The combination of two sequencing techniques has unveiled features of a subpopulation of cells that could be producing plaques in atherosclerosis. This process is associated with an autoimmune component driven by CD4+ T cells, according to a study from researchers at Leiden University.
Biobeat Technologies Ltd. expanded its U.S. FDA-cleared remote patient monitoring offerings with a double nod from the agency for its sensors to monitor stroke volume and cardiac output. The two new indications join its capabilities for measuring the five vital signs assessed in any medical visit—blood pressure, blood oxygen saturation, pulse rate, respiratory rate and body temperature—all of which can be done using photoplethysmography (PPG) on sensors embedded on either a short-term chest patch or a more durable wrist monitor.
Shockwave Medical Inc. will acquire Neovasc Inc. for just under $108 million, if all terms of the deal are met. Shockwave will pay $27.25 in cash for each of Neovasc’s 2.71 million outstanding shares or approximately $73.78 million at close. Shockwave said the offer corresponds to an enterprise value of $100 million. Neovasc could receive an additional payment of up to $47 million, if the company’s Reducer system for refractory angina obtains U.S. FDA marketing approval within a specified time frame.
Nuralogix Corp. is taking its selfie-based health monitoring platform to the next level, offering continuous health and vital signs tracking during video calls. The launch of Anura Telehealth is the newest addition its Anura app, which uses video cameras on smartphones and other consumer devices to extract facial blood flow information and provide a personalized snapshot of health and wellness.
Zylox-Tonbridge Medical Technology Co. Ltd. has obtained marketing approval for its retrievable inferior vena cava (IVC) filter Zylox Octoplus in China. “Zylox Octoplus is approved for the prevention of pulmonary embolism (PE) and deep vein thrombosis (DVT) in the peripheral vasculature,” a spokesperson at Zylox-Tonbridge told BioWorld. The approval is based on a multi-center, randomized and positive control clinical trial in China. The trial was conducted in nine peripheral vascular intervention centers in China.
Carmat SA just completed a flash fundraising of $33 million to increase production of its Aeson total artificial heart and support sales growth in Europe. The operation featured two distinct but concurrent actions: a reserved offer and a public offer. The reserved offer, intended for specialist investors, raised $28.9 million.
A new acute coronary syndrome detection system developed by Neuome Peptides Pte. Ltd.’s aims to make tests for the frequently lethal condition faster, more precise and less invasive. Neuome’s Truheart is a point-of-care assay for cardiovascular disease that is used in the company’s established Instadetect assay development platform. The assay measures the biomarkers troponins I and T and myoglobin.
The U.S. False Claims Act (FCA) provides one of the more potent legal weapons in the federal government’s enforcement arsenal and three companies felt the sting of the FCA in the closing weeks of December 2022. Advanced Bionics LLC fell under the sway of the FCA related to allegations that it misused a performance standard in its premarket filing for cochlear implants, while Biotelemetry Inc. and its Cardionet LLC subsidiary will fork over more than $44 million for improper claims filed with the Medicare program.
Damage to the left ventricle may be more common than damage to its cousin on the other side, but right heart failure is still a unique syndrome with its own specific needs. Chuck Simonton, the chief medical officer at Abiomed Inc., told BioWorld that both the company and the U.S. FDA are keen to remind cardiologists that early detection and treatment of right heart failure vastly improves outcomes, including a huge reduction in mortality in these desperately ill patients.
The move away from in-clinic testing continues, with another company offering a convenient, at-home sensor that gathers critical health information without requiring any change on the part of the patient, which may provide even more accurate, real-world data on patient health than the tests they replace.