Diagnostics

Diagnostics
Pharmaceuticals

Royal Osteoporosis Society urges Britons to check bone health risk

New polling shows 80% of UK adults have never assessed their bone health, despite osteoporosis causing 550,000 fractures annually.
New polling shows 80% of UK adults have never assessed their bone health, despite osteoporosis causing 550,000 fractures annually.
Diagnostics
Digital Health

Gates Foundation and Wellcome Leap commit $100m to cut stillbirths

The Uzima programme targets a 50% reduction in stillbirth rates across select countries over a decade, led by AI diagnostics and biomarker tools.
The Uzima programme targets a 50% reduction in stillbirth rates across select countries over a decade, led by AI diagnostics and biomarker tools.
Diagnostics
Genomics

Freenome's updated SimpleScreen CRC test improves APL sensitivity

Validation data show the next-generation blood test lifted advanced precancerous lesion sensitivity to 18.2%, the highest reported for any non-invasive CRC screening
Validation data show the next-generation blood test lifted advanced precancerous lesion sensitivity to 18.2%, the highest reported for any non-invasive CRC screening
Diagnostics
Genomics

Cerenome wins Florida Blue coverage for CNSide CSF molecular tests

The payer agreement adds six million covered lives and is the first to include CNSide's new DNA and RNA molecular profiling tests alongside tumour
The payer agreement adds six million covered lives and is the first to include CNSide's new DNA and RNA molecular profiling tests alongside tumour
Medical Devices
Diagnostics
Pharmaceuticals

Profound Medical and Telix link up on PSMA-PET and MRI prostate care

The two commercial-stage companies will co-educate physicians on combining PSMA-PET imaging with Profound's MRI-guided TULSA-PRO ablation platform.
The two commercial-stage companies will co-educate physicians on combining PSMA-PET imaging with Profound's MRI-guided TULSA-PRO ablation platform.
Digital Health
Diagnostics
Bioinformatics

BioNexus secures exclusive CogniAI licence for Malaysian healthcare AI

BioNexus Gene Lab will build AI document-processing applications for Malaysia's public healthcare digitisation programme under a ten-year exclusive licence.
BioNexus Gene Lab will build AI document-processing applications for Malaysia's public healthcare digitisation programme under a ten-year exclusive licence.
Medical Devices
Diagnostics
Digital Health

Spectral AI files NTAP application for DeepView burn-wound system

Spectral AI has applied to CMS for additional Medicare reimbursement for its AI-powered DeepView burn-wound imaging device, cleared by the FDA in May
Spectral AI has applied to CMS for additional Medicare reimbursement for its AI-powered DeepView burn-wound imaging device, cleared by the FDA in May
Medical Devices
Diagnostics

NeuroOne joins Dartmouth NIH grant for neurotransmitter sensing

NeuroOne will receive around $200,000 from a $1 million NIH BRAIN Initiative grant to co-develop real-time neurotransmitter sensing with Dartmouth College.
NeuroOne will receive around $200,000 from a $1 million NIH BRAIN Initiative grant to co-develop real-time neurotransmitter sensing with Dartmouth College.
Pharmaceuticals
Diagnostics

Sagimet's denifanstat shows sustained acne efficacy at 52 weeks

Phase 3 extension data from Ascletis' China trial show 57% IGA success and 77% inflammatory lesion reduction; Sagimet's US AURORA trial is now screening
Phase 3 extension data from Ascletis' China trial show 57% IGA success and 77% inflammatory lesion reduction; Sagimet's US AURORA trial is now screening
Diagnostics
Genomics
Biologics

Myriad Genetics and SOPHiA GENETICS team up on prostate HRD biomarker

The two NASDAQ-listed companies will co-develop a decentralised companion diagnostic for prostate cancer genomic instability scoring, with AstraZeneca involved.
The two NASDAQ-listed companies will co-develop a decentralised companion diagnostic for prostate cancer genomic instability scoring, with AstraZeneca involved.
Biotech
Diagnostics
Bioinformatics

