Biopsys resolves FDA labeling issue
Mammography biopsy developer Biopsys of Irvine, CA, announcedlast week that the Food and Drug Administration has accepted itsplan to resolve the agency's concerns about labeling of the company'sMammotome biopsy device. The FDA was concerned about
Mammography biopsy developer Biopsys of Irvine, CA, announcedlast week that the Food and Drug Administration has accepted itsplan to resolve the agency's concerns about labeling of the company'sMammotome biopsy device. The FDA was concerned about marketingmaterials for Mammotome that suggested that the device could beused for therapeutic applications, such as complete excision ofsuspicious breast lesions (SCAN 2/19/97).
As part of the resolution, Biopsys on Feb. 12 submitted a new510(k) application for Mammotome indicating that the product isspecifically intended for breast biopsy for diagnostic purposes.Biopsys will be able to continue selling Mammotome while the FDAreviews the new 510(k).
FDA Clears Virtually Helium-Free 1.5T MRI System from Siemens Healthineers
June 26th 2025Offering a cost- and resource-saving DryCool magnet technology, the Magnetom Flow.Ace MRI system reportedly requires 0.7 liters of liquid helium for cooling over the lifetime of the device in contrast to over 1,000 liters commonly utilized with conventional MRI platforms.
