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BioWorld - Saturday, December 27, 2025
Home » Authors » Annette Boyle

Articles by Annette Boyle

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FDA grants EUAs for multiple devices that address COVID-19 cytokine storm

April 14, 2020
By Annette Boyle
Since April 10, 2020, the FDA has issued emergency use authorizations (EUAs) to several companies that make blood purification devices that can clear excess cytokines in the blood of patients with COVID-19. Monmouth Junction, N.J.-based Cytosorbents Corp.; Lakewood, Colo.-based Terumo BCT Inc.; and Marker Therapeutics AG, a subsidiary of Marker AG, of Zug, Switzerland, have all recently received EUAs for use of their products in adults with confirmed COVID-19 infections who are admitted to intensive care.
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One Drop acquires assets of Sano Intelligence

April 13, 2020
By Annette Boyle
Informed Data Systems Inc., doing business as One Drop, purchased the assets and intellectual property of Sano Intelligence Inc. for an undisclosed amount. San Francisco-based Sano has been developing a wearable continuous glucose sensor that enables users to track blood glucose levels and other blood chemistry via a smart phone app for nearly a decade. One Drop will integrate the stick-on device into its personalized digital care program for diabetics and people with other chronic conditions.
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Sandia Labs develops a wearable brain imager

April 13, 2020
By Annette Boyle
Albuquerque, N.M.-based Sandia Labs received a $6 million grant from the NIH to build a prototype for a wearable brain scanner. The noninvasive functional brain imaging system will use optically pumped magnetometers (OPMs) to conduct more accurate magnetoencephalography (MEG), while improving accuracy, increasing comfort, reducing imaging costs, and enabling use in more patients.
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COVID-19 will permanently restructure health care

April 6, 2020
By Annette Boyle
Many adaptations to the coronavirus pandemic will remain standard features of health care long after the pandemic wanes, according to Brian Chapman, managing partner at ZS Associates, an Evanston, Ill.-based pharmaceutical and medical technology consultancy. In the long term, telehealth will be a clear winner as payers look to lower ongoing costs, more procedures and care will move out of hospitals, rapid diagnostics will gain importance, and government and payer coverage of infectious disease testing of all kinds will expand, he predicted.
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CT scans interpreted by AI can help diagnose coronavirus

April 1, 2020
By Annette Boyle
An artificial intelligence-based system can accurately detect COVID-19 using thoracic CT scans in patients with respiratory symptoms, according to a preprint study published on arXiv.org. The system can also help monitor patients with the disease. Other teams have employed AI to speed diagnosis and develop clarity on the signature appearance of the disease in the lungs of symptomatic patients.
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Excellent outcomes for Medtronic Evolut TAVR in low-risk bicuspid AVS patients

March 31, 2020
By Annette Boyle
Results of a study presented at the American College of Cardiology's Annual Scientific Session on March 29 demonstrated “excellent” outcomes following transcatheter aortic valve replacement (TAVR) using the Medtronic plc Evolut in low surgical risk patients with bicuspid aortic valve stenosis.
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Renal denervation significantly reduces untreated hypertension

March 30, 2020
By Annette Boyle
Results of the pivotal Spyral-HTN OFF MED study presented at the American College of Cardiology's Annual Scientific Session on March 29 demonstrated significant reduction in blood pressure three months after renal denervation (RDN) in patients with unmedicated hypertension.
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FDA authorizes Pear Therapeutics' prescription digital insomnia therapy

March 27, 2020
By Annette Boyle
Pear Therapeutics Inc. obtained FDA approval for Somryst, the first prescription digital therapeutic for chronic insomnia. The app provides structured cognitive behavior therapy (CBT) with clinical dashboards for physicians. While CBT is the recommended first-line therapy for insomnia, the U.S. has only 500 therapists certified to provide CBT for insomnia (CBTi) for the estimated 30 million Americans who suffer from chronic difficulty going to and staying asleep.
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Everlywell restricts at home testing to health care professionals

March 24, 2020
By Annette Boyle
Everlywell Inc. stepped back from its announcement that consumers could access at-home testing for COVID-19 starting on March 23, 2020, following a U.S. FDA update that cautioned against fraudulent at-home tests.
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Beta-O2 Technologies to begin human trials on new artificial pancreas

March 16, 2020
By Annette Boyle
Beta-O2 Technologies Ltd. plans to enroll its first patients in clinical trials for its second-generation bio-artificial pancreas, ßAir, in the coming months. The small, implantable titanium device has separate components that hold pancreatic cells and a rechargeable oxygen tank. Beta-O2 is based in Rosh-Haayin, Israel.
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