Lungpacer Medical, based in Vancouver, Canada, announced that its Diaphragm Pacing Therapy (DPT) System received FDA Emergency Use Authorization for use in weaning COVID-19 patients off of ventilators. Patients on prolonged mechanical ventilation may experience diaphragm disuse atrophy and ventilator-induced diaphragmatic dysfunction (VIDD), which makes it harder for patients to breathe on their own and […]
Tag: Anesthesiology
Camera Images Blood Perfusion at High Resolution Thanks to Pulse Oximeter
How blood moves throughout the body and into the smallest capillaries is hard to observe using existing imaging methods. Yet, poor blood perfusion can be an indicator for a variety of medical conditions, potentially serving as a diagnostic tool and a way to help manage diseases. Infrared thermography is a decent tool for this, but […]
CardioQuip’s Cooler-Heaters EU Cleared to Help With Respiratory Distress
CardioQuip, a firm based in College Station, Texas, won European regulatory approval (CE Mark) for its MCH-1000 cooler-heaters that are used to control patient body temperature, typically during lung or heart procedures. This could be particularly useful during the current COVID-19 pandemic, since the MCH-1000 can be used alongside extracorporeal membrane oxygenation (ECMO) to address […]
RAPIDPoint 500e Blood Gas Analyzer FDA Cleared to Help Ventilated Patients
To help address the COVID-19 emergency that’s taking over emergency rooms and intensive care units in the United States, the FDA has cleared the RAPIDPoint 500e blood gas system from Siemens Healthineers. The device uses the company’s Integri-sense technology to provide results on blood gas, electrolyte, metabolite, CO-oximetry, and neonatal bilirubin. This is important during […]
University of Minnesota Develops Simpler, Inexpensive Mechanical Ventilator
With the rise of COVID-19 cases throughout the United States, one of the biggest concerns is the potential shortage of ventilators for patients who have severe viral pneumonia. A team at the University of Minnesota has designed a mechanical ventilator that is inexpensive and made of easy to obtain materials. Unlike traditional ventilators, the Coventor […]
MIT Emergency Ventilator Submitted for FDA Review
The ongoing COVID-19 emergency affecting nearly the entire globe is making medical ventilators into a hot commodity. During normal times, busy intensive care units can expect to use a dozen or so ventilators at the same time. As a respiratory virus, COVID-19 can make breathing on one’s own impossible, so ventilators are expected to be […]
ViTrack for Direct, Continuous, Non-Invasive Blood Pressure Monitoring: Interview with CEO of Dynocardia, Dr. Mohan Thanikachalam
Most modern blood pressure cuffs use the oscillometric technique, in which the cuff measures one value (mean arterial pressure) and an algorithm calculates systolic and diastolic blood pressure readings. However, this indirect method can produce inaccuracies, and single-point measurements lead to an inaccurate hypertension diagnosis in 30% of patients. While intraarterial lines can be used […]
EchoNous Receives EU Approval for Kosmos AI Ultrasound Platform
EchoNous announced that it has received the Eurepean CE Mark of approval for its Kosmos platform, an ultrasound and AI-based software system that helps physicians obtain diagnostic imaging and make clinical decisions at the bedside. The Kosmos platform consists of an eight-ounce ultrasound device, the Kosmos Torso, which also has ECG and digital auscultation functions. […]
Iris Needle Guidance for Lumbar Punctures: Interview with Dev Mandavia, CEO of Ethos Medical
Ethos Medical, a startup founded by Georgia Tech alumni, has developed the Iris needle guidance system to assist clinicians in successfully performing lumbar punctures. The system allows a clinician to visualize the needle traveling through tissue in real time. Tracking the needle path in this way is intended to improve the success rate and reduce […]
Masimo Receives FDA Approval for Continuous RRp Monitoring
Masimo announced that it received FDA clearance for continuous RRp (respiration rate from the photoplethysmograph) monitoring with its with Rad-97, Radical-7, and Radius-7 Pulse Co-Oximeters. Usually, monitoring respiration rate involves manually counting breaths with a timer or using chest straps that need to be fitted. The newly-approved Masimo RRp monitor allows clinicians to conveniently measure respiration […]
