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.
Taking a step forward in an increasingly crowded market that has long been dominated by non-Chinese players, Magassist Co. Ltd. got positive clinical results from its extracorporeal membrane oxygenation (ECMO) system Breathmo to provide support for patients with serious heart failure or lung failure, with a study showing that the system can provide pulmonary and cardiac support effectively and safely.
Riparian Pharmaceuticals Inc., a Viva Biotech Holdings Group portfolio company, has entered into an exclusive license agreement and research agreement with Pfizer Inc. in cardiovascular disease.
Several patents from Bristol Myers Squibb Co. describe relaxin receptor 1 (RXFP1; LGR7) agonists reported to be useful for the treatment of heart failure and fibrosis.
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