GE (NYSE:GE) issued an urgent field safety notice in the United Kingdom for an issue with the server of its ApexPro telemetry system. The issue with the telemetry system is that the central monitoring station or bedside monitor may not provide visual or audible alarms for electrocardiogram arrhythmias, lead failures or SpO2 monitoring when affected. The […]
Patient Monitoring
Medtronic adds an AI Klue to its diabetes management lineup
Medtronic (NYSE:MDT) said today it has completed the acquisition of Klue, a San Jose, Calif.-based software company that tracks people’s eating in real-time and analyzes it with artificial intelligence (AI) to help control diabetes. Medtronic plans to incorporate Klue’s technology into its Personalized Closed Loop (PCL) insulin pump system, which won FDA breakthrough device designation in February. PCL is […]
Baebies wins CE Mark for near-patient testing platform
Baebies today said it received CE Mark for its Finder near-patient testing platform. Finder is an in vitro diagnostic device (IVD) that features an instrument and cartridge that can test for Glucose-6-Phosphate Dehydrogenase from low blood volume, or a single drop of whole blood. It can provide results within 15 minutes after sample introduction. “The […]
Dexcom CEO apologizes for remote monitoring outage
Dexcom (NSDQ:DXCM) CEO Kevin Sayer publicly apologized on Friday for an outage over Thanksgiving weekend that cut off users’ ability to share glucose monitoring data with caregivers and loved ones. The Dexcom Follow app normally allows users of the company’s G6 continuous glucose monitor to share that data with up to 10 people, according to the company’s […]
Nihon Kohden launches new patient monitor
Nihon Kohden (TYO:6849) announced the U.S. launch of its Life Scope SVM-7200 series vital signs monitor for outpatient facilities and beds that aren’t continuously monitored. The Life Scope SVM-7200 is designed to provide customizable early warning scoring to help clinicians identify patients who are deteriorating or at risk of deterioration. It combines vital signs data with […]
Iradimed renews CE mark for MRI-safe patient monitor
Iradimed (NSDQ:IRMD) today said it completed the CE mark renewal process and resumed shipments of its patient vital signs monitoring systems. “We are very pleased with obtaining the CE mark renewal certificate for our patient monitors. With the renewed certificate, we are immediately resuming shipments to the impacted customers and thank them for their patience,” president […]
ImpediMed lands expanded 510(k) clearance for Sozo
ImpediMed this week said it received expanded FDA 510(k) clearance for its Sozo bioimpedance spectroscopy device. The expanded clearance allows the Carlsbad, Calif.-based company to market the Sozo device for assessing patients that are at risk of Protein Calorie Malnutrition (PCM) and for tracking clinically relevant body composition parameters in all patients. “Many chronic diseases, […]
Masimo touts study on remote monitoring for desaturation and bradypnea
Masimo (NSDQ:MASI) announced today that its study of the Masimo Patient SafetyNet and rainbow acoustic monitoring (RAM) with RRa revealed that use of monitoring systems might provide a safety net for postoperative patients. Irvine, Calif.-based Masimo’s Patient SafetyNet is a supplemental remote monitoring patient surveillance and clinician notification system designed to work with Masimo and third-party […]
GE Healthcare safety notice: Telemetry alarms may not sound
GE Healthcare (NYSE:GE) released an urgent field safety notice to warn of six potential safety issues with its ApexPro telemetry system under certain conditions. The ApexPro is supposed to provide vital patient information in healthcare settings. But when the ApexPro telemetry transmitter is out of wireless range, its battery has been depleted or a communication failure […]
FDA panel wants info on metal implant reactions
This article has been updated with a link to the FDA webcasts of the proceedings. An FDA panel will meet this week to discuss immunological responses to medical device implants made of metal, including artificial hips and the Essure permanent birth control device. The Immunology Devices Panel of the agency’s Center for Devices and Radiological […]
Philips launches next-gen vital signs monitor for early patient intervention
Royal Philips (NYSE:PHG) said today that it has initiated the U.S. launch of the EarlyVue VS30 monitor — meant to help clinicians catch problems with hospital patients early and prioritize treatments. The EarlyVue VS30 uses automated early warning scoring (EWS) to collect the vital signs and calculate the alerts to allow clinicians to identify subtle signs […]