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BioWorld - Saturday, January 24, 2026
Home » Authors » Mark McCarty

Articles by Mark McCarty

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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PIE Act reintroduced in US House of Representatives

Nov. 30, 2022
By Mark McCarty
The U.S. House of Representatives has resurrected the Pre-approval Information Exchange (PIE) Act, a bill that would bolster the prospects for drugs and devices by improving communications with payers prior to U.S. FDA clearance or approval of the product.
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European Union flag

EU states working around MDR issues, but the scope of solutions remains fragmented

Nov. 30, 2022
By Mark McCarty
A variety of governmental entities in the EU are feeling pressure to address the issues with the rollout of the Medical Device Regulation, and some EU member states have taken matters into their own hands.
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NICE greenlights the Boston Scientific Greenlight XPS for high-risk patients

Nov. 29, 2022
By Mark McCarty
The U.K. National Institute for Health and Care Excellence has expanded its endorsement for the Greenlight XPS system for benign prostatic hyperplasia to no longer exclude patients deemed at high risk for hemorrhage, a decision that may boost utilization and thus sales of the XPS.
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Former PTO commissioners come out in support of latest US Senate push for patent reform

Nov. 29, 2022
By Mark McCarty
U.S. Supreme Court case law on patent subject matter eligibility has provoked several attempts by Congress to rewrite the statute, but there are lingering concerns about the latest proposal, the Patent Eligibility Restoration Act of 2022. Among these concerns is that the revised set of exceptions to subject matter eligibility might take time to work through both in terms of litigation and patent prosecution, but the bill has the support of a number of stakeholders, including two former commissioners of the U.S. Patent and Trademark Office (PTO).
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