Acorai AB received a U.S. FDA breakthrough device designation for its Heart Monitor, a noninvasive intracardiac pressure monitoring device for patients with heart failure. The Acorai Heart Monitor can estimate diastolic pulmonary artery pressure, systolic pulmonary artery pressure and mean pulmonary artery pressure in patients with Stage C heart failure who have been referred for hemodynamic monitoring.

The $1.83 million grant Fesarius Therapeutics Inc. was recently awarded will allow the company to work on the next generation of dermal repair products to treat complex wounds. The funds from the National Institutes of Health (NIH) will go towards further development of the company’s advanced dermal regeneration scaffold for reconstructive surgery and takes the total amount of non-dilutive grant funding Fesarius has received to develop its hydrogel technology, Dermisphere, to $4 million.

Theranica Bio-Electronics Ltd. received expanded CE mark approval for Nerivio, a therapy that can both prevent and treat acute migraine in adults and adolescents. The Netanya, Israel-based company is now partnering with a large, publicly traded, pharmaceutical firm to launch the device later this year, first in Germany and then roll out commercial operations in several other European countries in 2024, Alon Ironi, CEO and co-founder of Theranica, told BioWorld.

Trinity Biotech plc. received U.S. FDA 510(k) clearance for its lab-based hemoglobin diagnostic system, the Premier Resolution system, which the company hopes will allow it to regain its market leading position in hemoglobin variant detection. The Premier Resolution system is an automated analyzer which quantifies fetal hemoglobin and hemoglobin A2 and detects more than 200 hemoglobin variants. The device is a modern successor to the company’s Ultra system which once held a leading position in the U.S. hemoglobin variant diagnostic market.

Three former employees of Bose Corp. are banking on their audio experience and Ozlo Sleepbuds helping the millions of people who struggle to sleep soundly each night. That prospect is music to the ears of investors Lifearc Ventures and Artis Ventures, who led Ozlo Sleep Inc.’s $10 million round to bring the wireless, in-ear headphones to market in the next few weeks.

Personadx Inc. and researchers from the University of Chicago Medicine Comprehensive Cancer Center have developed a method to accurately predict which patients with metastatic colorectal cancer will have a favorable treatment outcome following surgical removal of liver metastases, according to a study published in JAMA Oncology. The prognostic tool combines a panel of genetic biomarkers and clinical features of the tumor to determine distinct subgroups of cancer that correspond to different treatment outcomes.

In game-changing news for parents of children with cerebral palsy, researchers demonstrated significant clinical improvement in the sensorimotor function of children who underwent sessions using Spinex Inc.’s Spinal Cord Innovation in Pediatrics (Scip) therapy. With current treatment options limited to physical therapy, medication and/or surgery, Parag Gad, co-founder and CEO of Spinex, told BioWorld he believes that Scip therapy “can be the new standard of care” for children with cerebral palsy.

Ultromics Ltd.’s Echogo Heart Failure system detects heart failure with preserved ejection fraction (HFpEF) from a single apical four-chamber video clip, according to a study published in JACC Advances. The study follows a consensus statement from American College of Cardiology which said that although there are now effective therapies to treat HFpEF, there is an increasing urgency for accurate diagnosis as the number of patients with HFpEF is on the rise, accounting for more than 50% of all heart failure cases.