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Considerations for Mobile Health Technology Developers: Part 2

pharmaphorum

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criterion 1. Criterion 2.

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FDA clears AI-powered prostate cancer detection software

pharmaphorum

. “The authorization of this AI-based software can help increase the number of identified prostate biopsy samples with cancerous tissue, which can ultimately save lives,” said Tim Stenzel, director of the FDA’s office of in vitro diagnostics and radiological health. That compared to 90.9%

In-Vitro 108
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Vir awarded $1 billion multi-year BARDA influenza contract

pharmaphorum

The US Government’s Biomedical Advanced Research and Development Authority (BARDA) has made an initial investment of approximately $55 million for rapid development of VIR-2482, the Vir Biotechnology’s investigational prophylactic monoclonal antibody (mAb) for seasonal and pandemic influenza viruses.

Antibody 110
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New HCV Test Enables Diagnosis and Treatment in a Single Visit

XTalks

” The Xpert HCV test’s development was validated through the Independent Test Assessment Program (ITAP), part of the National Institutes of Health’s (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program. The infection, if left untreated, can lead to severe health issues such as liver cancer and liver failure.

RNA 97
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Healthy.io’s Smartphone-Powered Minuteful Kidney Test Gets FDA Clearance

XTalks

Around one in three adults in the US (or about 80 million Americans) are at risk of developing CKD. The Minuteful Kidney test kit is delivered to the patient’s home and is made up of all these things needed for in vitro home ACR testing: A urine collection cup. Healthy.io An early diagnosis would help avoid end-stage kidney disease.

Reagent 98
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A Final LDT Rule in April!? Will FDA be prepared?

FDA Law Blog

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

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How Advanced Diagnostics are Shaping the Future of Precision Medicine and Gene Therapy

Cloudbyz

In this blog, we will explore how diagnostics play a pivotal role in these cutting-edge fields, enhancing patient outcomes, and accelerating the development of personalized treatments. The landscape of modern medicine is rapidly evolving, driven by groundbreaking advancements in diagnostics.