Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
OIG Gives Green Light to Employee Tuition Reimbursement Benefits
Could paying the tuition costs of employees seeking certification put you at risk of violating the AKS?
Eight Lab Sales & Marketing Liability Pitfalls to Avoid
How to avoid eight of the most common liability pitfalls when it comes to sales and marketing operations in your lab.
Ransomware Response Checklist
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Hematology Testing Solution Company Earns Key Grant
YOKNEAM ILLIT, ISRAEL — PixCell Medical, innovator of rapid hematology testing solutions at the point-of-care, announced on Feb. 22 that it has been awarded a grant by the International Health-Tech Pilot Program. PixCell will utilize this grant to develop and...
Patents Granted Relating to Urine Drug Screen Sample Validity Test Panels
BRANFORD, FL — Vision Diagnostics, Inc., DBA Validity Diagnostics (VDx), is a research-based developer and manufacturer of diagnostic products, announced Feb. 24 that the United States Patent and Trademark Office (USPTO) has issued two patents and VDx expects the...
Helping Patients with Cancer Better Manage Ocular Toxicities
CAMBRIDGE, MA — On Feb. 23, Voluntis, an Aptar Pharma company and leader in digital therapeutics, announced a partnership with Tilak Healthcare, a digital therapeutics company specializing in clinically validated medical mobile apps for chronic diseases. Under this...
Deep Learning Poised to Improve Breast Cancer Imaging
WASHINGTON, DC — Researchers have developed a new image reconstruction approach that could contribute to better breast cancer detection. The deep learning algorithm overcomes a major hurdle in multi-modality imaging by allowing images to be recovered in real time....
Element and Jumpcode Team Up to Boost Many Genomic Applications
SAN DIEGO, CA — Element Biosciences, Inc., developer of a new and disruptive DNA sequencing platform, today announced a collaboration and co-marketing partnership with Jumpcode Genomics that validates Jumpcode’s CRISPRclean technology on Element’s AVITI System. The...
Feds Target Fraudulent Billing of Genetic Cancer Tests
False ordering and billing of cancer genetic (CGx) tests has become a favorite target for federal fraud enforcers, with the U.S. Department of Justice (DOJ) reporting two notable convictions in the closing months of 2021. On Nov. 17, a 57-year-old former lab sales...
Healthy Growth Predicted for Global Aspiration & Biopsy Needles Market
According to a recently released report from market research company Research and Markets, the global aspiration and biopsy needles market is poised for solid growth over the next five years. The report valued the market at an estimated $879 million US for 2021 and...
