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Diagnostics
Medical Devices
Digital Health

Adaptyx wins FDA Breakthrough Device tag for cortisol monitor

Adaptyx Biosciences has secured FDA Breakthrough Device Designation and TAP entry for its continuous cortisol wearable, targeting Cushing syndrome and adrenal
Adaptyx Biosciences has secured FDA Breakthrough Device Designation and TAP entry for its continuous cortisol wearable, targeting Cushing syndrome and adrenal
The Biotech Times Editorial Team  · 
Diagnostics
Digital Health

PhAST Corp. wins FDA clearance for rapid blood culture AST panel

PhAST Corp.'s Gram-negative panel delivers antimicrobial susceptibility results in under 2.5 hours directly from positive blood cultures, cutting a typical 24-48
PhAST Corp.'s Gram-negative panel delivers antimicrobial susceptibility results in under 2.5 hours directly from positive blood cultures, cutting a typical 24-48
The Biotech Times Editorial Team  · 
Digital Health

New Era Energy inks 20-year, 207 MW power deal with Vistra

New Era Energy & Digital has contracted firm power for Phase 1 of its Texas data centre, with Vistra supplying up to 207 MW from an
New Era Energy & Digital has contracted firm power for Phase 1 of its Texas data centre, with Vistra supplying up to 207 MW from an
The Biotech Times Editorial Team  · 
Medical Devices
Digital Health
Diagnostics

Philips wins two ITEA 2026 awards for AI-enabled healthcare projects

Philips-led consortia SYMPHONY and AI FORSchung received ITEA Awards of Excellence for connected clinical AI and fibre-optic data compression.
Philips-led consortia SYMPHONY and AI FORSchung received ITEA Awards of Excellence for connected clinical AI and fibre-optic data compression.
The Biotech Times Editorial Team  · 
Diagnostics
Digital Health
Medical Devices

Spectral AI showcases DeepView burn diagnostic at SRBC

Spectral AI displayed its FDA-cleared DeepView multispectral imaging system at the Southern Regional Burn Conference, with two KOL presentations backing its clinical
Spectral AI displayed its FDA-cleared DeepView multispectral imaging system at the Southern Regional Burn Conference, with two KOL presentations backing its clinical
The Biotech Times Editorial Team  · 
Digital Health
Diagnostics

Ultrahuman merges ring data with medical records via HealthEx

Ultrahuman's HealthEx PowerPlug links continuous wearable biomarkers to a member's full medical history, aiming to close gaps in fragmented US healthcare records.
Ultrahuman's HealthEx PowerPlug links continuous wearable biomarkers to a member's full medical history, aiming to close gaps in fragmented US healthcare records.
The Biotech Times Editorial Team  · 
Diagnostics
Digital Health
Medical Devices

Firefly Neuroscience Evoke platform to join Radial's AI clinical OS

Firefly's FDA-cleared EEG/ERP brain-function platform will be embedded into RadialOS, the AI-guided operating system used across 27 US brain medicine
Firefly's FDA-cleared EEG/ERP brain-function platform will be embedded into RadialOS, the AI-guided operating system used across 27 US brain medicine
The Biotech Times Editorial Team  · 
Diagnostics
Digital Health

uMETHOD Health publishes real-world study on AI dementia care plans

A retrospective study of 345 paired tests found 83.5% of patients on RestoreU showed stable or improved cognition over 14 months.
A retrospective study of 345 paired tests found 83.5% of patients on RestoreU showed stable or improved cognition over 14 months.
The Biotech Times Editorial Team  · 
Medical Devices
Digital Health

Flow Neuroscience launches FDA-cleared at-home tDCS device FL-100

Flow Neuroscience's FL-100 headset is now available by US prescription, becoming the first FDA-approved at-home tDCS treatment for moderate to severe
Flow Neuroscience's FL-100 headset is now available by US prescription, becoming the first FDA-approved at-home tDCS treatment for moderate to severe
The Biotech Times Editorial Team  · 
Medical Devices
Digital Health
Diagnostics

Sonus Microsystems and Medtronic partner on AI wearable for preeclampsia

The Gates Foundation-funded collaboration will run field studies in Kenya, integrating Sonus's autonomous ultrasound patch with Medtronic's patient monitoring platform.
The Gates Foundation-funded collaboration will run field studies in Kenya, integrating Sonus's autonomous ultrasound patch with Medtronic's patient monitoring platform.
The Biotech Times Editorial Team  · 
Digital Health
Medical Devices

NightWare wearable cuts nightmare distress in first responder study

A peer-reviewed pilot in Frontiers in Sleep found NightWare halved nightmare distress in San Francisco police and fire personnel with PTSD over 60 days.
A peer-reviewed pilot in Frontiers in Sleep found NightWare halved nightmare distress in San Francisco police and fire personnel with PTSD over 60 days.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics
Digital Health

Magrabi Health spotlights Centres of Excellence at Forbes Riyadh summit

The Saudi specialist healthcare group used the Forbes Middle East Healthcare Summit 2026 to set out its expansion plans and tout a first-in-world
The Saudi specialist healthcare group used the Forbes Middle East Healthcare Summit 2026 to set out its expansion plans and tout a first-in-world
The Biotech Times Editorial Team  · 
Digital Health
Regulatory Science

Sequoia Project, AHIMA and HCPro launch information blocking training

The three organisations have released a four-course online series to help healthcare workforces comply with US federal information blocking rules now under active
The three organisations have released a four-course online series to help healthcare workforces comply with US federal information blocking rules now under active
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics
Digital Health

Nanox reports 37% revenue rise but takes $40.7m impairment charge

Nano-X Imaging grew Q2 revenues to $4.2m but recorded a $40.7m intangible asset impairment, widening its GAAP net loss to $55.5m.
Nano-X Imaging grew Q2 revenues to $4.2m but recorded a $40.7m intangible asset impairment, widening its GAAP net loss to $55.5m.
The Biotech Times Editorial Team  · 
Diagnostics
Pharmaceuticals
Digital Health

Cerenome secures $20m royalty-based facility to scale CNSide platform

The Houston CNS oncology company said the senior secured facility extends its cash runway into 2028 and funds commercial scale-up of its CSF assay
The Houston CNS oncology company said the senior secured facility extends its cash runway into 2028 and funds commercial scale-up of its CSF assay
The Biotech Times Editorial Team  · 
Medical Devices
Pharmaceuticals
Digital Health

HOPE Therapeutics first to deploy Zeta Surgical's robotic TMS system

NRx subsidiary HOPE Therapeutics is training clinical staff on Zeta Surgical's FDA-cleared robotic TMS platform ahead of Florida deployment and a DARPA-backed
NRx subsidiary HOPE Therapeutics is training clinical staff on Zeta Surgical's FDA-cleared robotic TMS platform ahead of Florida deployment and a DARPA-backed
The Biotech Times Editorial Team  · 
Medical Devices
Digital Health
Diagnostics

Circle CVI positions cvi42 for TAVR volume surge after CMS ruling

CMS has finalised expanded Medicare coverage for TAVR in asymptomatic aortic stenosis, and Circle CVI says its imaging platform is ready to absorb the expected
CMS has finalised expanded Medicare coverage for TAVR in asymptomatic aortic stenosis, and Circle CVI says its imaging platform is ready to absorb the expected
The Biotech Times Editorial Team  · 
Digital Health
Diagnostics

Instinct Science launches Attending, an AI clinical assistant for vets

Instinct Science says its Attending tool answers clinical questions using peer-reviewed veterinary content, with safety-critical dosing drawn directly from Plumb's.
Instinct Science says its Attending tool answers clinical questions using peer-reviewed veterinary content, with safety-critical dosing drawn directly from Plumb's.
The Biotech Times Editorial Team  · 
Medical Devices
Digital Health

ONWARD Medical doubles revenue as ARC-EX unit sales surge 430%

The Eindhoven neurotechnology company reported EUR 4.2M in H1 2026 revenue and enrolled 22 participants in its pivotal ARC-IM blood pressure study.
The Eindhoven neurotechnology company reported EUR 4.2M in H1 2026 revenue and enrolled 22 participants in its pivotal ARC-IM blood pressure study.
The Biotech Times Editorial Team  · 
Digital Health
Regulatory Science

Nokia and BeeHealthy deploy network-based verification in healthcare

Nokia's Network as Code platform replaces SMS one-time passcodes for BeeHealthy, a white-label health SaaS serving providers across Europe and the Middle
Nokia's Network as Code platform replaces SMS one-time passcodes for BeeHealthy, a white-label health SaaS serving providers across Europe and the Middle
The Biotech Times Editorial Team  · 
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