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Home » Authors » Mark McCarty

Articles by Mark McCarty

U.S. at night from space with circuit board overlay

Telehealth legislation again on tap in US House of Representatives

April 17, 2024
By Mark McCarty
Telehealth received a much-needed boost from the COVID-19 pandemic, but normal reality has settled in and a number of telehealth bills have surfaced in the U.S. House of Representatives. However, Rep. Brett Guthrie (R-Ky.) advised other members of the House that a recent extension of temporary Medicare telehealth coverage added $2 billion to Medicare spending, a fact which he said forces legislators to ensure that “whatever we move out of committee is paid for.”
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1-10-abbott-heartmate3.png

Long-term use of Heartmate devices associated with obstruction

April 16, 2024
By Mark McCarty
The long-term use of ventricular assist devices is becoming a problem for at least some of these devices, as demonstrated by the recall of the Heartmate II and Heartmate 3 devices by Abbott Laboratories’ Abbott Vascular division due to obstruction of the outflow graft used to attach the device to the human heart.
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Cloud/cybersecurity illustration

US House hearing includes calls for federal cybersecurity support

April 16, 2024
By Mark McCarty
With the recent hack of Change Healthcare back in the news, a committee of the U.S. House of Representatives took up the subject of cybersecurity, which included only a couple of mentions of medical devices. However, witnesses at the hearing emphasized the role of the federal government in thwarting foreign cybersecurity threats against health care facilities, with John Riggi of the American Hospital Association stating, “we need the [federal] government to go after bad actors overseas.”
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Gavel and vials

Decision Diagnostics CEO Berman hit with stiff prison sentence

April 15, 2024
By Mark McCarty
The U.S. Department of Justice announced that Keith Berman, formerly the CEO of Los Angeles-based Decision Diagnostics Corp., has received a prison sentence of seven years for misrepresenting the company’s developmental test for the SARS-CoV-2 virus during the height of the COVID-19 pandemic.
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CMS logo and website

US CMS eyes alternative to accountable care for FFS beneficiaries

April 15, 2024
By Mark McCarty
In the inpatient draft for fiscal 2025, the U.S. Centers for Medicare & Medicaid Services has proposed an accountable care model for beneficiaries on fee-for-service care, one which is designed to provide the coordination of care ordinarily seen only in accountable care organizations.
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Architectural pillars

Edwards comes up short in US case testing Hatch-Waxman safe harbor

April 12, 2024
By Mark McCarty
The Hatch-Waxman Act provides a safe harbor that allows importation of an FDA-regulated article that would otherwise be deemed a case of patent infringement so long as the importation is for purposes reasonably related to obtaining regulatory approval. Edwards Lifesciences Corp. sued Meril Life Sciences Pvt Ltd. for importation of heart valves in a manner that Edwards argued was infringement under Hatch-Waxman, but while the Federal Circuit ruled 2-1 against Edwards, the dissenting opinion recommended an appeal to a full 12-judge panel that could reverse this outcome.
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CMS logo and website

US CMS eyes new cutoff date for new tech add-on payments

April 12, 2024
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services has proposed a few significant changes to the new technology add-on program for the fiscal year 2025 inpatient prospective payment system, including a boost in NTAP rates for gene therapy services.
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Architectural pillars

Edwards comes up short in US case testing Hatch-Waxman safe harbor

April 11, 2024
By Mark McCarty
The Hatch-Waxman Act provides a safe harbor that allows importation of an FDA-regulated article that would otherwise be deemed a case of patent infringement so long as the importation is for purposes reasonably related to obtaining regulatory approval. Edwards Lifesciences Corp. sued Meril Life Sciences Pvt Ltd. for importation of heart valves in a manner that Edwards argued was infringement under Hatch-Waxman, but while the Federal Circuit ruled 2-1 against Edwards, the dissenting opinion recommended an appeal to a full 12-judge panel that could reverse this outcome.
Read More
Flag of Australia, sky background

TGA eyes guidance on regulatory status of CDS software

April 10, 2024
By Mark McCarty
Australia’s Therapeutic Goods Administration decided to take another look at the regulatory definition of the clinical decision support (CDS) system, a move driven by technological advances and some confusion as to what type of CDS is exempt from registration requirements.
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Phillips Recall Mask BiPAP CPAP

Philips hit with consent decree over CPAP foam materials

April 10, 2024
By Mark McCarty
The U.S. FDA and Department of Justice have announced a consent decree entered into district court that enjoins Philips Respironics LLC North America from manufacturing and distributing respiratory devices from three company facilities in the state of Pennsylvania.
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