Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Cardiac Pathways

This article was originally published in The Gray Sheet

Executive Summary

Ultrasound Tracking System computer system and catheters are expected to gain 510(k) clearance in late January-early February and March, respectively, the firm announces at AHA Nov. 8. The submissions were made in August. The system uses ultrasound transducers "to precisely triangulate, in real time, the position of the catheters within the heart during the diagnostic procedure," without the use of fluoroscopy, Cardiac Pathways explains. The firm plans to integrate the Tracking System with its Chilli cooled radiofrequency ablation catheter which received FDA premarket approval on Feb. 2 (1"The Gray Sheet" Feb. 8, p. 11)

You may also be interested in...

Chilli RF Ablation System Approval Broader Than Recommended By Panel

Cardiac Pathways Corporation's Chilli cooled ablation system, approved via premarket approval application Feb. 2, has received a much less restrictive indication from FDA than recommended by the agency's Circulatory System Devices Advisory Panel.

Atlas Biomed Unlocking Japan’s OTC Market With Direct-To-Consumer DNA And Microbiome Tests

Can Atlas Biomed unlock Japan's self-care market with its direct-to-consumer DNA and microbiome tests? HBW Insight catches up with the company's co-founder and CEO to discuss this and also how Atlas has been driving its European expansion plans despite coronavirus. 

Hair Supplement Linked To Cases Of Severe Hepatitis In France

France's ANSES warns women using oral contraceptives not to use a supplement marketed by UK firm Hairburst after linking the product's consumption to two cases of severe acute hepatitis.




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts