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Artificial intelligence (AI) is transformative technology that has captured industries worldwide and is here to stay. Defined as a system designed to operate with a certain level of autonomy, AI uses machine learning and...more
In recent months, there has been an onslaught of negative news surrounding startup investment. However, recent reporting from The Information points to two specific sectors where investment is actually on the rise....more
We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more
Picture this: At a meeting of local landlords, one participant raps his knuckles on the table and announces his grand idea for increasing the group’s collective profits. Each landlord should “independently” contract with a...more
The preceding articles of this series laid out how the new EU Medical Device Regulation 2017/745 (“MDR”) leads to a broader coverage of medical devices and an overall deeper level of regulation in areas already regulated...more
This session will focus on ISO and IEEE standards/regulations for AI. It also intersects with concerns regarding racial justice and discrimination issues associated with technology, which highlights transparency/translucency...more
The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance...more
Until now, humans have not only been responsible for operating automobiles but also acting as their moral decision-makers. The invention of “fully autonomous” vehicles raises the question of how vehicles are—or whether they...more
Mobile devices within the Internet of Things (IoT) are continuously benefitting from rapid technological advancements. And once those devices are sold to consumers, over-the-air (OTA) software updates ensure they can be...more
Last week, FDA released updates to its Software Precertification (Pre-Cert) Pilot Program, including release of a working model reflecting the Agency's vision of the pilot and outlining its most critical components. The...more