DEALS Abbott and Alere Reach New Deal Terms From - Laboratory Industry Report Abbott's deal to acquire Alere is back on. Both companies announced Friday, April 14, 2017, that they will move forward with the deal and have revised its terms… Read More
FDA Test Kits Included in Class I Devices Exempt from 510k Filing From - National Intelligence Report The FDA has determined that 71 device types, including some diagnostic test kits, should be exempt from 510k filings. These devices are deemed "sufficiently well understood and do not present risks that… Read More
TESTING TRENDS Screening Test Use Up After ACA From - Diagnostic Testing & Emerging Technologies There was an uptick in preventive screening after enactment of the Affordable Care Act (ACA), yet cancer-screening rates in the United States remain below… Read More
ENFORCEMENT Avoid Liability for Commission-Based Marketing Arrangements From - G2 Compliance Advisor Contracts between labs and sales and marketing firms raise red flags under both the Anti-Kickback Statute (AKS) and Stark Law, especially when payment is by commission or based on… Read More
