Stemming from this alleged oversight, a “threat actor” gained access to its network and stole personal health information from 198,260 patients across the U.S. 

The civil case has a very high profile since the story unfolded in excruciating detail in a widely viewed documentary.

"Instead of Congress making payment adjustments every year, it's time we address the underlying issues and make long-term reforms," said Sen. John Thune. 

The FDA issued its own statement about the approval, highlighting the importance of taking the drug in combination with an improved diet and regular physical activity.  

Ultromics thinks the significant payment increase will help ramp up utilization among U.S. healthcare providers.

The system, designed for patients with uncontrolled hypertension who are unresponsive to medication, uses ultrasound ablation to target nerves in the renal arteries, increasing blood flow. This approval comes just months after an FDA advisory panel voted in favor of the system. 

The agency received “considerable interest” in a comment solicitation on this topic, with respondents providing “various insights and potential policy changes.” 

Radiology Business Management Association leaders contend that slashing Medicare reimbursement "ignores overwhelming public wisdom."