Digital

Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.

A new study by Tufts CSDD performed a deep dive into use of decentralized clinical trial techniques, but one of the study’s authors said DCTs have been dialed back.

Eko hopes its new partnership with Boehringer Ingelheim to develop algorithms for accurately detecting heart murmurs in dogs will pave the way for more collaborations with medical and pharmaceutical companies to advance early detection in humans as well as animals.

Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.

The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.

Roche Pharmaceuticals’ area head, Asia Pacific, outlines how the Swiss group is helping nurture the wider ecosystem and setting itself up for a bigger play in the ophthalmology space by combining scientific expertise with regional insights.

As the EU Life Sciences Strategy aims to drive innovation, the medtech sector is pushing for a pivotal role in a mission intended to embrace green and digital transitions, address regulatory obstacles and reduce dependency on external sources.

Medtech Insight sat down with Jared Bunch, chair of AF Center of Excellence Task Force, at HRS 2025 to discuss the newly HRS released framework for Afib Center of Excellence and get his perspective on the role industry could play to help clinicians improve patient outcomes.

In the final part of an interview with Scrip, Menarini’s Asia-Pacific CEO talks about the group’s digital capabilities, including their impact on a shortage issue in Australia, and leveraging RWE to inform healthcare practices across the region. The Italian company is also revving up its business development and alliance engine.

Precision’s recent FDA clearance for a core part of its next-generation wireless brain-computer interface system opens the pathway to a safer, more humane BCI for researchers to use compared to higher-risk intracortical arrays, according to BCI expert Naveen Rao.

Dexcom announced it received US clearance for its 15-day CGM, which has a MARD of 8.0% and is expected to launch in the second half of 2025 to allow for integration with insulin pumps.

The four-year-old firm said it plans to advance programs toward the clinic from the funding round, which comes just over a year after signing two major pharma partnerships.