US FDA oncology officials are concerned that the entities sponsors are consulting in developing and implementing clinical trial diversity plans are not sufficiently diverse themselves and do not represent patients in underserved communities.

Theradaptive, which makes a device-biologic combination product to help speed bone healing, recently got authorization to start human trials from the US FDA. Medtech Insight spoke to CEO Luis Alvarez about the company’s past, present and future.

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.

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.

This week, Paragonix announced that its BAROguard lung preservation system is now available throughout the US; Brazil planned to leverage some foreign device approvals; Medical Microinstruments’ Symani Surgical System won de novo clearance; and the FDA updated its safety warnings for Essure and certain plastic syringes.

This week, Abbott, Click and Otsuka, Prenosis won the FDA nod respectively for an in vitro diagnostic to evaluate patients for concussion, the first prescription digital therapeutic to treat major depressive disorder and a software to predict sepsis. Also on the regulatory front, the FDA will now take 513(g)s forms via its eSTAR framework. In Europe, the debate of what personal information can be shared continues. 

Europe’s largest national in vitro diagnostics market is evolving post-COVID, under the effects of new digital laws, artificial intelligence-enabled devices, apps on prescription and the rising popularity of continuous glucose monitors. The VDGH industry association’s latest survey indicates a changing market landscape for IVDs in 2024.

Theradaptive, which makes a device-biologic combination product to help speed bone healing, recently got authorization to start human trials from the US FDA. Medtech Insight spoke to CEO Luis Alvarez about the company’s past, present and future.

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.

Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.

Errors or omissions are commonplace when sponsors write their clinical investigation plans. Good signposting is urgently needed. Industry expert Maria Donawa gave some useful tips in how to best read the latest EU clinical trials guidance.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights her interview with Verily’s CMO and CSO, Andrew Trister at ViVE on leveraging AI for precision health and a DHIS West conference panel discussion on use cases of generative AI. Elizabeth Orr discusses the impact on the newly adopted EU AI Act on device makers and concerns raised by industry members.

In this episode, US regulatory reporter Hannah Daniel speaks to Ocutrx CEO Michael Freeman about augmented reality in medical products and their not-so-unique regulatory requirements. 

iRhythm CEO Quentin Blackford returned to Medtech Insight’s Cardio Conversations podcast to talk about the launch of his company’s new Zio monitor patch supported by a sophisticated neural network. He also addressed the company’s plans to improve its position in the mobile cardiac telemetry market, the impact of pulsed field ablation on the cardiac monitoring business, and more.

US FDA oncology officials are concerned that the entities sponsors are consulting in developing and implementing clinical trial diversity plans are not sufficiently diverse themselves and do not represent patients in underserved communities.

Theradaptive, which makes a device-biologic combination product to help speed bone healing, recently got authorization to start human trials from the US FDA. Medtech Insight spoke to CEO Luis Alvarez about the company’s past, present and future.

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. 

AdvaMed’s new online clock documents the time since CMS promised to replace MCIT, a program guaranteeing coverage for FDA-cleared breakthrough devices.

The US FDA continues to provide updates on the safety and efficacy of surgical mesh sling procedures, a common surgery to correct stress urinary incontinence.

Ekso Bionics’ exoskeleton received a final payment determination from the Centers for Medicare and Medicaid Services, paving the way to faster rehabilitation for more patients.

Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.

Roche announced on 11 April it received FDA breakthrough device designation for a blood test used for early detection of Alzheimer’s disease.

The National Academy of Medicine developed a code of conduct for health care AI development, as well as commitments for code implementation. 

Technology partners, Orthobond and Onkos Surgical, announced they received FDA de novo approval for their respective technologies to actively kill bacteria that could contaminate medical devices.