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BioWorld - Monday, June 29, 2026
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Medical technology
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Regulatory actions for July 30, 2024

July 30, 2024
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Airs Medical, Haemonetics, Stryker, Varian, Vialase .
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WHO preps for human avian flu spread with mRNA vaccine project

July 30, 2024
By Mari Serebrov
With the COVID-19 pandemic still visible in the rearview mirror, the World Health Organization (WHO) is taking no chances as it preps for human avian influenza, or H5N1, a subtype of influenza A.
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Guardant wins nod from FDA for Shield test for colorectal cancer

July 29, 2024
By Mark McCarty
The U.S. FDA approved the PMA application for the Shield test by Guardant Health Inc., a diagnostic for colorectal cancer that avoids some of the issues with alternative diagnostic methods. There are lingering questions about Medicare coverage and physician adoption, however, the answers to which may take a year or two to emerge.
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Med-tech gainers and losers for July 22-26, 2024

July 29, 2024
The top 10 med-tech stock gainers and losers for the week.
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Neurons with dendrites affected by amyloid plaques in Alzheimer's disease

C2N, Quanterix blood tests diagnose 90% of early-stage Alzheimer's

July 29, 2024
By Annette Boyle
C2N Diagnostics LLC’s two-factor blood test, Precivity AD2, showed 90% accuracy in diagnosing Alzheimer’s disease in a study presented at the Alzheimer’s Association International Conference in Philadelphia on July 28 and simultaneously published in the Journal of the American Medical Association. The following day, Quanterix Corp. presented results from its study that showed a multi-marker approach could maintain the 90% accuracy of its Lucentad test, while reducing the percentage of uncertain results from more than 30% to 10%, in line with the intermediate results demonstrated by Precivity.
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AI dollar sign

Deepc raises $13M in series A extension for AI-based radiology platform

July 29, 2024
By Shani Alexander
Deepc GmbH recently raised a further $13 million in a series A extension round to close the round at $26 million for its artificial intelligence (AI)-based operating system, Deepcos, which is designed to provide radiologists with a wide variety of AI-based solutions.
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guardant bloodkit

Guardant wins nod from FDA for Shield test for colorectal cancer​

July 29, 2024
By Mark McCarty
The U.S. FDA approved the PMA application for the Shield test by Guardant Health Inc., a diagnostic for colorectal cancer that avoids some of the issues with alternative diagnostic methods. There are lingering questions about Medicare coverage and physician adoption, however, the answers to which may take a couple of years emerge.
Read More
Thyroid anatomy illustration

Austria’s HTA authority not yet sold on thyroid nodule thermoablation

July 29, 2024
By Mark McCarty
Thermoablation of thyroid nodules meets the patient’s standard of minimal invasiveness and is supported by the literature as an effective treatment for these nodules, which may become cancerous.
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Appointments and advancements for July 29, 2024

July 29, 2024
New hires and promotions in the med-tech industry, including: Intelliguard, SHL Telemedicine.
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Waveview bc diagnostic
Patents

Wave View patenting microwave technology for pain-free, timely breast imaging

July 29, 2024
By Simon Kerton
The first patenting to be published in the name of Wave View Imaging Inc. sees its co-founders file for additional protection of their imaging technology which can be used to monitor breast cancer treatment.
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