Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alivecor, Alr Technologies, Baxter, Tandem Diabetes Care.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Dariohealth, Geneoscopy, Sequana Medical, Teleflex.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Path, Invent Medical, Lucira Health.
The European Commission has awarded the CE mark to Hologic Inc. for its Genius Digital Diagnostics system for cervical cancer screening. According to the company, it is the first digital cytology platform to combine a new artificial intelligence (AI) algorithm with advanced digital imaging to assist cytotechnologists and pathologists in detecting precancerous lesions and malignant cells in women.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3D Systems, Allotrope Medical, Co-Diagnostics, Hologic, Safkan, Sommetrics, Tissium.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cala Health, Istar Medical, Liberate Medical, Qlarity Imaging.
PERTH, Australia – The COVID-19 pandemic has highlighted the importance of digital health technology, and the Australian government quickly enabled programs in telehealth and e-prescriptions. It now is embracing opportunities to build on this momentum to accelerate the country’s economic digital transformation. Not only will this transformation contribute to Australia’s recovery, but also to its long-term prosperity, said Sue MacLeman, chair of Australia’s Medical Technologies and Pharmaceuticals Industry Growth Centre (MTPConnect), during a recent ANDHealth teleconference.
The U.S. FDA granted 510(k) clearance to Lantheus Holdings Inc.'s artificial intelligence (AI)-enhanced automated bone scan index (aBSI) product for prostate cancer on GE Healthcare's Xeleris platform. ABSI improves quantification and management of disease progression in advanced prostate cancer patients.
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