相关临床试验
114
6 进行中
药物批准
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监管机构
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进行中（未招募）
1
0.9%
已完成
86
75.4%
尚未招募
5
4.4%
招募中
2
1.8%
终止
18
15.8%
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1.8%
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- Danaher's stock fell over 22% year-to-date, driven by concerns over its $9.9 billion acquisition of Masimo and a patent dispute with Apple. - The Masimo deal is expected to add $0.15–$0.20 to adjusted diluted EPS in the first full year, scaling to $0.70 per share by year five. - Second-quarter earnings beat estimates, but management reduced full-year core sales growth guidance for its highest-margin biotechnology segment. - CEO Rainer Blair attributed the biotech guidance cut to delayed chromatography resin shipments from large commercial drug manufacturers.
- Danaher will acquire pulse oximeter maker Masimo for $9.9 billion at $180 per share, representing a 38.3% premium to expand its diagnostics portfolio into patient monitoring technologies. - The acquisition allows Danaher to complement its invasive Radiometer blood analyzer devices with Masimo's non-invasive pulse oximeters and gain a foothold in the growing patient-monitoring device market. - Masimo is expected to add $0.15 to $0.20 to Danaher's adjusted diluted net earnings per share in the first full year and about $0.70 in the fifth full year following completion. - The deal represents Danaher's largest acquisition since its $5.7 billion purchase of Abcam in 2023 and is expected to close by the second half of 2026.
- The U.S. FDA is considering revoking the GRAS safety status of processed refined carbohydrates including corn syrup following a petition, potentially requiring food companies to prove these ingredients are safe and not contributing to obesity. - Health Secretary Robert F. Kennedy Jr. announced this potential regulatory shift that could significantly impact the food industry's use of processed sweeteners and carbohydrates. - Major corporate consolidation is occurring with Danaher approaching a $10 billion acquisition of medical technology company Masimo, marking significant consolidation in the medical technology sector. - Edwards Lifesciences has abandoned its anti-copycat policy to close an EU antitrust investigation, while pharmaceutical companies continue expanding with obesity drug developments and global market strategies.
- Clairity raised $43 million in Series B funding led by ACE Global Equity and Santé Ventures to commercialize its FDA-authorized AI platform that predicts five-year breast cancer risk from routine mammograms. - The Clairity Breast platform represents the first FDA-cleared artificial intelligence tool capable of estimating a woman's five-year breast cancer risk directly from standard 2D mammogram images. - The funding will accelerate U.S. commercialization, expand partnerships with imaging centers and health systems, and support development of additional AI-based predictive tools for cardiovascular disease. - The company aims to shift breast cancer care from detection to prevention by enabling earlier intervention and reducing late-stage diagnoses through predictive risk assessment.
- A California federal jury awarded Masimo $634 million after finding Apple Watch's heart-rate alert functions infringed on Masimo's patent for heart and oxygen monitoring technology. - The patent covers a power-saving system using light to track pulse and oxygen levels and expired in June 2022, with the case focusing on Apple Watch alerts that notify users of abnormal heart rates. - Apple plans to appeal the verdict, arguing the feature is a fitness aid rather than medical monitoring, while Masimo views this as validation of their medical device innovations. - The verdict represents one component of a broader legal battle between the companies over wearable sensor technology and medical monitoring capabilities.
- FDA advisory panel suggests more inclusive clinical trials for pulse oximeters, addressing concerns about accuracy variations across different skin tones. - The panel proposes using the Monk Skin Tone (MST) scale to ensure representation of diverse skin tones in pulse oximeter evaluations. - Recommendations include increasing the minimum number of participants in clinical trials to better reflect real-world performance and reduce health disparities. - The FDA is considering whether over-the-counter pulse oximeters should meet the same accuracy standards as prescription devices, potentially impacting labeling and accessibility.
