Companies with new, often implantable devices that enable the remote monitoring of patients aim to enable a new, more efficient kind of disease management. However, one of the biggest hurdles to adoption of disease management to date has been lack of reimbursement. The patients that can most benefit from disease management--sufferers of congestive heart failure, for example--tend to be elderly people that are covered by Medicare, which has no mechanisms to reimburse for disease management. So, beyond the usual hurdles that device companies face, of working the kinks out of technology and proving its clinical value to physicians, patient monitoring companies also need to find the right delivery model that helps them get paid for their technology.
by Mary Stuart
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
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.
Former FDA Commissioner Robert Califf urged the Heart Rhythm Society to engage actively amid federal funding cuts. He highlighted collaboration among researchers, advocates for healthcare integration, and the importance of addressing social determinants of health, while discussing lobbying strategies and the challenges faced by medtech companies.
Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.
The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.
Diabetes company Insulet announced that former longtime J&J executive Ashley McEvoy will succeed Jim Hollingshead as president and CEO effective today. Analysts applauded the appointment, noting McEvoy’s strong background in medtech and diabetes.
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.
Former FDA Commissioner Robert Califf urged the Heart Rhythm Society to engage actively amid federal funding cuts. He highlighted collaboration among researchers, advocates for healthcare integration, and the importance of addressing social determinants of health, while discussing lobbying strategies and the challenges faced by medtech companies.
