Medical Device - Only three of 1,357 FDA-cleared AI devices tested patient outcomes
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Using ML to streamline E&L screening and toxicological risk assessmentUsing ML to streamline E&L screening and toxicological risk assessment

Extractables and leachables screening can hinge on uncertain surrogate calibration. In this Q&A, Jordi Labs explains how Lumo applies machine learning to predict LC-MS response factors, reduce standards dependency, flag low-confidence results, and support faster, more defensible toxicological risk assessments for medical device chemical characterization workflows.

Read the interview today
 
   Only three of 1,357 FDA-cleared AI devices tested patient outcomesOnly three of 1,357 FDA-cleared AI devices tested patient outcomes
 
Researchers found that among 1,357 FDA-cleared or approved AI/ML-enabled medical devices, only 34 were linked to registered clinical trials and just three had been evaluated for patient-centered outcomes. The study highlights major gaps in prospective testing, demographic representation, transparency, and evidence showing whether medical AI meaningfully improves patients’ health.
 
   Wearable sensors coupled with AI can non-invasively monitor blood pressureWearable sensors coupled with AI can non-invasively monitor blood pressure
 
Wearable sensors coupled with AI can generate blood pressure readings nearly as well as the invasive and risky arterial lines relied on in intensive care units and operating rooms, new work by Johns Hopkins University researchers demonstrates.
 
 New lightweight knee exoskeleton helps older adults walk more easily
 
New lightweight knee exoskeleton helps older adults walk more easilyThe knee is a key weight-bearing and stabilizing joint in daily locomotion, supporting body weight, maintaining balance, and enabling flexible movement during level walking, ramp ascent and descent, and stair ascent and descent.
 
 
 Functional angiography outperforms conventional imaging in AIR-STEMI trial
 
Functional angiography outperforms conventional imaging in AIR-STEMI trialFunctional coronary angiography significantly reduced cardiovascular events and improved safety compared with conventional angiography in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease.
 
 
 Digital registry strategy doubles heart failure treatment uptake
 
Digital registry strategy doubles heart failure treatment uptakeA registry-based digital strategy that identified untreated patients and invited them to a telephone consultation more than doubled implementation of an effective type of heart failure treatment.
 
 
 New artificial lung mimics breathing and alveolar movement
 
New artificial lung mimics breathing and alveolar movementAlmost everyone has blown a soap bubble through a straw at least once. Inspired by this thin soap bubble film, an "artificial lung that breathes" like a real lung has been developed.
 
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