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BioWorld - Tuesday, December 23, 2025
Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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Fidget spinner toy and diagnostic fidget spinner

Centrifugation can be child’s play with fidget spinners

June 2, 2020
By John Fox
Fidget spinners are hand-held toys based on a roller bearing and three weighted lobes, which can spin freely, creating centrifugal force when activated manually.
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Woman in lab

Exact Sciences highlights data backing value of Oncotype Dx in guiding neoadjuvant treatment decisions

June 2, 2020
By Liz Hollis
Exact Sciences Corp., of Madison, Wis., detailed three studies of the Oncotype Dx Breast Recurrence Score test during the virtual 2020 American Society of Clinical Oncology Annual Meeting.
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Memed secures CE mark for new POC blood test

June 2, 2020
By Nuala Moran
LONDON – After eight years in development, Memed Diagnostics Ltd. has secured CE marking for its point-of-care blood test, which is able to distinguish between bacterial and viral infections in 15 minutes.
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FDA approves Tauvid for PET imaging in patients being evaluated for AD

June 2, 2020
U.S. FDA headquarters

FDA’s Hahn emphasizes regulatory flexibility, but FDA not ‘walking away’ from RCTs

June 1, 2020
By Mark McCarty
The COVID-19 pandemic has demanded much of the FDA, and commissioner Stephen Hahn said on a June 1 conference call that “there have been hiccups along the way” as the enormity of the threat came into view. The agency’s use of emergency use authorizations (EUAs) has drawn criticism, but Hahn defended those EUAs and other regulatory flexibilities even has he declared that the FDA is not “walking away from” randomized, controlled clinical trials as the gold standard for premarket review.
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Lung cancer illustration

Inivata reveals collaboration, investment from Neogenomics

June 1, 2020
By Nuala Moran
LONDON – Neogenomics Laboratories Inc. is to make a $25 million equity investment in Inivata Ltd. and has taken an option to acquire all of the company as part of a U.S. commercialization agreement with the U.K. liquid biopsy specialist. Under the deal, Neogenomics will take over sales, marketing and billing for Inivata’s Invisionfirst circulating tumor DNA lung cancer test, which is intended to replace tissue biopsies.
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Components of the self-collection kit

Quest gains EUA for COVID-19 diagnostic self-collection kit

May 29, 2020
By Annette Boyle
The U.S. FDA granted an emergency use authorization (EUA) for Quest Diagnostics Inc.’s self-collection kit for COVID-19. The kit allows individuals to collect their own specimens at home or in a health care setting.
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Components of the nasal sample kit

FDA clears the way for Letsgetchecked’s at-home COVID-19 test

May 29, 2020
By Meg Bryant
New York-based at-home testing startup Letsgetchecked said Friday that the U.S. FDA has granted emergency use authorization (EUA) for its COVID-19 Sure-track Test for signs of active SARS-CoV-2 infection. The polymerase chain reaction (PCR) nasal swab test is for use by at-risk individuals in the home and delivers results within 24 hours of a sample being received by the company’s CLIA-certified laboratory.
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Illustration of Lucid system

Neural Analytics aims robotic transcranial doppler at COVID-19 patients

May 28, 2020
By Meg Bryant
Doctors are reporting a proliferation of dangerous blood clots in the lungs and other major organs of COVID-19 patients, raising the risk of stroke and other life-threatening complications. While anticoagulant medications can reduce that risk, patients need careful monitoring to ensure their blood is neither too thick nor too thin. To that end, Los Angeles-based startup Neural Analytics Inc. is deploying its robotically assisted transcranial doppler (TCD) system for real-time identification of blood clots and disruptions in blood flow to the brain.
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Artist’s rendering of patient lying on Izotropic’s 3D breast CT scanning platform

Izotropic, Starfish set to commercialize new breast CT system

May 28, 2020
By David Godkin
TORONTO – Vancouver, British Columbia-based Izotropic Corp. has inked a deal with Victoria, British Columbia-based based Starfish Medical Inc. to commercialize a CT scanner Izotropic CEO Robert Thast said will be a major disruptor of the breast imaging industry. Izotropic has spent approximately $20 million over the past 15 years to develop the system and is counting on Starfish to help translate this into a market-ready 3D breast CT imager by the end of 2020.
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