The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Limaca Medical for its Precision GI endoscopic ultrasound biopsy device. This clearance follows the device’s breakthrough designation in May 2022. The Precision GI device is designed to obtain biopsies for diagnosing pancreatic and gastrointestinal cancers. Initial patient trials have shown that the device can obtain contiguous intact core tissue samples that are adequate for definitive diagnoses of pancreatic lesions. The device’s design features a unique motorized, automated rotational cutting needle, which offers advantages over manual hand-operated biopsy devices. The Precision GI device has demonstrated faster tissue sampling times and higher histologic scores compared to another biopsy device in a first-in-human trial.
- Efficiency and Quality: The Precision GI device averaged a tissue sampling time of 3.87 minutes, compared to 5.64 minutes with another biopsy device. It also achieved a histologic score of 4.6 out of 5, compared to 3.2/5 with the other device.
- Unique Design: Unlike other endoscopic ultrasound fine-needle biopsy devices that require manual operation, Precision GI features a motorized, automated rotational cutting needle. This design ensures successful, safe, and high-quality tissue acquisition.
- Challenges with Existing Devices: Current endoscopic biopsy devices often face issues like tissue fragmentation, inadequate tissue amounts, and blood contamination. The Precision GI device aims to address these challenges and provide more consistent and high-quality tissue samples.