FDA grants regulatory clearance to XSense Cryoablation System in many indications

Key takeaways:

• XSense Cryoablation System with CryoProbes is cleared for general minimally invasive cryoablation.
• The system can be used across specialties for conditions such as tumors, skin lesions, warts and more.

IceCure Medical has received marketing authorization from the FDA for its next-generation single probe cryoablation system, the company announced in a press release.

XSense Cryoablation System with CryoProbes is cleared for the general minimally invasive cryoablation across many specialties, including dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology and urology. Designed to destroy tissue with the use of extreme cold temperatures, XSense Cryoablation System with CryoProbes can treat fibroadenomas, kidney tissue, liver metastases, tumors, skin lesions and warts.

“This latest FDA regulatory clearance further validates the safety and efficacy of our platform cryoablation technology,” Eyal Shamir, MBA, CEO of IceCure, said in the release. “The next-generation XSense system is cleared for the same indications as our flagship ProSense system and we believe it has future potential to address other indications in the U.S. for significant indications with unmet needs.”

According to the release, using cryoablation for the treatment of tumors and other indications can help curb potential complications such as pain, surgical risks and a slow recovery.