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Source: Mass Device
Condition: Atrial Fibrillation

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Total 67 results found since Jan 2013.

Conformal Medical launches LAA seal study
Conformal Medical said yesterday that it launched an investigational device exemption trial for a device designed to seal off the heart’s left atrial appendage to help prevent stroke in atrial fibrillation patients. Nashua, N.H.-based Conformal’s device is designed to adapt to the each patient’s individual physiology, to be easier to implant with less imaging and without general anesthesia. The 45-patient, single-arm study is designed to evaluate the device’s performance, with an estimated primary completion date of April 2020 and a final completion date of June 2025, according to ClinicalTrials.gov. Th...
Source: Mass Device - April 10, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Clinical Trials Featured Conformal Medical Source Type: news

Omron wins FDA nod for combined blood pressure monitor, EKG
Omron Healthcare (TYO:6645) has won FDA 510(k) clearance for its Blood Pressure Monitor + Echocardiogram device, according to a recently posted FDA release. The device, which was developed in collaboration with AliveCor, allows users to monitor both high blood pressure and atrial fibrillation, which the company said are critical risk factors for stroke. The newly cleared device is designed to sync with the Omron Connect mobile application to store, track and share heart health data with physicians to improve outcomes, the company said in its original product release. The combined product, under the moniker BP7900, was cle...
Source: Mass Device - March 25, 2019 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance AliveCor Omron Source Type: news

ACC 2019: Medtronic, Edwards low-risk TAVR trial data could pave way to new indications
Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology. Data from the trials were presented over the weekend at the American College of Cardiology 68th Annual Scientific Session 2019 in New Orleans and simultaneously published in the New England Journal of Medicine. Currently, TAVR devices are only approved by the FDA for treating severe aortic valve stenosis in patients at inte...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Medtronic Source Type: news

Using wearable devices in clinical trials
Brandy Chittester, chief of clinical operations, IMARC Globally, more than 325 million people own wearable, connected devices, and more than 2.5 billion own smartphones. Using wearable devices in clinical trials can bring huge benefits, however, there are also concerns. Here’s a look at how researchers are using wearable devices — and what you should consider before using them in your own research. How wearable devices are advancing medicine Right now, ClinicalTrials.gov, a global database of clinical trials, lists nearly 200 trials with “wearable devices” or “wearable technology” in the description. This in...
Source: Mass Device - March 12, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news

Sotera Wireless adds tools to patient monitoring system
Sotera Wireless said it has upgraded its ViSi Mobile patient monitoring system to detect atrial fibrillation, ventricular fibrillation and ventricular tachycardia, and to provide asystole analysis. Often asymptomatic, atrial fibrillation may remain undiagnosed until or even after the development of complications, such as stroke. Post-operative atrial fibrillation is the most common arrhythmia that occurs after both cardiac and noncardiac surgery and is associated with increased morbidity, longer hospital stays and higher hospital costs. ViSi Mobile was previously FDA-cleared to monitor continuous noninvasive blood pressure...
Source: Mass Device - March 6, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: 510(k) Blog Food & Drug Administration (FDA) Health Information Technology mHealth (Mobile Health) News Well Patient Monitoring Regulatory/Compliance Sotera Wireless Source Type: news

Study: Catheter ablation better for AFib, heart failure than drugs
A meta-analysis of randomized controlled trials has found that catheter ablation was superior to conventional drug therapy alone for patients with atrial fibrillation (AFib) and heart failure. AFib may lead to thromboembolic stroke, systemic embolism, and decompensated heart failure. Although catheter ablation is an established therapeutic strategy for AFib, guidelines recommend caution in certain patients, and the benefits and harms of catheter ablation versus drug therapy for Afib patients have not been firmly established. Get the full story on our sister site, Medical Design & Outsourcing. The post Study: Catheter a...
Source: Mass Device - December 26, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiovascular Catheters Research & Development icahnschoolofmedicine Source Type: news

Conformal Medical raises $9m Series B for anti-stroke cardiac implant
Conformal Medical said today that it raised $9 million in a Series B round for the anti-stroke cardiac implant it’s developing. Nashua, N.H.-based Conformal is working on a left atrial appendage seal to prevent stroke in atrial fibrillation patients. It’s designed to adapt to the each patient’s individual physiology, to be easier to implant with less imaging and without general anesthesia. The funding round was led by Catalyst Health Ventures and included “a supportive group of Series A investors,” Conformal said. “This financing will allow us to validate our novel sealing technology ...
Source: Mass Device - December 3, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Featured Funding Roundup Wall Street Beat Conformal Medical Source Type: news

NYT Report: Apple Watch ‘ should not be considered a medical device ’
The new electrocardiogram-equipped Apple (NSDQ:AAPL) Watch should not be considered a medical device, according to a new report from the New York Times. The article, written by Indiana University School of Medicine pediatrics professor Aaron Carroll, calls into question the downsides of the newly released device and the potential for both false positives and false negatives. Carroll acknowledged the possible positives of the device, including the ability for physicians to monitor patients from a distance and diagnosing heart problems in individuals that would possibly go undetected, but said that “just because somet...
Source: Mass Device - October 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Diagnostics mHealth (Mobile Health) Apple Source Type: news

