FDA clears Ethicon's 1st surgical set docs can assemble inside the body | Regulatory Roundup

The FDA grants de novo clearance to Johnson & Johnson subsidiary Ethicon Endo-Surgery's Percutaneous Surgical Set; European resolutions post-breast implant scare raise eyebrows among device makers; FDA grants PMA to Medinol's Presillion coronary stent; Nephros lands 510(k) for Hemodiafiltration; Toshiba touts FDA clearance for Aquilion Prime 80 CT system; Theragenics scores FDA clearance for Market Galt valved tearaway introducer; Spectranetics wins FDA clearance for its GlideLight laser sheath; and more.