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Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
New EU IV Diagnostic Regulation Set to Roll Out
The IVDR will bring around 80 percent of in vitro diagnostic medical devices under the control of so-called Notified Bodies.
New EU IV Diagnostic Regulation Takes Effect on May 26
While the much-delayed IVDR will take effect at the end of the month, it will be rolled out gradually.
Many Medical Device Companies Are Not Ready for Cyberattacks
According to a recent survey of product security experts, despite many saying their companies are ready for hacks, data show otherwise.
Watch Out for Fake COVID-19 Tests, FDA Warns
Agency warns the public to be on the lookout as counterfeit at-home OTC COVID-19 diagnostic tests appear on the US market.
OIG: Medicare Advantage Plans Are Stiffing Physicians on Reimbursement
New report shows a fair portion of prior authorization and physician reimbursement request denials actually met Medicare coverage rules.
Precision Oncology Company Nabs Coverage for Advanced Cancer Test
In this month’s Business Roundup, we cover key happenings including Medicare coverage and reimbursement, as well as the US surpassing Europe as medtech’s market of choice.
Labs in Court Weekly Roundup
In last week’s announced enforcement actions involving the healthcare industry, two defendants were sentenced, one was convicted, and two others were charged in various fraud-related schemes.
Florida Lab Owner Jailed for Telemedicine Genetic Test Ripoff
Case is part of a larger coordinated enforcement action targeting COVID-19-related fraud spanning seven judicial districts.
New Tech Could Make At-Home Disease Diagnosis More Feasible
A research team has developed a new, simpler microfluidic chip that could make at-home diagnosis of diseases faster and more affordable
PAMA Hasn’t Reduced Part B Lab Test Costs
For the third straight year since the PAMA pricing system has been in place, overall year-over-year spending on lab tests increased in FY 2020.