DESKi granted FDA clearance for cardiac AI software

AuntMinnie.com staff writers
Apr 15, 2025

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to DESKi for its HeartFocus AI-enabled cardiac exam software.

HeartFocus enables healthcare providers to perform diagnostic-grade echocardiograms from any compatible handheld, portable, or cart-based device, according to DESKi. The Bordeaux, France-based company said that its use requires only a few hours of training to use.

HeartFocus is available as an app or as a software development kit, according to the company. The HeartFocus app runs Al models to guide, detect, and capture the 10 ultrasound cardiac reference views in real time.

The FDA also approved DESKi’s Predetermined Change Control Plan (PCCP) for HeartFocus. This approval will expedite collaboration with other ultrasound systems, DESKi said.

Latest in FDA
Ct Scanner Control Room2 Radiologist
Brainomix stroke software granted FDA clearance
April 8, 2025
Fda Logo V2 Social
FDA greenlights Telix NDA for prostate imaging agent Gozellix
March 21, 2025
Fda Sign Dc 400
Xeris secures FDA approval for Gvoke VialDx for x-ray exams
March 18, 2025
Ge Hc Logo 400
GE HealthCare secures 510(k) for updated Voluson Expert ultrasound
January 28, 2025
Related Stories
Heart Glowing Red 400
AI
CPT codes approved for AI-assisted cardiac risk assessment
Heart
Imaging Informatics
Medicare contractors approve reimbursement for AI heart scans
2023 01 19 22 41 2203 Business Development Graph Up 400
Ultrasound
Education is the catalyst to increased adoption of handheld ultrasound
Ct Scanner Control Room2 Radiologist
FDA
Brainomix stroke software granted FDA clearance
More in FDA
Brainomix stroke software granted FDA clearance
By AuntMinnie.com staff writers
The U.S. FDA has granted 510(k) clearance to Brainomix for a feature of its 360 Stroke software.
April 8, 2025
Ct Scanner Control Room2 Radiologist
FDA greenlights Telix NDA for prostate imaging agent Gozellix
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has approved a new drug application (NDA) for Telix's TLX007-CDx for prostate cancer imaging.
March 21, 2025
Fda Logo V2 Social
Xeris secures FDA approval for Gvoke VialDx for x-ray exams
By AuntMinnie.com staff writers
Biopharma firm Xeris has received FDA approval for its Gvoke VialDx to be used as a diagnostic aid for abdominal x-ray exams.
March 18, 2025
Fda Sign Dc 400
GE HealthCare secures 510(k) for updated Voluson Expert ultrasound
By AuntMinnie.com staff writers
Enhancements support AI in women's imaging, particularly in complex, high-risk pregnancies.
January 28, 2025
Ge Hc Logo 400
FDA issues guidance on scanning interference with implanted medical devices
By AuntMinnie.com staff writers
The FDA has received some reports of electronic medical devices being damaged during CT scans.
October 25, 2024
Fda Logo
FDA accepts Lumicell breast cancer optical imaging agent NDA
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has accepted for review Lumicell's new drug application for its Lumisight optical imaging agent for breast cancer and a premarket approval application for the company's direct visualization system.
May 21, 2023
2021 04 29 18 14 4885 Breast Cancer 3 D 400
Lumicell submits application to FDA
By AuntMinnie.com staff writers
Lumicell has submitted a premarket approval application to the U.S. Food and Drug Administration (FDA) for the company's investigational direct visualization system.
April 19, 2023
2016 10 05 17 45 45 493 Breast Cancer 400
Seno secures supplemental PMA for Imagio
By AuntMinnie.com staff writers
Optoacoustic imaging firm Seno Medical Instruments has received supplemental premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its Imagio breast imaging system.
June 27, 2022
2021 04 29 18 14 4885 Breast Cancer 3 D 400
ViewRay submits 510(k) for updated version of MRIdian
By AuntMinnie.com staff writers
Image-guided radiation therapy vendor ViewRay has submitted a 510(k) application for an updated version of its MRIdian MRI-guided radiation therapy system.
October 3, 2021
2019 09 17 17 11 0207 Viewray Astro 2019
FDA launches online 510(k) submission tracker
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has launched a 510(k) submission tracker to enable companies to follow their regulatory submissions to the agency.
August 29, 2021
2019 02 13 19 24 5396 Fda Logo V2 400
Nanox files 510(k) for multisource tomo x-ray
By AuntMinnie.com staff writers
X-ray developer Nanox said it has applied for 510(k) clearance with the U.S. Food and Drug Administration (FDA) for the first version of the company's multisource 3D digital tomosynthesis x-ray system.
June 16, 2021
2021 04 02 17 34 8177 2021 04 02 Nanox Beauty Shot 20210402171431
BWXT to manufacture Boston Scientific's TheraSphere glass microspheres
By AuntMinnie.com staff writers
Medical isotope and radiopharmaceutical supplier BWXT Medical has signed an agreement with Boston Scientific to manufacture that firm's TheraSphere yttrium-90 glass microspheres.
May 9, 2021
2018 04 24 20 24 4264 Isotope 400
Page 1 of 31
Next Page