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Home » Authors » Mark McCarty

Articles by Mark McCarty

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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U.S. Capitol and $100 bills

US House subcommittee kicks breakthrough device coverage into gear

Nov. 16, 2023
By Mark McCarty
Medical device companies and trade associations alike have been clamoring for some time for a leaner path to Medicare coverage for their more novel product offerings, a message that may be gaining traction.
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Art concept for gene therapy research
2023 Artificial Intelligence Summit

Uncertainty drives concerns over bias risk in artificial intelligence

Nov. 16, 2023
By Mark McCarty
The U.S. FDA’s approach to bias covers a large swath of territory, including the potential for bias to creep invisibly into artificial intelligence (AI) products. Yarmela Pavlovic, vice president for global regulatory affairs at Medtronic plc, said at this year’s Artificial Intelligence Summit that regulators may be more wary of the potential hazards of bias in AI compared to non-AI software simply because of the difficulty in anticipating how bias might affect the function of these advanced algorithms.
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2023 Artificial Intelligence Summit

Consumerism expected to play a major role in AI regulation

Nov. 15, 2023
By Mark McCarty
The artificial intelligence (AI) space doesn’t exactly lack for stakeholders, but the roster of stakeholders in the U.S. is poised to grow by hundreds of millions, according to Laura Adams, senior advisor at the U.S. National Academy of Medicine.
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US Senate patent reform bill draws mixed reviews

Nov. 14, 2023
By Mark McCarty
The America Invents Act of 2011 was designed to provide a durable overhaul of the U.S. patent system, but the inter partes review process has drawn fire from inventors as a patent-killing machine.
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2023 Artificial Intelligence Summit

Artificial intelligence concerns resist regulatory quick fixes

Nov. 14, 2023
By Mark McCarty
In the following years, 2023 may come to be seen in medical device circles as the year of artificial intelligence (AI), but that doesn’t mean that 2023 will be seen as the year of regulatory clarity for AI.
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Olympus voluntarily recalls bronchoscopes over airway burn concern

Nov. 13, 2023
By Mark McCarty
Olympus Corp., of Center Valley, Pa., reported Nov. 9 a voluntary field corrective action for bronchoscopes prompted by complaints of endobronchial combustion during procedures that involve the use of high-frequency (HF) therapy equipment.
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US Senate patent reform bill draws mixed reviews

Nov. 13, 2023
By Mark McCarty
The America Invents Act of 2011 was designed to provide a durable overhaul of the U.S. patent system, but the inter partes review process has drawn fire from inventors as a patent-killing machine. The Senate is considering a new bill to address some of these concerns, but witnesses at a hearing this week were anything but united in their assessment of the status quo, making it difficult to forecast the fate of this latest effort at patent reform.
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U.S. Capitol building, Washington D.C.

US Senate patent reform bill draws mixed reviews

Nov. 10, 2023
By Mark McCarty
The America Invents Act of 2011 was designed to provide a durable overhaul of the U.S. patent system, but the inter partes review (IPR) process has drawn fire from inventors as a patent-killing machine. The Senate is considering a new bill to address some of these concerns, but witnesses at a hearing this week were anything but united in their assessment of the status quo, making it difficult to forecast the fate of this latest effort at patent reform.
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UK’s NICE says hybrid closed-loop CGMs are primed for type 1 diabetes

Nov. 9, 2023
By Mark McCarty
The U.K. National Institute for Health and Care Excellence (NICE) has seen the nation’s spending numbers for diabetes, which is said to account for roughly 10% of healthcare spending in the U.K., and responded in a collaboration with the National Health Service (NHS).
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