FDA Clearance Archives - The Dark Intelligence Group

TAG:

FDA Clearance

Expert Sees Pros, Cons In DP and WSI Systems

By Joseph Burns | From the Volume XXVI No. 13 – September 23, 2019 Issue

CEO SUMMARY: Now that the FDA has cleared two digital pathology systems for use in primary diagnosis, a growing number of pathology groups are taking up the question of whether and when they should adopt and use a digital pathology system and whole slide imaging. One pathologist with hand…

PGx Testing Labs Concerned by FDA’s Statements, Actions

By Mary Van Doren | From the Volume XXVI No. 12 – September 3, 2019 Issue

This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…

PGx Labs Concerned by FDA’s Statements, Actions

By Joseph Burns | From the Volume XXVI No. 12 – September 3, 2019 Issue

CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to ce…

FDA Clears Aperio’s Digital Pathology System

By Joseph Burns | From the Volume XXVI No. 10 – July 22, 2019 Issue

CEO SUMMARY: In May, the FDA announced clearance for Leica Biosystems to market its Aperio AT2 DX System for clinical diagnosis in the United States. The Aperio AT2 DX System is intended for in vitro diagnostic use as an aid to pathologists reviewing and interpreting digital images of sur…

Outside US, Digital Path Moves Ahead Rapidly

By Joseph Burns | From the Volume XXVI No. 10 – July 22, 2019 Issue

CEO SUMMARY: Implementation of digital pathology and whole-slide imaging systems in the United States lags behind that of other countries for two reasons. One is a more acute shortage of pathologists in those countries and the other is a less restrictive regulatory environment. In some lo…

What’s Coming Next for Anatomic Pathologists?

By R. Lewis Dark | From the Volume XXVI No. 7 – May 20, 2019 Issue

INTERESTING THINGS ARE UNFOLDING within the profession of anatomic pathology. If the adage of “follow the money” applies to understanding why things happen, then recent events support some surprising conclusions. Take the news reported in this issue of The Dark Report that PathGroup …

April 29, 2019 Intelligence: Late Breaking Lab News

By Robert Michel | From the Volume XXVI No. 6 – April 29, 2019 Issue

Investor interest in digital pathology (DP) and the use of artificial intelligence (AI) to analyze digital pathology images seems to be at a fever pitch recently. In the last three weeks, investors poured almost $85 million of capital into just three digital pathology companies, as noted below. This…

Georgia Micro Lab Slashes TAT by Almost Two Days

By Joseph Burns | From the Volume XXV No. 6 – April 16, 2018 Issue

CEO SUMMARY: Two projects to boost the performance of the microbiology laboratory at University Health Services in Augusta, Ga., significantly reduced test turnaround times in ways that contributed to improved patient outcomes. The first project was in 2016, when the lab introduced mass s…

Newsmaker Interview: Healthcare’s Transformation Now Bringing Changes to Lab Industry

By Joseph Burns | From the Volume XXV No. 3 – February 12, 2018 Issue

“Today, patients want to get diagnosis and treatment faster with fewer visits to the doctor’s office. They want speedier and more comprehensive delivery of clinical services, be it laboratory tests, imaging, or other procedures.” …

Beckman Coulter Sues Quidel for Right to Sell BNP Assay

By Jon Stone | From the Volume XXV No. 1 – January 2, 2018 Issue

THERE IS AN INTERESTING COURT FIGHT UNFOLDING between Beckman Coulter Corporation and Quidel over the rights to sell a B-type natriuretic peptide (BNP) assay. The lawsuit is a consequence of Abbott Laboratories’ acquisition of Alere, Inc….

Volume XXVII No. 8 – June 1, 2020

THE DARK REPORT brings news that the national media has overlooked: Lab revenues, cut precipitously during the coronavirus pandemic, will leave many labs without the resources to continue operation in the near future. As calculated by THE DARK REPORT, the nation’s clinical lab industry had lost $6.8 billion in revenue by week 12 of the crisis. Also reported is that in many cases, the culprit is a frustrating lack of supplies that would allow labs to replace lost routine testing with new COVID-19 testing.

See the full table of contents

How Much Laboratory Business Intelligence Have You Missed?

Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!

Need A Group Membership? Company Discounts are Available!

Sign up for TDR Insider

Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.

Topics

Visit The Dark Library