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Home » Authors » Mark McCarty

Articles by Mark McCarty

Cybersecurity data lock

Failure to protect data lands 1Health in hot water with FTC

June 20, 2023
By Mark McCarty
The U.S. Federal Trade Commission (FTC) reported a settlement with San Francisco-based 1Health.io Inc. for allegations that the consumer gene testing company failed to properly secure customers’ data, an oversight that will cost the company only $75,000 in fines.
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Radiotherapy of cancer

UK’s NICE says radiotherapy dosing can be decreased for some breast cancers

June 20, 2023
By Mark McCarty
Radiotherapy fractionation has had a significant impact on the morbidity associated with the procedure across a number of cancer types, and the U.K. National Institute for Health and Care Excellence (NICE) says it may be time to fractionate further for some breast cancer patients.
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Vanta device image

Medtronic presses physicians to revisit label instructions for Vanta during cardioversion

June 19, 2023
By Mark McCarty
The Vanta device by Medtronic plc, provides relief from pain for thousands of patients, but the Vanta might also feel the pain when the patient is undergoing cardioversion. According to a field safety notice from Dublin-based Medtronic, two patients in Europe have undergone explant procedures for the device due to damage sustained during cardioversion, but the company urges physicians to pay heed to the labeled indication, which recommends that the device be temporarily reprogrammed to reduce the risk of damage to the device, an action that Medtronic indicated should ward off any such issues.
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2023 Medtech Forum

Physicians the next audience for selling artificial intelligence in the EU

June 19, 2023
By Mark McCarty
Artificial intelligence (AI) faces a number of interesting hurdles in the EU, such as the still-developing Artificial Intelligence Act (AI Act), which seems destined to treat health care uses as high-risk propositions. Corinne Dive-Reclus, director of global lab insights at Roche Diagnostics, said there are possible solutions, such as overwriting the AI Act’s risk classifications with the risk category provided by existing regulations, but there is an open question as to whether a fix will be in place to prevent a potentially disastrous risk framework for AI in health care.
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SX-One device by Sonex Health

Sonex Health presses FDA to avoid down-classification of SX-One device

June 16, 2023
By Mark McCarty
The U.S. FDA’s citizen’s petition process doesn’t always yield the desired outcome, but the agency must nonetheless respond to these petitions. Sonex Health Inc., has petitioned the FDA to rethink a proposal to reclassify the company’s SX-One device for treatment of carpal tunnel syndrome, an unusual instance in which a medical device maker has resisted a proposal to make a device exempt from regulatory requirements.
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Lab tech holding test tube

FDA adds lab-developed test rulemaking to its regulatory agenda

June 15, 2023
By Mark McCarty
A committee of the U.S. House of Representatives wrapped up business in a late-running June 14 markup of spending bills that would give the U.S. FDA roughly $6.6 billion to work with in fiscal 2024. However, the final bill omits language in the manager’s mark that had called on the FDA to engage in rulemaking or guidance development for lab-developed tests, but the FDA made up for that by adding a proposal to engage in rulemaking for LDTs in its regulatory agenda.
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AI silhouette

Medtech Europe, others voice concerns regarding EU’s Artificial Intelligence Act

June 14, 2023
By Mark McCarty
Negotiations over the text of the EU’s Artificial Intelligence Act (AI Act) are drawing to a close, but stakeholders are concerned about several key aspects of the legislation, such as how the term “artificial intelligence” is defined. However, Medtech Europe and other groups, including medical professional societies, are also concerned that the provisions for governance of data would seem to exclude real-world data as a source of evidence, an oversight they say will diminish the utility of AI software in health care.
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US House committee recommends FDA move on rulemaking for LDT regulation

June 14, 2023
By Mark McCarty
The June 14 hearing of the House Appropriations Committee was focused largely on spending levels for the Department of Agriculture, but there was also some concern over the proposed spending levels for the FDA. One of the more conspicuous features of the legislative report is the recommendation that the FDA finalize guidance or rulemaking for risk-based regulation of lab-developed tests (LDTs), a clear departure from the stance taken by Congress for a number of years.
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Rapid testing result for COVID-19

US authorities continue to pursue COVID testing fraud

June 13, 2023
By Mark McCarty
U.S. federal authorities continue to wrap up cases in connection with COVID fraud, the latest of which yielded a $30 million fine for a single defendant accused of fraud and money laundering.
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Democrats, Republicans spar over FDA drug shortage authority in PAHPA reauthorization

June 13, 2023
By Mark McCarty
The need to reauthorize the U.S. Pandemic and All-Hazards Preparedness Act (PAHPA) prompted a June 13 hearing in the House of Representatives, but a major fissure appeared between the Republican and Democratic Parties regarding FDA’s authorities for managing drug shortages.
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