Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott Labs, Calyxo, Endostart, Polymedco, Syntheticmr.
In what represents its first patenting, Sonura LLC has been issued with a patent for an aural device designed to protect the hearing of infants in a neonatal intensive care unit (NICU) by active filtering, while, at the same time, providing aural stimulation for neurological development.
Avicenna.AI SAS received clearance from the U.S. FDA for two of its artificial intelligence (AI)-based solutions, Cina-Ipe and Cina-Aspects, which provide for the detection of pulmonary embolism (PE) and the assessment of stroke severity in CT scans, respectively.
Abbott Laboratories landed CE mark for two versions of its Assert-IQ insertable cardiac monitor (ICM), one with a three-year battery life, the other lasting six years. Designed for long-term remote monitoring of individuals with abnormal heartbeats or at risk of developing arrhythmias, the device helps detect often-fleeting irregularities in heart rhythm to assist in diagnosis and care management.
Scientists from the Australian National University have discovered the gene mutation responsible for causing psoriasis, and the findings could lead to improved diagnosis and treatment for patients with psoriasis and psoriatic arthritis, a chronic inflammatory skin disease. “We were able to identify the gene that could be important in enabling this progression from a skin-only condition to a skin-and-joint condition,” lead study author Chelisa Cardinez told BioWorld.
Clarity Pharmaceuticals Ltd. raised AU$121 million (US$79.29 million) through a private placement that will fund the company’s radiopharma pipeline comprising targeted copper therapies out to early 2026.
Metyos SAS has raised €2.3 million (US$2.7 million) in pre-seed funding for its biowearable sensor technology which monitors patients with chronic kidney disease (CKD). The funds will be used to progress the technology through clinical trials ahead of FDA approval.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avicenna.AI, Cerus, Endosound, Getinge, Medtronic, Roche, Shockwave.