Heartbeam Inc. received U.S. FDA 510(K) clearance for its portable, non-invasive electrocardiogram system that enables on-the-go recording of heart signals. The cable-free, credit card-sized device uses five electrodes to capture signals from three directions and can be used whenever a patient feels symptoms, overcoming the challenge of identifying intermittent arrhythmias, which are often not experienced during scheduled appointments, without requiring patients to wear a device continuously. Read More
Lanua Medical Ltd. raised €6 million (US$6.3 million) in seed funding for its Encore device, which is designed to enhance embolization procedures. The funds will be used to accelerate the development of the technology as well as expand operations into the U.S. The funding round was co-led by Elkstone and Atlantic Bridge, with participation from Enterprise Ireland and Furthr VC. Read More
Investigators at the Institute for Research in Biomedicine (IRB Barcelona) have unraveled how and why the absence of a neuronal microexon in cytoplasmic polyadenylation element-binding 4 (CPEB4) gives rise to autism. In 2018, investigators from IRB, co-led by Raúl Méndez, identified the overt correlation between defects in CPEB4 and the onset of autism. However, the previous work did not provide the molecular mechanism explaining the correlation. Read More
Med-tech deal values climbed to $424.5 million in November, after October ranked as the lowest monthly total of the year with $15.9 million in deal value. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Icecure, Mannkind, Reprieve Cardiovascular. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Helius Medical, Jenavalve, Spectral AI, T2 Biosystems. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Heartbeam. Read More
