AI in Health Care: Balancing Benefits and Barriers
AI can help alleviate the burden on clinical labs—but only with sufficient investment, enthusiasm, and understanding
Clinical Diagnostics Insider
(formerly Diagnostic Testing and Emerging Technologies)
Keep up to date on new and emerging diagnostic tests, testing trends and opportunities, and disruptive technologies
Esophageal Pre-Cancer Testing Gaining Greater Traction
How three companies are addressing screening challenges with tests that help improve chances of early detection
Computing the Future of the Lab
Computational biology expert Keaun Amani shares his advice and insights on AI and machine learning tools for the clinical lab
SARS-CoV-2 Saliva Testing Gains Traction
Saliva testing for the virus that causes COVID-19 is gaining acceptance in both the scientific community and US market.
New Breast Density Notification Final Rule to Publish Soon
The FDA recently confirmed that a new rule requiring healthcare providers to notify patients of their breast density status will be released in late 2022 or early 2023.
AACC Updates Guidelines for Use of Reproductive POC Testing
The new guidelines address issues with false negatives and positives from POC testing for fertility and reproductive health.
December 2022 FDA Watch: COPD, COVID-19, and MDD Tests Gain Clearance
A roundup of the significant new diagnostic tests and products that received regulatory approval in the US and around the world.
Want Breakthrough Device Designation? You’ll Need to Consider Health Equity
In draft guidance, the FDA is proposing that medical device makers will need to consider how accessible their products are to underserved populations.
New Urine Test Can Detect Synthetic Cannabinoids in Marijuana
Recent study shows the new test can identify a widespread and dangerous class of synthetic cannabinoids called BZO-CHMOXIZID.
New Study Supports Accuracy of Diagnoses from Video Visits
Video telehealth during the early period of the COVID-19 quarantine was actually highly effective in providing accurate diagnoses, research shows.
Polygenic Risk Scores Can Predict Chance of Sudden Cardiac Death
Recent study shows scores capable of assessing genetic risk of coronary artery disease can also ID those at high risk of death.
November 2022 FDA Watch: Pace of New Approvals Slows
Though there were fewer new approvals last month, the impact of the products that did gain approval more than made up for the drop in volume.
Abbott Ushers Monkeypox Testing into Its New Commercial Phase
Abbott has once more gotten the jump by becoming the first company to get EUA clearance for a commercial monkeypox RT-PCR test kit.
