Philips gets FDA clearance for inpatient continuous monitoring system

Philips Wearable Biosensor
Philips Wearable Biosensor

Friday, Royal Philips said that it has received Food and Drug Administration clearance for IntelliVue Guardian, a monitoring system that detects subtle signs of impending health issues for hospitalized patients. The 510(k) clearance allows the global company to pair IntelliVue Guardian with the single-use, adhesive Philips Wearable Sensor in the U.S.

The software acquired CE Mark certification for sale in Europe in October.

“This little biosensor is the gap filler” that facilitates continuous monitoring of heart rate and respiration in high-acuity patients, said Dr. Kevin Dellsperger, CMO of Augusta (Georgia) University Health. Dellsperger was one of several participants in a Philips-sponsored breakfast discussion Monday at the annual Healthcare Information and Management Systems Society conference in Orlando, Florida.

In a pilot at Augusta University Medical Center, IntelliVue Guardian regularly was able to head off cardiac arrest and found an 88 percent reduction in “predictable” codes, Dellsperger reported.

“We found that…

Nanowear gets FDA clearance for cardiac-monitoring clothing

New York City-based Nanowear has received FDA clearance for SimpliECG, a “remote cardiac-monitoring undergarment”. This is the first clearance for the company, which has been in talks with the FDA since 2015, according to a press release.

“This is a big milestone for our young company,” Cofounder and CEO Venk Varadan said in a statement. “The FDA’s decision not only positions us for commercial opportunities in remote cardiac monitoring, but more importantly, it provides accreditation of the company’s one-of-a-kind, cloth-based sensor technology as medical-grade. This is the first step and foundation of what we believe to be an extensive array of applications for our nanosensor technology – including numerous other electrical, biometric and biochemical signals that can be measured directly from the skin without conductive gels, adhesives or skin preparation. The market of applications for healthcare alone is a multi-billion-dollar…

The PatSim200 Patient Simulator: Interview with Andrew Upton of Seaward Group

Taken: Wednesday 19th October 2016 Rigel Medical shoot at South Tyneside Hospital Photographer/Byline Dave Charnley Photography

Patient monitors collect and record data on the vital signs of patients. This includes heart-rate, body temperature, blood pressure, and respiration. However, making sure that such devices are functioning correctly means careful testing and maintenance. Hooking monitors up to patients or volunteers for the purposes of finding faults in the equipment is not always practical or reliable. For the biomedical engineers and technicians responsible for the development and maintenance of such equipment, a patient simulator that can be plugged directly into patient monitors and that can emulate vital signs is an important tool. Rigel Medical, part of Seaward Group, has unveiled its PatSim200 patient simulator at the MEDICA trade fair in Dusseldorf. The PatSim200 features an intuitive interface and is compatible with most patient monitoring equipment, which can be plugged directly into the unit.

Medgadget asked Andrew Upton, managing director of Seaward Group, some questions about the PatSim200.

Conn Hastings, Medgadget: Rigel Medical offers a variety of products to help test medical equipment. Does such equipment typically need testing only during development and manufacturing, or is regular testing necessary throughout the life of many devices?

Andrew Upton. Image credit: Keith Taylor

Andrew Upton, Seaward Group: Obviously it’s important to make sure medical equipment is accurate when it first arrives on the hospital floor, but yes ongoing testing is key too. Every healthcare facility I know of does regular testing of some kind – normally every one to three years, and even if this tells you that your kit is working fine, then that gives you real peace of mind. If you think about it, some equipment is now decades old: I wouldn’t want to drive a car which hadn’t been serviced for 30 years!

Medgadget: Can you give…

Blood-Monitoring Disposable Smart Patch Delivers Blood Thinners On-Demand


Thrombosis, the occlusion of vasculature by blood clots, is a precursor to debilitating conditions including stroke, pulmonary embolism, and heart attack. Blood thinners such as heparin or Coumadin are used to treat thrombosis, but necessitate ongoing blood tests for precise drug dosing. Researchers from the University of North Carolina at Chapel Hill and North Carolina State University have developed and tested a self-regulating drug eluting patch that monitors the level of thrombin (a clot initiating enzyme) in the blood, and releases appropriate amounts of heparin in response.

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The microneedle patch is meant…

New suite of sensors can help monitor patients to prevent heart failure events

A suite of sensors can predict heart failure events by detecting when a patient’s condition is worsening, according to Dr. John Boehmer, professor of medicine, Penn State College of Medicine, who presented the findings at the American Heart Association annual meeting in New Orleans.

Heart failure is responsible for more than 1 million hospitalizations each year and more than $20 billion in costs. The new technique could help prevent costly hospitalizations and poor health outcomes including death.

Current efforts to manage heart failure by monitoring weight and symptoms have not significantly reduced hospitalizations. More than one in five patients are readmitted within 30 days after being hospitalized for heart failure.

An international team of researchers set out to investigate if implantable devices already used in heart failure patients could be retrofitted with sensors to track their condition. Their results will also to be published in JACC Heart Failure.

Nine hundred heart failure patients were followed for up to one year. At the beginning of the study, the researchers uploaded software to each patient’s implanted defibrillator, a battery-powered device that delivers an electric shock if the patient’s heart stops beating.

The software allowed the defibrillators to also act as sensors, monitoring the patients’ heart rate, activity, breathing, heart sounds and electrical activity in the chest.