IceCure Medical (Nadsaq:ICCM) announced today that the FDA responded affirmatively to a request for supervisory review. This follows the agency’s 2022 denial of IceCure’s de novo classification request for its ProSense cryoablation system. The Caesarea, Israel-based company sought clearance for ProSense to treat patients with early-stage, low-risk breast cancer. FDA’s affirmative response reopens the de […]
IceCure Medical Ltd.
IceCure Medical today said it received FDA breakthrough device designation for its ProSense cryoablation system. ProSense is a liquid nitrogen-based cryoablation system that is a minimally invasive treatment for cancer tumors. It is designed for use in the treatment of TI invasive breast cancer or in patients not suitable for surgical alternatives for treating breast […]
IceCure Medical said today that it has signed Terumo (OTC:TRUMY;TYO:4543) as the exclusive distributor of its tumor-freezing technology in Japan and Singapore. Terumo will pay IceCure $2 million for the distro rights if IceCure obtains the appropriate regulatory approvals for its ProSense cryoablation device, designed to treat malignant breast tumors without surgery. This will include […]
IceCure Medical yesterday said it received Israeli AMAR authorization to use its freezing technology in specific indications. The approval will allow the Israel-based company to use the technology to freeze benign and malignant tumors, including breast, lungs, bones, liver, lymphatic tissue, lymph nodes and endocrine glands. “This specific approval in Israel is an important achievement […]
IceCure Medical yesterday released data from an interventional radiology study of its liquid-nitrogen-based cryoablation technology. Results from the study were presented at the Annual European Association of Urology Congress in Barcelona, the Israel-based company said. IceCure Medical’s ProSense cryoablation system uses liquid nitrogen technology for the treatment of benign and cancerous tumors through freezing, the […]
MASSDEVICE ON CALL — A duo of U.S. veterans filed a lawsuit against the Veterans Administration this month after a South Carolina medical center reported a missing laptop with records on more than 7,000 patients.
Earlier this year the William Jennings Bryan Dorn VA Medical Center in Colombia reported a laptop missing from a testing lap in the center’s respiratory therapy department, warning that the theft may have exposed patients’ names, birth dates, and the last 4 digits of their social security numbers, among other information.
Through an innovative partnership with an Israeli technology incubator, Akron venture capital firm Everett Partners is hoping to bring several medical device firms’ U.S. headquarters to Northeast Ohio.
Israeli device company IceCure Medical Ltd. scoped Cleveland for its U.S. headquarters, a move the company’s CEO hinted at in February.
IceCure’s lead product, IceSense3, freezes and destroys benign breast tumors using cryoblation, a technique using extreme cold to kill tissue. It won 510(k) clearance from the U.S. Food and Drug Administration late last year.
The company plans to open its U.S. headquarters at the Cleveland Clinic-led Global Cardiovascular Innovation Center campus on June 1, according to a statement from IceCure.