Thermedical announced today that it received FDA approval for a clinical trial to evaluate its SERF ablation system. Waltham, Massachusetts-based Thermedical will conduct an open-label, single-arm interventional clinical trial to evaluate the safety and efficacy of the Thermedical SERF ablation system with the Durablate catheter in people with ventricular tachycardia (VT) resistant to conventional treatment. […]
Thermedical
Thermedical wins FDA nod for Durablate catheter trial
Thermedical said today that it won an investigational device exemption from the FDA for a clinical trial of its Durablate catheter for treating ventricular tachycardia. The Durablate catheter is designed to simultaneously inject hot saline and use radiofrequency energy to effect the ablation; the Thermedical claims that the method is 20 times more effective than conventional RF […]
Thermedical raises $3m for tissue ablation device
Thermedical raised $3 million in a new round of funding, according to regulatory filings. The private company is developing a treatment for ventricular tachycardia, an irregular heartbeat that can result in sudden cardiac arrest, and a treatment for soft tissue conditions, including liver, kidney, lung and uterine tumors. The company’s ablation system uses saline-enhanced radio […]
Thermedical adds $5M to Series A round for tissue ablation device
Thermedical said it raised $5 million in a Series A2 round for the soft tissue ablation technology it’s developed.
The Waltham, Mass.-based medical device company said the round, led by chairman Samuel Maslak and Karl Johannsmeier, takes its total outside investment to $7 million.
Thermedical lands FDA nod for its new ablation system
Waltham, Mass.-based medical device company Thermedical landed FDA clearance for its new ablation system, designed to coagulate and ablate soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.
The regulatory win allows Thermedical to market its ablation systems in the U.S. and to investigate the impact of the technology in treating large, solid tumors in clinical testing.*
Analyst: CRM market “bad as it’s ever been” | Wall Street Beat
The cardiac rhythm management market is "about as bad as it has ever been," according to an analyst with Gabelli & Co., due in part to headwinds from a federal probe and a negative journal article.
