Kardium Inc.’s Globe pulsed field system received U.S. FDA premarket approval, making it the fourth PFA system in the rapidly expanding market for cardiac ablation for atrial fibrillation. The system’s introducer sheath and mapping software also received clearance. Read More
The Sept. 3 congressional hearing on AI in health care raised questions about whether the U.S. FDA enjoys the statutory authorities it needs to properly regulate this class of products, but witnesses at the hearing said a lack of trust in AI is a substantial roadblock to adoption. Read More
Vicentra BV’s insulin patch pump, Kaleido, will soon reach more patients with diabetes after it raised $85 million in a series D funding round. The company said the Kaleido is among the smallest, lightest, and most precise insulin patch pumps available. Read More
The Office of Inspector General recently reported that billings for remote patient monitoring eclipsed the $500 million mark in 2024, but the agency stated that more scrutiny will be necessary going forward to keep waste, fraud and abuse at bay. Read More
Two independent studies have linked neuronal injury, inside or outside the brain, to cancer progression and offer new biomarkers and strategies for prevention. While cerebral cancer cells damage axons and drive tumor development, in other types of cancer affecting other organs, nerve disruption caused by tumor proximity triggers inflammation and a suppressive environment that may also be associated with immunotherapy resistance. Read More
New hires and promotions in the med-tech industry, including: Aclarion, Electrocore, Cardiac Dimensions, Fractyl Health, Sanara Medtech, Seer, Viz.ai. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alcon, Alivedx, Bearpac, Monod Bio, Quipt Home, Staar Surgical, Syndeo Medical, Pulse, Stereotaxis, Trinity. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Curvafix, Fairtility, Geneseeq, Kardium, Mainz, Medtronic, Qiagen. Read More
