TAG:
laboratory medicine
Millennials’ Healthcare Demands Will Be Radically Different from Others
By Robert Michel | From the Volume XXVIII, No. 6 – May 3, 2021 Issue
This is an excerpt of a 1.620-word article in the May 3, 2021 issue of Ā THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: In just 42 months, Millennials will make up 75% of the workforce, according to U.S. Department of Co…
Millennials Set to Reorder Healthcare & Lab Testing
By Robert Michel | From the Volume XXVIII, No. 6 – May 3, 2021 Issue
CEO SUMMARY: In just 42 months, Millennials will make up 75% of the workforce, according to U.S. Department of Commerce statistics. As consumers and patients, they are already triggering changes, reforms, and innovation in healthcare. It is timely for clinical lab administrators and…
New Twist: HHS Exerts Authority Over FDA on LDTs
By Robert Michel | From the Volume XXVII, No. 16 – November 16, 2020 Issue
CEO SUMMARY: In a recent memo, the federal Department of Health and Human Servicesā general counsel rendered a legal opinion that FDA would need to issue new regulations to regulate LDTs. By stepping into this years-long dispute and saying that FDA cannot regulate LDTs through gui…
FDA Will Have No Authority Over Laboratory-Developed Tests, HHS Says
By Robert Michel | From the Volume XXVII, No. 12 – August 24, 2020 Issue
This is an excerpt of a 2,029-word article in the August 24, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: A directive from the federal Department ofĀ Health and Human Services (HHS) may have long-lasting implic…
HHS āStands Downā FDA on Its Oversight of LDTs
By Robert Michel | From the Volume XXVII, No. 12 – August 24, 2020 Issue
CEO SUMMARY: A directive from the federal Department ofĀ Health and Human Services (HHS) may have long-lasting implicationsĀ for the federal Food and Drug Administrationās efforts toĀ assert regulatory oversight of laboratory-developed tests (LDTs).Ā In a statement last week, HHS said t…
Amazon Targets COVID-19 Testing in its New Lab-Building Venture
By Robert Michel | From the Volume XXVII, No. 11 – August 3, 2020 Issue
This is an excerpt of a 1,980-word article in the August 3, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: For pathologists and clinical lab directors,Ā Amazonās nascent COVID-19 t…
Amazon Building Labs to Do COVID-19 Testing
By Robert Michel | From the Volume XXVII, No. 11 – August 3, 2020 Issue
CEO SUMMARY: For pathologists and clinical lab directors,Ā Amazonās nascent lab-testing venture for employees could be aĀ significant concern given that the e-commerce company couldĀ disrupt the clinical lab business nationwide. The online retailĀ giant has long had an interest in medic…
Employers, Others Looking to Build New Clinical Labs
By Robert Michel | From the Volume XXVII, No. 11 – August 3, 2020 Issue
CEO SUMMARY: Employers, universities, municipalities,Ā and other large organizations are interested in building theirĀ own clinical laboratories. In addition, entrepreneursāmanyĀ with no prior experience in laboratory medicineāwant to makeĀ money providing COVID-19 testing. Many of th…
Itās a Clinical Lab Moment … But No Advocates!
By R. Lewis Dark | From the Volume XXVII No. 10 – July 13, 2020 Issue
Nearly every day since the onset of the SARS-C0V-2 outbreak,Ā there have been stories in the national news about clinical laboratory testingĀ for COVID-19. No laboratory professional alive today has seen such anĀ endless stream of news stories about clinical lab testing. This is a once-in-a-lifetime …
Why Local Labs Deserve More COVID-19 Supplies
By Robert Michel | From the Volume XXVII No. 10 – July 13, 2020 Issue
CEO SUMMARY: As government officials and IVD firms divertĀ the lionās share of COVID-19 tests to a handful of billion-dollarĀ labs, in thousands of hospitals across the nation COVID-19Ā patients languish days longer before discharge because their hospitalĀ lab must send COVID-19 tests t…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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