The U.S. Centers for Medicare & Medicaid Services will hold an advisory meeting regarding devices for treatment of symptoms for Parkinson’s disease, but the agency indicated that it expects to see longer-term data for these treatments if manufacturers want Medicare coverage.
Health care technology company Wearoptimo Ltd. developed a next-generation microwearable sensor that accurately detects hydration levels, outperforming the needle-based gold standard.
With April 29 being Day 100 for U.S. President Donald Trump, his staff observed the day by touting the achievements of the administration’s first 100 days in office, especially new commitments made by the private sector to invest more than $5 trillion in U.S.-based manufacturing, R&D, infrastructure and technology.
The Heart Rhythm Society and American College of Cardiology published guidance for same-day discharge of cardiac ablation patients during Heart Rhythm 2025, the society’s annual meeting, which was held in San Diego April 26-27.
Using step counts and heart rate readings from Google’s Fitbit devices, a machine learning model accurately predicted the risk of hospitalization, a study presented at Heart Rhythm 2025 found. The study used data from participants in the National Institutes of Health’s All of Us research program.
The first 100 days of the Trump administration have been nothing short of chaotic, both in the U.S. and throughout the world. Shining a light through the uncertainty, BioWorld continues to cover the administration’s latest policy decisions and actions affecting the life sciences sector, as well as their impacts across the globe. It’s all right here at Trump administration impacts.
The U.S. FDA issued a complete response letter (CRL) to Telix Pharmaceuticals Ltd. for its NDA for glioma imaging agent, TLX-101-CDx (floretyrosine F18 or 18F-FET, Pixclara), citing the need for additional confirmatory clinical evidence.
First quarter earnings reports from Edwards Lifesciences Corp., Intuitive Surgical Inc. and Boston Scientific Corp. support trends seen earlier: Larger med-tech companies expect substantial tariff hits, but also have confidence that they can absorb the impact with fairly minor adjustments.
The U.S. FDA granted breakthrough device designation to Mursla Bio Ltd.'s Evoliver. The biopsy blood test uses extracellular vesicles to survey hepatocellular carcinoma in high-risk cirrhotic patients.