Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: United Imaging Intelligence.
Loss of function variants in the lipid transporter gene ATP-binding cassette ABC transporter A7 (ABCA7) nearly double the risk of developing Alzheimer’s disease (AD), which makes ABCA7 the strongest AD genetic risk factor after ApoE4.
In a real-world study, Eko Health Inc.’s AI-enabled digital stethoscope dramatically increased detection rates for atrial fibrillation, heart failure and valvular heart disease in primary care settings. Researchers from Imperial College London presented results from the study at the European Society of Cardiology in Madrid.
Regulatory and reimbursement challenges in Europe are leading an ever-increasing number of med tech companies to prioritize the U.S. market for the launch of their devices. However, certain technologies can reach European patients more quickly, presenting valuable opportunities with the EU, delegates heard at the LSI Europe ’25 conference in London this week.
Health Canada posted a report on reduction of red tape, which includes a proposal for mutual recognition of other regulators’ inspections of device and drug manufacturing facilities.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bausch+Lomb, Caristo Diagnostics, Eko Health, GT Medical, Inspira.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biodesix, Bioaffinity, Datasea, Dnanexus, Fujifilm, Guardant, Ignite, Lunit, Masimo, Mendaera, Personalis, Royal Philips.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Centinel Spine, Fraiya, Naitive Technologies, Qiagen.
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