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FDA clears Expanse Ice system for small vessel aspiration

Expanse Ice Inc. received U.S. FDA clearance for its Ice Aspiration system, which is designed to clear blood clots in peripheral vessels. The system uses distal cyclical aspiration to “harness the aspiration power typical of a large bore catheter, but within the slender profile of a much smaller device,” Expanse Founder and CEO Eitan Konstantino said.

Eitan-konstantino
Expanse-ice-inc
Expanse-ice
Ice-aspiration
Bioworld-medtech

Neurovalens gets FDA nod for neurostimulator to treat anxiety

Neurovalens Ltd recently received U.S. FDA clearance for its Modius Stress device, a neurostimulator that treats people suffering from generalized anxiety disorder (GAD). It also closed a £2.1 million (US$2.65 million) funding round and is planning to raise up to $50 million in a series B fundraising round to be launched later this year.

Neurovalens-ltd
Modius-stress
Bioworld-medtech
Electromedical-products-international-inc
Fisher-wallace-laboratories
Generalized-anxiety-disorder
Neurovalens-ltd
Neuro-fitness-llc
Insomnia
Stress
Regulatory

Quest adds pTau217 to Alzheimer's test portfolio

Quest Diagnostics Inc. expanded its Alzheimer’s disease (AD) portfolio with a blood-based biomarker test for phosphorylated tau 217 (pTau217). The test joins the company’s plasma tests for p-tau181, beta-amyloid 42/40 ratio and ApoE genetic risk as well as several cerebrospinal fluid tests for Alzheimer’s.

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Quest-diagnostics
Helmholtz-diabetes-center
Cachexia
Cancer-induced-cachexia
Penx-acip
Bioworld-medtech
Quest-diagnostics-inc
Alzheimers-disease
Ptau-217
P-tau217

Lumicell shines a light on residual breast cancer with FDA approvals

Lumicell Inc. sees a brighter future now that it has secured U.S. FDA approval for both its new drug application for Lumisight (pegulicianine) optical imaging agent and premarket approval for the Lumicell direct visualization system . The company markets the two together as the Lumisystem to detect and resect residual breast cancer. Newton, Mass.-based Lumicell expects the Lumisystem will be available in the fourth quarter of 2024, Lumicell President and Chief Operating Officer Howard Hechler told BioWorld.

Howard-hechler
Lumicell-inc
Lumicell-president
Chief-operating-officer-howard-hechler
Helmholtz-diabetes-center
Cachexia
Cancer-induced-cachexia
Penx-acip
Bioworld-medtech
Lumicell-inc
Lumisight
Breast-cancer

South Korea approves first AI software to assess knee arthritis

Crescom Co. Ltd., of Seongnam-si, Gyeonggi-do, gained domestic approval for its AI-powered software to grade knee osteoarthritis, dubbed MediAI-OA, while launching a new AI-mobile platform, Onzaram, to help manage child growth care.

Crescom-co
Bioworld-medtech
Arthritis
Crescom-co-ltd-
Mfds
Mediai-oa
Knee-osteoarthritis
Onzaram
Bone-age-analysis
Mediai-ba
Mediai-fx

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