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Home » Authors » Mark McCarty

Mark McCarty

Articles

ARTICLES

Beckman Coulter, Agena hit with recent FDA warnings

April 4, 2024
By Mark McCarty
The U.S. FDA posted two device warning letters in the first week of April 2024, including one each to Beckman Coulter Inc., of Brea, Calif., and Agena Bioscience Inc. of San Diego, the former of which was directed toward the Chaska, Minn., facility that manufactures the Beckman Coulter Dxl 9000 analyzer.
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Cyber security padlock

US cybersecurity rule may increase device reporting requirements

April 3, 2024
By Mark McCarty
Makers of medical devices already have a substantial series of requirements related to cybersecurity, but those requirements may increase per a draft rule released by the U.S. Cybersecurity and Infrastructure Security Agency.
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Eko Health Low EF Stethoscope

Eko grabs a nod from US FDA for AI-enabled ejection fraction detector

April 3, 2024
By Mark McCarty
Artificial intelligence (AI) is steadily making inroads into the world of health care, and San Francisco-based Eko Health Inc. has taken up the AI call with a stethoscope developed in conjunction with the Mayo Clinic that can detect low ejection fraction of the heart.
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Angiovac

Bard, Angiodynamics come to terms over series of patent disputes

April 2, 2024
By Mark McCarty
Angiodynamics Inc. said it has settled with the parent company of C.R. Bard Inc., over a series of conflicts over patents held by Bard that will cost Angiodynamics nearly $10 million just in 2024, potentially significantly more.
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Gears with regulatory words

MHRA’s regulatory update adds a rule for stand-alone device software

April 2, 2024
By Mark McCarty
The U.K. Medicines and Health Care Products Regulatory Agency is in the thick of its proposed regulatory overhaul for medical technology, which the agency promises will hew closely to the regulations still in deployment in the European Union.
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Image from pilot animal study

​US FDA wary of predicate devices in draft guidance for jawbone grafts​

April 1, 2024
By Mark McCarty
The U.S. FDA issued a draft guidance for premarket applications for class II bone grafting devices, a policy that would supplement a guidance issued nearly two decades ago.
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Illustration of the inside of an eye with macular degeneration

FDA advisory panel sees benefit in ocular negative pressure therapy

April 1, 2024
By Mark McCarty
The notion of using vacuum pressure on the anterior portion of the human eye as a treatment for open-angle glaucoma might be a clinical novelty, but Balance Ophthalmics Inc. is poised to change that. The company recently won a favorable outcome at a U.S. FDA advisory panel for its Fsyx negative pressure pump for ocular use, although the company is likely to have to drum up a large body of data in post-approval studies, assuming the FDA gives the Fsyx the nod.
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Senate presses HHS on data breach that cost $7.5M

March 26, 2024
By Mark McCarty
The U.S. Department of Health and Human Services (HHS) was quite vocal in its statement regarding a recent hospital cybersecurity breach, but HHS recently suffered an undisclosed data breach that cost $7.5 million in taxpayer monies.
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Regulatory icons

FDA reissues revised versions of pre-sub, thermal effects guidances

March 26, 2024
By Mark McCarty
The U.S. FDA released two draft guidances in the third week of March 2024, one of which is a modest edit of an existing guidance for pre-submission activities between the agency and manufacturers.
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Cloud/cybersecurity illustration

Senate presses HHS on data breach that cost $7.5M

March 25, 2024
By Mark McCarty
The U.S. Department of Health and Human Services (HHS) was quite vocal in its statement regarding a recent hospital cybersecurity breach, but HHS recently suffered an undisclosed data breach that cost $7.5 million in taxpayer monies.
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View All Articles by Mark McCarty

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