News
Artera's prostate biopsy and breast cancer assays receive CE mark
4+ hour, 32+ min ago (271+ words) The Artera AI prostate biopsy assay predicts the risk of prostate cancer progression. Artera has secured CE marking under the European Union In Vitro Diagnostic Regulation (EU IVDR) for its Artera AI prostate biopsy and breast cancer assays, expanding the…...
FDA clears Sibel Health's ANNE Maternal wireless system
1+ week, 5+ day ago (325+ words) ANNE Maternal is a sister platform to ANNE One, which has also been cleared by the FDA for adolescent and adult monitoring. Sibel Health has received 510(k) clearance from the US Food and Drug Administration (FDA) for ANNE Maternal, a wireless…...
Clairity raises $43m to fuel US rollout of AI breast cancer platform
5+ mon, 1+ week ago (367+ words) Clairity Breast is claimed to be the first FDA-authorised platform for predicting a woman's five'year risk of developing breast cancer via mammogram analysis. Clairity has concluded a $43m funding round, setting the company up to advance commercialisation efforts for its AI-powered…...
FDA approves Ice Cure's Pro Sense system for breast cancer
6+ mon, 2+ week ago (370+ words) Ice Cure Medical has received US Food and Drug Administration (FDA) marketing authorisation for its Pro Sense cryoablation system to treat breast cancer." The FDA's approval requires Ice Cure to conduct a post-market surveillance study involving around 400 patients across 30 sites…...
Global Data highlights current and future landscape of breast cancer IVDs
6+ mon, 4+ week ago (606+ words) IVD devices enable earlier breast cancer diagnoses than mammograms, and detect genetic abnormalities that can contribute to the disease. October is Breast Cancer Awareness Month. Breast cancer is the most frequently diagnosed cancer in women globally. A key factor in…...
University of Turku develops probe to visualise breast cancer cell movement
10+ mon, 2+ week ago (317+ words) Finland's University of Turku researchers have developed a fluorescent probe for visualising the signalling dynamics in cancer cells that move, potentially opening new therapeutic avenues for breast cancer treatment. The team, spearheaded by Dr James Conway and Professor Johanna Ivaska,…...