Abbott wins CE Mark for new TactiCath ablation catheter
Abbott (NYSE:ABT) said today that the TactiCath sensor-enabled ablation catheter it bought along with St. Jude Medical (NYSE:STJ) this year won CE Mark approval in the European Union. The Chicago-area healthcare giant said the new TactiCath device can be integrated with another St. Jude product, the EnSite Precision heart mapping system it launched earlier this year. “The goal in developing the TactiCath contact force ablation catheter, sensor enabled, was to provide the most innovative solution for treating atrial fibrillation and lead the way in clinical outcomes for patients with cardiac arrhythmias – even dur...
Source: Mass Device - May 9, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Catheters Regulatory/Compliance Wall Street Beat Abbott stjudemedical Source Type: news

Abbott wins CE Mark for Confirm Rx cardiac monitor
Abbott (NYSE:ABT) said today that its St. Jude Medical (NYSE:STJ) subsidiary won CE Mark approval in the European Union for the ConfirmRx insertable cardiac monitor, touting as the world’s 1st smartphone-compatible ICM. The continuous heart monitor is designed to work with St. Jude’s myMerlin mobile app to allow physicians to remotely follow  patients and diagnose arrhythmias. Abbott said it’s on the market in 10 “select” countries in Europe, with a full release slated for the 2nd quarter. The FDA is also reviewing the device, the Chicago-area healthcare giant said. “Incorporating w...
Source: Mass Device - May 8, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Patient Monitoring Regulatory/Compliance Abbott st-jude-medical Source Type: news

Abbott announces CE Mark and first use of the world's first smartphone compatible insertable cardiac monitor
Abbott (NYSE: ABT) today announced CE Mark and first use of the new Confirm RxTM Insertable Cardiac Monitor (ICM), the world's first smartphone compatible ICM that will help physicians identify difficult to detect cardiac arrhythmias, including atrial fibrillation (AF), to help guide therapy. Since CE Mark approval, adoption of the device has been strong and implants have occurred in 10 countries across Europe. (Source: World Pharma News)
Source: World Pharma News - May 8, 2017 Category: Pharmaceuticals Tags: Featured Abbott Business and Industry Source Type: news

Abbott Announces CE Mark and First Use of the World's First Smartphone Compatible Insertable Cardiac Monitor
Abbott (NYSE: ABT) today announced CE Mark and first use of the new Confirm RxTM Insertable Cardiac Monitor (ICM), the world's first smartphone compatible ICM that will help physicians identify difficult to detect cardiac arrhythmias, including atrial fibrillation (AF), to help guide therapy. Since CE Mark approval, adoption of the device has been strong and implants have occurred in 10 countries across Europe. (Source: eHealth News EU)
Source: eHealth News EU - May 8, 2017 Category: Information Technology Tags: Featured Industry Business and Industry Source Type: news

Digital health news briefs for 5/4/2017: CardioNet HIPAA settlement, Telemedicine lactation consulting
OCR settles HIPAA complaint with CardioNet.  CardioNet, one of the oldest companies in the mobile cardiac arrhythmia monitoring space, has agreed to pay the Office of Civil Rights $2.5 million and enter into a corrective action plan in the end result of a HIPAA breach investigation that ' s been going on since 2012. (Source: mobihealthnews)
Source: mobihealthnews - May 4, 2017 Category: Information Technology Source Type: news

Advanced Cardiac Therapies lands $45m round led by new PE shop Ajax Health
Ajax Health, the medical device portfolio management company newly formed by KKR and Aisling Capital, led a $45 million round for Advanced Cardiac Therapeutics and the next-generation ablation catheter it’s developing. Earlier today the private equity giants launched tapped Spirox chairman & CEO Duke Rohlen to lead Ajax Health. Rohlen, the former president of FoxHollow Technologies and the founder & former chief executive of CV Ingenuity, is also CEO at ACT. That Santa Clara, Calif.-based company said existing backer New Enterprise Assoc. and new investor Questa Capital Management also participate...
Source: Mass Device - May 2, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Catheters Funding Roundup Wall Street Beat Advanced Catheter Therapies ajaxhealth New Enterprise Associates questa Source Type: news

Binge drinking could trigger abnormal heart rhythms
Conclusion This cross-sectional study found binge drinking is associated with an increased risk of having an irregular heartbeat. However, the type of irregular heartbeat found was mainly sinus tachycardia, which isn't life threatening but involves the heart beating at an abnormally fast rate of over 100 heartbeats a minute. This research also has some notable limitations: The ECG recordings from the acute alcohol group were taken using a smartphone application operated outside the manufacturer's recommended environment. The lively atmosphere within the beer tent may have caused inaccurate recordings. The populati...
Source: NHS News Feed - April 27, 2017 Category: Consumer Health News Tags: Heart/lungs Lifestyle/exercise Source Type: news

