Mayo Clinic launches two tech companies modernhealthcare.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from modernhealthcare.com Daily Mail and Mail on Sunday newspapers.
By Yakir Benzion, United With Israel
The Israeli medical device company IceCure received a huge boost after American authorities approved the company’s revolutionary ProSense system for treating cancerous tumors by freezing them,
Globes reported Sunday.
The U.S. Food and Drug Administration (FDA) gave marketing approval to ProSense as part of the FDA’s Breakthrough Devices Program that fast-tracks new devices to the market.
Based in Caesarea, north of Tel Aviv, and with offices in America, IceCure Medical developed a system that uses liquid nitrogen-based technology to freeze tumors so they can be removed without the need for surgery.
Shoshanna Solomon is The Times of Israel s Startups and Business reporter
The technology developed by IceCure Medical Ltd. destroys tumors by freezing them in a minimally invasive procedure with no surgery or hospitalization requirement (Courtesy)
IceCure Medical, an Israel-based maker of tumor-freezing technology, said Sunday that it had received notification from the US Food and Drug Administration recognizing its ProSense product as a “breakthrough device” to freeze tumors in a number of medical conditions including breast cancer.
The breakthrough devices recognition is given by the FDA for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, IceCure Medical said in a filing to the Tel Aviv Stock Exchange, where its shares are traded.
Medicare Coverage Breakthrough Delayed | King & Spalding jdsupra.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from jdsupra.com Daily Mail and Mail on Sunday newspapers.
Share this article
Share this article
PORTLAND, Ore., Feb. 23, 2021 /PRNewswire/ Inovise Medical today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its AUDICOR
® heart failure management system. The system uses clinically tested algorithms to detect the risk of decompensation at home in patients who have been previously hospitalized for heart failure.
Inovise Medical, Inc.
Michael Mirro, MD, Director of the Parkview Mirro Center for Research and Innovation, and Clinical Professor of Medicine at Indiana University, commented, This technology promises to enhance the management of heart failure patients and keep them out of the hospital. Early detection of potential problems outside of the hospital can allow clinicians to modify the patients therapeutic regimens and maintain their stable condition.