Cardiovalve Wins FDA Breakthrough Device Designation for Transcatheter Tricuspid Valve Replacement System
Cardiovalve announced that it received FDA Breakthrough Device Designation for its Transcatheter Tricuspid Valve Replacement System. The company also received approval for an Early Feasibility Study of the device for tricuspid and mitral valve regurgitation indications. The Cardiovalve transcatheter system is designed for treatment of mitral and tricuspid regurgitation by replacement of the native valves via […]
New HydroPICC Prevents Clogged Central Line Catheters
Access Vascular, based in Bedford, Massachusetts, won FDA clearance for the latest version of its HydroPICC anti-thrombogenic central line catheter. As with the original, which was cleared two years ago, the new device features Access’s unique “bulk-hydrophilic” material that prevents clogging by being rich in water while carrying a neutral surface charge. Proteins and other […]
FDA Clears First Pulse Oximeter to Measure Breathing Rate
Masimo just received the first FDA clearance for a fingertip pulse oximeter that can measure respiration rate. The MightySat Rx spot-check pulse oximeter includes a technology known as Respiration Rate from the Pleth (RRP) that makes it unnecessary to perform manual counts or use chest electrodes to measure respiration rate. The device can be used […]
VistaScan Ultrasound Probes for Your Smartphone Cleared by FDA
Emagine Solutions Technology, a startup based in Tucson, Arizona, won FDA clearance for its VistaScan mobile ultrasound system. The product includes ultrasound probes that can interface with a clinician’s own smartphone or tablet, and the company’s app is used to display and manipulate live images produced by the probes. The company developed special software that […]
Novalung FDA Cleared to Provide Long-Term Lung Failure Treatment
Critically ill patients with acute respiratory or cardiopulmonary failure who are on long-term mechanical ventilation too often suffer a variety of side effects. These can include ventilator associated lung injury, pneumonia, and diaphragm dysfunction. Moreover, related sedation and lack of movement can aggravate an already difficult situation. To help address these challenges, the FDA has […]
Ethos AI-Powered Radiotherapy System Follows Movement of Tumors
Varian has won FDA clearance for its Ethos therapy technology, which the company describes as an Adaptive Intelligence solution for improved tumor targeting during radiotherapy. Adaptive therapy allows clinicians to target tumors based on imaging performed during treatment sessions. This is important, as the internal anatomy tends to shift and tumors can move away from […]
First AI-Guided Ultrasound Gets Green Light from FDA
Caption Health, a company based outside of San Francisco, CA, won the first authorization from the FDA for an ultrasound software that guides clinicians at capturing images of the heart. The Caption Guidance software should work with any number of ultrasound system from different manufacturers, but currently it can only be used with a diagnostic […]
Wireless Lumee Oxygen Platform Cleared in EU
The European Union cleared Profusa’s Wireless Lumee Oxygen Platform, a system designed to measure tissue oxygen levels in patients with diseases such as peripheral artery disease and critical limb ischemia. The wired version of the Lumee was cleared in Europe back in 2016 and the new device fundamentally works the same. It consists of a […]
SAFIRA Lets Lone Anesthesiologists Administer Regional Blocks
Medovate, a two-year-old UK firm, is bringing its SAFIRA regional anesthesia system to the United States. The SAFIRA (Safer Injection for Regional Anesthesia) allows anesthesiologists to deliver regional anesthesia (block) without relying on an assistant to actually inject it at the right pressure. Regional anesthesia procedures currently demand one person to operate an ultrasound to […]
Serenno System Unveiled for Continuous Kidney Monitoring
Serenno Medical, an Israeli firm, has unveiled its Sentinel automatic device for monitoring and detecting kidney damage. Designed for use within the hospital, the Sentinel works by continuously measuring urine output and volume to help detect cases of Acute Kidney Injury (AKI). These days, nurses typically manually measure the amount of urine a patient produces. […]