Skip to main content
  • Clinical
      |Clinical
    • Acute Coronary Syndromes
    • Cardiac Surgery
    • Covid-19
    • Heart Failure
    • Heart Health
    • Heart Rhythm
    • Hypertension
    • Interventional Cardiology
    • Mitral Valve
    • Pharmaceutics
    • Structural Heart Disease
    • TAVR
    • Tricuspid Valve
    • Vascular & Endovascular
  • Management
      |Management
    • Chest Pain Guidelines
    • Compensation
    • Economics
    • Education & Training
    • Legal News
    • Patient Care
    • Policy & Regulations
    • Professional Associations
    • Quality
    • Revenue
    • Staffing
  • Technology
      |Technology
    • AI
    • Cardiac Imaging
    • Cath Lab
    • CT
    • CVIS
    • ECG
    • Echo
    • EP Lab
    • Informatics
    • MRI
    • Nuclear Cardiology
    • Remote Monitoring
  • Videos
  • Conferences
      |Conferences
    • ACC
    • AHA
    • ASE
    • ASNC
    • ESC
    • EuroPCR
    • HFSA
    • HRS
    • SCAI
    • SCCT
    • SIIM
    • SNMMI
    • STS
    • TCT
    • VIVA
  • Custom Content
      |Custom Content
    • Experience Stories
    • Webinars & Videos
  • Subscribe
  • Forty Under 40 Award
      |Forty Under 40 Award
    • Class of 2026
    • Class of 2025

Search form

Home

Week in Review: Major recalls hit cardiology | AI approvals continue | Robotic mitral repair | Rising interest in LBBAP

News You Need to Know Today
Week in Review: Major recalls hit cardiology | AI approvals continue | Robotic mitral repair | Rising interest in LBBAP
Saturday, January 18, 2025
Link to Twitter Link to Facebook Link to Linkedin Link to Vimeo

This Week’s News

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. 

READ MORE >
the words "FDA recall" on a board
Share on Twitter Share on Facebook Share on Linkedin

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

Share on Twitter Share on Facebook Share on Linkedin
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 >

FDA announces another recall for surgical devices over safety concerns—7 new injuries reported

Maquet Cardiovascular, a subsidiary of Getinge, is recalling two of its endoscopic vessel harvesting devices due to issues with different pieces bending, peeling or detaching during use. Some of the company's other EVH devices were recently involved in a separate recall for similar reasons. 

READ MORE >
Product Recall
Share on Twitter Share on Facebook Share on Linkedin

FDA announces another recall for surgical devices over safety concerns—7 new injuries reported

Share on Twitter Share on Facebook Share on Linkedin
Product Recall
Maquet Cardiovascular, a subsidiary of Getinge, is recalling two of its endoscopic vessel harvesting devices due to issues with different pieces bending, peeling or detaching during use. Some of the company's other EVH devices were recently involved in a separate recall for similar reasons. 
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. 

READ MORE >
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
Share on Twitter Share on Facebook Share on Linkedin

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. 
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. 

READ MORE >
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.
Share on Twitter Share on Facebook Share on Linkedin

Medtronic expands carotid portfolio with Contego Medical deal

Share on Twitter Share on Facebook Share on Linkedin
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. 
READ MORE >

Imaging specialist Rebecca Hahn explores key details about the Evoque TTVR device

Rebecca Hahn, MD, discussed key takeaways from the TRISCEND II trial for the Edwards Lifesciences Evoque TTVR valve and shared additional details related to patient selection and implanting the device.

READ MORE >
Rebecca Hahn, MD, a principal investigator for the TRISCEND II trial, discusses key takeaways of the Edwards Lifesciences Evoque tricuspid TTVR valve.
Share on Twitter Share on Facebook Share on Linkedin

Imaging specialist Rebecca Hahn explores key details about the Evoque TTVR device

Share on Twitter Share on Facebook Share on Linkedin
Rebecca Hahn, MD, a principal investigator for the TRISCEND II trial, discusses key takeaways of the Edwards Lifesciences Evoque tricuspid TTVR valve.
Rebecca Hahn, MD, discussed key takeaways from the TRISCEND II trial for the Edwards Lifesciences Evoque TTVR valve and shared additional details related to patient selection and implanting the device.
READ MORE >

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.

READ MORE >
Share on Twitter Share on Facebook Share on Linkedin

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

Share on Twitter Share on Facebook Share on Linkedin
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 >

Momentum continues for renal denervation as CMS considers national Medicare coverage

CMS is accepting public comments on the topic for a period of 30 days. Recor Medical and Medtronic have both shared statements in support of the potential policy shift.

