Developing an Automated HIV Self-Test for Use in Developing Countries
Principal investigator discusses a new research initiative to create a low-cost, rapid HIV self-test.
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AI Combined with DM and ABUS Can Improve Breast Cancer Detection
Researchers found that combining AI with both imaging technologies can improve the detection of cancer in women with dense breasts.
New Breakthrough Device Designations Fall 37 Percent in 2022
According to the FDA’s recently-released annual report, only 135 devices received the designation last year, versus 213 in 2021.
Huge Decline in Medicare Laboratory Testing Due to COVID-19
According to a recent OIG report, fewer Medicare Part B beneficiaries received lab tests during the first 10 months of the pandemic.
The Promise of State-of-the-Art Sequencing Technologies for Cancer Screening
Circulating tumor DNA sequencing technologies are tackling the challenges of early cancer detection.
How the Use of MALDI-TOF MS Is Expanding in Clinical Diagnostics
Advances in MALDI time-of-flight mass spectrometry have significantly expanded its use in high-throughput diagnostic labs.
Recent Discovery Could Lead to a Better Lyme Disease Test
Researchers have identified 35 genes found in high expression in people with long-term Lyme disease, which could lead to earlier detection.
Improving the Chances of Early Breast Cancer Detection in High-Risk Patients
A new test targeting changes in serum proteins can detect breast cancer up to two years before the condition would normally be diagnosed.
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In draft guidance, the FDA is proposing that medical device makers will need to consider how accessible their products are to underserved populations.
