TAG:
ivd manufacturer
2009’s Top Ten Lab Stories Reflect Some Good, Bad
CEO SUMMARY: As the closing year of the first decade of the new century and the new millennium, 2009 brought neither disruption nor upheaval to the majority of laboratories in the United States. Rather, it was marked by at least two themes. One was how public disclosure of problems with l…
Mickey Mouse to Educate Kids About Allergy Lab Test Options
THIS MAY BE A FIRST IN LABORATORY TEST SALES AND MARKETING! Mickey Mouse will star in a new children’s book designed to educate children and parents about diagnosis and management of allergies. This unique marketing campaign is the brainchild of Siemens Healthcare and Walt…
Olympus Diagnostics Unit Sold to Beckman Coulter
CEO SUMMARY: For Beckman Coulter, the opportunity to acquire the diagnostics business of Olympus Corporation was compelling for at least two reasons. One, the chemistry and automation products of both companies are quite complementary. Two, in a steadily-consolidating in vitro di…
Competition in Rapid Tests Means Value to Labs
CEO SUMMARY: One of the hottest market segments in in vitro diagnostics (IVD) is rapid testing. However, because labs now often have multiple choices when selecting a rapid test, IVD manufacturers recognize the need to differentiate their products by adding additional features an…
ISO 15189 Work Advances at Meeting in Vancouver
CEO SUMMARY: Laboring quietly out of the public eye, an international work team of professionals, including representatives from the CDC, the FDA, and global in vitro diagnostics (IVD) manufacturers, has spent the past 14 years developing an important series of quality and safety standard…
Federal Court Rules on Specimen Ownership
CEO SUMMARY: Recently, a federal appeals court affirmed a district court ruling concerning who owns human tissue specimens that are stored for research and other uses. While most clinical laboratories routinely discard many types of human specimens after use, any research facility or IVD …
Heparin, China, Reagents, and Your Lab
MANY OF YOU HAVE HEARD THE NEWS about the contaminant that was found in the heparin manufactured and sold by Baxter International, Inc. Authorities, responding last fall to reports of hundreds of bad reactions and 19 deaths to the drug, quickly focused on the Chinese companies that s…
More Labs Actively Adopt Quality Management
CEO SUMMARY: With almost 300 speakers, attendees, and vendors in attendance from seven countries, Lab Quality Confab was a significant milestone for the global lab industry. On one level, it was a sign that the quality improvement trend has come of age. On another level, it provided ample…
Siemens Acquires Dade, Builds IVD Powerhouse
CEO SUMMARY: In just 15 months, Siemens AG has pulled out its checkbook three times to spend more than $14 billion to acquire major in vitro diagnostics (IVD) companies. When it closes the purchase of Dade Behring, Siemens will be in the first rank of global IVD manufacturers. It has also…
Unprecedented Activity Across Lab Medicine
CEO SUMMARY: Laboratory medicine is now considered one of the best opportunities to profit as the demand for healthcare services skyrockets, both in the United States and throughout the world. This is why a flood of investment capital is washing into the laboratory industry. Loaded with c…
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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