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BioWorld - Sunday, March 22, 2026
Home » Topics » Medical technology, BioWorld

Medical technology, BioWorld
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FDA looks to AI to streamline drug development and approval process

Aug. 23, 2019
By Mari Serebrov
While regulatory science can lag behind technology advances, the FDA has for the past few years been exploring ways to harness the potential of artificial intelligence (AI) to streamline drug development and the approval process.
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American AI Initiative

Aug. 23, 2019
By Mari Serebrov
Recognizing that the age of artificial intelligence (AI) has arrived and, with it, the potential to transform everything from health care to transportation and manufacturing, U.S. President Donald Trump issued an executive order earlier this year that launched the American AI Initiative.
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China on the cusp of regulating AI-based devices

Aug. 23, 2019
By Elise Mak
BEIJING – With home-grown artificial intelligence (AI) medical devices under priority review, mainland China is quickly putting together a regulatory framework to more rapidly tap into the power of AI to develop devices and drugs.
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Japan to develop assessment system to speed up AI development

Aug. 23, 2019
By Jihyun Kim
HONG KONG – With an aging population and a shortage of doctors, Japan is now working to develop artificial intelligence (AI)-based medicine faster than any other country in Asia.
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Australia: No plans to regulate AI, machine learning via separate pathway

Aug. 23, 2019
By Tamra Sami
PERTH, Australia – It's likely that Australia will not draft separate guidance or regulations for software applications that use artificial intelligence or machine learning (AI/ML) for drug development or medical devices.
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South Korea's insurance, personal information law slows use of AI devices

Aug. 23, 2019
By Jihyun Kim
HONG KONG – South Korea is actively working to expand its artificial intelligence (AI) capabilities in health care, but outdated regulations and concerns over privacy and profit sharing are proving to be significant stumbling blocks.
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AI microchip illustration

Transforming R&D and health care with artificial intelligence

Aug. 22, 2019
By Jennifer Boggs
The convergence of artificial intelligence (AI) and the health care sector was inevitable. The advent of machine-learning and deep-learning technologies capable of analyzing and synthesizing massive amounts of data with algorithms designed to mimic human-level decision-making seems a natural fit for an industry in dire need of greater efficiency.
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Biopharmas move into deep waters of massive data, high R&D potential

Aug. 22, 2019
By Karen Carey
As a cautious swimmer slips slowly into the cool waters of a giant swimming pool so do biopharma executives: They tread into the murky abyss known as artificial intelligence (AI).
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AI propels med tech into new partnerships, new possibilities

Aug. 22, 2019
By Karen Carey
Artificial intelligence (AI) is a technology that takes over when the human brain has reached its limit. For medical technology companies, it could help in the creation of more precise tools and devices that support diagnostic, therapeutic and surgical decisions. Instead of shooting an arrow into the sky, the bullseye target is clear, backed up by volumes of data and a machine learning algorithm designed to pinpoint the biomarker, the abnormality and the probability of success.
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No Pfizer common divisor in DMD; tox woe bestows 'Solid' favor on Sarepta

July 29, 2019
By Randy Osborne
In late June, when Pfizer Inc. unveiled the first phase Ib data, mixed safety signal and all, for its Duchenne muscular dystrophy (DMD) gene therapy, PF-06939926, investors in Sarepta Therapeutics Inc. as well as Solid Biosciences Inc. watched with particular interest. The latter firm seems none the worse for wear, though, raising $60 million in a private placement.
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