Medtronic received FDA approval for its CoreValve Evolut Pro transcatheter valve for implantation into symptomatic patients with severe aortic stenosis who are too fragile for open heart surgery. The self-expanding valve is based on the CoreValve Evolut R, and has a porcine pericardial tissue wrap that makes contact with the native valve and promotes a good […]
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Siemens won FDA clearance for its new ARTIS pheno robotic angiography C-arm. The system is essentially an upgraded version of the company’s Artis zeego (even the capitalization of the name has changed), sporting a zen40HDR flat panel detector and GIGALIX X-ray tube. The system features automatic dose selection to minimize radiation exposure and generates 3D scans that need […]
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Finding retinal abnormalities should lead to more aggressive management of risk factors to prevent their progression as well as future peripheral artery disease, a study suggests. Heartwire from Medscape
Medtronic won FDA clearance for its Reveal LINQ Insertable Cardiac Monitor with TruRhythm Detection. The device is used to spot and analyze difficult to diagnose arrhythmias over periods as long as three years. It is an upgrade of the original Reveal LINQ, now sporting algorithms that significantly reduce the number of false positive cases of atrial […]
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ZOLL Medical, now a part of Asahi Kasei, a Japanese corporation, received FDA approval to introduce its Hospital Wearable Defibrillator (HWD) in the U.S. Intended for use on patients that may exhibit ventricular tachycardia or ventricular fibrillation (VT/VF) during their hospital stay, the HWD shares much with implantable defibrillators but can be used across multiple patients […]
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Velano Vascular won FDA clearance for its second version of the PIVO needle-free vascular access device. The disposable device helps to gather blood samples from indwelling peripheral IVs, helping to avoid extra needle sticks and not using central lines to draw blood. The PIVO has a catheter that is placed into the peripheral IV and pushed […]
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Tryton Medical out of Durham, North Carolina won FDA approval for its Tryton Side Branch Stent. The innovative device is designed to be placed into a side branch artery while allowing a traditional drug eluting stent to be placed into the branch’s main artery, thereby treating the entire lesion at the bifurcation. The Tryton Side Branch […]
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The Azurion system builds on Philips’ many decades of imaging expertise combined with a growing integrated therapy portfolio, enhanced by the 2015 acquisition of Volcano. It is is expected to form the core of Philips’ integrated image-guided systems including vascular surgery, cardiology, oncology, and neuroradiology. The new imaging platform is underpinned by Philips’ redesigned operating system, […]
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Liberating. Jabra’s Elite Sport true wireless earbuds are truly liberating. I no longer have to worry about a tangle of wires in my workouts. Nor do I have to worry about sweat contaminating and damaging my gear – they’re waterproof and are backed by a three-year “sweat proof” warranty. Nor do I have to worry […]
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Meril, a large Indian medical device firm, has developed a drug-eluting bioresorbable vascular scaffold, which looks like a stent but that eventually and slowly degrades is washed away by the body. The MeRes100 is made of PLLA coated with PDLLA, both biodegradable polymers, while Sirolimus (rapamycin), the immunosuppressant common in drug eluting stents, is embedded within the […]
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Clarius, a company based in British Columbia, Canada, received European CE Mark approval for its wireless C3 and L7 ultrasound scanners. These devices are highly portable, battery powered, and use an Android or iOS smartphone or tablet for displaying the scans. They’re even water resistant, so can be used in a wide variety of in-clinic and […]
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Masimo has announced that European regulatory authorities have given clearance for its MightySat Rx fingertip pulse oximeter to be used to measure the respiration rate of patients, in addition to all the other measurements it performs. The respiration rate from the pleth (RRp), as Masimo calls it, notices how the respiratory cycle changes the nature […]
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A company called swyMed out of Lexington, Massachusetts is releasing a portable telemedicine solution designed to link patients with doctors, whether they are at home, in an ambulance, or in a hard to reach location. The plug-and-play solution can be quickly deployed to begin a consultation, particularly important in emergency scenarios. The DOT Telemedicine Backpack features […]
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At the York University in Toronto, Canada researchers have come up with a way of integrating three different cardiac cell types into a single functional, 3D beating tissue. Unlike many other tissue engineering techniques, the York team didn’t use any scaffolding to hold the cells in place. The cells, which were contractile myocardial cells, connective tissue […]
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BIOTRONIK, a company known best for its implantable pacemakers and defibrillators, has just landed its first FDA approval for a coronary stent. The PRO-Kinetic Energy Cobalt Chromium (CoCr) metal stent is intended for placement within narrow arteries, only between 2.25 and 4 mm in diameter, and features struts that are nearly microscopic at 60 µm in width. […]
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Medtronic is releasing a few new coronary devices, including the new DxTerity diagnostic angiography catheters, DxTerity TRA diagnostic catheters, InTRAkit access kit, and the TRAcelet compression device. All the products already have received U.S. and European regulatory approvals. While both of the DxTerity catheter lines are used to evaluate the need for revascularization procedures, the DxTerity […]
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A collaboration between scientists at University of Washington and University of Michigan has led to the development of a new way of imaging atherosclerosis within blood vessels. The technology relies on delivering a tiny camera into a vessel’s lumen and illuminating the plagues using red, green, and blue lasers. The scanning fiber endoscope (SFE) was […]
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Researchers are solving the issue of chronic underreporting of medical device adverse events. In the New England Journal of Medicine last month, they described their use of DELTA (Data Extraction and Longitudinal Analysis), a statistics software that prospectively monitors safety events stored in registries and databases. Moving forward from the current voluntary reporting method by physicians and patients, […]
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ABBOTT, having recently purchased St. Jude Medical, is already reaping rewards. The FDA has issued MR-conditional labeling for the Assurity MRI pacemaker and the matching Tendril MRI lead. This makes the Assurity MRI concurrently the smallest pacemaker (6mm thick) and one with the longest lifetime (10 years) of any wireless pacemaker that can be safely worn (under certain […]
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Three months ago we sat down with Dr. Beth Kolko, CEO of Shift Labs, to learn more about DripAssist Infusion Rate Monitor, a device that automates the calculation of IV infusion drip rates and total infusion volumes while also being able to alert a nurse when a drip rate changes or stops. At that time, […]
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