Enforcement & Litigation

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.

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.

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

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. 

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.

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

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

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.

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. 

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

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

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.

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.  

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

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