The New York Times is reporting that Medtronic’s new heart monitor, the Chronicle, is likely to be rejected by the FDA. Why? Because it’s not keeping patients out of the hospital — it’s main selling point:
The device’s manufacturer, Medtronic, has been developing wireless data-gathering technology for implanted therapeutic devices like defibrillators and insulin pumps. It aimed to make the product reviewed yesterday, a device the size of a pocket watch and known as the Chronicle implantable hemodynamic monitor, the first major implant approved solely for diagnostic monitoring.
The Chronicle monitors blood pressure and other conditions inside the hearts of patients suffering heart failure, a disease that reduces the amount of blood the heart pumps. The goal is to warn patients, their doctors and other people who care for them when they are in danger at a point before they need to be hospitalized.
This failure to prevent hospital visits stands […]
Published by Nicholas
Continue reading: Telemedicine Setback: Medtronic’s Chronicle Fails
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