St. Jude Announces CRM Approvals, Progress With Warning Letter
This article was originally published in The Gray Sheet
Executive Summary
FDA approval of several St. Jude Medical’s new cardiac rhythm management devices, including a new defibrillator lead, suggest the agency is largely satisfied with the company’s steps to resolve a January 2013 warning letter.
You may also be interested in...
Challenges With ICD Leads Are Under Control, St. Jude Tells Investors
The company was prepared for FDA’s recent warning letter, executives said on an earnings call. But the scrutiny is not over, analysts suggest.
St. Jude Warning Letter Adds More Pressure On Firm’s Leads Division
The company stresses that FDA’s letter does not identify any specific concerns about Durata or any other product, but the citation nonetheless states that the leads are “adulterated” due to quality system violations and “misbranded” due to adverse event reporting lapses.
UK Medtech Strategy Sets Out Schedule Of Milestones To FY 2026
Fourteen months on from the release of its inaugural medtech strategy, the UK MedTech Directorate has laid firm foundations and reports progress on initiatives aimed at improving technology adoption. A schedule of ambitious future timelines has also been published.