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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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
CMS Mulls Automatic Medicare Coverage of MCIT Breakthrough Devices
Manufacturers of innovative medical devices are on pins and needles right now. That is because the Centers for Medicare and Medicaid Services (CMS) delayed implementation of a final rule that was supposed to take effect on March 15, 2021 that would have ensured at...
Antitrust Regulators Derail Plans for Illumina-Grail Cancer Genomics Powerhouse
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AMA Creates New PLA Code 0247U for Sera Prognostics PreTRM Test
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Massachusetts Mental Health Hospital Fined $65,000 for HIPAA Right of Access Violation
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AMP Survey Finds that Inadequate Reimbursement Hinders Use of Molecular Diagnostics
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First De Novo Clearance Signals that Premarket Pathway Is Open for COVID-19 Tests
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Agency Opens Premarket Pathway for Post-Emergency COVID-19 Test Marketing
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Abbott Lands $255 Million Rapid COVID-19 Antigen Test Pentagon Contract
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New Study Supports Use of Liquid Biopsy Technology to Bolster MRI Accuracy in Cancer Treatment
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Silicon Valley Becomes Epicenter of Lab Investment Scams
On paper, the Silicon Valley venture capital and innovation that have lifted so many other industries seem like the perfect elixir for medical labs. Perhaps one day it will prove to be just that. But so far at least, things haven’t gone well. Instead of driving...
