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BioWorld - Tuesday, January 27, 2026
Home » Topics » Science » Artificial intelligence

Artificial intelligence
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Artificial intelligence and digital health icons

AI could overwhelm ability of US FDA to keep up

Dec. 14, 2023
By Mark McCarty
Artificial intelligence has morphed from a buzzword referencing a popular curiosity to a series of national security and competitiveness considerations, which was reflected in the tone of a recent hearing in the U.S. House of Representatives.
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lunit

Lunit to acquire Volpara for $193M, targeting US breast cancer market

Dec. 14, 2023
By Marian (YoonJee) Chu
South Korean artificial intelligence software developer Lunit Inc. plans to acquire Volpara Health Technologies Ltd. for $193 million (AUD 292 million) by mid-2024, taking a global leap to the U.S. market and becoming an AI-based platform health care firm.
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AI could overwhelm ability of US FDA to keep up

Dec. 13, 2023
By Mark McCarty
Artificial intelligence has morphed from a buzzword referencing a popular curiosity to a series of national security and competitiveness considerations, which was reflected in the tone of a recent hearing in the U.S. House of Representatives.
Read More

Medical AI remains a high-risk product under updated AI Act

Dec. 12, 2023
By Mark McCarty

The European Union’s Artificial Intelligence Act (AI Act) is widely seen as a groundbreaking piece of legislative handiwork, but companies in the life sciences may see it as a groundbreaker with negative consequences. The latest edition of the AI Act continues to treat medical AI software as a high-risk product, which would make these products exceptionally expensive and burdensome to bring to market in the EU and convince some companies in the medical AI business to skip the European market altogether.


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Sofinnova launches AI platform to transform its investment approach

Dec. 5, 2023
By Shani Alexander
Venture Capital firm Sofinnova Partners has launched Sofinnova.AI, an artificial intelligence (AI) platform that it hopes will transform its approach to life sciences investment. The platform harnesses billions of data points spanning scientific literature, emerging therapeutic fields, and technological breakthroughs, and connects them with the firm’s own proprietary knowledge accumulated over 50 years.
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A patient with ReWalk Robotics exoskeleton

Rewalk moves closer to a smart exoskeleton

Dec. 1, 2023
By Shani Alexander
Rewalk Robotics Ltd. has integrated advanced sensing technologies and artificial intelligence (AI) into its latest exoskeleton prototype to enable autonomous decisionmaking. This milestone, coupled with Rewalk’s capabilities, holds enormous potential to create a new generation of exoskeletons that are more intuitive and respond to real-world conditions that users encounter daily, Rewalk CEO Larry Jasinski told BioWorld.
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US FTC seeks yet more broad AI investigative authority

Nov. 22, 2023
By Mark McCarty
The U.S. Federal Trade Commission is clearly a more activist agency of late, although much of that activism has been around mergers and acquisitions. The latest FTC move, however, deals with investigative authorities that will be applied toward artificial intelligence (AI), which Katie Bond of Keller & Heckerman LLP said will give the agency considerable powers of discovery regardless of the merits of the enforcement action.
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Astrazenca launches Evinova digital health business

Nov. 21, 2023
By Shani Alexander
Astrazeneca plc launched a health-tech business aimed at bringing to market digital technological solutions that will optimize clinical trial design and delivery. The company, called Evinova, will offer solutions to reduce the time and cost of developing new drugs, bring care closer to patients at home and reduce the burden on health systems.
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South Korean flag on building

MFDS leads global AI-based med device standardization effort

Nov. 20, 2023
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety (MFDS) will head an international team of regulatory experts from 19 drug agencies worldwide, including the U.S. FDA and China National Institute for Food and Drug Control (NIFDC), to draft an international standard for artificial intelligence (AI)-based software.
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2023 Artificial Intelligence Summit

US applying more pressure to med-tech industry around cybersecurity

Nov. 17, 2023
By Mark McCarty
The medical device industry might at times believe that it is the sole focus of the U.S. federal government thinking about cybersecurity, but the FDA is hardly alone in leaning hard on industry to stand up a solid cybersecurity regime. The Securities and Exchange Commission (SEC) is also turning the screws on corporate America regarding cybersecurity as seen in enforcement against Solarwinds Corp., an enforcement action that Seth Carmody of Medcrypt Inc., said highlights the breadth of regulatory hazards for the med-tech industry.
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