BrainSpace gets 510(k) nod for brain fluid management system and more FDA clearances
BrainSpace gets 510(k) nod for brain fluid management system and more FDA clearances | MobiHealthNews
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Tag: FDA
Teal Health Expands Nationwide – Bringing FDA Authorized At-Home Cervical Cancer Screening to All 50 States
What You Should Know:
– Teal Health, a virtual women’s health company on a mission to eliminate cervical cancer in the U.S., today announced the national availability of its comprehensive telehealth platform and its FDA-authorized self-collection…
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Who Made Your Medicine? How to Use ProPublica’s Rx Inspector to Audit Your Generics
What You Should Know
– ProPublica has released Rx Inspector, a first-of-its-kind database that allows Americans to identify the exact facility where their generic prescriptions were manufactured.
– By connecting disparate FDA databases and suing for…
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The EEG as a ‘Vital Sign’: Ceribell’s AI Pivot to In-Hospital Stroke Detection
What You Should Know:
– Ceribell’s LVO Stroke Breakthrough In January 2026, the FDA granted Breakthrough Device Designation to Ceribell for its LVO (Large Vessel Occlusion) stroke monitor.
– This first-in-class tool applies an AI algorithm…
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Real-Time Pharma Insights: Philip Poulidis on Scaling ODAIA AI – Life Sciences Today Podcast Ep. 41
We're excited to be back for another episode of the Life Sciences Today Podcast by Healthcare IT Today. My guest today is Philip Poulidis, CEO at Toronto-based ODAIA. Poulidis is tackling one of pharma’s…
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Freeze-Drying the Future: 43 Years of Innovation at OFD – Life Sciences Today Podcast Episode 40
We're excited to be back for another episode of the Life Sciences Today Podcast by Healthcare IT Today. My guest today is Walt Pebley, Chief Scientific Officer at OFD Life Sciences. With over four…
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Why Cardiologists Are Betting $19M on Wearlinq to Fix the “Single-Lead” Problem in Heart Monitoring
What You Should Know:
– Wearlinq has secured $14M in Series A funding (plus $5M in venture debt) to scale its eWave device, the first continuous 6-lead wireless ECG that offers hospital-grade diagnostics in a…
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News 12/17/25
Top News
FDA updates its policy to accept de-identified real-world evidence to support drug and device application reviews. This change allows use of registries, insurance claims, and EHR data that were previously excluded because they…
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HIMSSCast: Should GPT-5 be HIPAA compliant, FDA regulated?
HIMSSCast: Should GPT-5 be HIPAA compliant, FDA regulated? | MobiHealthNews
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FDA Clears Ceribell’s AI-Powered EEG as First Device for Continuous Delirium Monitoring
What You Should Know:
– Ceribell, Inc. has secured FDA 510(k) clearance for the world’s first continuous, AI-powered delirium monitoring solution, expanding its existing EEG platform beyond seizure detection.
– The technology addresses a massive gap…
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