Ultromics Ltd.’s Echogo Heart Failure system detects heart failure with preserved ejection fraction (HFpEF) from a single apical four-chamber video clip, according to a study published in JACC Advances. The study follows a consensus statement from American College of Cardiology which said that although there are now effective therapies to treat HFpEF, there is an increasing urgency for accurate diagnosis as the number of patients with HFpEF is on the rise, accounting for more than 50% of all heart failure cases.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ceribell, Polarean.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bridge to Life, Curetis, Grail, Mirvie, Pacbio, Realm Idx, Roche, Synaptic, Sysmex, Transmedic, Vicarious.
A huge sigh of relief from the life sciences industry greeted U.S. President Joe Biden’s executive order that’s intended to shore up domestic manufacturing of products developed with taxpayer support. “It’s like the Titanic, [but] we just missed the iceberg,” Joseph Allen, executive director of the Bayh-Dole Coalition, told BioWorld. The fear for the past few years has been that the administration would follow in the wake of the Department of Energy, which broadly expanded the current Bayh-Dole U.S. manufacturing preference.
The first participants are being treated in a clinical trial assessing a neuromodulation system developed by Magnus Medical Inc. to treat depression. The system employs the recently FDA-cleared Saint neuromodulation technology that saw remarkable results in a clinical trial for treating major depressive disorder (MDD). The new Open Label Optimization (OLO) clinical trial is evaluating the effectiveness of this platform in conjunction with the medtech’s Magnus Neuromodulation System.
The U.S. Centers for Medicare & Medicaid Services (CMS) finalized the Medicare inpatient prospective payment system for fiscal year 2024 with a number of new and renewed new technology add-on payments (NTAPs) for the coming fiscal year. Controversially, however, the agency retained a proposal from the draft that requires that a product have received market authorization from the FDA by no later than May 1 of the prior fiscal year to qualify for NTAP payment, a provision that industry has blasted as exclusionary of products that merit an NTAP payment.
The FDA’s recent clearance of Ultrasight Inc.’s artificial intelligence (AI)-powered ultrasound guidance technology will allow for the widespread detection of heart diseases in the U.S. and ease bottlenecks in the healthcare system that currently restrict access for many people, Davidi Vortman, CEO of Ultrasight told BioWorld. Ultrasight’s software helps medical professionals without sonography experience acquire cardiac ultrasound images at the point of care in multiple settings.
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