The FDA has given Delphinus Medical Technologies 510(k) clearance to market its SoftVue system, a whole breast ultrasound tomography device intended for use in diagnostic breast imaging after mammography. Testing with the device takes just about one to two minutes per breast.
The FDA has cleared Philips Healthcare to market its spectral breast density measurement tool. The technology, which is used in conjunction with the company's MicroDose SI full-field digital mammography device, is designed to measure volumetric breast density by distinguishing adipose from glandular tissue.
The FDA has granted U-Systems approval for its somo-v Automated Breast Ultrasound System, the first such device to be cleared in the U.S. as an ancillary tool to mammograms in screening women with dense breasts. The FDA said the device, which was initially approved in 2005 as a diagnostic tool, takes less than a minute to perform automatic breast scans.
The FDA has granted St. Jude Medical approval for its Epic replacement heart valve. The company plans to unveil the device, which uses a technology that helps keep tissue from hardening because of calcification, in early 2008.
The FDA has given Johnson & Johnson's Ethicon Endo-Surgery approval to market its Realize Band surgical implant device, designed to limit the food intake of patients with morbid obesity, the company said. The device moderates the digestion process while making patients feel full faster and longer.