MeMed Sepsis Test Gains Breakthrough Device Designation
The 15-minute assay to detect sepsis and assess its severity and risk is expected to get full FDA approval by 2026
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The 15-minute assay to detect sepsis and assess its severity and risk is expected to get full FDA approval by 2026
The assays were developed with the CDC as part of recent trend of public-private partnerships to improve pandemic preparedness
Quest Diagnostics will find out as it launches a new health coaching business that relies on lab testing, via its Pack Health subsidiary
The company has lost nearly $36 million since 2023, but its CEO is aggressively pursuing new revenue options
Although the timelines have been extended several times, IVDR complexity has created a concerning bottleneck in the approval process
The new rules, which were approved by the FTC in October and will go into effect in mid-January, aim to put a damper on consolidation
The EasyScreen assay received 510(k) clearance from the Food and Drug Administration earlier this year–but with a catch
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
How three companies are addressing screening challenges with tests that help improve chances of early detection
$152.1 million SYNLAB deal is expected to create a new channel for Labcorp to market its sophisticated specialty assays