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Teal Health's At-Home Cervical Cancer Test Gains FDA Approval, Expands Access for Women

Teal Health's At-Home Cervical Cancer Test Gains FDA Approval, Expands Access for Women

Teal Health has developed an at-home cervical cancer screening test, which has been approved by the U.S. Food and Drug Administration (FDA). This test allows women aged 25 to 65 across the United States to collect a vaginal sample at home and send it to a lab for analysis. The test has shown a 96% accuracy rate in identifying pre-cancer, comparable to traditional in-office tests. The approval and subsequent rollout of this test mark a significant advancement in women's health, providing a convenient and private option for cervical cancer screening. The initiative aligns with efforts to eliminate cervical cancer, which the World Health Organization (WHO) has identified as an eliminable disease due to advancements in diagnostics and vaccination.
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Datar Cancer Genetics Secures FDA Clearance for Genomic Profiling Assay, Enhancing Cancer Treatment Options

Datar Cancer Genetics Secures FDA Clearance for Genomic Profiling Assay, Enhancing Cancer Treatment Options

Datar Cancer Genetics has received clearance from the U.S. Food and Drug Administration (FDA) for its CellDx-Tissue assay, a comprehensive genomic profiling tool for solid tumors. This assay utilizes DNA and RNA sequencing to analyze 517 cancer-associated genes, providing oncologists with detailed genomic information to guide treatment decisions. The FDA's clearance process is known for its rigor, covering analytical, clinical, and IT domains, which underscores the assay's reliability and potential impact on cancer treatment. The clearance allows Datar Cancer Genetics to collaborate with international partners in clinical management and research, reinforcing its commitment to precision oncology.
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Synnovis and SOPHiA GENETICS Partner to Expand Blood-Based Cancer Testing in the U.K.

Synnovis and SOPHiA GENETICS Partner to Expand Blood-Based Cancer Testing in the U.K.

SOPHiA GENETICS has partnered with Synnovis to introduce liquid biopsy testing for lung and breast cancer patients across the U.K. This initiative is part of NHS England's 'blood test-first' program. The test, MSK-ACCESS®, uses SOPHiA DDM™ technology to analyze circulating tumor DNA (ctDNA) from a single blood draw, offering a minimally invasive alternative to traditional biopsies. The partnership aims to fast-track cancer patients to targeted therapies and reduce the need for invasive treatments. Synnovis is already supporting around 400 patients monthly with this testing, and the program is expected to expand significantly.
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FDA Clears Glooko's EndoTool IV Cloud for Hospital Insulin Dosing

FDA Clears Glooko's EndoTool IV Cloud for Hospital Insulin Dosing

FDA Clears Glooko's EndoTool IV Cloud for Hospital Insulin Dosing
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Shyld AI Secures $13.4M to Enhance Autonomous Disinfection in U.S. Hospitals

Shyld AI Secures $13.4M to Enhance Autonomous Disinfection in U.S. Hospitals

Shyld AI Secures $13.4M to Enhance Autonomous Disinfection in U.S. Hospitals
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Roche Receives CE Mark for Alzheimer's Blood Test, Aiming to Accelerate Diagnosis

Roche Receives CE Mark for Alzheimer's Blood Test, Aiming to Accelerate Diagnosis

Roche has announced the receipt of a CE Mark for its Elecsys® pTau217 blood test, developed in collaboration with Eli Lilly and Company. This test is designed to detect phosphorylated Tau (pTau) 217 protein, a key indicator of amyloid pathology associated with Alzheimer's disease. The Elecsys® pTau217 test offers a minimally invasive alternative to traditional diagnostic methods like PET-CT scans and cerebrospinal fluid assessments, which are often costly and less accessible. The test aims to provide a faster and more convenient diagnosis for Alzheimer's, potentially reducing the average 3.5-year delay in diagnosing dementia. This development is significant as it could help address the issue of underdiagnosis, with an estimated 75% of dementia cases currently undiagnosed.
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bioAffinity Technologies Achieves Record Sales for CyPath® Lung Diagnostic Test

bioAffinity Technologies Achieves Record Sales for CyPath® Lung Diagnostic Test

bioAffinity Technologies Achieves Record Sales for CyPath® Lung Diagnostic Test
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Renalytix and Carna Health Partner to Address Kidney Disease Crisis with Innovative Care Model

Renalytix and Carna Health Partner to Address Kidney Disease Crisis with Innovative Care Model

Renalytix and Carna Health Partner to Address Kidney Disease Crisis with Innovative Care Model
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Boehringer and Brainomix Initiate New Trial for AI in Lung Fibrosis Diagnosis

Boehringer and Brainomix Initiate New Trial for AI in Lung Fibrosis Diagnosis

Boehringer and Brainomix Initiate New Trial for AI in Lung Fibrosis Diagnosis
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Incyte to Present Over 20 Abstracts at European Hematology Association 2026 Congress

Incyte to Present Over 20 Abstracts at European Hematology Association 2026 Congress

Incyte to Present Over 20 Abstracts at European Hematology Association 2026 Congress
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Curis Reports First Quarter 2026 Financial Results Amid Ongoing Clinical Trials

Curis Reports First Quarter 2026 Financial Results Amid Ongoing Clinical Trials

Curis Reports First Quarter 2026 Financial Results Amid Ongoing Clinical Trials
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GLOBO Language Solutions Recognized as a Top Workplace in Healthcare for 2026

GLOBO Language Solutions Recognized as a Top Workplace in Healthcare for 2026

GLOBO Language Solutions Recognized as a Top Workplace in Healthcare for 2026