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.
Lexeo Therapeutics Inc. has announced that its IND for LX-2020 has been cleared by the FDA. LX-2020 is an AAVrh10-based gene therapy candidate designed to intravenously deliver a functional PKP2 gene to cardiac muscle for the treatment of arrhythmogenic cardiomyopathy (ACM) caused by variants in PKP2 (PKP2-ACM).
Cardiologists have debated for some time whether obstructive sleep apnea (OSA) is a proven factor in a patient’s risk for heart disease, but the U.S. National Institutes of Health says newly published studies identify the specific mechanisms for this association. The studies offered data from more than 4,500 subjects and affirms the notion that OSA-driven hypoxia correlates well with the occurrence of a primary cardiovascular event, but the NIH says these findings need to be confirmed in another trial, hopefully one with enrollees whose OSA is deemed a high-risk version of the condition.
During the week of July 24, 2023, the FDA published several notifications of potentially elevated risks associated with medical devices, including a recall of a delivery sheath for the Amplatzer device by Abbott Laboratories. The agency also announced that Abiomed Inc. will provide a correction for the instructions for use (IFUs) for the Impella because of an issue seen when implanting the left ventricular assist device in patients with transcatheter aortic valve replacement (TAVR) devices.
Arsenal Medical Inc. said its Neocast embolic material for neurovascular conditions was successfully used to treat its first patient. The patient was embolized as part of a first-in-human study to assess the safety and feasibility of Neocast for the embolization of brain tumors to more easily enable surgical removal.
Hangzhou Adamerck Pharmlabs Inc. has disclosed uracil derivatives reported to be useful for the treatment of cardiovascular and cerebrovascular disorders.
The U.K. government and the health care industry should focus more on behavioral-based approaches and preventative care in a bid to tackle health inequality, rising costs and an ageing population, Anton Derlyatka, CEO and co-founder of Sweatcoin Ltd., told BioWorld. Sweatcoin is a step-counting app that rewards users for their daily steps. The company has worked with the NHS for the last three years and is currently working on pilot programs to help tackle type 2 diabetes and cardiovascular diseases by incentivizing people to move.
Protein tyrosine phosphatase nonreceptor type 22 (PTPN22) has been previously linked to several chronic inflammatory disorders and it has been established that PTPN22 regulates T-cell receptor signaling. Recent studies have also shown that PTPN22 plays a role in thrombosis, suggesting its potential use as target for cardiovascular diseases. In the current study, researchers from Southern Medical University and affiliated organizations aimed to assess the role of PTPN22 in the pathogenesis of calcific aortic valve disease (CAVD).
Australia’s Therapeutic Goods Administration (TGA) is reconsidering its approach to regulating devices that bear materials of animal, microbial or recombinant origin, a broad class of products that includes transcatheter aortic valve replacement (TAVR) devices.
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