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Home » FDA

Articles Tagged with ''FDA''

Nerivio with Phone app

Theranica’s Nerivio adds new migraine indication

March 1, 2023
By Annette Boyle
Theranica Bio-Electronics Ltd. broadened its U.S. FDA clearances for the Nerivio prescription wearable to include migraine prevention in individuals with or without aura. The remote electrical neuromodulation (REN) device offers an alternative to the significant population of migraine patients who do not respond to or cannot tolerate prescription drugs that treat the condition.
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Pipet, test tubes, chemical structure
ACLA Annual Meeting

Hillebrenner says FDA no longer waiting on Congress for LDT regulation

March 1, 2023
By Mark McCarty
The question of the U.S. FDA’s authority to regulate lab-developed tests (LDTs) has been percolating for more than a decade, but the recent failure of Congress to pass legislation granting the agency explicit authority to do so is seen in some quarters as a missed opportunity. The FDA’s Elizabeth Hillebrenner said that while the agency would prefer to regulate LDTs under new statutory authorities, the agency sees a public health problem with the current state of affairs, and thus, “we are moving forward with rulemaking.”
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FDA says Abbott Trifecta valves may be susceptible to early deterioration

Feb. 27, 2023
By Mark McCarty
The U.S. FDA announced Feb. 27 that it is aware of data that suggest that the Trifecta surgical aortic valve replacement (SAVR) devices are potentially prone to early structural deterioration that could compromise both valve performance and valve durability.
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Product recall concept image

GE Healthcare recall for imaging systems addresses potentially fatal detector collapse

Feb. 22, 2023
By Mark McCarty
GE Healthcare Technologies Inc. reported a recall of several systems in its nuclear medicine line of high-end imaging systems for two potential issues that could lead to the collapse of a detector weighing more than half a ton onto the patient. According to the U.S. FDA listing for the recall, no injuries or fatalities have been reported in connection with these issues, but the announcement resurrects an episode from 2013 in which a patient in New York lost his life when a nuclear imaging camera collapsed during an imaging procedure.
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Artificial intelligence and digital health icons

Rapidai expands pulmonary embolism care with Rapid RV/LV clearance

Feb. 22, 2023
By Annette Boyle
Rapidai Inc. Received U.S. FDA 510(k) clearance for Rapid RV/LV, the latest addition to its pulmonary embolism (PE) solution. Rapid RV/LV uses artificial intelligence to quickly calculate the right ventricle to left ventricle ratio based on an analysis of computerized tomography pulmonary angiograms. The ratio provides critical information for prioritization of PEs and integrates with Rapidai’s triage and notification and workflow products to manage patient care from suspected embolism to treatment.
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US FDA’s final amended rule for radiological products in force

Feb. 21, 2023
By Mark McCarty
The U.S. FDA recently proposed a modest overhaul of the rules pertaining to radiological products and other categories of products in an effort to eliminate duplicative or obsolete rules, such as a requirement for triplicate reports for variances in system performance.
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Industry has multiple misgivings about US FDA’s voluntary summary draft

Feb. 17, 2023
By Mark McCarty
The U.S. FDA’s 2018 program for voluntary malfunction summary reporting (VMSR) was intended to ease the burden for both industry and the agency regarding low-risk malfunctions associated with a limited set of device types. However, a new draft guidance on the subject drew criticism from two trade associations for being administratively cumbersome, suggesting the guidance will need considerable cleaning up before presentation in final form.
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Breast cancer illustration

Merit’s guidance system scouts new ground in soft tissue cancers

Feb. 17, 2023
By Annette Boyle
Merit Medical Systems Inc. received a U.S. FDA breakthrough device designation for its Scout MD surgical guidance system, which enables physicians to pinpoint tumor location in soft tissue. The system uses up tiny reflectors to provide multidimensional location data that can improve the ability to remove the entire tumor with minimal trauma to the surrounding tissue, which can be a challenge in surgeries such as lumpectomies.
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Hyperfine Swoop in ICU

Hyperfine gets FDA nod for Swoop MRI software upgrade

Feb. 15, 2023
By Meg Bryant
The U.S. FDA granted 510(k) clearance to Hyperfine Inc. for improved artificial intelligence (AI)-powered software for its Swoop portable magnetic resonance imaging (MRI) device. The company launched the new software this week.
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Website of The Federal Trade Commission

FTC adopts more strident tone in revised version of health products compliance guide

Feb. 13, 2023
By Mark McCarty
The U.S. Federal Trade Commission (FTC) has updated a 1998 compliance guidance for health care products, much of which reiterates the provisions of the legacy edition. However, this updated version calls for randomized, controlled clinical trials to substantiate any claims made in connection with medical devices. 
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