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BioWorld - Saturday, June 10, 2023
Home » Topics » Cardiovascular, BioWorld MedTech

Cardiovascular, BioWorld MedTech
Cardiovascular, BioWorld MedTech RSS Feed RSS

Sonic DL imaging vs. conventional

FDA clears GE’s AI-powered Sonic DL for faster MRI

June 9, 2023
By Meg Bryant
No Comments
GE Healthcare Technologies Inc. has launched Sonic DL, a deep learning technology designed to significantly accelerate magnetic resonance imaging (MRI) exams, after receiving regulatory clearance from the U.S. FDA.
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Pulse Medical’s non-invasive μFR system granted breakthrough device designation by FDA

June 9, 2023
By Doris Yu
No Comments
Pulse Medical Technology Inc. obtained breakthrough device designation from the FDA for its fourth generation μFR system, which would accelerate the commercialization of the device. “The fourth generation μFR system is currently not available on the market, but Pulse Medical is preparing for the marketing approval of the product in the U.S.,” Jingfeng Han, director of science division at Pulse Medical, told BioWorld.
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Smartphone displaying Stethophone app

Sparrow’s smartphone stethoscope gets FDA nod

June 7, 2023
By Meg Bryant
No Comments
The U.S. FDA has given the greenlight to Sparrow Acoustics Inc. (dba Sparrow Bioacoustics) for its Stethophone, a software-based technology that allows doctors and nurses to check a patient’s heart and lung sounds using a smartphone. Providers simply hold the smartphone against the patient’s chest to listen for possible abnormalities.
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CLAAS left atrial appendage occluder

Conformal seals $35M series D for ‘CLAASy’ LAAO device

June 7, 2023
By Annette Boyle
No Comments
Conformal Medical Inc. plugged the gap in funding needed to complete enrollment in the pivotal CONFORM trial for its left atrial appendage occlusion (LAAO) technology with completion of an oversubscribed $35 million series D fundraising round. The Conformal left atrial appendage seal (CLAAS) system is designed to close off the left atrial appendage in individuals with non-valvular atrial fibrillation to cut the risk of stroke and avoid the use of anticoagulants.
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Abiomed’s fix for purge issues in some Impella 5.5 units falters

June 5, 2023
By Mark McCarty
No Comments
The U.S. FDA reported a class I recall for a subset of the Impella 5.5 with Smartassist due to leakage of purge fluid from a pump sidearm that could ultimately lead to a loss of pump function. Abiomed Inc., the maker of the device, had previously introduced corrective measures intended to suppress the problem with leakage, but those corrections have not completely resolved the problem, leading to the withdrawal of 466 units that were distributed in the U.S. between Sept. 8, 2021, and March 6, 2023.
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Brightheart raises €2M for software to detect congenital heart defects in fetuses

June 1, 2023
By Shani Alexander
No Comments
Startup Brightheart SAS raised €2 million (US$2.14 million) in seed financing, from Sofinnova Partners, that will allow the company to accelerate the development of its artificial intelligence software, which helps physicians detect congenital heart defects in fetuses. Brightheart hopes that the technology will improve the detection of complex congenital heart defects during prenatal ultrasound screening as intervening early could address fetal malformations or abnormalities and improve a baby’s chance of survival.
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Machine-Models-5-31.jpg

Machine models enhance cardiac surgery mortality risk prediction

May 31, 2023
By Bernard Banga
No Comments
Researchers at Mount Sinai Hospital have demonstrated that a machine learning-based model enables medical institutions to predict mortality risk for individual cardiac surgery patients.
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Cardiex - Connect Pulse

Cardiex gets FDA nod for vascular biometric monitor

April 28, 2023
By Meg Bryant
No Comments
Cardiex Ltd. won U.S. FDA clearance for its Conneqt Pulse vascular biometric monitor. According to the digital health and wearables company, the device is the first in the world to provide measurements of both brachial blood pressure in the arm and central blood pressure in the heart and aorta, as well as arterial waveform analysis and other clinically relevant vascular biomarkers, outside the hospital, research institutions or clinical trial sites.
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Technegas illustration

US FDA resets review clock for Cyclopharm’s Technegas for pulmonary embolism

April 25, 2023
By Tamra Sami
No Comments
After receiving a U.S. FDA complete response letter nearly two years ago, Cyclopharm Ltd. said the agency has accepted its response and reset the clock for the NDA review of its Technegas combination product for pulmonary embolisms, with a new PDUFA date set for Sept. 29.
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Accucinch system

Ancora Heart’s Accucinch improves heart failure outcomes

March 22, 2023
By Meg Bryant
No Comments
Ancora Heart Inc. reported 12-month data showing its Accucinch system significantly improves outcomes in heart failure (HF) patients, including positive changes in cardiac structure and function. The results, presented at the Technology and Heart Failure Therapeutics conference (THT 2023) in Boston, were simultaneously published in the Journal of Cardiac Failure.
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