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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Articles and Reports
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
Four Things You Need to Know About the 2023 OPPS Payments Rule
The final Outpatient Prospective Payment System Final Rule for 2023 provides for a rate increase of nearly four percent.
Court Nixes COVID-19 Lab Test Reimbursement Lawsuit Against Private Payor
Despite Congress’ clear policy on private insurer payment of COVID-19 tests, many labs have been struggling to get reimbursed.
What Can You Do About Medical Lab Staffing Shortages?
Solutions you can implement right away to address current lab staffing concerns and prepare for the future.
Heart Attack Diagnostics Market to Be Worth More than $22B in a Decade
Increasing incidences of heart disease, as well as technological advances, will drive growth over the next eight to 10 years, reports say.
Digital Health Startup Fundraising Remains Robust Despite H1 2022 Declines
According to a recent report, digital health companies are on track to rake in $21 billion for 2022, below the 2021 total of $29.1 billion.
M&A Report: Fewer Deals, Higher Impact
Continuing recent patterns, M&A deal-making in the diagnostics space was low in volume but high in impact in October.
FDA Watch: Monkeypox, COVID-19, and MDD Tests
While new test approvals were scarce in October, they were particularly impactful; here are three approvals you should know about.
Getlabs Continues In-Home Phlebotomy Services Advance
The Miami-based startup has secured major in-home phlebotomy services contracts from some of the nation’s biggest lab companies.
Labs in Court: Could Elizabeth Holmes Get a New Trial?
In this month’s roundup of key lab-related cases, a bizarre twist in the Theranos saga leads to a slim chance of a mistrial.
November 2022 Enforcement Scorecard: UDTs and Genetic Tests
Most of the recent settlements and enforcement actions involving labs related to medically unnecessary UDTs and genetic tests.
