Heartpoint Global Inc. will begin human trials of its Intellistent device shortly and expects to make submission to the U.S. FDA in 2024, Seth Bogner, its chairman and CEO told BioWorld in an interview on the sidelines of the EuroPCR conference in Paris. Intellistent is a multi-lumen stent system for interventional adjustment of pulmonary blood flow in congenital heart disease. It is a minimally invasive device that will meet an unmet need in pulmonary artery hypertension caused by congenital heart disease, said Bogner. Read More
GE Healthcare Technologies Inc. launched a 3Dstent imaging tool at the EuroPCR conference in Paris which it said will allow a new perspective on stent visualization, helping doctors do a better job. The company warned however that it is still in the process of validating the technology, which complements existing technologies and provides intraprocedural 3D and multi-slice images of stent but has certain limitations. Read More
The U.K. health technology assessment body has given its approval to the use of nine digital health products for treating mental disorders, enabling them to get conditional reimbursement in the National Health Service (NHS), while real world evidence of their cost effectiveness is collected. Read More
The EU’s Artificial Intelligence (AI) Act is still in the thick of the legislative process, which seems likely to ladle even more regulatory liabilities onto AI software used for medical purposes. Bodo Wiegand, senior advisory at Viopsy, told attendees at a May 18 webinar that between the promise of yet more regulation along with existing coverage and reimbursement hurdles in the EU, developers of medical software are considering whether they should steer clear of developments that qualify as AI simply because of the extraordinary time and expense associated with generating revenues for these projects. Read More
A collaboration between Aegis Ventures LLC and Northwell Holdings invested $12 million to launch New York-based Optain Inc., an artificial intelligence company created to enable early identification and disease prevention through retinal imaging. Retinal imaging is well known for identifying eye diseases including diabetic retinopathy, age-related macular degermation and glaucoma, but it can also provide insight into cardiovascular and neurological conditions. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bio-Techne, Creative Medical Technology, Lifescan. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 10x, Bodyport, Dariohealth, Marker Diagnostics, Nanostring Technologies. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, CTL Amedica, Inheart, Locate Bio. Read More
