AngioScore has obtained 510(k) clearance from the FDA to market its AngioSculpt balloon catheter for use in the dilatation of lesions in renal arteries. The company said it expects its percutaneous transluminal angioplasty device, which already is cleared for the treatment of lesions in other types of arteries, could help treat those with renal artery stenotic disease.
The FDA has granted investigational device exemption approval to CardioVascular Systems to allow it to test its Diamondback 360 catheter in patients with calcified coronary lesions. The FDA cleared the device in 2007 as a treatment for peripheral arterial disease.
Scintimammography developer Dilon Technologies said its
breast-specific gamma imaging system helped reduce the number of unnecessary biopsies compared with MRI and saved patients from more invasive surgeries.
Dilon Technologies has signed a three-year deal with MedAssets Supply Chain Systems that will give MedAssets customers access to the Dilon 6800 Gamma Camera. The breast-specific gamma-imaging tool can detect cancer in its early stages.