Executive Exclusives

Vijay Ravindran, founder of autism therapy digital therapeutic firm Floreo, spoke to Medtech Insight about working with the FDA, and why the TAP pilot made sense for them.

Andrew Trister, Verily’s chief medical and scientific officer, spoke with Medtech Insight at the HLTH Europe conference about Verily’s newly launched Lightpath Metabolic solution, featuring GLP-1 prescription, AI and strengthened clinical support. Trister also talked about plans for the Study Watch and offered views on the Alzheimer’s research landscape and AI development and regulation in a new era of uncertainty.

Implantica AG continues European rollout of RefluxStop, a non-active, laparoscopically implanted device for treating gastroesophageal reflux disease (GERD) that offers key advantages over other surgical interventions and drug therapy, according to the company. CEO Peter Forsell discusses global market opportunity and the firm’s growing body of research to support reimbursement.

The AI medtech revolution could be a “huge, missed opportunity” for the EU without an effective and efficient regulatory infrastructure. Answers are needed fast, MedTech Europe’s Oliver Bisazza said during a recent interview.

Leading digital therapeutic maker’s CEO David Benshoof Klein and CMO Shaheen Lakhan discuss outlook on the DTx space, priorities going forward, and what makes Click a standout player in a changing game.

Australia-based Nexsen BioTech is developing StrepSure, a rapid lateral flow test for detecting Group B Streptococcus (GBS) infection in pregnant women. Designed to provide results within 15 minutes, with the potential to save "millions of babies’ lives,” StrepSure will be assessed in a 5,000-patient clinical trial targeted for summer 2025, which will support Australia and US submissions for market authorization. Thomas Hanly, Nexsen managing director, discusses. 

Proposals for substantial changes to oversight of medtech notified bodies are likely to be part of the European Commission’s targeted evaluation of the MDR and IVDR, EU medtech lawyer, Erik Vollebregt, tells Medtech Insight.

In the emerging field of therapeutic endoscopy, Creo Medical’s Speedboat devices are advancing minimally invasive treatment by combining advanced bipolar radiofrequency and super high frequency microwave energy in a single device, says CTO and founder Chris Hancock.

Medtech Insight talked to two leaders at the Alzheimer’s Drug Discovery Foundation about current therapies and the role of biomarkers and digital tools to build on recent advancements in the space and accelerate progress to identify the disease early and slow cognitive decline.

A new round of tariffs imposed by the Biden administration on various Chinese goods, including medical devices, points to a broader shift in US strategy for strengthening supply chains and ensuring Americans have reliable access to safe products, according to analysts who spoke to Medtech Insight about the tariffs. While fueled by the pandemic, the momentum pushing this change in trade policy has been growing for some time.

In an interview with Medtech Insight sister publication the Pink Sheet, Troy Tazbaz, director of the US FDA's Digital Health Center of Excellence, says the agency lacks authority to regulate assurance labs, which would be used to help AI developers ensure their models are working correctly before submitting them for approval.

Innovation has been hindered in the EU by the costs and complexities of compliance, including in the medtech sector. Bisazza looks at how high-level, multi-sectoral moves are underway to create a more innovation-friendly environment.

The US FDA recently announced a new initiative aimed at improving access to cancer trials among traditionally underserved populations. myTomorrows CEO Michel van Harten talked to Medtech Insight about how the agency’s plan might reshape the landscape of clinical trials going forward.

The France-based, clinical-stage medtech has enrolled first patients in a pivotal trial to evaluate overall survival in glioblastoma patients using its implanted SonoCloud-9 ultrasound device combined with a chemotherapy. If successful, it will become the first technology to optimize drug delivery by opening the blood-brain barrier.

Stacey Churchwell, VP and general manager for cardiovascular diagnostics and services, discusses how AI has enabled Medtronic to “clean up the noise” and vastly reduce false alerts sent by its Reveal LINQ insertable cardiac monitor, saving clinics many hours of needless reviews, bolstering confidence in continuous monitoring, and alleviating liability concerns among health care providers.

When looking for a standard for AI development, expert Eric Henry recommends turning to the tried-and-true Standard Delivery Organizations (SDOs).