Digital Health

In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.

Annual survey of patients and professionals shows how attitudes to health system transformation are evolving and what stakeholders are demanding as acceptance of AI tools accelerates.

Peerbridge Health is preparing to submit its next-generation ECG patch, CorMDx, for US FDA clearance this quarter, with plans to launch in the second half of 2025. The rechargeable device is designed for continuous, real-time heart monitoring from the hospital to home, aiming to detect early signs of heart failure and reduce emergency room visits.

Congress launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices.

Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?

Industry waits to see if there will be a surge in demand for orthopedic and cardiology devices as IHI’s EU Ambulatory Surgical Centers proposal awaits sign-off.

The deadline for comments is 30 June 2025

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.

Enovis has named veteran medtech leader Damien McDonald as its new CEO effective 12 May as the orthopedic company reaffirms first-quarter 2025 revenue guidance of between $555m and $563m. Medtech Insight spoke with Tim Czartoski, Enovis’ president of US surgical and global product and enabling technologies, about the firm’s growth strategy and innovation plans.

Cybersecurity, sustainability and regulatory intelligence all need factoring into risk management today as AI and data availability change the goalposts. Eight experts tell Medtech Insight how compliance efforts must adapt.

Vektor Medical is ramping up efforts to bring its vMap technology used to identify arrhythmia sources to more US hospitals, start enrollment in a multinational trial, and commercialize in Europe, pending the CE mark. Medtech Insight sat down with CEO Rob Krummen at LSI 2025 to discuss their plans.

Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.