Limaca Medical Ltd. received U.S. FDA 510(k) clearance for its Precision for gastrointestinal (GI) endoscopic ultrasound (EUS) biopsy device which the company said allows for faster, more efficient and safer collection of tumor tissue samples. The approval follows the receipt of breakthrough device designation, and the deployment of the device into the U.S. market should lead to more efficient and effective diagnosis of GI cancers.
LONDON – Ibex Medical Analytics is preparing for commercial rollout in Europe after receiving CE-IVD marking for its artificial intelligence (AI) decision support system for automated interpretation of prostate cancer biopsies. Galen Prostate, trained on more than 60,000 samples from multiple institutions, is intended to give a second opinion on digitized slides, following initial assessment by a pathologist.
PARIS – The European mammography division of GE Healthcare Inc., based in Buc, France, has just performed the first breast biopsy guided by angiomammography, using the Pristina Serena biopsy robot on a patient at the Gustave Roussy Institute in Villejuif, France.
Rarecyte Inc., a Seattle-based company making products for tissue and cell analysis, reported picking up $22 million in a series F financing round led by Healthquest Capital. Also participating in the round were existing investors 5AM Ventures and Ron Seubert, Rarecyte’s founder and chief technology officer. The company plans to use the funds to expand global sales of its instruments and consumables platform in research clinical markets.