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Medtech in a Minute: FDA’s Flawed Testing Guidance and More

FDA Admits to Flaws in Testing Guidance

Nearly one year ago, FDA allowed many antibody tests to be sold and shipped unreviewed. It was an effort to get tests onto the market as quick as possible to deal with growing threat of COVID-19. In an editorial published in The New England Journal of Medicine, FDA officials admitted this measure was a mistake.

Liquid Biopsy is Hotter than Ever

Guardant Health launched a liquid biopsy test for the detection of residual and recurrent colorectal cancer. The Guardant Reveal is considered the industry’s first blood-only test designed to detect, with seven-day turnaround time, residual disease after surgery and recurrence months earlier than current standard-of-care methods. In other liquid biopsy news, Personal Genome Diagnostics raised $103 million in a series C round to help with the advancement of its tissue and liquid biopsy tests.

And in case you missed our last Medtech in a Minute report…

AliveCor Hits Its Stride with Two Key Milestones

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 Reaches for the Cloud

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 Recalls Emblem S-ICD Electrode

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.

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