Limaca Medical Receives FDA Approval for Cutting-Edge Precision GI™ Endoscopic Biopsy Device
Limaca Medical has officially announced that its Precision GI™ Endoscopic Ultrasound (EUS) Biopsy Device has received FDA 510(k) clearance. This development comes after Limaca had previously obtained FDA Breakthrough Device Designation for its Precision GI™ technology. The Precision GI™ device is poised to revolutionize the diagnostic process for critical GI cancers such as pancreatic cancer, promising faster and less invasive biopsy procedures compared to existing devices.
What sets Precision GI™ apart is its automated design, offering increased efficiency and precision in diagnosing GI cancers. This innovation results in significantly higher-quality and quantity of biopsy tissue with diagnostic relevance. In contrast to all current endoscopic ultrasound fine needle biopsy (EUS-FNB) devices that require manual operation, Precision GI™ incorporates a unique motorized, automated rotational cutting needle, ensuring successful, safe, and high-quality tissue acquisition.
Initial trials with a group of patients have shown that Precision GI™ enables the retrieval of contiguous intact core tissue samples sufficient for precise diagnoses of pancreatic lesions. These samples are known for their cleanliness, absence of contaminants, and a high percentage of tumor content, with minimal blood and extraneous fluids.
Precision GI™ opens the door to its introduction in the market, aligning with Limaca Medical's commitment to consistently provide precise, efficient, and definitive biopsy samples. This achievement has the potential to transform the landscape of GI cancer diagnosis, offering optimism to both patients and healthcare providers.