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Self-Driving Car Pioneer David Stavens’ Company Earns First 510(k) For AI-Based Teleradiology Tech To Help Triage Brain Injury Patients

 
• By Marion Webb

David Stavens’ company recently gained US FDA clearance for AI-powered software to help radiologists triage intracranial hemorrhage and mass effect from non-emergent cases.

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Nines recently became the first company to gain 510(k) clearance from the US Food and Drug Administration to market an algorithm-based software solution called NinesAI that allows radiologists to triage intracranial hemorrhage and mass effect on computed tomography (CT) scans. Mass effect, which is associated with such conditions as stroke and brain tumor, causes the surrounding areas of the brain to be compressed.

Nines’ co-founder and CEO David Stavens said it will make the technology available to existing and new customers who sign up with the company before 30 June for in-house use...

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TRiCares Tricuspid Valve Replacement System Reduces Regurgitation In First-In-Human Study

 
• By Natasha Barrow

TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.

Disparities — Including Financials Shortcomings — Remain In Women’s Health, Execs Say

 
• By Brian Bossetta

FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women’s health market during SiS New York last week. They also offered solutions.

Digital Health And AI Tools Advance Cardiac Event Prediction, SCAI 2025 Data Show

 
• By Shubham Singh

Out-of-hospital cardiac arrest remains one of the most challenging and resource-intensive emergencies in cardiovascular care. At SCAI 2025, clinicians presented a novel algorithm that improved triage decisions and reduced unnecessary interventions.

SpotitEarly Raised $20.3M In New Funding To Bring AI- And Dog-Sniffing-Powered Early Cancer Detection Test To US

 
• By Marion Webb

Israeli-based SpotitEarly hopes to bring an early cancer-detection test, which uses dogs’ noses to detect compounds in exhaled breath and AI analysis, to US homes in 2026.

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Edwards Lifesciences Holds 2025 EPS Outlook Despite Tariff Headwind

 
• By Shubham Singh

The brunt of the tariff exposure stems from Singapore and Costa Rica, which together account for an estimated 70% to 80% of the tariff-related cost burden. Less than 10% of the exposure is tied to China.

Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 
• By Natasha Barrow

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.