• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices

Affera

FDA approves Medtronic’s Affera cardiac mapping and ablation system and Sphere-9 catheter

October 24, 2024 By Sean Whooley

Medtronic (NYSE:MDT) today said it received FDA approval for its Affera mapping and ablation system with the Sphere-9 catheter. The all-in-one, high-density (HD) mapping, pulsed field ablation (PFA) and radiofrequency (RF) ablation system treats persistent atrial fibrillation (AFib) and offers RF ablation for cavotricuspid isthmus (CTI) dependent atrial flutter. Medtronic also recently received the FDA’s […]

Filed Under: Cardiovascular, Catheters, Featured, Food & Drug Administration (FDA), Pulsed-Field Ablation (PFA), Radiosurgery/Radiation therapy, Regulatory/Compliance Tagged With: Affera, FDA, Medtronic, nitinol, pulse field ablation

Medtronic wins CE mark for Affera ablation system

March 15, 2023 By Sean Whooley

Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Affera mapping and ablation system. The Affera system includes the Sphere-9 catheter and Affera Prism-1 mapping software. Together, the system integrates Sphere-9 pulsed-field ablation (PFA), radiofrequency (RF) and high-density (HD) mapping. It maps and ablates atrial arrhythmias — including AFib — and provides […]

Filed Under: Business/Financial News, Cardiovascular, Catheters, Featured, News Well, Pulsed-Field Ablation (PFA), Radiosurgery/Radiation therapy Tagged With: Ablation, Affera, Medtronic

Medtronic offered early retirements as medtech industry layoffs mount

Employees in supply chain, cybersecurity and other specific roles were excluded from the offer.

March 9, 2023 By Jim Hammerand

Medtronic (NYSE:MDT) offered early retirement incentives in recent weeks as the world’s largest medical device company seeks to cut costs before the end of its fiscal year in April. The medical device developer and manufacturer has said little about potential job cuts among its ranks, which it reported as more than 95,000 people worldwide at […]

Filed Under: Business/Financial News, Featured, News Well, Wall Street Beat Tagged With: Affera, Intersect ENT, Medtronic

The top 10 cardiac device stories of 2022

December 22, 2022 By Chris Newmarker

From pulsed-field ablation to noninvasive monitoring, this was an exciting year for cardiac device tech. Here are the top 10 cardiac device stories from MassDevice and its sister sites: 10. Medtronic to pay Acutus $17M following EU MDR submission of left-heart access portfolio Earlier this year, Acutus agreed to sell its left-heart access portfolio to […]

Filed Under: Business/Financial News, Cardiac Implants, Cardiovascular, Catheters, Pulsed-Field Ablation (PFA), Replacement Heart Valves, Stents, Structural Heart Tagged With: Abbott, Abiomed, Acutus Medical, Affera, Boston Scientific, Cordis, Edwards Lifesciences, iRhythm Technologies, Johnson & Johnson, Johnson & Johnson MedTech, MedAlliance, Medtronic

Medtronic completes enrollment in pulsed-field ablation catheter trial

December 5, 2022 By Danielle Kirsh

Medtronic today announced it completed enrollment and final treatment in the Sphere Per-AF pivotal trial to study Affera’s pulsed-field ablation catheter tech. The trial is evaluating the safety and effectiveness of the Sphere-9. The Sphere-9 is a pulsed field (PF) and radio frequency (RF) ablation and high-density mapping catheter. Along with the Affera cardiac mapping and […]

Filed Under: Cardiovascular, Catheters, Clinical Trials, Featured, News Well, Pulsed-Field Ablation (PFA) Tagged With: Affera, Medtronic

Medtronic completes Affera acquisition

August 30, 2022 By Sean Whooley

Medtronic (NYSE:MDT) announced today that it completed its $1 billion acquisition of cardiac mapping and ablation technology developer Affera. Newton, Massachusetts-based Affera designs and manufactures cardiac mapping and navigation systems, as well as catheter-based cardiac ablation technologies, including a differentiated, focal pulsed-field ablation platform for treating cardiac arrhythmias like AFib. In January, Medtronic announced an agreement to […]

Filed Under: Business/Financial News, Cardiovascular, Catheters, Featured, Imaging, Mergers & Acquisitions, Structural Heart, Wall Street Beat Tagged With: Affera, Medtronic

What is the future of cardiac ablation?

April 14, 2022 By Chris Newmarker

Pulsed-field ablation (PFA) — a non-thermal method for cardiac ablation — has the potential to positively disrupt the atrial fibrillation market. Amid the excitement around the technology, Medtronic announced in January that it would acquire cardiac mapping and ablation technology developer Affera for nearly $1 billion. Meanwhile, Boston Scientific in February closed its $1.75 billion […]

Filed Under: Cardiovascular, Catheters, Featured, Pulsed-Field Ablation (PFA) Tagged With: Acutus Medical, Affera, Boston Scientific, DeviceTalks Boston, Medtronic

Medtronic to acquire cardiac arrhythmia treatment developer Affera

January 10, 2022 By Sean Whooley

Medtronic (NYSE:MDT) announced today that it agreed to acquire cardiac mapping and ablation technology developer Affera. Medtronic CEO Geoff Martha described the deal as a nearly $1 billion transaction at the J.P. Morgan Healthcare Conference today, though he added it includes a $250 million contingent consideration. The company expects the transaction to close in the […]

Filed Under: Business/Financial News, Cardiovascular, Catheters, Featured, Imaging, Mergers & Acquisitions, Structural Heart, Wall Street Beat Tagged With: Affera, Medtronic

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy