SonaCare Medical LLC
Latest From SonaCare Medical LLC
The global market for prostate cancer diagnostics is expected to see double-digit growth, reaching $460.5m in 2023 and is driven by new technologies, in particular liquid biopsies and new genetic marker tests, according to a new report by Informa's Meddevicetracker.
Almost four years after the agency first authorized a prostate ablation device, regulators have proposed a number of requirements for clinical studies that sponsors would have to meet to comply with special controls needed for the devices to be cleared for marketing.
Cancer rates are rising worldwide and as diagnostic techniques continue to improve, new surgical ablation devices are becoming crucial weapons in the growing arsenal of cancer treatment tools. These devices allow doctors to burn away tumors with precision, speed and safety, without the side-effects that patients undergoing radical cancer therapy often experience. This article provides an overview of the cancer ablation market, highlights the key players working on these devices and discusses their potential applications. It also includes critical insights from a leading interventional urologist on the pros and cons of using these various technologies in treating prostate cancer.
With the 510(k) clearance of EDAP TMS' Ablatherm HIFU and the first US procedure performed with SonaCare Medical's recently cleared Sonablate system, a European rivalry in high-intensity focused ultrasound machines for prostate cancer has moved to the US. And EDAP's CEO argues it was positive for long-term adoption that his firm's system ultimately gained 510(k) clearance as a surgical tool rather than the originally sought PMA approval for a prostate cancer indication.
Diagnostic Imaging Equipment & Supplies
- Diagnostic Imaging Equipment & Supplies
- Therapeutic Areas
- US HIFU LLC
- North America
- Parent & Subsidiaries
- SonaCare Medical LLC
- Senior Management
Michael Klein, CEO
Naren Sanghvi, PhD, CSO
John Linn, VP, Fin.
- Contact Info
SonaCare Medical LLC
Phone: (704) 332-4308
801 E. Morehead St.
Charlotte, NC 28202
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