Holobiome and Radicle Science launch 6,000-person gut-brain trial

The ARPA-H-backed GUT-FEELINGS study will test 19 prebiotic formulas against anxiety outcomes across 6,000 participants, with initial results expected in late
The ARPA-H-backed GUT-FEELINGS study will test 19 prebiotic formulas against anxiety outcomes across 6,000 participants, with initial results expected in late
Biologics
Pharmaceuticals
Diagnostics

FDA approves Roche's Tecentriq for adjuvant stage III dMMR colon cancer

Roche's PD-L1 inhibitor becomes the first approved adjuvant immunotherapy for dMMR stage III colon cancer, cutting recurrence risk by 50% in the ATOMIC
Roche's PD-L1 inhibitor becomes the first approved adjuvant immunotherapy for dMMR stage III colon cancer, cutting recurrence risk by 50% in the ATOMIC
Medical Devices
Diagnostics
Regulatory Science

SeaStar Medical wins seventh Breakthrough Device tag for SCD in sepsis

The FDA designation covers hyperinflammation in adult sepsis patients, a population with no currently approved immunomodulatory therapy.
The FDA designation covers hyperinflammation in adult sepsis patients, a population with no currently approved immunomodulatory therapy.
Medical Devices
Diagnostics

Autonomix Medical secures FDA support for 510(k) sensing platform

Autonomix Medical says FDA pre-submission feedback supports a Class II substantial-equivalence route, targeting clearance of its neural sensing platform in roughly 15
Autonomix Medical says FDA pre-submission feedback supports a Class II substantial-equivalence route, targeting clearance of its neural sensing platform in roughly 15
Medical Devices
Diagnostics
Pharmaceuticals

IBA to distribute ARTMS QIS cyclotron technology for theranostics

IBA will offer ARTMS's solid-target QUANTM Irradiation System to cyclotron customers worldwide, supporting local radiometal production for theranostics.
IBA will offer ARTMS's solid-target QUANTM Irradiation System to cyclotron customers worldwide, supporting local radiometal production for theranostics.
Medical Devices
Digital Health
Diagnostics

ViCentra Kaleido patch pump hits TIR targets in 3,918-patient study

Real-world data from nearly 4,000 European type 1 diabetes patients shows Kaleido met consensus time-in-range targets with median hypoglycaemia of just
Real-world data from nearly 4,000 European type 1 diabetes patients shows Kaleido met consensus time-in-range targets with median hypoglycaemia of just
Medical Devices
Digital Health
Diagnostics

Ceribell wins FDA clearance for qEEG trending on its AI platform

Ceribell's 510(k)-cleared software adds three quantitative EEG tools to its point-of-care platform, covering patients from premature neonates to adult ICU
Ceribell's 510(k)-cleared software adds three quantitative EEG tools to its point-of-care platform, covering patients from premature neonates to adult ICU
Diagnostics
Digital Health

Hub71 and Unilabs partner to bring diagnostics to Abu Dhabi startups

Unilabs joins Hub71+ Life Sciences as an anchor partner, with live collaborations already under way with mental health and biological-age testing startups.
Unilabs joins Hub71+ Life Sciences as an anchor partner, with live collaborations already under way with mental health and biological-age testing startups.
Digital Health
Diagnostics

DarDoc launches truesight beta AI layer inside Lifestyle Rx platform

Dubai-based DarDoc has launched a machine learning intelligence layer that proactively surfaces patient context between appointments, available to Lifestyle Rx members.
Dubai-based DarDoc has launched a machine learning intelligence layer that proactively surfaces patient context between appointments, available to Lifestyle Rx members.
Medical Devices
Diagnostics
Digital Health

CapsoVision wins FDA clearance for AI Highlights capsule endoscopy tool

CapsoVision's AI-assisted reading tool for its CapsoCam Plus system has received FDA clearance, following an earlier EU launch under MDR.
CapsoVision's AI-assisted reading tool for its CapsoCam Plus system has received FDA clearance, following an earlier EU launch under MDR.
Subscribe to Diagnostics