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.

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.

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.

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.

Ankur Dhingra has replaced Joydeep Goswami as Illumina’s chief financial officer after Goswami spent just 14 months on the job. The San Diego-based sequencing and array tech company also appointed Jakob Wedel as chief of strategy and corporate development officer.

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.

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.

Dozens of researchers signed a letter condemning the AvertD test from SOLVD, which looks for genes that may contribute to a propensity toward opioid addiction. But the FDA and the manufacturer both say the test is effective.

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.