BIOTRONIK won FDA approval and is releasing in the U.S. its Intica DX and Intica cardiac resynchronization therapy (CRT)-DX implantable cardioverter defibrillators (ICD). The DX indicator refers to BIOTRONIK’s technology that obviates the necessity of having an atrial lead to monitor the electrical activity in the atrium, a way that cardiolog (Read more...)
Tag Archive for Cardiology
Cardiologs Cloud-Based Software FDA Cleared to Spot Arrhythmias in ECGs
by Medgadged • • 0 Comments
Cardiologs, a company based in Paris, France, won FDA clearance for its software that analyzes electrocardiograms (ECG) for signs of cardiac arrhythmias. The system is based on a neural network, an artificial intelligence technique, that was trained by feeding it more than half a million previously gathered ECG recordings. The Cardiologs system liv (Read more...)
Researchers Work to Grow Capillaries Inside 3D Printed Molds
by Medgadged • • 0 Comments
Researchers at Rice University and Baylor College of Medicine have overcome an important challenge to using endothelial cells sourced from induced pluripotent stem cells to generate bioengineered blood vessels. Specifically, the investigators were able to watch and guide the formation of tiny blood vessels within specially built molds that promote (Read more...)
Medtronic’s CoreValve Evolut Transcatheter Aortic Valves Now Approved for Intermediate Risk Patients
by Medgadged • • 0 Comments
Medtronic has announced that its CoreValve Evolut transcatheter aortic valve replacement platform, consisting of CoreValve, CoreValve Evolut R, CoreValve Evolut PRO, is now FDA approved for patients with “symptomatic severe aortic stenosis who are at an intermediate risk for open-heart surgery.” Previously, the products were o (Read more...)
Masimo’s EU Approved Super Sensor Monitors Variety of Physiologic Parameters
by Medgadged • • 0 Comments
Masimo just announced receiving European approval for its new rainbow Super DCI-mini sensor, a pulse oximeter that can simultaneously monitor arterial oxygen saturation (SpO2), hemoglobin (SpHb), carboxyhemoglobin (SpCO), methemoglobin (SpMet), pleth variability index (PVi), index of perfusion (Pi), and pulse rate (PR). This is the first non-i (Read more...)
New Software Diagnoses Cardiac Arrhytmias from ECGs Better Than Cardiologists
by Medgadged • • 0 Comments
Stanford researchers claim to have developed an algorithm that “exceeds the performance of board certified cardiologists in detecting a wide range of heart arrhythmias from electrocardiograms [ECG] recorded with a single-lead wearable monitor,” according to a study published in arXiv. The team used the Zio patch from iRhythm T (Read more...)
Nokia Launches Portfolio of Digital Health Products: Interview with VP Nokia Digital Health, Cedric Hutchings
by Medgadged • • 0 Comments
Nokia announced its re-entry into the consumer market in late June by launching a portfolio of digital health products ranging from elegant activity/sleep trackers to smart scales and a home air-quality monitor. As the largest line of connected consumer health products on the market, they are now available for purchase on their website an (Read more...)
CathVision: A Smoother Look at Cardiac Electrograms
by Medgadged • • 0 Comments
CathVision is a Danish company that aims to reduce noisy electrogram signals during cardiac arrhythmia ablation procedures. With cleaner signals, cardiologists can better locate the areas that generate arrhythmias and ablate them. For example, with a higher signal-to-noise ratio, cardiologists can have higher confidence when probing the l (Read more...)
Medtronic’s Micra Pacemaker Survives Flight to Space
by Medgadged • • 0 Comments
This is an update to a recent story of ours on the first pacemaker in space. The Medtronic Micra is the smallest pacemaker currently available. It’s so small that it’s delivered via a catheter and attached to the endocardium of the heart, where its internal battery paces the heart for years. It’s certainly an incredible piece (Read more...)
Edwards INSPIRIS RESILIA Aortic Valve Now Approved in U.S.A.
by Medgadged • • 0 Comments
Edwards Lifesciences has announced that the FDA has issued approval for its INSPIRIS RESILIA prosthetic aortic valve, which is based on the popular Carpentier-Edwards PERIMOUNT device. Cleared in Europe just under a year ago, the INSPIRIS RESILIA features flaps made from RESILIA material, a tissue developed by Edwards that helps maintain the i (Read more...)
3D Printed Patient Cardiovascular Anatomy to Guide Replacement Heart Valves
by Medgadged • • 0 Comments
In cases of heart valve replacements, surgeons have different sizes and options to choose from, each prosthetic device having its unique qualities and limitations. Predicting the best replacement heart valve for patient’s specific morphology may soon be easier to figure out thanks to the use of 3D printing. Researchers at Georgia Tech are pri (Read more...)
Calon Cardio’s MiniVAD Left Ventricluar Assist Device Set for 2018 Clinical Trials
by Medgadged • • 0 Comments
Working with the University of Swansea, Calon Cardio, a Welsh firm, has created the first UK-developed Left Ventricluar Assist Device (LVAD). The MiniVAD is scheduled to begin a 50 patient clinical trial in late 2018, with a full clinical rollout planned for 2020. Calon Cardio’s miniature implantable heart pump is used to treat advanced (Read more...)
Pulsed High Intensity Ultrasound Removes Calcified Buildup from Prosthetic Heart Valves
by Medgadged • • 0 Comments
Prosthetic heart valves that fit inside failed natural valves have now been used for years to treat thousands of patients. As time passes following implantation, the man-made valves tend to accumulate calcified debris over their leaflets. This slowly degrades their functionality and eventually requires revision procedures that may involve repl (Read more...)
Medtronic’s Tiny Micra Pacemaker Going on a Space Flight
by Medgadged • • 0 Comments
These days astronauts are some of the healthiest and physically robust individuals that NASA can get a hold of. But one day we may see all kinds of people going to space, even those with heart conditions. Shelbi Klingsporn, a Nebraska high school student had the idea to test whether an existing pacemaker is able […]
FDA Clears MAGNETOM Vida 3 Tesla MRI with BioMatrix Technology
by Medgadged • • 0 Comments
Siemens is reporting that the FDA has cleared its MAGNETOM Vida 3 Tesla MRI scanner. The device features the new BioMatrix technology from Siemens that takes into account individual patient anatomy, physiology, and even the differences in MRI operators to produce optimal image quality. Essentially, the scanner’s table has a built-in (Read more...)
Tiny Forward Facing Ultrasound Drill to Bust Through Blood Clots
by Medgadged • • 0 Comments
Intravascular ultrasound devices are used on a regular basis to break up blood clots. These devices deliver high frequency ultrasound energy from a side facing transducer, shaking up clots and opening up blood vessels. Because of engineering limitations that have resulted in ultrasound being emitted laterally, the clots don’t break up as well (Read more...)
BIOTRONIK’s Pacemakers Get 3 Tesla MR-Conditional Approval in Europe
by Medgadged • • 0 Comments
BIOTRONIK won European regulatory approval allowing its Edora, Evity, and Enitra series of pacemakers to be safe for 3 Tesla full body scans, as long as certain precautionary measures are taken. This approval will allow more patients to take advantage of the high quality imaging that the more powerful MRI scanners offer, as previously these [&helli (Read more...)
OrbusNeich Is Bringing Its Sapphire PTCA Balloon Catheters to U.S.
by Medgadged • • 0 Comments
OrbusNeich, a company based in Hong Kong, is releasing in the U.S., following FDA clearance, its Sapphire II PRO and the Sapphire NC Plus PTCA balloon dilation catheters. Both devices are indicated for dilation of coronary artery or bypass graft stenoses in cases of ischemia, and for opening up coronary artery occlusions following an infarct. (Read more...)
AliveCor and Microlife Detected 67% and 83% of Patients with Atrial Fibrillation
by Medgadged • • 0 Comments
A study from The University of Hong Kong in a primary care setting showed that the AliveCor Heart Monitor and Microlife WatchBP Office AFIB demonstrated less than expected sensitivity. 2052 patients (mean age = 68 years old) with hypertension and/or diabetes were screened for atrial fibrillation using these two automated devices and (Read more...)
BIOTRONIK Releases in U.S. Its Compact Edora Line of MR Conditional Pacemakers
by Medgadged • • 0 Comments
BIOTRONIK is releasing in the U.S. its Edora line of pacemakers that come with the firm’s MRI AutoDetect technology. MRI AutoDetect, which makes the Edora SR-T the smallest MR conditional device on the market, is a setting that is enabled by a physician up to fourteen days prior to an MRI scan. When the patient […]