission April 12 for Siemens Medical Solutions to market its U04 urology system. The fluoroscopic x-ray system is designed for urologic, gastroenterologic, and gynecologic treatment, planning, and diagnostic procedures. The product features an undertable image intensifier and can be operated using either tableside handheld controls or from a control desk. System and stand are based on components built into Siemens’ Iconos R200 product. The primary distinction between the new device and preceding ones is a digital imaging system with CCD camera built into the U04.
Fiesta 2-D and 3-D, developed by GE Medical Systems, are designed to enhance contrast and temporal resolution in MRI scans. The option, which was cleared April 11 by the FDA, uses balanced gradients to maintain phase coherence of transverse magnetization. The agency judged Fiesta to be substantially equivalent to the fast gradient-echo technique implemented in the Signa CV/i system, which is optimized for cardiovascular imaging. Intended for whole-body applications, Fiesta 2-D may be especially helpful in imaging dynamic structures, such as the heart. Fiesta 3-D may be particularly useful in imaging of the bile ducts and may also be suited for rapid acquisition of such static structures as joints and the cochlea, in which high spatial resolution is important.
Three of the oncology products cleared by the FDA were radionuclide products designed for implantation. One of these, GliaSite RTS (radiation therapy system), was evaluated in both in vitro and clinical testing by developer Proxima Therapeutics of Alpharetta, GA. In vitro tests demonstrated substantial equivalence to existing brachytherapy applicators. A multicenter phase II clinical study demonstrated safety and effectiveness in patients with resected intracranial tumors, according to the company. The product, which cleared the FDA April 25, is designed specifically for treating malignant brain tumors following tumor resection. It includes a catheter and accompanying tray, an iodine-125 radiation source called Iotrex, and an access tray. The catheter is a double-balloon applicator that positions the radiation source within a resected cavity. The access tray contains items needed for afterloading and retrieval of the radiation source.