Remote Monitoring

Remote cardiac monitoring technologies enable patient health to be tracked outside the clinical setting. It can be used for longer term monitoring to help diagnosis arrhythmias or other cardiac conditions. Remote monitoring also can keep tabs on chronic conditions such as heart failure or hypertension and alert clinicians to worsening symptoms to avoid an acute care episode or hospitalization.

FDA announces Class I recall of Boston Scientific pacemakers—replacement may be necessary

These safety issues have been linked to more than 800 injuries and two deaths. It is possible, the FDA warned, that some patients may require a device to be removed and replaced. 

cybercrime data breaches in healthcare

FDA warns of cybersecurity vulnerabilities in patient monitors

The agency said Contec and Epsimed monitors connected via WiFi are particularly susceptible to cyberattack and could be used to gain access to hospital systems. 

the words "FDA recall" on a board

FDA announces recall after Philips heart monitor software failed to send alerts—multiple deaths reported

Philips is recalling the software associated with its Mobile Cardiac Outpatient Telemetry devices after certain high-risk ECG events were never routed to trained cardiology technicians as intended. The issue, which lasted for two years, has been linked to more than 100 injuries. 

FDA has now cleared more than 1,000 AI models, including many in cardiology

Cardiology is the medical speciality with the second most FDA clearances overall. 

Withings, a French medtech company known for its remote monitoring devices, has multiple new services on display at CES 2025.

CES 2025: Cardiologist check-ups, AI-powered smart mirrors coming to heart patients’ homes

Healthcare companies from all over the world are showing off their newest cardiovascular offerings at CES 2025 in Las Vegas.

https://www.dynocardia.care/

NIH awards commercialization grant for wrist-worn continuous ICU-grade blood pressure monitor

Dynocardia has now received nearly $5.1 million in funding from the NHLBI to help speed commercializing its wrist-worn monitor to avoid the need for invasive catheter BP monitoring.

Monitoring acute heart patients at home linked to considerable cost savings

The new report could go on to help guide decisions made by CMS and hospital leadership teams for years to come.

Thumbnail

Watchdog group, fearful of fraud, wants more oversight for remote patient monitoring

Cardiologists and other physicians may soon need to provide much more information when ordering remote patient monitoring for Medicare patients.

Around the web

“Now more than ever, we must recognize that our country’s leadership in groundbreaking medical research spurs scientific innovation, improves public health and creates new innovations that save and improve lives nationwide,” Joseph C. Wu, MD, PhD, explained in a statement. 

The technology used to diagnose, treat and manage cardiovascular disease is always evolving, keeping FDA officials quite busy. But have the agency's standards been slipping in recent years? A cardiologist with Cedars-Sinai Medical Center explored that very question.

No devices need to be returned at this time. However, the FDA warned, using these heart pumps without reviewing the updated instructions could result in "serious injury or death.”