Boston Scientific puts $270m on the table for Claret Medical
Boston Scientific (NYSE:BSX) said today that it agreed to pay as much as $270 million to acquire Claret and its Sentinel device. Marlborough, Mass.-based Boston Scientific said the deal involves an ip-front cash payment of $220 million and another $50 million pegged to a reimbursement milestone. Claret’s Sentinel device is designed to trap and remove debris dislodged during transcatheter aortic valve replacements to prevent stroke and other neurological damage. After landing CE Mark approval in the European Union in 2014, Santa Rosa, Calif.-based Claret won de novo clearance from the FDA last year for the Sentinel d...
Source: Mass Device - July 20, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Replacement Heart Valves Wall Street Beat Boston Scientific Claret Medical Inc. Source Type: news

NIH director Collins touts AF detection capabilities of iRhythm ’ s Zio ECG patch
iRhythm Technologies‘ Zio ECG patch won praises from NIH Director Dr. Francis Collins this week for its ability to aid in the detection of atrial fibrillation. In an NIH Director blog post, Dr. Collins warned that while the dangers of atrial fibrillation are known, many individuals do not know they have atrial fibrillation and therefore cannot receive appropriate care. While doctors mainly screen for AFib by checking pulse, Dr. Collins recommended new mobile health technologies for detecting AF, including iRhythm’s Zio patch. Results from the mSToPS trial of the patch, which Dr. Collins referenced, indicated that t...
Source: Mass Device - July 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular iRhythm Technologies Inc. Source Type: news

HRS 2018: Study questions benefit of ablation over drug therapy for atrial fibrillation
Long-awaited data released today from a large clinical trial comparing catheter ablation with drug therapy in treating atrial fibrillation showed no significant benefit for ablation, according to Dr. Douglas Packer, who presented the findings today at the annual meeting of the Heart Rhythm Society in Boston. The 2,204-patient trial, sponsored by the National Institutes of Health and industry players Medtronic (NYSE:MDT), Boston Scientific (NYSE:BSX), Abbott (NYSE:ABT) and Johnson & Johnson (NYSE:JNJ) unit BioSense Webster, focused on a primary composite endpoint of total mortality, disabling stroke, bleeding an...
Source: Mass Device - May 10, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Wall Street Beat Cardiac Rhythm Management HRS 2018 Source Type: news

Medtronic touts reduced AF, improved activity in AdaptivCRT studies
Medtronic (NYSE:MDT) today released results from two real-world analyses of its AdaptivCRT algorithm, touting that its use was linked to a reduction in atrial fibrillation episodes and higher patient activity levels. Results from the analyses, which involved a total of 408 patients at 26 centers in Italy, were presented at the European Heart Rhythm Association’s Scientific Sessions 2018 in Barcelona, Spain, the company said. Medtronic’s AdaptivCRT algorithm is designed to adjust pacing to the heart dependent upon evaluations of heart rhythm made every minute, the company said. The program has been shown to in...
Source: Mass Device - March 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Software / IT Medtronic Source Type: news

J & J ’ s Biosense Webster launches WaveCrest study
Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster said today that the first patient has been enrolled in an investigational device exemption trial for its WaveCrest system. The 1,250-patient study is designed to assess the safety and efficacy of the WaveCrest left atrial appendage occlusion system as a way to reduce the risk of embolic stroke in atrial fibrillation patients. “The WaveCrest System is designed to enable physicians to close the heart’s LAA, where most stroke-causing blood clots occur,” Dr. Larry Chinitz, who treated the first patient in the trial at New York University Hospital, s...
Source: Mass Device - January 16, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials BioSense Webster Inc. johnsonandjohnson Source Type: news

Report: Apple is working on an in-house Apple Watch ECG to compete with AliveCor ’ s Kardiaband
Apple (NSDQ:AAPL) is reportedly developing an in-house ECG for its Apple Watch that would compete with the recently approved KardiaBand made by AliveCor. The Apple ECG, which is still being testing, involves smartwatch users squeezing the frame of the device with the opposite hand, allowing Apple Watch to pass an imperceptible current across the chest to assess heart rhythm, according to Bloomberg, which cited “people familiar with the plan.” Last month the FDA cleared AliveCor’s KardiaBand ECG device for the Apple Watch, designed to monitor for early signs of atrial fibrillation. First introduced in M...
Source: Mass Device - December 22, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular mHealth (Mobile Health) Wall Street Beat AliveCor Apple Source Type: news

FDA clears AliveCor ’ s KardiaBand ECG for Apple Watch
AliveCor said today that the FDA cleared its KardioBand electrocardiogram device for the Apple Watch, designed to monitor for early signs of atrial fibrillation. First introduced in March 2016, KardiaBand is the first medical device accessory to be cleared by the federal safety watchdog for the Apple Watch, Mountain View, Calif.-based AliveCor said. It’s designed to display and record clinical-grade cardiac rhythm readings in real time in about 30 seconds, the company said. AliveCor also said it launched the SmartRhythm artificial intelligence app for the Apple Watch, which is designed to continuously evaluate the ...
Source: Mass Device - November 30, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Patient Monitoring Wall Street Beat AliveCor Cardiac Rhythm Management Source Type: news