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BioWorld - Friday, December 26, 2025
Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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Liver disease

Sonic Incytes raises $7.3M to commercialize Velacur

Dec. 8, 2021
By Annette Boyle
Sonic Incytes Medical Corp. collected $7.3 million in a series A fundraising round to bring its liver-focused point-of-care ultrasound solution to commercialization. Nimbus Synergies led the round with participation from Nicola Wealth, Mint Venture Partners, Consortium Medteq, Wavemaker Three-Sixty Health, Gaingels, INP Capital and several angel investors. The round was oversubscribed by 150%. The hand-held Velacur system noninvasively quantifies liver volume, stiffness and attenuation, critical factors in diagnosing and monitoring liver disease in a process that takes about five minutes and can be performed in a physician’s office. The system received FDA clearance late last year.
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Dan Forche headshot

Preludedx’s DCISionrt further validated in randomized breast cancer study

Dec. 7, 2021
By Meg Bryant
Prelude Corp. (dba Preludedx) reported positive results from the SweDCIS randomized trial showing its DCISionrt test predicts radiation benefit for lowering 10-year local invasive breast cancer risk. The prognostic, artificial intelligence (AI)-based tool assesses and predicts the benefit of radiotherapy for women with ductal carcinoma in situ (DCIS) following breast-conserving surgery (BCS).
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Qiastat-Dx Respiratory SARS-CoV-2 panel, hospitalized patient in background
In vitro diagnostics on the rise

COVID-19 puts IVDs in the spotlight, but global investment seeks to bolster their use elsewhere

Dec. 7, 2021
By Catherine Longworth
Due to COVID-19, diagnostics are in the limelight, and public and private investors are watching how the pandemic may impact the in vitro diagnostics (IVD) market in the future. As the sector receives an influx of investment, companies will be in strong positions to expand their portfolios. So, with 2022 around the corner – what are the investment trends to watch?
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Brain waves

Nextsense emerges from stealth with biosensing earbuds

Dec. 6, 2021
By Annette Boyle
Nextsense Inc. reported partnerships with global biopharma company UCB SA, Heraus Holding GmbH, the University of California San Diego and Emory University at its first public appearance at the American Epilepsy Society Annual Meeting in Chicago this past weekend. The Nextsense platform uses biosensing earbuds to perform ongoing electroencephalograms (EEGs).
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Man wearing Ophthalmic Sciences' VR headset

Ophthalmic Sciences eyes 2023 for launch of AI device for glaucoma

Dec. 6, 2021
By Catherine Longworth
Israeli startup Ophthalmic Sciences Ltd. is targeting 2023 for regulatory clearance of its artificial intelligence (AI)-based contactless intraocular pressure (IOP) measuring device, IO Perfect. The technology, which combines AI visual analysis in a virtual reality headset, enables remote monitoring of glaucoma. The device is designed to be used at home, in eye clinics, emergency room departments, pharmacies and primary physician settings.
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Hand holding lightbulb

Med-tech innovations selected for The Royal Academy of Engineering’s LIF Advance program

Dec. 6, 2021
By David Ho
The Royal Academy of Engineering in the U.K. has selected 15 entrepreneurs from seven different countries for the latest edition of its Leaders in Innovation Fellowships Advance (LIF Advance) program, including some that offer med-tech solutions.
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Opportunity compass with Chinese flag

Chinese med-tech companies are prepping for the future

Dec. 3, 2021
By Zhang Mengying
With large amounts of cash in hand from exponentially higher sales related to COVID-19, some Chinese med-tech companies are now implementing plans to continue growing in a post-pandemic world.
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Omicron presents a greater risk of reinfection compared to Delta, Beta

Dec. 3, 2021
By Nuala Moran
LONDON – The latest epidemiological data from South Africa show it has entered a fourth wave of the COVID-19 pandemic, fueled by the Omicron variant of concern that was first detected in the country in late November. “We have moved from a total of 2,465 new cases last Thursday, when this variant was announced, to yesterday’s high of 11,535 [PCR confirmed infections],” said health minister Joseph Phaahla, in a briefing on Dec. 3.
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Coronavirus mutation illustration

White House calls for COVID boosters for all eligibles, coverage of at-home testing

Dec. 2, 2021
By Mark McCarty
The emergence of the Omicron variant of the SARS-CoV-2 virus has sparked a vigorous reaction around the globe, which in the U.S. includes steps taken by the Biden administration to ensure that the roughly 100 million people who have received an initial vaccination regime will receive a booster if eligible. The administration also reported Dec. 2 that it will take steps to ensure that home testing will be covered by private payers, all of which amounts to a massive boost in business for manufacturers of vaccines and tests despite concerns about how the Omicron variant might affect vaccine and test performance.
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Photo of Septicyte rapid cartridge

FDA gives green light to Septicyte rapid one-hour blood test for sepsis

Dec. 2, 2021
By Tamra Sami
PERTH, Australia – The FDA has cleared Immunexpress Inc.’s 510(k) for its Septicyte rapid diagnostic test for sepsis that quantifies the relative expression levels of genes involved in a patient's immune response to infection to aid in a diagnosis in one hour for patients suspected of sepsis. The test uses peripheral blood gene expression biomarkers to provide a probability of sepsis in patients presenting with clinical signs of systemic inflammation.
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