Avicenna.AI has enjoyed a head-spinning series of regulatory nods for its artificial intelligence (AI)-based solutions for serious vascular conditions including stroke, pulmonary embolism (PE) and aortic dissection. The Marseille, France-based company gained CE mark for its tool that quantifies the severity of a stroke based on a CT scan of the brain and displays regions that have suffered infarcts in late May, followed by CE mark and FDA 510(k) clearance for its product that permits emergency triage of PE and aortic dissection from CT-scan imaging in early June.

Medtronic plc won expanded FDA 510(k) approval for its Arctic Front family of cardiac cryoablation catheters for alternative treatment of recurrent symptomatic paroxysmal atrial fibrillation (AF) as an alternative to the current standard first-line treatment, antiarrhythmic drug (AAD) therapy. The Arctic Front family of catheters are the first catheter ablation devices in the U.S. approved to help physicians improve AF patient outcomes before drug failure. They have also been proven to shorten the time to diagnosis, according to Dublin-based Medtronic.

Cleerly Inc. snapped up $43 million in a series B fundraising round to develop artificial intelligence (AI)-enhanced imaging to better understand heart disease and more accurately project patient outcomes. Vensana Capital led the round with participation from the American College of Cardiology, Cigna Ventures, Dititx Partners, Lrvhealth (formerly Long River Ventures), New Leaf Venture Partners and returning investors.

Paris – Cardinor AS has secured $1.44 million to commercialize development of a novel ELISA (enzyme-linked immunosorbent assay) blood test that uses secretoneurin as a blood-based biomarker for heart disease and sudden cardiac arrest. London-based Intuitive Investments Group plc participated in this third seed round, along with existing Belgium and German investors.

The U.S. Supreme Court will not take up Amarin Corp. plc’s appeal of a September Federal Circuit decision that opened the door for generics of the company’s fish oil-derived cardiovascular drug, Vascepa (icosapent ethyl), to enter the U.S. market.

Acutus Medical Inc. scored big with regulators in recent weeks. The company, which focuses on devices to diagnose and treat cardiac arrhythmias, received FDA approval to launch an investigational device exemption clinical trial for its Acqblate Force sensing ablation catheter and system in atrial fibrillation just two weeks after gaining CE mark approval for a broad suite of electrophysiology products.

The FDA granted breakthrough device designation to Volumetrix LLC for its NIVAHF monitoring system for heart failure. The device is the first application of the company’s noninvasive venous waveform analysis (NIVA) technology, which captures and analyzes vital information about blood volume to assess patient status.

The controversy over the use of paclitaxel in devices for the peripheral vasculature has taken a significant bite out of sales, but a new study serves to help reverse the narrative regarding mortality. According to a study of more than 168,000 Medicare patients, stents and angioplasty balloons coated with paclitaxel (PTX) were non-inferior to non-coated devices for mortality out to nearly three years, a finding that may encourage clinicians to return to normal utilization patterns and thus help to restore sales volumes.

Sirtuins, which are a highly conserved family of NAD+-dependent deacetylases, have been shown to be involved in a wide range of physiological and pathological processes, including aging, energy responses to low calorie availability and stress resistance, as well as apoptosis and inflammation.