Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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


US Approvals Analysis: Slow Month For PMAs, Better For 510(k)s

Executive Summary

PMA, supplement and de novo approvals from US FDA came in relatively low in November, while the agency's 510(k) clearance volume was ahead of the 2016 average. Highlighted clearances for the month include an expanded indication for Medtronic's Solitaire stent retriever system for stroke and Brightwater Medical's ConvertX nephroureteral stent system for ureteral obstructions.

You may also be interested in...

FDA Hits User-Fee-Era Record For 'Novel' Devices: A New Normal?

Approvals of PMAs and panel-track supplements, as well as de novo devices, hit a 15-year high in calendar year 2015, according to a "Gray Sheet" analysis. FDA and industry experts respond to the data; also, check out our infographic of 2015 FDA approval trends, including a tally of the firms that captured the most PMAs and 510(k)s last year, and more.

PODCAST: A New Era In Stroke Care – An Interview With Medtronic's Brett Wall

Positive data from five clinical trials and new treatment guidelines for mechanical thrombectomy devices have ushered in a new era in stroke care. In this first in a new series of podcasts, Medtech Insight spoke at the recent SNIS meeting with Brett Wall, vice president and president of the Neurovascular group at Medtronic, to find out what impact the trials and guidelines are having on stroke care, the market for mechanical thrombectomy devices, demand for Solitaire FR and the company's plans for innovation.

FDA Eyes Upclassification, Labeling Guidance To Address Stapler Risks

The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.


Related Companies

Latest Headlines
See All



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