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BioWorld - Saturday, January 17, 2026
Home » Authors » Mark McCarty

Articles by Mark McCarty

Website of The Federal Trade Commission

US FTC deems Illumina’s open offer as opaque and resistant to enforcement

Dec. 14, 2022
By Mark McCarty
The latest U.S. Federal Trade Commission (FTC) hearing on the merger between Illumina Inc., and Grail Inc., highlighted some sharp disagreements over the impact of the transaction on the market for multi-cancer early detection (MCED) tests, but Illumina has vowed to take steps to blunt any such effects in an open offer.
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Laptop displaying FDA logo
2022 FDLI Enforcement Conference

Industry sees potential for undue risk in FDA’s remote regulatory audit program

Dec. 13, 2022
By Mark McCarty
The U.S. FDA’s use of remote regulatory assessments (RRAs) during the pandemic may have been inevitable, but a proposed continuation of the program in the endemic phase of the SARS-CoV-2 contagion hasn’t necessarily won over device manufacturers.
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2022 FDLI Enforcement Conference

Use of outside counsel for quality systems investigations carries limited privilege

Dec. 9, 2022
By Mark McCarty
Medical device manufacturers that hire outside counsel to conduct investigations of a facility’s quality system can expect an outsider’s view and might have the benefit of more candor on the part of quality staff than would otherwise be available.
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OIG sees issues with COVID-related add-on diagnostic testing

Dec. 8, 2022
By Mark McCarty
The U.S. Office of Inspector General examined the volume of tests for allergies and respiratory pathogens conducted during the COVID-19 pandemic, and found a few outlier testing labs that billed a conspicuous volume of such tests. While the agency recommended that the CMS examine these claims more closely, the results also suggest that enforcement action may be en route for the more than 160 labs identified as having filed a higher than typical volume of claims for these tests.
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2022 FDLI Enforcement Conference

Theranos convictions highlight role of fraud allegations in prosecutions of life science firms

Dec. 8, 2022
By Mark McCarty
The conviction and sentencing of Elizabeth Holmes and Sunny Balwani of Theranos Corp. might be seen as an example of retribution for testing technology that didn’t exist and thus endangered patients, but that perception doesn’t stand up to scrutiny.
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2022 FDLI Enforcement Conference

US DOJ’s Rao says self-disclosure policies for corporate misconduct in the works

Dec. 7, 2022
By Mark McCarty
The U.S. Department of Justice (DOJ) has developed a number of policies related to corporate misconduct over the past couple of decades, some of which were stood up only to be reversed a short time later.
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U.S. flag, stethoscope

IABP recall catches up with Getinge’s Datascope subsidiary, triggering shortages

Dec. 6, 2022
By Mark McCarty
Getinge AB reported that intraortic balloon pumps (IABPs) manufactured by its Datascope subsidiary are in short supply following a recall of some of these devices in 2019. Getinge said manufacturing of units and parts is proceeding at the maximum pace allowed by supply chain volatility and recommended that hospitals facing shortages contact other nearby hospitals in the event of a lack of device availability.
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PAS for Abiomed Impella RP shows poor outcomes for patients not eligible for pivotal study

Dec. 6, 2022
By Mark McCarty
The U.S. FDA reported that the post-approval study (PAS) for the Impella RP by Abiomed Inc. of Danvers, Mass., demonstrated that the device performed well for patients who would have been eligible for the pivotal study, providing a 69.7% survival rate at 30 days after device explant.
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3D heart in chest
RSNA 2022

One X-ray predicts MACE risk; steroids reduce pain, increase damage in knee osteoarthritis

Dec. 2, 2022
By Mark McCarty
The ability to inexpensively predict events such as stroke and heart attack is something of a holy grail for cardiologists, and a new study presented at this year’s annual meeting of the Radiological Society of North American (RSNA) provides just that capability. A study of an algorithm developed to examine a single chest X-ray suggests that the data generated by the algorithm can be as effective in establishing the patient’s risk of these events as a standard approach that relies on information that isn’t always readily available to the clinician.
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U.S. at night from space with circuit board overlay
FDLI Digital Health Conference

US FTC preparing to ‘think outside the box’ regarding the definition of health information

Dec. 1, 2022
By Mark McCarty
The U.S. Federal Trade Commission (FTC) has moved decisively in the area of mergers and acquisitions recently, but the agency also has a footprint in the enforcement space for health data disclosure. The FTC’s Ronnie Solomon said in a Dec. 1 public meeting that the agency will begin “thinking outside the box about what health information is in the 21st Century,” adding that the FTC is eyeing a more stringent enforcement regime regarding personal health data disclosures in the coming new year.
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