Merit Medical receives FDA clearance for new biopsy system

Merit Medical, a medical device company based out of South Jordan, Utah, announced this week that it has received 510(k) clearance from the FDA for its Corvocet Biopsy System.

The Corvocet Biopsy System was developed for obtaining core biopsy samples from the liver, kidney, prostate, breast, lung, and other soft tissue tumors.

"The Corvocet Biopsy System is Merit’s first entry into the biopsy market and is the first of several biopsy devices we expect to introduce in the future," Fred P. Lampropoulos, Merit chairman and CEO, said in a prepared statement.

Merit said in its statement the system is scheduled to be introduced in the United States “over the next thirty days or so.” A European release will follow once it receives the CE mark.

Michael Walter
Michael Walter, Managing Editor

Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.

Around the web

The patient, who was being cared for in the ICU, was not accompanied or monitored by nursing staff during his exam, despite being sedated.

The nuclear imaging isotope shortage of molybdenum-99 may be over now that the sidelined reactor is restarting. ASNC's president says PET and new SPECT technologies helped cardiac imaging labs better weather the storm.

CMS has more than doubled the CCTA payment rate from $175 to $357.13. The move, expected to have a significant impact on the utilization of cardiac CT, received immediate praise from imaging specialists.