Experts, medical organizations and advocates alike are coming forward saying that the new guidelines “do not go far enough,” particularly when it comes to addressing the screening needs of certain patients. 

The suit claims the group wrongfully billed CMS for over $6 million in image reads that did not qualify for Medicare reimbursement due to the subpar computer monitors used to view the studies.

The clearance covers the use of Sectra’s digital review application in conjunction with Leica’s Aperio GT 450 DX scanner.

The Amsterdam-based industry giant has extended its inspection window to ensure that no additional imaging equipment recalls are missed.

LumiSystem enables surgeons to intraoperatively illuminate residual cancerous tissue in the breast cavity during lumpectomy surgery.

There have been a total of 11 incidents so far, including seven injuries and two deaths. Boston Scientific said the agent can still be used if operators follow specific instructions during lower GI bleed embolization procedures.  

Fast Track designations are typically granted to drugs that target an unmet medical need. 

Interventional procedures play an integral role in managing traumatic pediatric injuries nonoperatively, though specific guidelines for the use of endovascular interventions in this setting have not been fully defined prior to these latest recommendations.