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BioWorld - Tuesday, February 17, 2026
Home » Topics » Diagnostics, Medical technology

Diagnostics, Medical technology
Diagnostics, Medical technology RSS Feed RSS

Microblate Flex device

Creo’s Microblate Flex poised to provide early lung cancer detection

June 5, 2023
By Nuala Moran
Creo Medical Group plc says it is poised to address the mismatch between the advances in screening technology, which are making it possible to detect early-stage lung cancer, and the current invasive and inappropriate methods of treating it, following the first-in-human use of its Microblate Flex microwave ablation device.
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Galleri instruction booklet on blood draw chair
ASCO 2023

Grail study validates MCED use in symptomatic patients

June 5, 2023
By Annette Boyle
The 2023 American Society for Clinical Oncology Annual Meeting featured several notable developments on the diagnostics side, including significant advances in multi-cancer early detection (MCED). Grail Inc. presented its results from SYMPLIFY, the first major study of its MCED test in symptomatic patients. The test showed a negative predictive value of more than 97% and a positive predictive value that exceeded 75% in individuals who presented to primary care with non-specific symptoms that prompted a referral for cancer evaluation.
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Acquisition puzzle

Avacta acquires Coris for £7.4M as it builds diagnostics business

June 2, 2023
By Shani Alexander
Avacta Group plc has continued its growth through M&A strategy with the acquisition of Coris Bioconcept Sprl, a developer of rapid diagnostic test kits, for an up-front cash consideration of £7.4 million (US$9.3 million). The Coris deal comes on the back of its £24 million purchase of Launch Diagnostics Holdings Ltd last year, as Avacta works on building up its diagnostics division.
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Wesper sleep testing platform

Gasp! Wesper challenges polysomnography with wireless, portable sleep lab

June 1, 2023
By Annette Boyle
Wesper Inc., a longitudinal and wireless clinical-grade sleep testing platform, showed ‘exceptional accuracy’ in a head-to-head comparison with polysomnography in a study published in The Journal of Clinical Sleep Medicine. The wireless, longitudinal sleep testing platform had a breathtaking 95% correlation with the cumbersome gold standard test for sleep apnea.
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Orlucent handheld molecular-based imager

Orlucent receives breakthrough device designation for hand-held mole imaging system

June 1, 2023
By David Godkin
If Orlucent Inc. has its way atypical moles in adults will soon give up their secrets to clinicians on the lookout for skin cancer, this after the Los Gatos, Calif.-based company received a U.S. FDA breakthrough device designation for its non-invasive Orlucent skin fluorescence imaging system. The system is a hand-held point-of-care molecular-based imaging device that identifies “tissue remodeling activity” inside atypical moles that could be a precursor to early melanoma.
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Brightheart raises €2M for software to detect congenital heart defects in fetuses

June 1, 2023
By Shani Alexander
Startup Brightheart SAS raised €2 million (US$2.14 million) in seed financing, from Sofinnova Partners, that will allow the company to accelerate the development of its artificial intelligence software, which helps physicians detect congenital heart defects in fetuses. Brightheart hopes that the technology will improve the detection of complex congenital heart defects during prenatal ultrasound screening as intervening early could address fetal malformations or abnormalities and improve a baby’s chance of survival.
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Prostate cancer cells

NICE sees evidence gaps for MRI-ultrasound fusion prostate biopsy systems

May 31, 2023
By Mark McCarty
In a new health technology assessment, the U.K. National Institute for Health and Care Excellence (NICE) has voiced misgivings about the evidence behind the use of MRI/ultrasound fusion systems to perform needle biopsy for suspected prostate cancer. NICE said the evidence for these systems could be bolstered by additional research comparing fusion biopsy to cognitive fusion-directed biopsy, suggesting that companies working in this space have a significant evidentiary lift in front of them.
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Omni Legend - GE Healthcare

GE Healthcare wins FDA OK for Precision DL PET/CT image processing software

May 31, 2023
By Meg Bryant
The U.S. FDA has granted 510(k) clearance to GE Healthcare Technologies Inc. for its Precision DL for PET/CT, an artificial intelligence (AI) and deep learning (DL)-powered software designed to sharpen quality and improve efficiencies in medical imaging. Part of the company’s Effortless Recon DL portfolio, the technology is available on GE’s Omni Legend PET/CT digital scanner.
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Freenome buys immunodiagnostics company Oncimmune for $16M

May 30, 2023
By Meg Bryant
Freenome Inc. has acquired U.K.-based immunodiagnostics developer Oncimmune Ltd. for £13 million (US$16 million), in a move that bolsters Freenome’s frontline early cancer detection efforts. While Freenome has been largely focused on getting the U.S. FDA’s nod for its colorectal cancer test, Oncimmune already has a CE-IVD marked EarlyCDT Lung blood test, an autoantibody platform and an R&D pipeline of over seven cancer detection signals.
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Vials, syringes, pills and masks

HELPful tip: Preparedness must see beyond pandemics

May 8, 2023
By Mari Serebrov
Even though COVID-19 is transitioning from pandemic to endemic across the world, it will remain first in mind as U.S. lawmakers look to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA) this year to ensure the country is better prepared for future threats. With a Sept. 30 deadline for reauthorizing PAHPA, the Senate Health, Education, Labor and Pensions (HELP) Committee has its work cut out for it. But it won’t be starting from scratch. In opening a May 4 hearing on the reauthorization, HELP Chair Bernie Sanders (I-Vt.) said the committee would build on the efforts started last year under then-Chair Patty Murray (D-Wash.) and now-retired Ranking Member Richard Burr (R-N.C.).
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