HONG KONG – Dia Imaging Analysis Ltd. has teamed up with Sonoscape Medical Corp. to deliver cardiac ultrasound artificial intelligence (AI) solutions. The partnership aims to reduce the variability associated with manual or visual analysis, and increase efficiency and accuracy throughout the analysis process. As a result, China-based Sonoscape's ultrasound devices will be offering a layer of automated AI-based analysis to support the clinician’s decision-making process, courtesy of Dia's AI-based cardiac solutions.
New and updated preclinical and clinical data presented by biopharma firms at the American College of Cardiology annual meeting, including: Amarin, Attralus, BMS, Esperion, Imbria, Janssen, Milestone, Stealth.
HONG KONG – Ultrasight Ltd. has closed a $13 million series B funding round, and is a step closer to entering the clinic in the U.S. with its cardiac ultrasound software. With the funds in hand, Rehovot, Israel-based Ultrasight aims to start clinical trials in the U.S. for its artificial intelligence (AI)-guided software for cardiac ultrasound.
Egnite Inc. emerged from stealth mode in February 2021 with the goal of combining data analytics and digital health technology to illuminate and solve persistent issues in the diagnosis and treatment of structural heart disease. Three months later, it has added artificial intelligence (AI) to its flagship solution, Cardiocare, to drive better diagnosis of aortic stenosis and help physicians predict patient outcomes.
The FDA’s Arthritis Advisory Committee panelists groped through cloudy data while complaining about the design of the phase III trial for Chemocentryx Inc.’s avacopan, and after going overtime ended up without consensus. Briefing documents ahead of the meeting darkened what had been a fairly bright picture for the complement C5a receptor inhibitor for anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, but Wall Street held out hope. Wainwright analyst Edward White opined in a May 5 report that the adcom’s outcome “could still be positive,” and a May 4 dispatch from Canaccord Genuity’s Michelle Gilson said the briefing docs “miss[ed] the big picture.”
Acutus Medical Inc. appears to have solved one of the more vexing problems in cardiology, the sheer persistence of persistent atrial fibrillation despite treatment. In a study recently published in Heart Rhythm, the Carlsbad, Calif.-based company demonstrated that 73% of patients undergoing ablation using the new pulmonary vein isolation plus core-to-boundary guided approach experienced acute termination of AF after one procedure, compared to 10% of patients undergoing ablation with the traditional posterior wall isolation approach.
Stock-price weakness that has beset Chemocentryx Inc. since early March – likely based on jitters ahead of the FDA advisory panel for avacopan slated for May 6 – became an outright tumble when Wall Street got a gander at briefing documents related to the meeting. Shares of the San Carlos, Calif-based firm (NASDAQ:CCXI) closed at $22.19, down $26.63, or 45%, as company backers sifted paperwork on the complement C5a receptor inhibitor for anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The compound has been assigned a PDUFA date of July 7.
The history of Medicare coverage of transcatheter aortic valve replacement (TAVR) devices has not lacked for controversy despite the massive positive impact on outcomes. Ashwin Nathan, of Hospital of the University of Pennsylvania, said a new analysis made clear that the expansion of centers qualified to perform TAVR procedures has been nearly all in high population density areas with an existing TAVR program, thus leaving out the still-forgotten rural patient.
Atricure Inc. has received the green light from the FDA for its Epi-Sense guided coagulation system with Visitrax technology to treat patients diagnosed with long-standing, persistent atrial fibrillation (AF). The device was previously cleared via a 510(k) for the coagulation of cardiac tissue, and is already available in the U.S. The FDA approval represents the first and only minimally invasive ablation therapy for the more than 3 million Americans with longstanding AF.
TORONTO – Opsens Inc. has inked an agreement with Madrid, Spain’s Cathmedical Cardiovascular SA to integrate its coronary physiology algorithms with the Spanish firm’s next generation hemodynamic system, notably Opsens’ diastolic pressure ratio (DPR) for measuring diastolic heart pressure.