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Enforcement & Litigation

Set Alert for Enforcement and Legislation

Class I Recall For Medline’s Saline Solution Packs

Medline Industries has issued a recall of some of its saline solution products for being non-sterile. The US FDA has designated the recall class I.

FDA Recalls

Representatives Press CMS On Coverage Of Innovative Devices

Medicare coverage of innovative and life-saving devices, drugs and diagnostics were the focus of a 19 September Congressional hearing during which representatives pressed for swifter and more predictable paths to reimbursement.

Policy Legislation

Federal Court Rejects Motion To Dismiss Case In Genomics Patent Infringement Suit

Parse Biosciences’ motion to dismiss a patent infringement case has been rejected by a US District Court.

Legal Issues Intellectual Property

GAO Report Highlights Concerns About Device Advertising

The US Government Accountability Office spoke to 11 stakeholder groups about potential trouble spots in FDA and FTC supervision of consumer ads for medical devices. 

Advertising, Marketing & Sales Regulation

Class I Recall For Abbott Implantable Pulse Generators

Abbott Medical has recalled several models of its implantable pulse generators (IPGs).  The devices are part of the company’s Proclaim neurostimulation systems, which deliver low-intensity electrical impulses to nerve structures.

FDA Regulation

As Digital Health Races Forward, Governments’ Understanding Of It May Be Stalling

The World Health Organization has published a report detailing the barriers to digital health’s adoption across the territories in which it operates.

Digital Health Legislation

PTAB Affirms Previous Decision In Favor Of Apple In Masimo Patent Case

A new decision from the PTAB upholds prior rulings rejecting four of Masimo’s appeals and reverses a decision on one.

Regulation Legal Issues

News We’re Watching: Philips And Walgreens Settlements, ReCor Readies For Takeoff, Farapulse Trial Results

This week, Philips announced a legal settlement on recalled CPAPs and BiPAPs; the FDA released emergency preparation recommendations; ReCor prepared to bring Paradise RDN to the US market; and Abbott released the results of a trial comparing optical coherence tomography (OCT) to angiography for guidance during cardiac surgery.

Clinical Trials Commercial

‘The Power Of Persuasion’: FDA Ombudsman Discusses Her Role

During a recent webinar, 20-year FDA chief ombudsman Laurie Lenkel explained why her office sees so many device-related cases and what and ombudsman can, and cannot, do for industry. 

Policy Leadership

Medtronic Faces Class-Action Lawsuit Over Alleged Patient Data Sharing From MiniMed, InPen Diabetes Devices

A class-action lawsuit alleges that Medtronic shared patient data with third parties.

Legal Issues Diabetic Care

Warning Letters And Close-Outs – August 2023

The FDA issued warning letters to three US device firms last month, as well as closing out a 2021 letter to Invacare.

Regulation Warning Letters

Digital Health Roundup: VR, AI Trends In Rehabilitation; Cybersecurity Regulations; Medicare Updates

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights VR, AI and other high tech trends in rehabilitation and gait training. Hannah Daniel discusses cybersecurity updates such as the new NIST published draft for an updated version of the Cybersecurity Framework, a recent report by Health-ISAC, and an interview with MedCrypt’s Naomi Schwartz about the upcoming FDA cybersecurity regulations for premarket approvals.

Digital Health Artificial Intelligence

News We’re Watching: ICD Trial Success, EOFlow Restraining Order, Hamilton Ventilator Recall

This week, Medtronic presented data from two new real-world trials confirming that ICDs save lives; a restraining order was issued against EOFlow in Insulet’s intellectual property case; and Polarean’s MRI gas XENOVIEW received a new Medicare reimbursement code.  

Commercial Clinical Trials

Medtronic HVAD Woes Continue

Medtronic has identified additional HeartWare Ventricular Assist Device pumps that the company says have a higher risk of failure than average for the devices.

FDA Cardiology

3M Takes Smaller Than Expected Hit For Earplug Failure Prior To Health Care Spin Out

3M will pay out more than $15bn in settlements reached this year after agreeing to a $6bn settlement over its ear defenders.

Commercial M & A
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