Daily Newsletter

12 September 2023

Daily Newsletter

12 September 2023

Limaca receives clearance from US FDA for biopsy device

The device helps enhance the diagnosis of GI cancers by generating a higher quality of diagnostically relevant biopsy tissue.

RanjithKumar Dharma September 12 2023

Limaca Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Precision GI endoscopic ultrasound (EUS) biopsy device.

This approval comes after the company received breakthrough device designation from the regulator for the device.

The automated device obtains biopsies for definitive pancreatic cancer and gastrointestinal (GI) cancer diagnoses more rapidly and less traumatically compared to existing products.

Limaca vice-chair Carl Rickenbaugh said: “We are dedicated to our mission to provide a far better endoscopic biopsy experience for the endoscopist and patient, with the goal of achieving faster, more efficient biopsy yield with highly consistent results. We look forward to soon bringing Precision GI to patients in the US.”

Limaca has designed the device to enhance the diagnosis of GI cancers by generating a higher quality and quantity of diagnostically relevant biopsy tissue.

It features a motorised, automated rotational cutting needle, which facilitates safe and high-quality tissue acquisition.

Limaca CEO Assaf Klein said: “The clean, non-contaminated tissue samples provide a high percentage of tumour content, with less blood and extraneous fluids.

“FDA clearance allows us to bring Precision GI to market to fulfil our mission to always achieve precise, efficient and definitive biopsy samples.”

Limaca is focused on the development and commercialisation of medical devices for gastroenterology and pulmonary cancers.

Generative AI set to transform the medical devices industry

Generative AI can improve personalized healthcare by collecting data from patients via wearable devices, which can provide continuous, real-time data that can complement traditional data sources such as imaging, patient records, and more. It can also enhance existing imaging techniques by generating high-quality images of organs using data from low-resolution images (such as ultrasounds). However, the collection and use of patient healthcare data through AI medical products could conflict with regulations around the globe.

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