FDA Approved Medtronic Insertable Cardiac Monitor

Photo: Medtronic

Medtronic announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its Reveal LINQ(TM) Insertable Cardiac Monitor (ICM) with TruRhythm(TM) Detection, an advanced cardiac monitor offering improved accuracy to better identify abnormal heartbeats.

Reveal LINQ ICM with TruRhythm Detection offers exclusive algorithms that result in a 95 percent reduction in false bradycardia (slow heartbeat) episodes and a 47 percent reduction in false pause (brief absence of cardiac activity) episodes when compared with its predecessor, the Reveal LINQ(TM) ICM. The device also features a self-learning atrial fibrillation (AF – an irregular and often very fast heart rate) algorithm, which learns and adapts to a patient’s heart rhythm over time.  AF episodes, which are most likely to trigger false positives with ICMs, experienced a 49 percent reduction in false detections with the Reveal LINQ ICM with TruRhythm Detection when compared to the Reveal LINQ ICM.

“ICMs help physicians find answers for patients at risk for cardiac arrhythmias to better manage a range of patient populations,” said James Allred, M.D., electrophysiologist at Cone Health Medical Group Heartcare in Greensboro, N.C. “The enhancements with the Reveal LINQ ICM with TruRhythm Detection make it smarter by streamlining device data review so physicians can make decisions more accurately and quickly for patients.”

Reveal LINQ ICM with TruRhythm Detection, which allows physicians to continuously and wirelessly monitor a patient’s heartbeat for up to three years, is approximately one-third the size of an AAA battery (~1 cc). It is placed just beneath the skin through a small incision of less than 1 cm in the upper left side of the chest, using a minimally invasive procedure, and its presence is often nearly undetectable to the naked eye once the incision has healed. The device communicates wirelessly with a patient bedside monitor that uploads device data to the Medtronic CareLink® network; it is MR-Conditional, allowing patients to undergo magnetic resonance imaging (MRI), if needed.

“For nearly twenty years, Medtronic has led innovation in cardiac monitoring, including Reveal(TM), the world’s first loop recorder, and Reveal LINQ, the world’s smallest ICM,” said Nina Goodheart, vice president and general manager of the Patient Monitoring & Diagnostics business at Medtronic. “We collaborated with hundreds of clinicians and analyzed more than 50,000 ECGs allowing us to pinpoint how we could redesign our algorithms to improve detection specificity, without compromising sensitivity.”

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.

Source: Medtronic

Profusa Device for Continuous Real-time Monitoring of Tissue Oxygen CE Approved

Bio Sensor

Profusa, Inc. announced that it received the CE Mark to market its Lumee Oxygen Platform™ for continuous, real-time monitor­ing of tissue oxygen. The company will initially market the system for monitoring tissue oxygen in the treatment of peripheral artery disease (PAD). With an annual economic burden of more than $74 billion dollars in the United States alone, PAD affects 202 million people worldwide. PAD leads to narrowing of blood vessels and reduced oxygenated blood flow that can result in amputation of an extremity.

Continue reading “Profusa Device for Continuous Real-time Monitoring of Tissue Oxygen CE Approved”

Firefighters’ positioning system may be used to monitor walking difficulty for elderly

A positioning system adapted for use in fire rescue operations will soon be tested on senior citizens in Sweden as a way to spot signs of early stage Parkinson’s disease and other mobility Problems.

Inside the heel of a boot, advanced sensors designed at KTH Royal Institute of Technology in Stockholm make it possible for emergency operations commanders to follow smoke divers’ exact movements in any building — even 25 metres below ground. The system, which includes an accelerometer and gyroscope, plus a processor, can withstand shock and high temperatures and remains operational where GPS positioning systems fail.

The small sensor in the shoe carefully measures the movement of the foot and directional changes, whether the user walks, runs, jumps or crawls. So, there are more potential uses for the technology. For example, behavioral research could take advantage of the data on people’s movements.

Sports is another area where positioning technology can be useful. Athletes can measure their own movements and analyse whether these can be optimised to improve performance or to reduce damage.

The Open Shoe Project started as a joint collaboration between KTH and the Indian Institute of Science (IISc), Bangalore. It is now run within SAATH (Seamless affordable assistive technology for health), which is a Indo-Swedish project with KTH, University of Gävle, Robotdalen and Brepus Castel AB as Swedish partners, and IIT Kanpur and IISc as Indian partners.

More details can be found from KTH Royal Institute website by clicking here.

