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BioWorld - Wednesday, December 31, 2025
Home » Topics » Diagnostics » Artificial intelligence

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Paige obtains CE marks for breast, prostate cancer options

Dec. 9, 2020
By Liz Hollis
Paige has received good news in the EU, securing a CE mark for its breast cancer detection software that highlights suspicious areas for pathologists to review further. It also received a CE mark for Paige Prostate Grading & Quantification, which offers slide level information for primary and secondary Gleason patterns and tumor size to inform treatment planning.
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Cyber eye illustration

Retinai partners with Novartis for use of AI in ophthalmology trials

Dec. 8, 2020
By Nuala Moran
LONDON – Retinai Medicine AG reported a three-year master agreement with Novartis AG to apply its artificial intelligence (AI) tools in ophthalmology clinical trials. The first project will look at how machine learning can be used to speed up and improve the interpretation of optical coherence tomography (OCT) images of patients with neovascular age-related macular degeneration (AMD).
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AI-focused Deepcell raises $20M in series A

Dec. 7, 2020
By Meg Bryant
Artificial intelligence (AI)-powered cell capture startup Deepcell Inc. scooped up $20 million in a series A round led by Bow Capital. The funds are earmarked for developing the company’s microfluidics-based technology, building out a cell morphology atlas of more than 400 million cells and advancing a hypothesis-free approach to cell classification and sorting.
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Doctor using Strokeviewer LVO on smartphone

FDA clears Nico.lab’s AI-powered Strokeviewer to speed stroke care

Dec. 3, 2020
By Annette Boyle
For the 795,000 Americans who suffer a stroke each year, time is brain. The U.S. FDA granted 510(k) clearance to a solution the developer says could cut time-to-treatment in stroke by an hour, preserving 3.6 years of healthy life. Nico.lab’s artificial intelligence-based CT scan analyzer, Strokeviewer LVO, uses an algorithm that enables faster triaging of stroke patients and enables physicians to see the location of occlusions in minutes.
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Siemens Healthineers wins FDA nod for AI-based radiation therapy planning tool

Nov. 30, 2020
By Meg Bryant
The U.S. FDA has granted 510(k) clearance to Siemens Healthineers AG for AI-Rad Companion Organs RT, the newest module in its platform of artificial intelligence-based software assistants. The radiation therapy planning aide joins earlier AI-Rad Companion modules for interpreting magnetic resonance imaging (MRI) studies of the brain and prostate, as well as one for chest computed tomography (CT) studies.
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Person wearing mask pointing at globe

Fionet receives COVID-19 RDTs for mobile testing and data capture platform

Nov. 30, 2020
By David Godkin
TORONTO – The Fionet Rapid Response Group formed by Toronto’s Fio Corp. and Relay Medical Corp. has received COVID-19 lateral flow rapid diagnostic tests (RDTs) from the European division of Abbott Laboratories Inc., Switzerland’s Roche Diagnostics AG and North York, Ontario’s Proprietary Innovation Labs Inc. for operation with its mobile testing and tracking platform.
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Agendia and Paige integrating AI-based diagnostics with genomic testing in breast cancer

Nov. 25, 2020
By Annette Boyle
New artificial intelligence capabilities will be integrated into widely used genomic testing for breast cancer under a new partnership formed by Agendia Inc. and Paige.ai. The two companies are working together to enhance the genomic information from Agendia's Mammaprint and Blueprint diagnostic tests with AI-based digital diagnostics provided by Paige with the goal of redefining precision oncology.
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Alivecor gains clearance for AI-driven personal ECG

Nov. 23, 2020
By Annette Boyle
The U.S. FDA cleared Alivecor Inc.'s Kardia AI V2 interpretive electrocardiogram (ECG) algorithm for use in its personal ECG app and devices. Currently, the Kardia line permits consumers to take a 30-second medical grade ECG at home and instantly see whether they are exhibiting symptoms of atrial fibrillation, bradycardia, tachycardia or have normal heart rhythm.
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Hologic wins CE nod for AI-enhanced digital diagnostics system

Nov. 17, 2020
By Meg Bryant
The European Commission has awarded the CE mark to Hologic Inc. for its Genius Digital Diagnostics system for cervical cancer screening. According to the company, it is the first digital cytology platform to combine a new artificial intelligence (AI) algorithm with advanced digital imaging to assist cytotechnologists and pathologists in detecting precancerous lesions and malignant cells in women.
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Software screenshot

Lantheus receives clearance for AI-enabled bone scan run on GE Healthcare's Xeleris platform

Nov. 13, 2020
By Annette Boyle
The U.S. FDA granted 510(k) clearance to Lantheus Holdings Inc.'s artificial intelligence (AI)-enhanced automated bone scan index (aBSI) product for prostate cancer on GE Healthcare's Xeleris platform. ABSI improves quantification and management of disease progression in advanced prostate cancer patients.
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