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Home » Topics » Diagnostics » Artificial intelligence

Artificial intelligence
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DNA data illustration

Fabric Genomics AI quickly identifies 90% of rare disease genomic variants

Oct. 14, 2021
By Annette Boyle
Fabric Genomics Inc.’s Gem artificial intelligence algorithm plus whole genome and whole exome data detected more than 90% of disease-causing variants in infants with rare diseases, a study in Genome Medicine demonstrated. The full process from blood sample to shortlist of causative variants and likely diseases takes just a matter of hours and the time to interpret whole genomes is condensed to about 15 minutes.
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telehealth-telemed-online-doctor.png

EY Pulse: Three ways med-tech companies can capitalize on pandemic shifts

Oct. 13, 2021
By Annette Boyle
The Ernst & Young Pulse of the Industry 2021 report outlined several ways med-tech companies can benefit from fundamental changes in business wrought by the pandemic to build a stronger foundation for the future. While the need for more agile supply chains and the drive to measure social and environmental impact as well as financial metrics have affected all economic sectors, COVID-19 transformed the med-tech industry in specific ways that could have long-lasting impact.
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Cgbio, NDR Medical Technology signing ceremony

Cgbio partners with NDR Medical for AI surgical system

Oct. 1, 2021
By David Ho and Gina Lee
South Korea’s Cgbio Inc. has entered a partnership agreement with Singapore-based NDR Medical Technology Pte. Ltd. to introduce and test an automated needle targeting (ANT)-X system to assist surgeons during minimally invasive surgery. The system will combine artificial intelligence (AI) and medical image processing, based on core technology from NDR Medical.
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Colonoscopy illustration showing endoscope, polyps in colon

Independent study confirms AI-assisted colonoscopies reduce rate of missed lesions

Sep. 30, 2021
By David Ho
Shanghai Wision AI Co. Ltd. (Wision AI) has shared positive data from a first-of-its-kind study on the use of artificial intelligence (AI) computer-aided polyp detection (CADe) system during colorectal cancer screening in a U.S. patient population. Published in the journal Clinical Gastroenterology and Hepatology, it marks the world’s first external independent randomized controlled trial of AI in the medical field conducted in the U.S.
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A visual for Nec Corp.’s new health care and life science sector

Nec extends to AI-driven health care, targets business value of $4.6B by 2030

Sep. 24, 2021
By Gina Lee
Nec Corp. is branching out into new health care and life science businesses, which will make use of artificial intelligence (AI) and other digital technologies. It is targeting a business value of ¥500 billion (US$4.56 billion) for these new areas by 2030. “Nec already announced this in our Mid-term Management Plan 2025 and is creating this health care and life sciences business to help drive future growth. As to why we chose 2030, it relates back to our Nec 2030VISION outlined in the plan,” an Nec spokesperson told BioWorld.
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Map of Europe

MHRA eyes overhaul of regulation of medical devices, SaMD and artificial intelligence

Sep. 21, 2021
By Mark McCarty
The med-tech regulatory picture is already in a state of flux thanks to changes imposed by the EU, but device makers and those in the digital health space might soon be facing yet another series of profound changes in Europe. The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) has proposed to revamp its regulatory framework for both traditional medical device and for software/artificial intelligence, adding yet more uncertainty to an already turbulent European regulatory environment.
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Proteomics platform in lab

Oncohost platform predicts response to lung cancer therapy

Sep. 20, 2021
By Annette Boyle
Prophet, Oncohost Ltd.’s artificial intelligence-driven proteomics profiling platform, predicted response to immune checkpoint inhibitor (ICI) therapy in non-small-cell lung carcinoma (NSCLC) patients in a study presented at the European Society for Medical Oncology Virtual Congress 2021. While ICI can generate a significant positive response in some patients with advanced NSCLC, in others the therapy promotes tumor growth, making identification of likely responders prior to treatment critical.
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Gold wireframe handshake

Medial Earlysign partners with Roche Diagnostics for early cancer detection tools

Sep. 14, 2021
By Catherine Longworth
Startup company Medial Earlysign Ltd. and Roche Diagnostics International Ltd. are teaming up to bring to market artificial intelligence (AI) solutions for early detection of cancer. Founded in 2013, Tel Aviv-based Medial Earlysign uses machine learning tools to flag patients with a high probability of developing specific illnesses. The partnership with Roche will initially focus on gastric cancer.
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Mammogram

Lunit secures South Korean innovative medical device designation for AI breast cancer detection software

Sep. 14, 2021
By Gina Lee
Lunit Inc. won an innovative medical device designation from South Korea’s Ministry of Food and Drug Safety (MFDS). The designation was for Lunit Insight MMG, its commercial artificial intelligence (AI) solution for breast cancer detection from mammography images. The company said that Lunit Insight MMG is now the first medical device of its type to receive the designation, and the company now has its second innovative medical device designation. “All of our commercialized products are now designated innovative medical devices by the MFDS. We will ensure that our Lunit Insight AI products allow medical staff to rapidly and accurately diagnose patients,” said Beomseok Suh, CEO at Lunit.
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FDA-icons
RAPS Regulatory Convergence

Guidance still lacking for AI, but existing standards, other guidances a good roadmap

Sep. 13, 2021
By Mark McCarty
There are few guidelines of any sort that are specific to artificial intelligence (AI) for medical devices, but that doesn’t mean there are no signposts for developers. There are existing product marketing authorizations that offer some insights, but the FDA’s Bakul Patel said a risk stratification guidance by the International Medical Device Regulators Forum (IMDF) is an example of a non-AI blueprint for how the FDA will ultimately approach regulation of AI.
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