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BioWorld - Wednesday, January 7, 2026
Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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China clarifies regulations on sharing human genetic resources

April 14, 2022
By Tamra Sami
China’s Ministry of Science and Technology issued a draft rule on regulations governing sharing of human genetic resources that provides clarity on parts of the regulation that were previously ambiguous, Katherine Wang, partner at Ropes & Gray in Shanghai, told BioWorld.
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Woman working at computer in laboratory

Clinisys purchases cloud-based laboratory system Apollolims

April 13, 2022
By Catherine Longworth
Diagnostic testing group Clinisys Inc. has acquired cloud-based laboratory operations software company Apollolims in an undisclosed deal. Headquartered in Chertsey, U.K., and Tucson, Ariz., Clinisys will expand its public health, toxicology, and molecular diagnostics offering through the acquisition. The deal builds on the company’s combination with Sunquest and Horizon announced in January.
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Illustration of cell dividing

Newstem files for haploid human embryonic stem cell-based diagnostic

April 12, 2022
By Catherine Longworth
Newstem Ltd. filed a presubmission to the U.S. FDA for a de novo request and an in vitro diagnostic device with the EMA for its Newstem software diagnostic device (NSDD). The bioinformatics-based platform is a personalized diagnostic to inform oncologists about the presence of mutations in tumors and predict a patients’ resistance to chemotherapy treatments. The technology utilizes specialized stem cells (haploid cells) that carry just one set of chromosomes.
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Cancer research illustration

Telix in-licenses Lilly’s failed olaratumab in deal worth up to $225M

April 12, 2022
By Tamra Sami
Telix Pharmaceuticals Ltd. has in-licensed Eli Lilly and Co.’s olaratumab antibody, agreeing to pay $5 million up front for exclusive worldwide rights to develop and commercialize radiolabeled forms of the antibody for the diagnosis and treatment of human cancers.
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Voqx digital stethoscope

FDA clears AI-infrasound smart stethoscope from Sanolla

April 12, 2022
By Catherine Longworth
Israeli startup Sanolla Ltd. won U.S. FDA 510(k) clearance for its smart-infrasound stethoscope Voqx. The artificial intelligence (AI)-based device is the first stethoscope cleared by the U.S. FDA to detect infrasound and audible information to identify clinical conditions. The auscultation capabilities are designed to support early assessment of cardiopulmonary conditions.
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Close-up of eye with digital focus

Meduni Vienna develops eye scanner for detecting early-stage neurodegenerative conditions

April 11, 2022
By Bernard Banga
Meduni Vienna, the Medical University of Vienna, Austria, is working on a novel eye scanner combining the structural and functional sensitivity of optical coherence tomography (OCT) with the chemical specificity of Raman spectroscopy, to acquire data from the living human eye.
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CHLOE system images showing various blastocyst development

Fairtility’s AI-based system outperforms experts in selection of implantable embryos for IVF

April 8, 2022
By Annette Boyle
Fairtility Ltd.’s artificial intelligence (AI)-trained embryo classification system offers patients struggling with infertility and their physicians a better way to maximize the likelihood of implantation following in vitro fertilization (IVF) without the risk of a multiple pregnancy, a study in the Nature portfolio journal Scientific Reports found.
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Blood sample, DNA

Quanterix Simoa leveraged in large reference study of sNfL to assess MS

April 8, 2022
By Meg Bryant
Quanterix Corp.’s Simoa technology helped drive a large, international study to establish reference ranges of serum neurofilament light chain (sNfL) to assess individual disease activity and drug response in multiple sclerosis (MS) patients. The study, published in The Lancet Neurology, utilized Simoa’s ability to precisely detect sNfL protein at ultra-low levels, enabling it to be reliably measured across a broad range of healthy individuals.
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Cancer cell and DNA

C2i reports European launch of its minimal residual disease diagnostic

April 8, 2022
By Nuala Moran
C2i Genomics Inc. reported the formal launch of its C2inform minimal residual disease diagnostic across Europe, after obtaining CE marking for the cancer test. The Cambridge, Mass.-based company also has completed several clinical trials it ran with research partners to validate the technology and will be presenting data in different cancers at the American Association for Cancer Research in New Orleans, April 8-13.
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Businessman riding unicorn atop arrows in the clouds

Viz.ai’s valuation surges to $1.2B with $100M series D

April 7, 2022
By Annette Boyle
Valuations in the med-tech space lately call into question the old medical adage: “If you hear hoofbeats, think horses.” These days, you would be wise to consider unicorns in the differential diagnosis. Two new companies achieved the formerly rare status just this week. Viz.ai Inc.’s closing today of a $100 million series D financing propelled it into the stratosphere with a $1.2 billion valuation, joining Bostongene LLC which completed its own $150 million round Wednesday.
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