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BioWorld - Friday, February 6, 2026
Home » Topics » Diagnostics, Medical technology

Diagnostics, Medical technology
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Australia and coronavirus

Australian researchers develop COVID-19 test that detects variability in patients’ immune systems

Dec. 18, 2020
By Tamra Sami
PERTH, Australia – Researchers at the QIMR Berghofer Medical Research Institute in Queensland have developed a way of testing whether COVID-19 patients’ immune systems are gearing up to fight the virus that causes the disease.
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Connecting puzzle pieces

Philips snaps up Biotelemetry for $2.8B

Dec. 18, 2020
By Meg Bryant
Royal Philips NV is expanding its cardio footprint with the acquisition of Biotelemetry Inc., a manufacturer of remote medical technologies, for $2.8 billion, or $72 per share. The proposed deal, announced Friday, furthers Philips’ goal of providing integrated solutions across the care continuum, with Biotelemetry’s cardiac diagnostics and monitoring tools joining Philips’ line of hospital-based patient monitoring solutions. Philips expects the Biotelemetry business to contribute to sales growth and EBITA margin in 2021 and deliver double-digit growth and improve profit margins to more than 20% by 2025.
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The Blue Box at-home breast cancer screener

At-home breast cancer screener Blue Box looking to begin clinical study

Dec. 17, 2020
By Gina Lee
HONG KONG – A new prototype hand-held device coupled with an artificial intelligence (AI)-powered app could make it possible for women to screen for breast cancer at home cheaply and efficiently. The device, the Blue Box, is the brainchild of Judit Giro? Benet, a 23-year-old junior specialist at the Center for Embedded Cyber-physical Systems at the University of California, Irvine, who is working with her Taiwanese partner Billy Chen to get their Blue Box to market.
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Exero sensor

Exero secures FDA breakthrough designation for GI smart sensor

Dec. 17, 2020
By Annette Boyle
The U.S. FDA granted a breakthrough device designation to Exero Medical Ltd.’s implantable smart sensor for early detection of anastomotic leaks after gastrointestinal (GI) surgery. The device continuously monitors the GI tract near the surgical site to alert providers about potentially deadly leaks.
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Binaxnow COVID-19 Ag Card Home Test

Abbott’s Binaxnow COVID-19 rapid test authorized for home use

Dec. 17, 2020
By Meg Bryant
As COVID-19 cases surge across the U.S., there is growing demand for greater access to testing to rein in the pandemic. On Wednesday, the U.S. FDA granted an emergency use authorization (EUA) to Abbott Laboratories for at-home use of the company’s Binaxnow COVID-19 Ag Card Home Test. Abbott has teamed up with Miami-based telehealth provider Emed to distribute and administer the tests, with an expected 30 million in the first quarter of 2021.
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BioWorld MedTech’s Diagnostics Extra for Dec. 17, 2020

Dec. 17, 2020
By Meg Bryant
Keeping you up to date on recent developments in diagnostics, including: Speeding triage of COVID-19 patients; New tests distinguishes COVID-19 and flu; Predicting heart failure; Expanding cryptosporidiosis testing in developing regions.
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Doctor viewing Brainquant software on computer

Braintale secures $1.2M seed round to boost commercialization of its brain injury assessment platform in Europe

Dec. 15, 2020
By Bernard Banga
PARIS – Braintale SAS has completed a $1.2 million seed round towards its portfolio of digital quantification and prediction medical devices for neurology and intensive care. This funding round, including a loan from Bpifrance, attracted investment from business angels, as well as industry and health care professionals.
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Product image

Pixcell's point-of-care Hemoscreen outperforms laboratory CBC analysis

Dec. 15, 2020
By Annette Boyle
Clinics, urgent care centers, busy hospitals, and patients can count on Hemoscreen, a miniaturized point-of-care hematology analyzer made by Pixcell Medical Technologies Ltd., to provide accurate complete blood count (CBC) results, according to a study published in the Journal of Applied Laboratory Medicine. The study found the small unit better differentiates between cells and adapts to inference than conventional laboratory blood analysis.
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Colorful illustration of the heart

FDA grants breakthrough device designation to Cardioflux

Dec. 15, 2020
By Liz Hollis
Genetesis Inc. received good news from the U.S. FDA in the form of a breakthrough device designation for Cardioflux for the diagnosis of myocardial ischemia and infarction in patients with symptoms suggestive of acute coronary syndrome. Mason, Ohio-based Genetesis provides biomagnetic imaging solutions with an eye toward ensuring safety. Its solution already has made an impression on clinicians.
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Ellume COVID-19 Home Test in use

FDA authorizes lateral flow antigen test as first OTC fully at-home test for COVID-19

Dec. 15, 2020
By Mark McCarty
In what U.S. FDA commissioner Stephen Hahn billed as “a major milestone” in testing for the COVID-19 pandemic, the FDA has granted an emergency use authorization (EUA) to Ellume Ltd., of East Brisbane, Australia, for the company’s COVID-19 home test. The rapid lateral-flow test for antigen detection can be obtained without prescription and will return results to the at-home user in 20 minutes, according to the FDA’s Dec. 15 statement.
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