FDA clears Prana System, a minimally invasive tool for tiny lung nodules

Prana Surgical’s new electrosurgical device received FDA clearance in April 2026, offering a lung-lumpectomy alternative for small nodules and aiming to improve outcomes for women with lung cancer.

In April 2026 the FDA approved Prana Surgical’s Prana System, a disposable electrosurgical device that combines CT-guided targeting with bipolar radiofrequency to remove tiny peripheral lung nodules in a single minimally invasive step. Early feasibility procedures performed at St. Vincent’s Hospital Melbourne in early 2026 demonstrated successful removal of nodules ranging from 4 to 10 mm, addressing a clinical need for patients who would otherwise face watchful waiting or extensive surgery.

Joanna Nathan, the company’s CEO, frames the technology as a “lumpectomy of the lung,” hoping it will benefit the growing cohort of women diagnosed with lung cancer, who now outnumber men for the first time. The tool arrives amid low federal funding for lung-cancer research and expanding low-dose CT screening that is expected to generate a surge of small nodule detections. Prana has raised about $14 million from investors including Johnson & Johnson, Texas Medical Center Venture Fund, New World Angels and cultivate(MD) Capital Funds, plus $4 million in grants from CPRIT. The company plans a staged rollout with select thoracic surgeons in the United States before broader commercial launch.