FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
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Medical Laboratory Personnel Shortage Relief Act Aims to Dent the Staffing Crisis
How the 2024 proposal will fare on Capitol Hill in 2025 remains to be seen, though
Dx Deals: BD Laboratory Business Is Up for Grabs in Bold Move
Becton Dickinson divisions responsible for $3.4 billion in annual revenue are on the block
CMS Proposes Modest Increase to Hospital IPPS Rates
Unsurprisingly, the American Hospital Association and other industry groups don’t think that increase is anywhere near adequate.
False Billing of UDTs Remains a Prime Target for Enforcement
UDT false billing cases seem to be on the rise again, accounting for a trio of recent multimillion dollar settlements.
OIG Issues First Positive Advisory Opinion for Free Genetic Testing
On April 11, the OIG approved a proposed arrangement involving the offering of free genetic tests and counseling services.
FDA Sounds the Alarm on Counterfeit OTC COVID-19 Tests
Counterfeit COVID-19 tests are being illegally imported into the US and being distributed to unsuspecting consumers across the country.
How the End of the COVID-19 PHE Will Impact Lab Compliance
A briefing on how labs should prepare for the inevitable end of the PHE after more than two years of unprecedented relief.
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.
Healthcare M&A Deal Volume & Size Bottom Out in First Quarter
Healthcare M&A might have bottomed out in the first quarter of 2022 in terms of both deal volume and size, according to a new report.
FDA Issues First Approval for SARS-CoV-2 Breathalyzer Test
InspectIR COVID-19 device detects the virus from breath samples in less than three minutes, offering a new screening option.
Onco Pharma Giants Team Up to Boost Access to Cancer Genomic Testing
The recently-formed Precision Cancer Consortium will make it easier for cancer patients around the world to get access to genomic testing.
CMS Highlights Threat of Healthcare Consolidation
The HHS recently published previously confidential data relating to consolidation of hospitals and nursing homes enrolled in Medicare.
