FDA cleared AlifeCor's technology for an expanded range of ECG determinations and had research with Mayo Clinic published in the peer-reviewed journal Circulation. AliveCor's KardiaMobile, a robust heart monitoring solution backed by strong data, is available on Amazon.
Hologic signed a multi-year agreement that will integrate the Google Cloud machine learning technologies into the Genius Digital System. The goal of the collaboration is to use artificial intelligence to enhance the screening of cervical cancer. Hologic said its expectation is that the Genius Digital Diagnostics System will derive even more actionable insights from cytology slides for cytotechnologists and pathologists. The system is available in Europe but has not yet reached the U.S. market.
Boston Scientific is recalling the Emblem S-ICD Subcutaneous Electrode because of increased risk of fractures at a specific point (distal to the proximal sense ring). So far, FDA said, there have been 27 complaints about this device issue and 26 reports of serious injuries associated with this recall. One death has also been reported. The Emblem S-ICD Subcutaneous Electrode is part of the Boston Scientific S-ICD System. The Boston Scientific S-ICD is an implantable cardioverter defibrillator that is intended to provide pacing for slow heart rhythms and electrical shock or pacing to stop dangerously fast heart rhythms. These cardiac devices are implanted under the skin in the upper chest area.
And in case you missed last week's Medtech in a Minute report...
Austin, TX-based Babson Diagnostics is focused on moving laboratory testing to the pharmacy counter. The company says it has developed a model for diagnostic blood testing that maintains a high standard of accuracy, yet requires only one-tenth the sample size of traditional venipuncture methods. The company also uses a proprietary blood collection device to collect the sample right there at the pharmacy, then the sample is processed back at Babson's labs. It's a story that feels familiar, yet Babson is taking a science-first approach that could make all the difference.
Valencia, CA-based SetPoint Medical has raised $64 million in a preferred stock financing. The financing is expected to help move SetPoint's pivotal trial through the development of its bioelectronic platform to treat rheumatoid arthritis.
Researchers at the University of California Los Angeles (UCLA) School of Dentistry are exploring the use of saliva in early lung cancer detection and analysis. Saliva is being looked at more closely than ever for its diagnostic possibilities, a trend somewhat driven by discoveries in testing for COVID-19.