Research In Brief

Data reports on prenatal testing, MRI and pacemakers, sleep apnea and more.

Ariosa Diagnostics' Harmony noninvasive prenatal blood test was found effective in screening a general population of pregnant women for trisomies that cause Down syndrome and Edwards syndrome in a study published in the September issue of the American Journal of Obstetrics & Gynecology. In the blinded cohort study of 2,049 pregnant women, the test detected all cases of fetal trisomies 21 and 18, with a false-positive rate of 0.1%, compared to 4.5% with traditional combined first trimester screening with serum markers and ultrasound-based nuchal translucency measurement. Previous clinical studies have mainly involved women at high risk of carrying a fetus with trisomy (the presence of three chromosomes instead of two), the authors noted.

"The study builds on other recent findings that support the utility of noninvasive prenatal testing for any pregnant woman, regardless...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

Digital Health Roundup: Synchron Syncs With Apple, Ketryx’s AI Agents, AdvaMed’s AI RoadMap

In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.

Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By 

Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.

Cardiosense Advances Noninvasive Heart Monitoring With Final Validation Study

 
• By 

Cardiosense has launched a nationwide clinical study, SEISMIC-HF II, to validate its non-invasive, AI-powered technology for monitoring heart failure. The data will be used to file for US regulatory clearance of the Cardiosense heart failure monitoring platform.

More from R&D

Johnson & Johnson MedTech: How To Scale Digital Solutions

 

J&J's EMEA head of digital solutions, Julia Fishman, talks about the major hurdles in scaling digital innovation, tips for clinical adoption and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.

J&J MedTech Launches KINCISE 2 Surgical Automated System In US

 

The KINCISE 2 Surgical Automated System aims to “reduce the physical burden on surgeons compared to manual impaction in primary and revision hip and revision knee replacement procedures,” said J&J MedTech.

Abbott Launches Next-Gen Delivery System For Proclaim DRG Neurostim

 
• By 

Allen Burton, Abbott’s medical director of neuromodulation told Medtech Insight that the delivery system was developed to make the procedure easier for physicians, especially those who perform the implantations infrequently.