Brazil Grants Regulatory Approval to ProSense Cryoablation System
The technology, created by IceCure Medical, freezes tumors and is an alternative to surgical intervention.
The Brazilian Health Regulatory Agency (ANVISA) granted regulatory approval to IceCure Medical’s ProSense System. The technology is approved for palliative intervention and the ablation of tumors (both benign and malignant) in skin, liver, lung, breast, prostate, and musculoskeletal tissue.
Eyal Shamir, IceCure’s CEO, said in a press release, “We are very pleased that ProSense has received regulatory approval in Brazil. We expect this to translate into near-term revenues. Early indications of market interest point to strong demand in the largest market in South America where cost-effective, minimally invasive, safe, and effective cryoablation procedures can offer great benefits compared to traditional surgical interventions.”
The technology works by freezing the tumors, which then in turn destroys them. When successful, it works as an alternative to surgical removal.
FDA issues de novo clearance for SonoMotion’s Stone Clear device, for kidney stone treatment
Stone Clear is the first and only device cleared by the FDA that uses external ultrasound pulses to facilitate passage of post-lithotripsy kidney stone fragments without surgery.
