GENE ONLINE|News &
Opinion
Blog

First AI-Guided Ultrasound ECHO Software Approved for Marketing

by Rajaneesh K. Gopinath
Share To

Caption Guidance, an echocardiography software, offers real-time guidance for ultrasound image acquisition using artificial intelligence technology.

On February 7th, San Francisco-based startup Caption Health (previously known as Bay Labs), announced the marketing approval for Caption Guidance, a software that could be integrated with compatible ultrasound devices. The software acts as a “co-pilot” to assist even inexperienced medics in acquiring ultrasound images of the heart. “This FDA authorization confirms our unique ability to couple breakthrough technology with robust clinical validation. And we’re just getting started.” said Charles Cadieu, co-founder and President. With this, Caption Guidance becomes the first AI-guided medical imaging system to acquire FDA authorization.

Like a seasoned sonographer, the software provides real-time guidance to optimize an image, manipulate the transducer, and also gives automated feedback on quality. It can currently be used as an accessory with the diagnostic ultrasound system produced by Teratech Corporation. “No patient should have to forgo a potentially life-saving cardiac ultrasound,” said Andy Page, the CEO. “Through the power of artificial intelligence, Caption Guidance will provide patients with unprecedented access to ultrasound when and where they need it most.”

The FDA approval was based on the software’s performance in two independent clinical trials, of which one was conducted by Northwestern Medicine and Minneapolis Heart Institute at Allina Health. The study evaluated the software’s value in assisting 8 registered nurses who lacked expert training in sonography to capture diagnostic quality images from 240 patients. Caption Guidance was approved through the FDA’s De Novo premarket review pathway, a regulatory pathway for novel devices whose type has not previously been classified.

“Echocardiograms are one of the most widely-used diagnostic tools in the diagnosis and treatment of heart disease,” said Robert Ochs, Ph.D., deputy director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Today’s marketing authorization enables medical professionals who may not be experts in ultrasonography, such as a registered nurse in a family care clinic or others, to use this tool. This is especially important because it demonstrates the potential for artificial intelligence and machine learning technologies to increase access to safe and effective cardiac diagnostics that can be life-saving for patients.”

Related Article: First AI-Designed Drug to Enter Phase I Clinical Trial

References

  1. https://www.prnewswire.com/news-releases/fda-grants-caption-health-landmark-authorization-for-first-ai-guided-image-acquisition-system-301001106.html
  2. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-cardiac-ultrasound-software-uses-artificial-intelligence-guide-user

 

©www.geneonline.com All rights reserved. Collaborate with us: service@geneonlineasia.com
Related Post
35% of Americans May Avoid Seeking Care Due to Concerns Over Healthcare Prices
2022-10-31
Thermo Fisher Announces $59 Million Lab Expansion In Kentucky, Reveals AI Deal With Genoox
2022-10-28
DeepMind’s AlphaFold Predicts Over 200 Million Protein Shapes in AI Breakthrough
2022-08-01
LATEST
Repairing Genetic Mutations in Neurological Diseases with RNA Targeting Strategy
2022-11-25
AstraZeneca Thailand Wins Two ACES Awards 2022: “Industry Champions of the Year” and “Community Initiative”
2022-11-24
Mabwell Announces the U.S. FDA approval of 9MW3011 (FIC) for IND
2022-11-24
Novartis Shifts Gear To Phase 3 For Anti-Malaria Drug
2022-11-24
Moving Past Animal Models with Better Data for Drug Discovery
2022-11-23
IonOpticks ushers in a new age of proteomics with Aurora Frontier
2022-11-23
Korea Ginseng Corp.: As an adaptogenic herb, Korean red ginseng boosts the human immune response
2022-11-23
EVENT
2022-12-01
BIOCHINA 2022
Online
2022-12-10
64TH ASH ANNUAL MEETING & EXPOSITION
New Orleans, USA
2022-12-14
BIOHK2022
Hong Kong, China
2023-01-07
7th Asia Microbiome Conference
Taipei, Taiwan
Scroll to Top

Create an account with us now to say goodbye to all the pop-ups!