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Home » Authors » Mark McCarty

Mark McCarty

Articles

ARTICLES

Generic drugs and bottle

US FDA’s Califf says supply chain issues with generic drugs are a national security risk

Aug. 22, 2023
By Mark McCarty
The U.S. FDA is in the midst of a shake-up of several major offices, including the Office of Regulatory Affairs, but its commissioner, Robert Califf, believes there are even greater issues faced by the agency. Califf said during an Aug. 22 public forum that prices for generic drugs are too low to encourage manufacturers to continue to produce these products, adding that the issue is sufficiently severe to constitute a national security risk.
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Architectural pillars

Bard loses appeal of US lawsuit after judge in jury trial disallows evidence of 510(k)

Aug. 21, 2023
By Mark McCarty
U.S. federal preemption of state liability law for medical devices is firmly established for PMA devices, but this is not the case for devices that are cleared via the U.S. FDA‘s 510(k) program. However, some courts have gone a step further in disallowing defendants in product liability litigation from entering evidence of 510(k) clearances from the FDA, a practice that played a role in a $3.3 million verdict against Murray Hill, N.J.-based C.R. Bard Inc. that the U.S. Court of Appeals for the Seventh Circuit decreed is not eligible for a new trial.
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FDA icons and doctor

FDA warns Integra on handling of wound care products at TEI subsidiary site

Aug. 18, 2023
By Mark McCarty
Some U.S. FDA inspections go better than other ones, but the agency’s inspection of the Boston plant operated by a subsidiary of Princeton, N.J.-based Integra Lifesiences Holding Corp. was not one of those with a quick resolution. The agency said in a July 17 warning letter that Integra will have to obtain certification for the site in each of the next three years after finding considerable fault with operations, including one citation the agency said is a carryover from a warning letter issued in 2019.
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U.S. FDA headquarters

Viz.ai poised to take a bite out of hypertrophic cardiomyopathy with FDA de novo

Aug. 17, 2023
By Mark McCarty
Hypertrophic cardiomyopathy (HCM) might not be the talk of the town in the world of cardiology medical devices, but the condition has a devastating effect on a large number of lives, particularly in the case of early disease onset. San Francisco-based Viz.ai Inc. has won a de novo from the U.S. FDA for its algorithm for identification of patients at risk of HCM, the aptly named Viz HCM, a product the company believes will not only save lives but may save the U.S. health care system a large amount of money as well.
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Illustration of Alzheimer’s in the brain.

US CMS may drop CED mandate, single PET scan limit for beta amyloids

Aug. 16, 2023
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services has proposed to terminate the coverage with evidence development requirement for the use of positron-emission tomography (PET) imaging for patients suspected of suffering from beta amyloids, a marker of Alzheimer’s disease (AD). However, CMS is also considering a removal of the coverage policy that limits each patient to a single PET scan per lifetime, although the proposal to allow Medicare administrative contractors (MACs) to determine coverage is drawing fire from industry and physician groups alike.
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Attorney says PCCPs with change in indication for use not completely impracticable

Aug. 16, 2023
By Mark McCarty
The U.S. FDA’s position on predetermined change control protocols (PCCPs) is still in draft form, even though at least one company has won a marketing authorization with a PCCP attached to the underlying artificial intelligence (AI) algorithm. While the agency is still on the fence about a PCCP that incorporates a potential change in the indication for use, regulatory attorney Brigid DeCoursey Bondoc told BioWorld that industry should not reflexively avoid proposing a PCCP with a such change so long as the proposal includes answers to the questions the FDA is sure to ask.
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U.S. White House

Biden administration proposes government-wide cybersecurity regulatory harmonization

Aug. 15, 2023
By Mark McCarty
The Biden administration recently announced an extension of the comment period for a request for information on harmonization of cybersecurity regulation, a proposal that could conflict with FDA regulation of medical device cybersecurity.
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Boston Scientific POLARx

Boston Scientific scores another win for Polarx with FDA approval

Aug. 15, 2023
By Mark McCarty
Boston Scientific Corp. has managed its Polarx device to another regulatory approval, this time a nod from the U.S. FDA, giving the company access to one of the world's premier markets. The news comes four months after the company obtained a CE mark for the device, opening the door to two jumbo markets in a move the company hopes will ensure the device will provide solid returns on its investment.
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GE Healthcare Portrait mobile

GE Healthcare snares clearance from FDA for the wireless, wearable Portrait vital signs monitor

Aug. 14, 2023
By Mark McCarty
A timely discharge from the hospital requires that a lot of things go just right, and GE Healthcare just scored a win from FDA for its Portrait vital signs monitoring system that offers wireless, wearable tracking of oxygenation, pulse and respiration rate. GE said this system allows patients to be mobile during those first few critical hours post-surgery while providing non-stop vital sign tracking, a development that may allow clinicians to intervene more quickly when problems arise and thus help the patient recover and head home without setbacks.
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Device in heart

UK’s NICE wary of routine use of Ozaki procedure for aortic valve reconstruction

Aug. 14, 2023
By Mark McCarty
Transcatheter aortic valve replacement (TAVR) devices are all the rage for treatment of aortic valve disease, but that doesn’t mean valve reconstruction via the so-called Ozaki procedure has been consigned to the pages of medical history. The U.K.’s National Institute for Health and Care Excellence has recommended that trusts in the U.K. health system use this procedure only in clinical trials at least for the time being, although the agency noted that the Ozaki procedure allows the patient to sidestep the need for long-term antithrombotic therapy, a big selling point for patients and clinicians alike.
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View All Articles by Mark McCarty

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