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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Aug. 23, 2019

View Archived Issues

FDA looks to AI to streamline drug development and approval process

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. A nexus for its efforts is the Information Exchange and Data Transformation (INFORMED) initiative anchored in the agency's Oncology Center of Excellence (OCE). At its inception in 2016, INFORMED was designed to tap into the power of big data and advanced analytics to improve disease outcomes. Read More

American AI Initiative

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China on the cusp of regulating AI-based devices

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. Read More

Japan to develop assessment system to speed up AI development

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Australia: No plans to regulate AI, machine learning via separate pathway

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. Instead, the Therapeutic Goods Administration (TGA) will classify AI and ML under software as a medical device (SaMD) when it is intended for diagnosis, prevention, monitoring or treatment or alleviation of disease. Read More

South Korea's insurance, personal information law slows use of AI devices

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India lags in regulating AI as development proceeds

NEW DELHI – Artificial intelligence (AI) is increasingly gaining a foothold in India's health care landscape, with investors pouring money into the new technology, companies developing products and regulators looking to come up with much-needed rules. India's Ministry of Health has reached out to the public for consultation on its national digital health blueprint that seeks to propel digital health care, including the use of AI in the biotech and medical technology sectors. Read More

Regulatory front

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Appointments and advancements

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Financings

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Biocardia touts milestones amid ongoing losses

Biocardia Inc. painted a largely upbeat picture for the second quarter of 2019, despite tallying a net loss of $3.8 million, up from $3.2 million in the same period a year ago. Among the quarter's highlights were U.S. FDA clearance to market the Advance steerable introducer for cardiac catheter procedures and expansion of the phase III CardiAMP Heart Failure Trial. Read More

Other news to note

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Product clinical data for Aug. 22, 2019

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Product regulatory actions for Aug. 22, 2019

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BioWorld MedTech's Diagnostics Extra

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U.S. AI med-tech regs in development 'not for the faint of heart'

The FDA's regulation of artificial intelligence (AI) is divided by product center for reasons that are obvious, but precisely what that regulation will look like is anything but. As the FDA's Center for Devices and Radiological Health (CDRH) goes through the comment period for its discussion draft for AI, other nations are starting their own efforts in this space. The American agency's efforts may foreshadow the approaches employed in other nations. Read More

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