Up to 71% of people carry at least one pathogenic variant that could contribute to development of a heritable disorder in offspring, but until now, prospective parents often had to undergo multiple tests to understand their risks. Pacific Biosciences of California Inc. (Pacbio)’s expanded Puretarget portfolio provides a quicker and more streamlined solution as it covers all challenging tier 3 genes identified in the American College of Medical Genetics technical standard.
A month after raising $55 million to advance its AI-enhanced ultrasound diagnostics for cardiovascular disease, Ultromics Ltd. presented strong results for its U.S. FDA-cleared AI analysis of echocardiograms at the American Society of Echocardiography's 2025 Scientific Sessions in Nashville, Tenn. Ultromics' Echogo Amyloidosis was able to detect cardiac amyloidosis earlier and more accurately than traditional methods, missing fewer cases without increasing unnecessary testing.
Xeltis BV reported successful clinical data from the Axess EU pivotal trial which demonstrated the transformative potential of its restorative vascular access conduit, Axess, in hemodialysis treatment.
Phase Scientific International Ltd. launched China’s largest clinical study for urine-based cervical cancer screening. If successful, the blood-based test could be the first non-invasive test for HPV.
Rakuten Medical Inc. is advancing a pipeline of solid tumor therapeutics built on its Alluminox platform worldwide, having gained conditional early approval of ASP-1929, an Alluminox-derived photoimmunotherapy, in Japan in 2020.
Billiontoone Inc.’s Unity Fetal Risk screen identifies fetuses at high risk for cystic fibrosis (CF), a study published in Journal of Cystic Fibrosis found.
Two recent studies should provide comfort to medical device manufacturers who develop tools and devices for bariatric surgery. Patients who undergo bariatric surgery lost nearly three times more weight than those who received prescriptions for glucagon-like peptide-1 receptor agonists (GLP-1 RA) or GLP-1/gastric inhibitory polypeptide (GIP) receptor agonists in a real-world, retrospective study published in JAMA Surgery.
A late-breaking study presented at the PERT Consortium 2025 Pulmonary Embolism Scientific Symposium in San Diego showed marked clot-burden reduction with no device-related serious adverse events for Imperative Care Inc.’s Symphony thrombectomy system, though other companies have a head start. Circulation: Cardiovascular Interventions simultaneously published the study in an article titled “A Prospective Multicenter IDE Study of the Next-Generation Precision Aspiration Thrombectomy System for Intermediate-Risk Pulmonary Embolism: The SYMPHONY-PE Trial.”
The Danish-German Cardiogenic Shock trial found that men implanted with Johnson & Johnson’s Impella CP after experiencing a heart attack with cardiogenic shock gain 600 days of life, on average, compared to usual care at 10 years. The study demonstrated no benefit for women.
Daewoong Pharmaceutical Co. Ltd. and Daewoong Therapeutics Inc. reported that their self-developed microneedle patch loaded with semaglutide demonstrated 80% relative bioavailability compared to an injectable subcutaneous formulation of semaglutide in a pilot human pharmacokinetic study. That far exceeds rates seen in other patches or oral formulations.