READ MORE >
The U.S. Food and Drug Administration (FDA) has approved Recor Medical’s Paradise Ultrasound Renal Denervation (RDN) system for uncontrolled hypertension. The Recor system gained FDA clearance in November 2023.
Share on Twitter Share on Facebook Share on Linkedin

Momentum continues for renal denervation as CMS considers national Medicare coverage

Share on Twitter Share on Facebook Share on Linkedin
The U.S. Food and Drug Administration (FDA) has approved Recor Medical’s Paradise Ultrasound Renal Denervation (RDN) system for uncontrolled hypertension. The Recor system gained FDA clearance in November 2023.
CMS is accepting public comments on the topic for a period of 30 days. Recor Medical and Medtronic have both shared statements in support of the potential policy shift.
READ MORE >

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? 

READ MORE >
Dual Energy ThermoCool SmartTouch SF Catheter
Share on Twitter Share on Facebook Share on Linkedin

Johnson & Johnson gains CE mark approval for catheter capable of radiofrequency, PFA ablation

Share on Twitter Share on Facebook Share on Linkedin
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? 
READ MORE >

New research highlights rising interest in LBBAP

The first patient has been enrolled in a new study of an optimized lead for LBBAP, an area with an explosion of interest in EP as a way to improve patient outcomes.

READ MORE >
The Medtronic SelectSecure MRI SureScan Model 3830 cardiac lead already gained FDA approval for His-Bundle pacing back in 2018. Now, the lead is also approved for left bundle branch area pacing, providing users with another option when treating patients for bradycardia. According to Medtronic, this marks the first time the FDA has approved a device for this indication.
Share on Twitter Share on Facebook Share on Linkedin

New research highlights rising interest in LBBAP

Share on Twitter Share on Facebook Share on Linkedin
The Medtronic SelectSecure MRI SureScan Model 3830 cardiac lead already gained FDA approval for His-Bundle pacing back in 2018. Now, the lead is also approved for left bundle branch area pacing, providing users with another option when treating patients for bradycardia. According to Medtronic, this marks the first time the FDA has approved a device for this indication.
The first patient has been enrolled in a new study of an optimized lead for LBBAP, an area with an explosion of interest in EP as a way to improve patient outcomes.
READ MORE >

AI uncovers ‘vascular fingerprints’ in the eye that can predict strokes

An advanced algorithm was trained to evaluate more than 100 different details about the inside of a patient's eye. Its ability to identify high-risk patients was comparable to more traditional techniques, exciting researchers. 

READ MORE >
eye vision
Share on Twitter Share on Facebook Share on Linkedin

AI uncovers ‘vascular fingerprints’ in the eye that can predict strokes

Share on Twitter Share on Facebook Share on Linkedin
eye vision
An advanced algorithm was trained to evaluate more than 100 different details about the inside of a patient's eye. Its ability to identify high-risk patients was comparable to more traditional techniques, exciting researchers. 
READ MORE >

Innovate Healthcare thanks our partners for supporting our newsletters.
Sponsorship has no influence on editorial content.

Interested in reaching our audiences, contact our team

*|LIST:ADDRESSLINE|*

You received this email because you signed up for newsletters from Innovate Healthcare.
Change your preferences or unsubscribe here

Contact Us  |  Unsubscribe from all  |  Privacy Policy

© Innovate Healthcare, a TriMed Media brand
Innovate Healthcare

Recent Newsletters

The risks of PFA | FDA's warning after patient death | Cardiac ablations in ASCs | Group wants TAVR changes
How TAVR implant depth impacts outcomes | A closer look at GLP-1 drugs & AFib | BATMAN technique to the rescue
Week in Review: Reprocessed catheters recalled | New payment model almost here | 3-year SMART data | Hypertension drug approved
New payment model on the way | Major recalls could impact care | Policy changes for breakthrough devices
FDA warns public after patient death | Medtronic recalls heart devices | 'Compelling' new PE data | Pushing for TAVR changes
News Alert: Medtronic recalls thousands of surgical devices
New IVL tech overcomes previous limitations | 3-year SMART data looks at TAVR outcomes | Artivion acquires Endospan for $135M

Pagination

    • First page « First
    • Previous page ‹‹
    • Page 1
    • Page 2
    • Page 3
    • Page 4
    • Current page 5
    • Page 6
    • Page 7
    • Page 8
    • Page 9 …
    • Next page ››
    • Last page Last »
  • Home
  • News
  • Article Archive
  • Custom Content
  • Webinars
  • Press Releases
  • Content Studio
  • Advertising
  • Submit Press Release
  • Contact Us
  • Terms of Use
  • Privacy Policy
  • Cardiovascular Business
  • HealthExec
  • Radiology Business
 
© 2026 Innovate Healthcare | All Rights Reserved. | Terms of Use | Privacy Policy
 
Design by Adaptive Theme
Trimed Popup