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News You Need to Know Today
New heart tech makes US debut | Defibrillation leads recalled | Telemedicine vs. in-person visits | The risks of cannabis use
Thursday, November 12, 2026
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Editor's Choice: Heart Rhythm

Cardiologist performs first US implant of new heart device

The Acticor Sky CRT-DX, which secured FDA approval in April, has officially made its debut in the United States.

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 The U.S. Food and Drug Administration (FDA) has granted market clearance for Biotronik's Acticor Sky and Rivacor Sky implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems. The new technology will be launches at the Heart Rhythm Society (HRS) annual meeting this week. #HRS2026
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Cardiologist performs first US implant of new heart device

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 The U.S. Food and Drug Administration (FDA) has granted market clearance for Biotronik's Acticor Sky and Rivacor Sky implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems. The new technology will be launches at the Heart Rhythm Society (HRS) annual meeting this week. #HRS2026
The Acticor Sky CRT-DX, which secured FDA approval in April, has officially made its debut in the United States.
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Medtronic recalls defibrillation leads due to risk of implant issues

Medtronic is recalling more than 700 OmniaSecure defibrillation leads, urging customers to quarantine and return them. The FDA has ruled this is a Class II recall. No adverse events have been reported.

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the words "FDA recall" on a board
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Medtronic recalls defibrillation leads due to risk of implant issues

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the words "FDA recall" on a board
Medtronic is recalling more than 700 OmniaSecure defibrillation leads, urging customers to quarantine and return them. The FDA has ruled this is a Class II recall. No adverse events have been reported.
READ MORE >

FDA approves Abbott’s new defibrillation lead for conduction system pacing

The UltiSynq defibrillation lead from Abbott gives clinicians a new option for left bundle branch area pacing. The device has also received CE mark approval.

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Abbott UltiSynq defibrillation lead
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FDA approves Abbott’s new defibrillation lead for conduction system pacing

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Abbott UltiSynq defibrillation lead
The UltiSynq defibrillation lead from Abbott gives clinicians a new option for left bundle branch area pacing. The device has also received CE mark approval.
READ MORE >

For new heart patients referred to a cardiologist, telemedicine as good as in-person visits

Researchers tracked data from nearly 6,000 patients being seen for suspected atrial fibrillation, coronary artery disease or heart failure. These data suggest patients can feel at ease meeting their cardiologist for the first time by video or telephone.

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Telehealth can provide significant value when it comes to managing and monitoring patients with CVD or suspected CVD. A new scientific statement from the American Heart Association explores the latest details on this evolving treatment option. 
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For new heart patients referred to a cardiologist, telemedicine as good as in-person visits

Share on Twitter Share on Facebook Share on Linkedin
Telehealth can provide significant value when it comes to managing and monitoring patients with CVD or suspected CVD. A new scientific statement from the American Heart Association explores the latest details on this evolving treatment option. 
Researchers tracked data from nearly 6,000 patients being seen for suspected atrial fibrillation, coronary artery disease or heart failure. These data suggest patients can feel at ease meeting their cardiologist for the first time by video or telephone.
READ MORE >

Cannabis legalization linked to more hospitalizations for heart attacks, other cardiovascular issues

Researchers tracked data from more than 50 million hospital discharges. Overall, legalizing recreational cannabis was linked to more patients being hospitalized for myocardial infarction, atrial fibrillation and heart failure.

READ MORE >
cannabis weed marijuana heart health doctor cardiologist
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Cannabis legalization linked to more hospitalizations for heart attacks, other cardiovascular issues

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cannabis weed marijuana heart health doctor cardiologist
Researchers tracked data from more than 50 million hospital discharges. Overall, legalizing recreational cannabis was linked to more patients being hospitalized for myocardial infarction, atrial fibrillation and heart failure.
READ MORE >

Medtronic recalls heart tech for managing pacemaker patients—software update fixes issue

Medtronic identified an issue with its CareLink SmartSync device manager providing inaccurate longevity estimates for certain leadless pacemakers. Customers can download a software update to resolve the issue going forward.

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Product Recall
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Medtronic recalls heart tech for managing pacemaker patients—software update fixes issue

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Product Recall
Medtronic identified an issue with its CareLink SmartSync device manager providing inaccurate longevity estimates for certain leadless pacemakers. Customers can download a software update to resolve the issue going forward.
READ MORE >

Abbott updates heart device instructions to highlight safety risk

The instructions for Abbott's Amplatzer Amulet Left Atrial Appendage Occluder now include more details about minimizing the risk of pulmonary artery injury. This a Class II recall, but no devices need to be returned.

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Physician warning
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Abbott updates heart device instructions to highlight safety risk

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Physician warning
The instructions for Abbott's Amplatzer Amulet Left Atrial Appendage Occluder now include more details about minimizing the risk of pulmonary artery injury. This a Class II recall, but no devices need to be returned.
READ MORE >

Nearly half of on-duty firefighter deaths are related to the heart

These findings call into question the types of screenings firefighters should undergo to detect potential heart problems.

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Firefighters during a training structure fire at Monroe Fire School in Wisconsin. Photo by Dave Fornell
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Nearly half of on-duty firefighter deaths are related to the heart

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Firefighters during a training structure fire at Monroe Fire School in Wisconsin. Photo by Dave Fornell
These findings call into question the types of screenings firefighters should undergo to detect potential heart problems.
READ MORE >

ACC among investors raising $2.75M for new LAAO tech

The new device from Chicago-based Parasol Med Tech uses gel to seal the left atrial appendage. It leaves no metal hardware behind.

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The Parasol Med Tech left atrial appendage closure (LAAO) system uses gel to completely fill and seal the LAA while a temporary shield prevents the gel from embolizing during delivery.
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ACC among investors raising $2.75M for new LAAO tech

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The Parasol Med Tech left atrial appendage closure (LAAO) system uses gel to completely fill and seal the LAA while a temporary shield prevents the gel from embolizing during delivery.
The new device from Chicago-based Parasol Med Tech uses gel to seal the left atrial appendage. It leaves no metal hardware behind.
READ MORE >

Medtronic gains CE mark for next-gen portfolio of conduction system pacemakers

These pacemakers were built with conduction system pacing in mind, giving clinicians several new tools for the management of heart patients. 

READ MORE >
Medtronic booth at HRS 2026
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Medtronic gains CE mark for next-gen portfolio of conduction system pacemakers

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Medtronic booth at HRS 2026
These pacemakers were built with conduction system pacing in mind, giving clinicians several new tools for the management of heart patients. 
READ MORE >

FDA clears AFib detection feature on advanced pulse oximetry system

California-based Masimo received the clearance just a few months after being acquired by Danaher Corporation in a deal worth approximately $9.9 billion.

READ MORE >
Masimo, a California-based medtech company, has secured U.S. Food and Drug Administration (FDA) clearance for its smartSET pulse oximetry platform to identify signs of atrial fibrillation (AFib) and deliver alerts to its Radius Vital Signs Monitor. The newly cleared feature continuously evaluates a patient’s pulse waveform data, flagging clinicians when additional follow-up care may be necessary.
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FDA clears AFib detection feature on advanced pulse oximetry system

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Masimo, a California-based medtech company, has secured U.S. Food and Drug Administration (FDA) clearance for its smartSET pulse oximetry platform to identify signs of atrial fibrillation (AFib) and deliver alerts to its Radius Vital Signs Monitor. The newly cleared feature continuously evaluates a patient’s pulse waveform data, flagging clinicians when additional follow-up care may be necessary.
California-based Masimo received the clearance just a few months after being acquired by Danaher Corporation in a deal worth approximately $9.9 billion.
READ MORE >

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