Business, energy, technology, markets and global industry news from Business News Today
Medical Devices & Diagnostics

Cortechs.ai adds FDA-cleared PET analysis as Alzheimer’s diagnosis becomes increasingly biomarker-driven

Cortechs.ai’s NeuroQuant PET can automatically quantify amyloid PET uptake, generate SUVR and Centiloid measurements and send structured results into imaging workflows.

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Medical Devices & Diagnostics

Can resurfacing the small intestine improve type 2 diabetes? Aqua Medical’s US IDE study starts testing the idea

Aqua Medical has treated the second US patient in RESTORE-1, a 20-person IDE study evaluating whether RF vapor ablation of proximal intestinal mucosa can improve HbA1c.

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Medical Devices & Diagnostics

Can tumor ablation help organize an immune response? Galvanize’s Aliya PEF data raise a bigger oncology question

A peer-reviewed NSCLC study found mature tertiary lymphoid structures in 47% of Aliya PEF-treated tumors versus 24% of controls, an exploratory signal that now needs clinical validation.

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Medical Devices & Diagnostics

ImpediMed wins FDA clearance for SOZO sarcopenia assessment, extending one scan beyond lymphedema monitoring

ImpediMed’s new FDA clearance adds sarcopenia risk assessment to the SOZO platform, potentially allowing muscle-loss monitoring alongside existing fluid and body-composition measurements.

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Medical Devices & Diagnostics

Can portable MRI close more of the image-quality gap? Hyperfine’s latest FDA clearance raises the stakes

Hyperfine’s newest FDA-cleared Optive AI software adds isotropic T1 imaging, stronger noise correction and workflow changes to its portable ultra-low-field Swoop MRI system.

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Medical Devices & Diagnostics

C2N Diagnostics takes Alzheimer’s blood testing younger as FDA clears PrecivityAD2 from age 40

C2N Diagnostics’ FDA-cleared PrecivityAD2 combines amyloid and tau measurements in a mass-spectrometry test intended to aid assessment of symptomatic adults aged 40 and older.

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Medical Devices & Diagnostics

Empatica turns its PKG Health acquisition into an FDA-cleared Parkinson’s monitoring platform

Empatica can now bring PKG-derived Parkinson’s measures into its wearable ecosystem after FDA clearance of a platform designed for continuous symptom monitoring.

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Medical Devices & Diagnostics

Carl Zeiss Meditec wins FDA clearance for CLINIC 360 ahead of US ophthalmology launch

ZEISS CLINIC 360 can consolidate ophthalmic images, diagnostic information and glaucoma progression analysis in a browser-based Class II medical device.

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Medical Devices & Diagnostics

Implantica wins FDA PMA for RefluxStop as five-year GERD data move into a US commercial test

FDA Premarket Approval gives Implantica a US launch pathway for RefluxStop after long-term clinical evidence tested an implant that avoids encircling the esophagus.

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Pharma & Biotech

Why UroGen Pharma is looking beyond bladder cancer with IntraGel’s cisplatin-loaded SRGel platform

UroGen Pharma will invest up to $7 million in IntraGel while securing an option on TumoCure and potential rights to three additional SRGel oncology programmes.

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