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News You Need to Know Today
Heart Rhythm Highlights: FDA says iRhythm committed multiple violations | Left bundle branch pacing | More
Friday, June 23, 2023
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Editor's Choice: Heart Rhythm

FDA warning letter: iRhythm committed multiple violations, failed to report patient deaths in time

“It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA,” according to the warning letter. These issues, the agency added, “may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.”

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Zio AT mobile cardiac telemetry device
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FDA warning letter: iRhythm committed multiple violations, failed to report patient deaths in time

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Zio AT mobile cardiac telemetry device
“It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA,” according to the warning letter. These issues, the agency added, “may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.”
READ MORE >

Ear clip offers non-pharmacological treatment for postural tachycardia syndrome

An ear clip device has been shown to effectively stimulate nerves to treat postural tachycardia syndrome.

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Ear-clip device offers non-pharmacological treatment for postural tachycardia syndrome (POTS). #HRS2023 #HRS
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Ear clip offers non-pharmacological treatment for postural tachycardia syndrome

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Ear-clip device offers non-pharmacological treatment for postural tachycardia syndrome (POTS). #HRS2023 #HRS
An ear clip device has been shown to effectively stimulate nerves to treat postural tachycardia syndrome.
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FDA clears first ablation catheter with flexible electrode tip, contact force sensing

Contact force-sensing catheters were developed to help overcome the issue of incomplete ablation lesions.

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Abbott's TactiFlex flexible tip, force sensing ablation catheter (right), and its integration with the EnSite X EP mapping system (left) showing the distance from the last ablation. and the contact force during an AFib pulmonary vein isolation.
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FDA clears first ablation catheter with flexible electrode tip, contact force sensing

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Abbott's TactiFlex flexible tip, force sensing ablation catheter (right), and its integration with the EnSite X EP mapping system (left) showing the distance from the last ablation. and the contact force during an AFib pulmonary vein isolation.
Contact force-sensing catheters were developed to help overcome the issue of incomplete ablation lesions.
READ MORE >

Conformal Medical raises $35M to continue development, research of next-gen LAAO device

The new investments were announced as the company continues developing its CLAAS device for sealing the LAA during LAAO procedures.

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The CLAAS device from Conformal Medical. The new investments were announced as the company continues developing its CLAAS device for sealing the LAA during LAAO procedures.
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Conformal Medical raises $35M to continue development, research of next-gen LAAO device

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The CLAAS device from Conformal Medical. The new investments were announced as the company continues developing its CLAAS device for sealing the LAA during LAAO procedures.
The new investments were announced as the company continues developing its CLAAS device for sealing the LAA during LAAO procedures.
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Left bundle branch pacing: A successful alternative to standard lead placement

Juan C. Diaz, MD, explained why conduction pacing may be the way of the future.

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Juan Diaz, MD, explains why left bundle branch (LBB) conduction pacing is better than conventional sinus node pacing in cardiac synchronization therapy (CRT) for heart failure patients. #HRS #HRS2023 #LBBAP
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Left bundle branch pacing: A successful alternative to standard lead placement

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Juan Diaz, MD, explains why left bundle branch (LBB) conduction pacing is better than conventional sinus node pacing in cardiac synchronization therapy (CRT) for heart failure patients. #HRS #HRS2023 #LBBAP
Juan C. Diaz, MD, explained why conduction pacing may be the way of the future.
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VIDEO: Jagmeet Singh details the SOLVE-CRT study for a leadless CRT system

Findings from the SOLVE-CRT study were presented to attendees at Heart Rhythm 2023. "Our results showed the study was safe, effective and feasible," Singh said. 

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Jagmeet Singh, MD, explains details of the SOLVE-CRT pivotal clinical trial at HRS 2023. #HRS #HRS2023
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VIDEO: Jagmeet Singh details the SOLVE-CRT study for a leadless CRT system

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Jagmeet Singh, MD, explains details of the SOLVE-CRT pivotal clinical trial at HRS 2023. #HRS #HRS2023
Findings from the SOLVE-CRT study were presented to attendees at Heart Rhythm 2023. "Our results showed the study was safe, effective and feasible," Singh said. 
READ MORE >

PHOTO GALLERY: Electrophysiology advances at Heart Rhythm 2023

Heart Rhythm 2023 in New Orleans brought together EP experts from all over the world. Scroll through a large selection of photos from the big event. 

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MRI-guided EP lab ablation procedure using mapping and MRI-safe catheters from Imricor, displayed at HRS 2023. Photo by Dave Fornell
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PHOTO GALLERY: Electrophysiology advances at Heart Rhythm 2023

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MRI-guided EP lab ablation procedure using mapping and MRI-safe catheters from Imricor, displayed at HRS 2023. Photo by Dave Fornell
Heart Rhythm 2023 in New Orleans brought together EP experts from all over the world. Scroll through a large selection of photos from the big event. 
READ MORE >

‘Notably high’ rates of PTSD, depression and anxiety seen in patients with implantable heart devices

"Psychologists have had little involvement in the care of cardiac patients but this needs to change," one researcher said in a statement. 

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‘Notably high’ rates of PTSD, depression and anxiety seen in patients with implantable heart devices
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‘Notably high’ rates of PTSD, depression and anxiety seen in patients with implantable heart devices

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‘Notably high’ rates of PTSD, depression and anxiety seen in patients with implantable heart devices
"Psychologists have had little involvement in the care of cardiac patients but this needs to change," one researcher said in a statement. 
READ MORE >

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