The American College of Cardiology (ACC) hopes artificial intelligence (AI) can dramatically increase adoption of its frequently ignored guidelines for cardiovascular care. In three new studies, the ACC will implement Healthreveal's AI to recommend personalized interventions with the goal of preempting adverse cardiovascular events and improving patient outcomes, while increasing physicians’ adherence to guideline-directed medical therapy.
CMS has posted the draft Medicare inpatient rule for fiscal year 2022, replete with the usual controversies over reassignment of procedures under the Medicare diagnostic grouping system. One bit of good news is that the agency may carry over several expired new technology add-on payments (NTAPs) into the coming fiscal year, a move prompted by the difficulty of collecting claims data from fiscal year 2020 due to the COVID-19 pandemic.
Medtronic plc reported positive interim results on the first 171 patients implanted with Evolut transaortic valve replacement (TAVR) devices in its OPTIMIZE PRO clinical trial. The postmarket, prospective, multicenter study is assessing procedural outcomes, including pacemaker rate, associated with in-procedure techniques and post-procedure TAVR care pathways when using the self-expanding, supra-annular Evolut Pro and Pro+ TAVR systems in patients with symptomatic severe aortic stenosis.
Twenty years after the first, exclusively white human genomes were fully sequenced, science finds itself in the same position as the rest of society: with the uncomfortable realization that old inequalities are often morphing, rather than disappearing. Vocal racists – scientists of the stripe of a James Watson – are by no means a thing of the past. But they are only the tip of the iceberg.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Task force affirms hypertension screening recommendation; FDA adds to list of recognized standards; New Jersey DOJ office announces $93M fraud take-down.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: International Medical Solutions, Magventure, Pixee Medical.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Corwave, Fast Biomedical, Medrhythms, Medtronic, Paragonix, Smith+Nephew, Veracyte.
New hires and promotions in the med-tech industry, including: Abiomed, Becton Dickinson, Caris, Healthware Group, Medminder, Mimedx, Quanterix, Revibe.