Useful Links
FDA Watch: Latest Plan to Simplify 510(k) Premarket Review of New Tests
From – National Intelligence Report
While everybody agrees that the FDA 510(k) premarket review pathway is antiquated and in desperate need of an overhaul…
G2 Blog
Is Your Billing Company Putting You At Compliance Risk?
By Sean McSweeney bio
Does your orthopedic billing company charge a percentage of collections for their coding and billing…
Donor-Derived, Cell-Free DNA May Predict Lung Transplant Rejection
From – Diagnostic Testing & Emerging Technologies
Elevated donor-derived, cell-free DNA (ddcfDNA) in the 3 months post-lung transplant can identify clinically silent allograft injury and…
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From – Laboratory Industry Report
After a slow January, new product development picked up steam in February. Here’s a rundown of the key new launches…
DX Earnings Report: Lab Companies Finish 2018 Strong but Growth Slows for Established Firms
From – Laboratory Industry Report
The diagnostics industry capped a robust 2018 with most companies posting strong fourth quarter results. Of course…
Enforcement Trends: Record Breaking Year for HIPAA Fines
From – National Intelligence Report
The federal Office for Civil Rights (OCR) reports that 2018 was a record year for HIPAA enforcement, with 10 settlements and one judgment bringing in…