BrightHeart receives clearance from FDA for ultrasound software

French BrightHeart Closes €2M Seed Financing from Sofinnova ...

BrightHeart's unique, AI-powered approach has the potential to revolutionize screening for congenital heart defects by supporting clinicians ...

医疗设备公司BrightHeart首款AI软件获FDA批准

BrightHeart Secures FDA Clearance for First AI Software Revolutionizing Prenatal Fetal Heart Ultrasound Evaluations ... received FDA 510(k) ...

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Get real-time updates ... OEM News BrightHeart Gains FDA Clearance for First AI Software for Prenatal Fetal Heart Ultrasound Evaluations ...

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June 10, 2024 — Siemens Healthineers announces the Food and Drug Administration clearance of the Biograph Trinion, a high-performance, energy-efficient positron ...

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"Receiving FDA clearance for the Plum Duo pump and LifeShield software is the first step in realizing ICU Medical's long-term vision of bringing ...

General/Specific Intended Use - Guidance for Industry - FDA

... receiving clearance from FDA. Devices determined to be substantially ... ultrasound technology. It would, therefore, constitute a ...

Breast Cancer: GE Healthcare lands FDA clearance for SenoBright ...

Candelis Inc. received 510(k) clearance from the federal watchdog agency for its Astra cloud-hosted medical software suite. Read more. Carticept ...

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Brightheart raises €2M for software to detect congenital heart defects ...

Brightheart hopes that the technology will improve the detection of complex congenital heart defects during prenatal ultrasound screening as ...

Pioneering histotripsy device receives FDA clearance to treat liver ...

The cutting-edge medical device and its technology were developed in part by Kendall and Laura Hendrick Junior Faculty Fellow Eli Vlaisavljevich ...

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BrightHeart Secures FDA Clearance for First AI Software Revolutionizing Prenatal Fetal Heart Ultrasound Evaluations ... received FDA 510(k) ...

FDA Grants Clearance for UltraSight's AI-Powered Cardiac ...

The UltraSight real-time AI guidance software can assist medical professionals without sonography experience in acquiring cardiac ultrasound ...