Enforcement & Litigation

The number of class I medical device recalls has increased over the last decade, and that concerns officials at the FDA.

Senator Bill Cassidy says FDA “disregarded” Congressional intent by expanding its authority to regulate clinical decision support software.

Philips CEO Roy Jakobs talks to Medtech Insight about the medtech firm’s decade-long history of embedding AI into its products and what he expects from the newly released draft framework by the National Academy of Medicine, which he helped develop as co-chair of the Steering Committee.

Abbott initiated a recall in February of thousands of Heartmate devices due to a system obstruction that can result in serious health outcomes, including death. The FDA has now designated the recall as class I.

The rulemaking is supposed to formalize the Patent Trial and Appeal Board process, which has been in an interim status since a Supreme Court decision, giving manufacturers more ability to request oversight of the decisions. 

At the recent Precision Med Tri-Con conference, health care leaders and AI enthusiasts Eric Topol and Doug Flora discussed how AI integration will change the way doctors practice medicine and patients receive care.

A consent decree agreed to in January between Royal Philips and the US government is now official. The decree stems from a recall in 2021 of millions of the company’s sleep therapy and breathing devices due to risks posed by the sound abatement foam inside the machines.

Abbott’s trial win for patent infringement by DexCom’s CGM systems still doesn’t have information on damages awarded due a hung jury.

The US FDA has labelled a recall of arterial catheterization kits from Arrow International class I and gave the same high-risk designation to a separate recall of neurovascular catheters from Johnson & Johnson company Medos International Sàrl.

After reports of eight serious injuries, Smiths Medical recalled nearly 3,000 ventilators used during emergency transport.

The ownership of all study data would be granted to the non-commercial sponsor, says one of the many provisions proposed in the model investigator-initiated study agreement that the Health Research Authority has released for consultation.

The Therapeutic Goods Administration says it has made a series of improvements in areas such as the recall and stakeholder communication process, reporting requirements, and the agency’s guidance materials.

A new report from the US Government Accountability Office found that the Veterans Health Administration does not track implanted devices at an individual-patient level, which could make it harder to communicate important safety information in the event of a recall.

The US FDA has labelled a recall of more than 6 million Airlife respiratory support devices class I. The recall covers devices manufactured in 2017 or earlier that can fail to provide adequate ventilation.

The US FDA wants to ban devices that use an electrical shock to stop aggressive behavior. The agency attempted to ban the devices in 2020 but failed after it was challenged in court.

During a recent hearing of the US House Energy and Commerce Health Subcommittee, lawmakers discussed the best approach to regulating laboratory developed tests (LDTs) with a panel of experts representing clinical labs. At issue was the FDA’s proposed rule that places LDTs under the same regulatory purview as other in vitro diagnostics, which would require medical facilities to receive agency approval for the LDTs they develop in their own labs.