AliveCor raises $30m
AliveCor has raised $30.1 million in a new round of equity financing, according to an SEC filing posted this week. The Mountain View, Calif.-based company produces the Kardia mobile platform, which includes smartphone apps and accessories to allow for the monitoring of multiple vital signals. AliveCor’s monitoring app can record 5 vital statistics, the company said, including blood pressure, heart rhythm, resting heart rate, weight and physical activity. Money in the round comes from 9 unnamed investors, with the 1st sale in the round dated on March 15, according to the SEC filing. The company has not yet said how it...
Source: Mass Device - March 31, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Diagnostics mHealth (Mobile Health) AliveCor Source Type: news

Heart Societies update guidelines to support cardiac monitors for syncope patients
Medtronic (NYSE:MDT) said today that new guidelines from the American College of Cardiology, the American Heart Association and the Heart Rhythm Society now recommend the use of cardiac monitors for patients with syncope. The updated guidelines for patients with syncope, or unexplained fainting, was published online in the Journal of the American College of Cardiology, Circulation and HeartRhythm. Medtronic said that the new guidelines support the use of its Seeq MCT system, a wireless continuous external heart monitor that can be worn up to 30 days, and its Reveal Linq ICM with TruRhythm detection, an implantable monito...
Source: Mass Device - March 24, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Patient Monitoring Medtronic Source Type: news

AliveCor raises $30m, launches Kardia Pro platform in U.S.
AliveCor said today that it landed $30 million in a series D funding round and that it released its artificial intelligence-enabled Kardia Pro platform in the U.S. The company’s platform enables doctors to remotely monitor their patients for early signs of atrial fibrillation, a common cardiac arrhythmia. “Heart disease is the No. 1 cause of death in the United States, claiming more lives than all forms of cancer combined. To manage heart disease and stroke risk, leading cardiologists want to see more than just ECGs from their patients,” CEO Vic Gundotra said in prepared remarks. “Kardia Pro tracks important meas...
Source: Mass Device - March 16, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Cardiovascular Funding Roundup Patient Monitoring Wall Street Beat AliveCor Source Type: news

Abbott announces FDA approval of Flexibility < sup > TM < /sup > Ablation Catheter, Sensor Enabled < sup > TM < /sup > to advance the treatment of complex cardiac arrhythmias
- Sensor EnabledTM tool complements the EnSite PrecisionTM cardiac mapping system and expands Abbott's comprehensive advanced cardiac mapping and ablation portfolio (Source: Abbott.com)
Source: Abbott.com - March 1, 2017 Category: Pharmaceuticals Source Type: news

Abbott wins FDA nod for FlexAbility sensor-enabled ablation cath
Abbott (NYSE:ABT) said today it won FDA approval for its sensor-enabled FlexAbility ablation catheter designed for cardiac ablation procedures to treat atrial flutter. The sensor-enabled FlexAbility ablation catheter is the Abbott Park, Ill.-based company’s 1st designed to collect electrical current resistance and magnetic data to produce accurate mapping and assist in treating sites that trigger or sustain abnormal heart rhythms. “I am seeing an increasing number of patients with complex cardiac arrhythmias, which has created a strong need for advanced tools that can meet the needs of those patients. Sensor En...
Source: Mass Device - March 1, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Catheters Food & Drug Administration (FDA) Regulatory/Compliance Abbott Source Type: news

Must-watch: video showing murder of Kim Jong Nam
Discussion on toxicology discussion boards have brought up the following possibilities: Tetramine: Tetramethylenedisulfotetramine (TETS) is a rat poison that has been banned since 1984 but which — according to Wikipedia — is still used in China. It is a white powder that is slightly soluble both in water and DMSO, a solvent that could accelerate dermal absorption. TETS is a neurotoxin that acts as a GABA antagonist causing refractory status epileptics, coma, and death. There is no specific antidote. Aconite: This plant poison is used in several Chinese herbal medicines.Aconite is a sodium channel opener, causing gast...
Source: The Poison Review - February 22, 2017 Category: Toxicology Authors: Leon Gussow Tags: Medical assassination Kim Jong Nam Kuala Lumpur International Airport malaysia murder North Korea Source Type: news

Medtronic wins FDA clearance for CardioInsight 3D mapping tech
Medtronic (NYSE:MDT) said today that it won 510(k) clearance from the FDA for its CardioInsight Noninvasive 3D mapping system, which was designed to map irregular heart rhythms in the upper and lower chambers of the heart and provide electroanatomic 3D maps of the heart. The CardioInsight system is the 1st commercially available, noninvasive cardiac electrical mapping system in the world, according to Medtronic, and avoids the invasive steps of a traditional procedure to determine the origin of a patient’s irregular heart rhythm. Medtronic’s 3D cardiac mapping system employs a 252-electrode sensor vest, which i...
Source: Mass Device - February 1, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Regulatory/Clearance Medtronic Source Type: news

Atrial fibrillation more prevalent in dialysis patients than expected
Atrial fibrillation, which is the most common cardiac arrhythmia, is an important risk factor for strokes. A multi-centre study shows that the prevalence of atrial fibrillation in haemodialysis patients in Vienna is significantly higher than previously thought. Moreover, only half of the patients affected are treated with an anticoagulant. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - January 16, 2017 Category: Science Source Type: news