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BioWorld - Wednesday, December 24, 2025
Home » Keywords » 510(k) clearance

Items Tagged with '510(k) clearance'

ARTICLES

Alivecor 12lead

Alivecor’s 12-lead, AI-powered ECG system wins FDA clearance

June 27, 2024
By Holland Johnson
After spending years battling with Apple Inc. over the consumer heart monitoring market Alivecor Inc. is hoping to bring its technology to the professional health care market with its new device, which recently received clearance from the U.S. FDA.
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3D illustration showing presence of tumor inside prostate gland

Profound snags FDA clearance for prostate disease contouring module

May 14, 2024
By Annette Boyle
Profound Medical Corp. received U.S. FDA 510(k) clearance for its second transurethral ultrasound ablation (TULSA) module using artificial intelligence. When used with Profound’s TULSA-Pro system, the Contouring assistant helps physicians more quickly and accurately segment prostate imaging and design treatments.
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epitomee capsule

Epitomee files FDA application for swallowable weight loss capsule

March 12, 2024
By Shani Alexander
Epitomee Medical Ltd submitted its application to the U.S. FDA for 510k regulatory clearance for its swallowable weight loss capsule. It joins a host of companies offering solutions to the global obesity crisis.
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Recor Medicaal Paradise renal denervation catheter

FDA greenlights Recor’s Paradise system for renal denervation

Nov. 9, 2023
By Shani Alexander
Recor Medical Inc. finally received U.S. FDA approval for its Paradise ultrasound renal denervation (RDN) system for the treatment of hypertension after more than ten years of research and clinical trials. Paradise is the first RDN system to reach the U.S. market, and its approval is good news for the technology after years of disappointment in the data from trials and concerns over the efficacy of RDN devices.
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Vuno

FDA clears Vuno’s AI-based MRI reading software for early Alzheimer’s detection

Oct. 25, 2023
By Marian (YoonJee) Chu
Vuno Inc. gained a U.S. FDA’s 510(k) clearance for its artificial intelligence (AI)-powered brain quantification device, Vuno Med-Deepbrain, to diagnose possible dementia in patients “even before mild cognitive impairment.”
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Lumos Febridx

Lumos gains FDA nod on third try for Febridx 510(k) as stock rockets 327%

July 5, 2023
By Tamra Sami
Rapid point-of-care diagnostics company Lumos Diagnostics Inc. saw its stock shoot up 327% on the news that it finally gained U.S. FDA 510(k) clearance for its Febridx rapid, point-of-care test for bacterial infections. Febridx is a finger prick blood test that can indicate if a person has a bacterial or viral acute respiratory infection within 10 minutes.
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