PROCEPT BioRobotics(PRCT.US) has received FDA approval for the HYDROS robotic system, causing the stock price to rise nearly 30%.

PROCEPT BioRobotics Inc. (PRCT.US), a surgical robotics company focused on innovative solutions for urology, announced on Wednesday that its HYDROS robotic system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the treatment of benign prostatic hyperplasia (BPH), a non-cancerous enlargement of the prostate gland. Shares of the company jumped on the news. By the end of trading Wednesday, shares had surged more than 28%, and the stock maintained its momentum in after-hours trading, rising another 3% or more.

PROCEPT BioRobotics, based in San Jose, California, said the FDA clearance for the artificial intelligence platform marked its entry into the U.S. market. The HYDROS robotic system provides water vapor therapy for BPH patients by combining real-time ultrasound imaging and cystoscopy data.

The system draws on more than 50,000 procedures of experience, with FirstAssist AI treatment planning, advanced image-guided technology, robotic resection capabilities and streamlined workflows. HYDROS is designed to improve efficiency, optimize the surgeon and medical team experience and provide more precise and consistent treatment plans to achieve better clinical outcomes.

The multi-dimensional visualization capabilities of the HYDROS system enable surgeons to customize individualized treatment plans for each patient, effectively relieving symptoms while minimizing impact on patients’ sexual function and continence.

Although PROCEPT BioRobotics plans to fully launch the HYDROS system in the current quarter, the company reiterated its previously announced annual financial guidance. The clearance not only presents new growth opportunities for the company but also signals a new chapter in the technological innovation of urology treatment.