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Heart monitor software recalled over failure to send alerts | Why EP needs a champion | Medtronic expands carotid portfolio

News You Need to Know Today
Heart monitor software recalled over failure to send alerts | Why EP needs a champion | Medtronic expands carotid portfolio
Tuesday, January 14, 2025
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Today's News and Trends

FDA announces recall after Philips heart monitor software failed to send alerts—multiple deaths reported

Philips is recalling the software associated with its Mobile Cardiac Outpatient Telemetry devices after certain high-risk ECG events were never routed to trained cardiology technicians as intended. The issue, which lasted for two years, has been linked to more than 100 injuries. 

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the words "FDA recall" on a board
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FDA announces recall after Philips heart monitor software failed to send alerts—multiple deaths reported

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the words "FDA recall" on a board
Philips is recalling the software associated with its Mobile Cardiac Outpatient Telemetry devices after certain high-risk ECG events were never routed to trained cardiology technicians as intended. The issue, which lasted for two years, has been linked to more than 100 injuries. 
READ MORE >

Why electrophysiologists needed a champion in Washington

Heart Rhythm Society President Kenneth A. Ellenbogen, MD, detailed a new advocacy group focused on improving EP reimbursements, patient care and access. “If you’re not at the table, you’re on the menu," he said.

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HRS President Ken Ellenbogen, MD, FHRS, explains the need for the Heart Rhythm Advocates lobby group in Washington, D.C. to push for policies in Congress over reimbursements.
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Why electrophysiologists needed a champion in Washington

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HRS President Ken Ellenbogen, MD, FHRS, explains the need for the Heart Rhythm Advocates lobby group in Washington, D.C. to push for policies in Congress over reimbursements.
Heart Rhythm Society President Kenneth A. Ellenbogen, MD, detailed a new advocacy group focused on improving EP reimbursements, patient care and access. “If you’re not at the table, you’re on the menu," he said.
READ MORE >

Medtronic expands carotid portfolio with Contego Medical deal

Medtronic entered into an exclusive U.S. distribution agreement with Contego Medical for carotid and peripheral vascular disease revascularization products. The agreement includes an option to acquire the full company at a later date. 

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Medtronic entered into an exclusive U.S. distribution agreement with Contego Medical for carotid and peripheral vascular disease revascularization products and includes option to acquire the company.
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Medtronic expands carotid portfolio with Contego Medical deal

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Medtronic entered into an exclusive U.S. distribution agreement with Contego Medical for carotid and peripheral vascular disease revascularization products and includes option to acquire the company.
Medtronic entered into an exclusive U.S. distribution agreement with Contego Medical for carotid and peripheral vascular disease revascularization products. The agreement includes an option to acquire the full company at a later date. 
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Featured Articles

Robotic mitral repair compares favorably to surgery—but some concerns remain

Robotic-assisted mitral valve repair is associated with short-term outcomes comparable to conventional surgery, according to a new analysis of more than 40,000 patients. Robotic treatment also helps patients spend less time in the hospital, but the costs are much higher.

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Robotic mitral repair compares favorably to surgery—but some concerns remain

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Robotic-assisted mitral valve repair is associated with short-term outcomes comparable to conventional surgery, according to a new analysis of more than 40,000 patients. Robotic treatment also helps patients spend less time in the hospital, but the costs are much higher.
READ MORE >

FDA has now cleared more than 1,000 AI models, including many in cardiology

Cardiology is the medical speciality with the second most FDA clearances overall. 

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GE Healthcare's CardIQ Suite offers AI to help automated cardiac CT assessments, including measurement of vessels and anatomy, visualization of chamber mobility, plaque imaging and calcium scoring. Photo by Dave FornellCoronary CCTA cardiac CT training for interventional cardiologists, GE session at TCT 2023. Photo by Dave Fornell
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FDA has now cleared more than 1,000 AI models, including many in cardiology

Share on Twitter Share on Facebook Share on Linkedin
GE Healthcare's CardIQ Suite offers AI to help automated cardiac CT assessments, including measurement of vessels and anatomy, visualization of chamber mobility, plaque imaging and calcium scoring. Photo by Dave FornellCoronary CCTA cardiac CT training for interventional cardiologists, GE session at TCT 2023. Photo by Dave Fornell
Cardiology is the medical speciality with the second most FDA clearances overall. 
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Johnson & Johnson gains CE mark approval for catheter capable of radiofrequency, PFA ablation

A new catheter from Johnson & Johnson MedTech is now approved to treat cardiac arrhythmias in Europe. Could FDA approval be on the horizon? 

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Dual Energy ThermoCool SmartTouch SF Catheter
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Johnson & Johnson gains CE mark approval for catheter capable of radiofrequency, PFA ablation

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Dual Energy ThermoCool SmartTouch SF Catheter
A new catheter from Johnson & Johnson MedTech is now approved to treat cardiac arrhythmias in Europe. Could FDA approval be on the horizon? 
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In Case You Missed It

Hydra TAVR valve gains key approval as global reach continues to grow

The self-expanding device is now available in more than 20 countries and received CE mark approval back in 2020. However, it has not yet been approved by the U.S. Food and Drug Administration for use in the United States.

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Sahajanand Medical Technologies (SMT) Hydra TAVR
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Hydra TAVR valve gains key approval as global reach continues to grow

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Sahajanand Medical Technologies (SMT) Hydra TAVR
The self-expanding device is now available in more than 20 countries and received CE mark approval back in 2020. However, it has not yet been approved by the U.S. Food and Drug Administration for use in the United States.
READ MORE >

Man gets 9 years in jail for attacking cardiologist with champagne bottle

The cardiologist suffered multiple fractures, had to have a blood clot removed from his skull and now has permanent hearing loss in one ear. He was also left with “severe and crippling depression" following the attack. 

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man in prison behind bars
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Man gets 9 years in jail for attacking cardiologist with champagne bottle

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man in prison behind bars
The cardiologist suffered multiple fractures, had to have a blood clot removed from his skull and now has permanent hearing loss in one ear. He was also left with “severe and crippling depression" following the attack. 
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FDA says years-long tirzepatide shortage is resolved, will give limited leeway to compounders

The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.

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artificial intelligence pharmaceutical industry
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FDA says years-long tirzepatide shortage is resolved, will give limited leeway to compounders

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artificial intelligence pharmaceutical industry
The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.
READ MORE >

In Other News

Hospital sued for $900K after man’s face ignites during surgery

John Michael Murdoch, then 51, was allegedly swabbed with alcohol prior to surgery when a spark from an instrument ignited his skin. His wife is suing Oregon Health & Science University on his behalf. 

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Medical malpractice gavel diagnostic error mistake stethoscope
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Hospital sued for $900K after man’s face ignites during surgery

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Medical malpractice gavel diagnostic error mistake stethoscope
John Michael Murdoch, then 51, was allegedly swabbed with alcohol prior to surgery when a spark from an instrument ignited his skin. His wife is suing Oregon Health & Science University on his behalf. 
READ MORE >

Lantheus to acquire PET agent developer Life Molecular Imaging for up to $750M

LMI is the maker of Neuraceq, a globally approved F-18 PET imaging agent used to detect beta-amyloid plaques in patients evaluated for Alzheimer’s

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Lantheus
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Lantheus to acquire PET agent developer Life Molecular Imaging for up to $750M

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Lantheus
LMI is the maker of Neuraceq, a globally approved F-18 PET imaging agent used to detect beta-amyloid plaques in patients evaluated for Alzheimer’s
READ MORE >

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