BIOTRONIK Receives FDA Approval of Insertable Cardiac Monitor

Biotronik announced Food and Drug Administration (FDA) approval of BioMonitor 2, an insertable cardiac remote monitor with ProMRI® technology.

BioMonitor 2 is designed to provide physicians with the ability to accurately detect and diagnose atrial fibrillation, ventricular tachycardia and fibrillation, and syncope. The device can also be used to monitor atrial events in patients who have undergone ablation procedures.

BioMonitor 2 is inserted subcutaneously through a minimally invasive process under local anesthesia. The device provides a flexible antenna and positioning, adapting easily to a patient’s anatomy, while providing unmatched sensing amplitude that ensures reporting accuracy. BioMonitor 2 also features BIOTRONIK’s ProMRI technology, ensuring patients have access to full-body magnetic resonance imaging (MRI) scans (both 1.5T and 3.0T) as needed throughout their lifetime.

More info can be found from Biotronik website by clicking this link.

Dexcom Recalls G4 Platinum and G5 Mobile Continuous Glucose Monitoring System

Dexcom Inc. is recalling the Continuous Glucose Monitoring Systems because the audible alarm may not activate in the receiver piece when low or high glucose levels (hypoglycemia or hyperglycemia) are detected.

Relying on this product for notification of low or high blood sugar could result in serious adverse consequences, including death as the auditory alarm may not sound and users might not be notified of low or high blood sugar.

Dexcom, Inc. issued a press release on 11 April, 2016 to supplement its previous customer notification and remind its patients to periodically test the audible alarms and alerts on certain receivers manufactured by Dexcom to make sure that the audible alarms and alerts are functioning properly. The notification constituted a voluntary recall and applied to those Dexcom G4 Platinum Receivers, Dexcom G4 Platinum Pediatric Receivers, Dexcom G4 Platinum Professional Receivers, Dexcom G4 Platinum with Share Receivers, Dexcom G4 Platinum with Share Pediatric Receivers and the Dexcom G5 Mobile Receivers that are experiencing problems with audible alarms and alerts. There is no reason for patients to return receivers to Dexcom that are functioning properly.

Dexcom issued the customer notification on February 23, 2016 via its website and certified mail to patients. The notification alerted customers of a potential issue affecting the audible alarms and alerts associated with the speaker component of certain receivers. Dexcom notified customers about this potential issue after receiving customer complaints about the receivers’ speaker component. Specifically, the speaker failed to properly provide audible alerts and alarms in some or all instances.

Customers who rely on audible alerts and alarms may not be notified of severe hypoglycemia or hyperglycemia if the speaker in their receiver does not function properly. The immediate health consequences of severe hypoglycemia include loss of consciousness, seizure, and in rare instances death.

The FDA has identified this as a Class I recall, the most serious type of recall. Relying on this device may cause serious injuries or death.

Recalled Devices
Name of device: Dexcom G4 PLATINUM Receiver, Dexcom G4 PLATINUM (Pediatric) Receive, Dexcom G4 PLATINUM (Professional) Receiver, Dexcom G4 PLATINUM Receiver with Share, Dexcom G4 PLATINUM (Pediatric) Receiver with Share, Dexcom G5 Mobile Receiver
Model numbers: all models
Lot numbers: all lots
Manufacturing dates: July 29, 2011 to March 10, 2016
Distribution dates: October 22, 2012 to March 10, 2016
Devices recalled in the U.S.: 263,520 units nationwide

More information can be found from FDA website by clicking below links:
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm495448.htm

http://www.fda.gov/Safety/Recalls/ucm495481.htm

CFDA approves 2 non-invasive fingertip mounted device from CNOGA

CNOGA Medical has received China CFDA approval for two of their non-invasive fingertip devices for detection of bio-parameters.
One product is named as the MTX, a novel Non-Invasive Fingertip mounted device designed to measure a wide range of physiological bio-parameters without the need to take painful invasive blood samples.

Based on tissue photography analysis of the fingertip capillaries, a single MTX device can analyze more than 14 different bio parameters within seconds. Combining the MTX with Cnoga’s mobile application and cloud-based services provides health care professionals and organizations with an easy access to medical data for better disease management thus enabling true ongoing remote monitoring.

The other product is the so called VSM cuff-less, simple to use, portable device which can measure blood pressure, pulse, blood Oxygen saturation and also fits into your pocket. Cnoga’s unique technology enables continuous blood pressure measurements without the need of using an arm cuff and air pressure.