Medtronic plc launched the newest product in its coronary portfolio, the Prevail drug-coated balloon (DCB) catheter, in Europe following CE mark approval. The device is intended for use during minimally invasive procedures to open narrowed or clogged arteries in patients with coronary artery disease. Read More
Researchers from Finland and Italy published a biomarker-based algorithm for the diagnosis of dementia in the journal Diagnostics. The algorithm enables clinicians to distinguish between various neurodegenerative diseases with shared clinical presentations and select appropriate treatment. The algorithm relies primarily on blood biomarker measurements to diagnose the type of dementia much earlier than is possible with the diagnostic tools in use today. Read More
The FDA advisory hearing for the Transmedics Organ Care System (OCS) resulted in a unanimous vote in favor of the OCS’s safety and efficacy numbers, although there will be a considerable post-approval study requirement. The company was able to overcome a number of problems with the pivotal study that might otherwise have tanked the application, such as the lack of blinding of transplant surgeons, which the FDA said could have biased the determination of whether a liver was acceptable for transplant. Read More
PARIS – The French government reported setting up the “Artificial Intelligence and Cancer” association, a public-private partnership that brings together the French National Cancer Institute (INCA), the Health Data Hub and the Health Industry Alliance for Research and Innovation (ARIIS), along with eight commercial firms. The eight commercial firms, whose identities have not yet been released, are drawn from a large consortium of pharmaceutical and information technology firms and health care insurers, that has been around since 2019. Read More
TORONTO – What do ER doctors want most for their patients? Never to return to the ER, said Giovanni Ferrara, a professor at Edmonton’s University of Alberta Hospital's Division of Pulmonary Medicine. Ferrara is heading a feasibility project to see if a wearable device developed by Rochester, N.Y.-based Heath Care Originals Inc. can predict with scientific certainty when the condition of a patient with lung disease is worsening and requires another visit to the hospital. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Caredx, Johnson & Johnson Vision, Medtronic, Neurometrix. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Alere, Beckman Coulter, Eyenuk, Gamidor Diagnostics, Pixcell Medical, Quidel, Speedx, Sqi Diagnostics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Evren. Read More
