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Enforcement & Litigation

Set Alert for Enforcement and Legislation

DOJ: Alere Unit Billed Medicare For Diabetic Testing Supplies For The Dead

Alere Medical and its now-defunct subsidiary Arriva Medical will pay the US government $160m to settle allegations that they violated the False Claims Act. It’s the second settlement that Alere has entered into with the Department of Justice in recent weeks.

Legal Issues Medicare Diabetic Care

Georgia Device Sterilizer Sued For Allegedly Causing Cancer, Death

The lawsuit against Kendall Patient Recovery accuses the company of intentionally ignoring decades of data warning against risks posed by ethylene oxide, causing harm to communities around its facility.

Legal Issues Safety

More Headaches For Philips As FDA Labels Another Ventilator Recall As High-Risk Class I

The recalled vents are designed to provide high-flow therapy to patients, but problems can crop up “if the system pressure reaches the default maximum limit,” the US agency says. The recall is more bad news for Philips, which recently initiated a separate class I recall of certain breathing and ventilator devices.

Recalls Safety

DOJ: Alere Unit Billed Medicare For Diabetic Testing Supplies For The Dead

Alere Medical and its now-defunct subsidiary Arriva Medical will pay the US government $160m to settle allegations that they violated the False Claims Act. It’s the second settlement that Alere has entered into with the Department of Justice in recent weeks.

Legal Issues Medicare

Come On In, The Water’s Fine: FDA Should Fully Embrace Remote Inspections

Former US FDA device center compliance chief Steve Silverman argues in this opinion piece that the agency and stakeholders should take steps now to develop a remote-inspection framework for medical device manufacturers.

FDA Enforcement

Warning Letter Close-Outs – July 2021

The resolution of a May 2020 warning letter to a breast implant manufacturer accounted for the only device-related close-out latter issued this month.

Device Warning Letters FDA

FDA Warning Letter Recap, July 2021: Device Center Brings Hammer Down On Face Mask Vendors

The US FDA says the 11 companies were selling masks without agency clearance, approval or authorization. A total of 13 device-related missives were released by the FDA in July.

Device Warning Letters FDA

Intuitive Fights Da Vinci Surgical Robot Monopoly Claims

Intuitive Surgical is facing multiple antitrust suits that say the company took advantage of its dominant market position by demanding hospitals come to it for expensive repairs and replacements.

Robotic Surgery Legal Issues

Recall Of Sleep, Ventilator Devices Lead To International Patient Suits For Philips

Patients in Canada and the US are suing Philips over issues related to the company’s recent recall of CPAPs, BiPAPs, and mechanical ventilators.

Regulation Respiratory
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