Pulse Medical Imaging Technology (Shanghai) Co. Ltd. has raised more than $100 million in a series C funding round to accelerate the R&D, clinical trials and commercialization of its products. “Pulse plans to use the funds to accelerate the commercialization of its fractional flow reserve (FFR) estimating systems,” Xiaojie Lin, marketing director of Pulse, told BioWorld. FFR is a method to measure blood pressure and flow within a coronary artery to check on the possibility that the stenosis impedes oxygen delivery to the heart muscle.
The FDA reported that Boston Scientific Corp. has recalled several models from the Ingenio line of cardiac electrophysiology devices in a class I action that affects 48,000 devices. The recall was triggered by the risk that these devices will inappropriately shift into safety mode and thus be unable to provide pacing, as demonstrated by 65 such incidents and three instances in which patients needed external pacing in response to the problem.
Catheter ablation for atrial fibrillation has enjoyed an uneven reputation at best over the years, but the prospect of eliminating anti-arrhythmic drugs has proven difficult for both patients and clinicians to ignore. A new analysis of data from the Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) study seems to answer the cost effectiveness question for ablation, however, representing yet another piece of evidence that should support increased sales of these devices in the coming years.
Tobacco firm Philip Morris International Inc. has announced another acquisition as it adopts a “beyond nicotine” strategy, snapping up Otitopic Inc., of Los Angeles, for an undisclosed sum.
PERTH, Australia – The Australian government’s Medical Research Future Fund (MRFF) has funded a new program called the Artificial Heart Frontiers Program that aims to develop and commercialize a world-first durable total artificial heart. The Medical Research Future Fund has provided A$1 million (US$739,000) in funding that will establish the program over the next five years.
Microport Scientific Corp.’s cardiac rhythm disorders subsidiary, Microport Cardiac Rhythm Management Ltd. (Microport CRM), has confirmed agreements for a series C financing that would net it total investment proceeds of $150 million. Hillhouse Capital Group and Microport will co-lead the series C investment with investments of $20 million and $47 million, respectively.
Abbott Laboratories has secured FDA clearance for its latest optical coherence tomography (OCT) imaging platform powered by the company’s new Ultreon software. The artificial intelligence (AI)-powered imaging software allows doctors to view coronary blood flow and blockages more clearly, aiding in care management and treatment decisions.
Biofourmis Inc. won a breakthrough devices nod from the FDA for its Biovitalshf solution, a digital therapeutic for patients with heart failure with reduced ejection fraction (HFrEF). The company, which is pursuing the de novo pathway for the therapy, plans to launch a pivotal trial next month. Biovitalshf is intended to augment guideline-directed use of heart failure medications to manage patients in combination with traditional pharmacotherapy. The software application integrates physiological monitoring, symptoms and signs reporting, patient engagement, medication management and communications to provide clinicians with personalized and specific recommendations about their medication.
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