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BioWorld - Sunday, June 15, 2025
Home » Topics » U.S., BioWorld MedTech

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CMS to hold advisory hearing for Parkinson’s devices​

April 29, 2025
By Mark McCarty
No Comments
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.
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LSX World Congress

Startup, strategic relationship dependent on fair terms

April 29, 2025
By Shani Alexander
No Comments
Partnership agreements between startups and strategics need to be based on terms that are fair otherwise they will be rejected.
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Wearoptimo microwearable hydration sensor

Wearoptimo’s hydration sensor outperforms gold standard tests

April 29, 2025
By Tamra Sami
Health care technology company Wearoptimo Ltd. developed a next-generation microwearable sensor that accurately detects hydration levels, outperforming the needle-based gold standard.
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EO record among Day 100 Trump achievements

April 29, 2025
By Mari Serebrov
No Comments
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.
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Heart Rhythm 2025

HRA/ACC release same-day discharge guidance for cardiac ablation

April 28, 2025
By Annette Boyle
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.
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Screen on Fitbit Sense reads "Take heart rhythm assessment"
Heart Rhythm 2025

Fitbit analysis predicts hospitalizations

April 28, 2025
By Annette Boyle
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.
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US flag, stock market chart, White House

100 days of uncertainty

April 28, 2025
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.
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Conceptual image for brain cancer treatment

FDA issues CRL for Telix's glioma imaging agent, wants more data

April 28, 2025
By Tamra Sami
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.
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Financial charts, test tubes, capsules, syringe

Med tech majors unfazed by tariffs

April 25, 2025
By Annette Boyle
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.
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Photomicrograph of liver biopsy in a patient with cirrhosis, showing bridging septal fibrosis and regenerative nodules.

Mursla Evoliver biopsy blood test granted breakthrough designation

April 25, 2025
By Shani Alexander
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.
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