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ivd manufacturer
Clinical Labs Spending Money in New Ways
CEO SUMMARY: In response to the many changes now unfolding in the U.S. healthcare system, labs are investing their scarce capital in different ways. Five trends in lab spending can be identified. They range from expanding the informatics capabilities of a lab organization to acquiring the…
Quality Assurance Regs to Tighten for UK Labs
CEO SUMMARY: In the United Kingdom, a window of opportunity has opened for improving the quality assurance activities of pathology and histopathology laboratories. Last week, at the Frontiers in Laboratory Medicine conference, the newly-published “Pathology Quality Assurance Review” w…
October 21, 2013 “Intelligence: Late Breaking Lab News”
There is progress on the integration of digital pathology systems and proprietary algorithms designed to help pathologists make diagnoses. This month, Visiopharm and Omnyx LLC, announced a joint venture. On its own, in Europe last year, Visiopharm earned a CE mark fo…
Abbott Says It Will Split into Two Firms in 2012
FURTHER CHANGES ARE COMING to the in vitro diagnostics (IVD) marketplace. On October 19, Abbott Laboratories, Inc., announced that it would separate into two publicly-traded companies sometime in 2012. One business will be the medical devices and diagnostics business. It w…
More IVD Consolidation as Danaher Buys Beckman
TODAY IT WAS ANNOUNCED that Danaher Corporation would acquire Beckman Coulter, Inc., in a transaction valued at $5.8 billion. The news was not a surprise, since word had leaked out last December that Beckman’s board of director had engaged Goldman Sachs …
Beckman Coulter and Genoptix Offer Themselves Up for Sale
FOR DIFFERENT REASONS, last month two large companies in the lab industry put themselves up for sale. Assuming that both companies are sold, one consequence may be further consolidation in both the in vitro diagnostics (IVD) manufacturing sector and the lab testing sector. It was on Decembe…
Many Questions About FDA Regulation of LDTs
CEO SUMMARY: Ask most pathologists and laboratory administrators about the FDA’s intent to regulate laboratory-developed tests (LDTs), and they will likely answer that it is to control web-based direct-to-consumer lab testing companies and the rapidly- growing number of proprie…
Social Networking Is New Lab Marketing Channel
CEO SUMMARY: Using social marketing sites on the Web allows labs and IVD manufacturers to interact with customers in ways that were not possible years ago. Marketers use these interactive web sites to supplement traditional methods of advertising. Inviting customers to discuss your compan…
2.3% Medical Device Tax Hits Clinical Labs in 2013
CEO SUMMARY: One aspect of the massive new health bill is that medical device companies will pay a 2.3% tax, effective January 1, 2013. Students of economics know that it is customers who invariably end up paying such direct taxes. Thus, clinical laboratories in the United States should p…
New Clinical Lab Trends To Shape Events in 2010
CEO SUMMARY: In presenting this list of macro trends for clinical laboratories, several themes are in play. They range from a continued emphasis on improving lab operations to the need to acquire and deploy sophisticated information technology. During the next few years, the long…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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