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Researchers Report First “Routine Clinical Use” of AI for Breast Biopsies
While AI as a diagnostic tool is still years away from regular clinical use, recent research is an important step.
Lab Compliance Will Change When Public Health Emergency Ends
Your current COVID-19 testing arrangements may no longer be compliant on May 11.
Weekly Enforcement Report: Telemedicine Scheme Trend Continues
Most of last week’s healthcare-related actions involved telemedicine in some way, with the lone lab-related case centering on genetic testing.
The 2022 Year in FDA 510(k) Approvals
Roche and Abbott received the most approvals for new lab tests last year.
Lab Companies See Massive Layoffs and Restructuring
Economic volatility and uncertainty is also making a significant impact on merger and acquisition activity in the diagnostics space.
Building an Effective Business Case for Your Lab
An effective business case communicates need, benefit, and risks.
FDA Watch: 2022 510(k) Lab Test Approvals Year in Review
Abbott and Roche garnered the lion’s share of new 510(k) lab test approvals in 2022.
Labs Partner with Pharma Companies to Develop New CDx Tests
There were three notable CDx alliances announced in January 2023, all of which involved cancer-related solutions.
Digital Health Fundraising Falls in 2022 but May Not Have Bottomed Out
According to a new report, tough macro-economic conditions caused digital health fundraising levels to fall off dramatically in 2022.
Does a Concierge Business Model Make Sense for Your Lab?
Factors to consider when determining if the concierge business model is best for your laboratory.
