Innovent Biologics Inc.’s PCSK9 inhibitor, IBI-306, intended for the treatment of heterozygous familial hypercholesterolemia (HeFH), has met its primary endpoint in a phase III study in Chinese patients.
Abbott Laboratories received FDA approval for its Amplatzer Amulet left atrial appendage occluder to treat people with atrial fibrillation who are at risk of ischemic stroke about a month earlier than generally expected, given the backlog at the FDA. The dual-closure device closes the left atrial appendage during the procedure, reducing the risk of blood clots immediately and eliminating the need for blood thinners both during the healing process and longer term.
The U.S. Centers for Medicare & Medicaid Services (CMS) has proposed to drop its national non-coverage policy for pulmonary embolectomy, a procedure for which multiple devices have been cleared or approved by the FDA. Several stakeholders, including more than one med-tech trade association, had requested such a change, and CMS indicated that much more evidence will be needed before it can forge a national coverage policy that would eliminate the impending geographically differentiated patient access.
Innovent Biologics Inc.’s PCSK9 inhibitor, IBI-306, intended for the treatment of heterozygous familial hypercholesterolemia (HeFH), has met its primary endpoint in a phase III study in Chinese patients.
While the increased use of virtual appointments has made care more accessible for many people during the pandemic, it has created challenges for providers who often lack a means to gather basic health data from patients. Advanced Human Imaging Ltd. (AHI), formerly Myfiziq Ltd., tackled the problem with a scanning technology that eliminates the need for basic vital sign equipment during telehealth visits by calculating blood pressure, heart and respiratory rate, and body mass index with a quick scan performed on a smartphone or webcam.
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.
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