Guilford, Conn.-based Hyperfine Research Inc. has received the U.S. FDA’s nod for a bedside magnetic resonance imaging (MRI) system and is eyeing this summer for shipments. The portable system can be wheeled directly to the patient’s bedside and plugs into a standard electrical wall outlet.
Palo Alto, Calif.-based Varian Medical Systems Inc. has won the U.S. FDA’s nod for its Ethos therapy, an artificial intelligence (AI)-driven holistic solution that is aiming to transform cancer care. This solution is designed to deliver an entire adaptive treatment in a typical 15-minute slot and is intended to put the patient at the center of care, noted Chris Toth, president of Varian Oncology Systems.
Brisbane, Calif.-based Caption Health Inc. received good news from the U.S. FDA, which has given a thumbs up to Caption Guidance. This software aims to assist medical professionals in the acquisition of cardiac ultrasound images and uses artificial intelligence (AI) to provide real-time guidance.
Keeping you up to date on recent developments in cardiology, including: Researchers find 'first responder' that triggers plaques; Heart muscle cells alter their energy source during regeneration; More evidence points to rosiglitazone, heart issues.
Soliton Inc., of Houston, unveiled positive proof-of-concept (POC) study results out to 12 weeks using its Rapid Acoustic Pulse (RAP) device for the treatment of fibrotic scars. Overall, the treatment of fibrotic scars using the device proved safe and tolerable during this POC study.
Aria CV Inc., which focuses on pulmonary arterial hypertension (PAH), has won a breakthrough device designation from the U.S. FDA for the Aria CV pulmonary hypertension (PH) system. The implanted Aria CV PH system aims to restore the benefits of a healthy, elastic pulmonary artery, which in turn reduces cardiac workload and enhances blood flow.
With an eye toward expanding the reach of its Febridx rapid point-of-care (POC) test, Lumos Diagnostics has seen the closing of a $15 million series A round from Australia’s Planet Innovation. The funds will back a U.S. FDA pivotal clinical trial, as well as additional development and manufacturing resources for the company’s expanding full-service POC business.
Zimmer Biomet Holdings Inc., of Warsaw, Ind., reported good news for the fourth quarter, which saw net sales of $2.126 billion, an increase of 2.6% over the prior year period. In terms of geography, the Americas and Asia-Pacific stood out. In addition, the company witnessed strong results globally in its knee and hip businesses.
The U.S. FDA has given its nod for a new trial of Abbott Laboratories’ Amplatzer Amulet left atrial appendage (LAA) occluder for those with atrial fibrillation (AF) who are at risk of stroke. Known as the CATALYST trial, it is the first study comparing the effectiveness of a LAA closure device to non-vitamin K antagonist oral anticoagulant (NOAC) drugs, a newer class of blood thinners, the Abbott Park, Ill.-based company said.
Keeping you up to date on recent developments in cardiology, including: Long QT genes mostly short on evidence; Cerebrospinal fluid is early culprit in stroke edema; Regenerative HBOT protocols appear to improve cardiac function in healthy aging heart population; Blood test IDs risk of disease linked to stroke, dementia.