Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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- Business deals in the diagnostics space, and more
Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Investment Trends: Dx/Tools Venture Capital Keeps Flowing Despite Decline in Early-Stage Investment
From - Laboratory Industry Report
Continuing a four-year trend, total U.S. venture capital investment in health care surged in 2018, reaching a new all-time high of…
Point-of-Care PCR Tests Better Diagnosis, Rx for Kids’ Sore Throats
From - Diagnostic Testing & Emerging Technologies
Given we are still in the midst of cold and flu season, a new study highlights the benefit of point-of-care (POC) polymerase chain reaction (PCR) testing among…
Compliance Perspectives: A 10-Step Compliance Strategy for OSHA Recordkeeping Rules
From - Lab Compliance Advisor
January is the season when employers must compile their OSHA logs for the previous year. The good news is that many labs are…
New Study Finds Lab Automation Market Poised for Continued Growth, Focus on Genomics Solutions
From - National Intelligence Report
The lab automation market is expected to reach $5.20 billion by 2022 from an estimated $4.06 billion in 2017, at a CAGR rate of…
Chicago Doctor Indicted for Approving Medically Unnecessary In-Home Tests
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Mergers, Acquisitions & Asset Sales Analysis – January 2019
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Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
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Inside the Lab Industry: 5.1% Growth Expected to Lift Lab Automation Market to $5 Billion by 2022
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From DAIA to the VALID ACT: The Latest Chapter in FDA Diagnostic Test Oversight Reform
From - Lab Compliance Advisor
While FDA oversight over new diagnostic tests is perfectly acceptable, what is objectionable is the…
Diagnostics Sector Saw Increased Investment, Exits in 2018
From - Diagnostic Testing & Emerging Technologies
Life science and health care companies had a banner year in 2018, with a record-breaking year for venture capital investment…