Vent Multiplexor LLC announced that it received FDA Emergency Use Authorization for its device that can split a single ventilator so that it can be used by two patients simultaneously. The Vent Multiplexor device was developed by a team of students and faculty at Yale University and Yale New Haven Hospital. It is a patent-pending […]
Tag: Cardiology
Oxygen Concentrator for N95 Masks to Make Breathing Easier
Paramedics, ICU staff, and anyone else currently working with patients in any capacity is probably wearing a face mask for extended periods of time. N95 masks, which are easy to wear while providing substantial protection, can reduce the amount of oxygen reaching the lungs by up to 20%. This causes fatigue, may lower blood-oxygen saturation, [&hell (Read more...)
B. Braun Infusion Pumps with Nebulizers Get FDA Emergency Authorization for COVID-19
Combining infusion pumps with nebulizers has been shown to help deliver nebulized medication to patients suffering from acute respiratory distress syndrome. Given the ongoing COVID-19 pandemic, the FDA has just issued Emergency Use Authorization for B. Braun’s Perfusor Space Syringe Infusion Pump, Infusomat Space Volumetric Infusion Pump, and (Read more...)
Blood Filtering Device Wins FDA Emergency Use Authorization for COVID-19
The FDA has issued the first Emergency Use Authorization for a device to help treat COVID-19 patients currently in the ICU. Terumo BCT’s Spectra Optia Apheresis System, combined with Marker Therapeutics’ D2000 Adsorption Cartridge, is now indicated for adult patients with COVID-19 udergoing respiratory failure. The device is intended to (Read more...)
Abbott TriClip Cleared in Europe for Minimally Invasive Tricuspid Valve Repair
Abbott announced that it received the European CE Mark for its TriClip Transcatheter Tricuspid Valve Repair System, a minimally-invasive device for tricuspid regurgitation repair. Like many other valve repair devices, TriClip is designed for implantation using a minimally-invasive transcatheter procedure. Unlike other devices, however, TriClip work (Read more...)
A Look at Tesla’s Prototype Ventilator
As the United States braces for what many think may be most critical weeks in the coronavirus crisis, many companies are temporarily pivoting their manufacturing capabilities to focus on the mass shortages of PPE and medical equipment. Most notably are car manufacturers that are using their expertise in hardware engineering and manufacturing to pro (Read more...)
Optimizer System for Cardiac Contractility Modulation: Interview with Dr. Ishu Rao, Medical Director of Impulse Dynamics
Impulse Dynamics, based in Mt. Laurel, New Jersey, has developed the Optimizer system, a device designed to improve myocardial contractility in patients with heart failure. The system is intended to improve the quality of life of heart failure patients by reducing the severity of their symptoms. At present, many heart failure patients have few opti (Read more...)
Oxford’s Emergency Ventilator Project Steaming Ahead
The University of Oxford and King’s College London have teamed up to develop and are now testing a new emergency ventilator that consists of devices that commonly exist in clinical spaces and scientific laboratories, and a few simple parts that can be created through 3D printing. Bringing together these devices allows the team to create [&hel (Read more...)
BiWaze Cough System Receives FDA Clearance to Help Clear Secretions
ABM Respiratory Care, a company with offices in USA, Singapore, and India, announced that it has received FDA 510(k) clearance to market its BiWaze Cough System, a device for removing secretions in patients who are unable to cough or clear secretions effectively. The BiWaze Cough System consists of a touch-screen device connected to a non-invasive (Read more...)
AnapnoGuard Helps Prevent Ventilator Complications
Ventilators are important to maintain patients with severe respiratory distress due to COVID-19, but the machines carry their own risks. An over-inflated endotracheal tube cuff could damage the trachea, while an under-inflated cuff could result in aspiration and pneumonia. AnapnoGuard, developed by Hospitech Respiration, an Israeli firm, is an endo (Read more...)
Next-Gen TherOx SuperSaturated Oxygen Delivery System FDA Approved
ZOLL Medical, now a part of Asahi Kasei Group, won FDA approval for the latest version of its TherOx System. The product is designed to deliver SuperSaturated Oxygen (SSO2) therapy to limit heart muscle loss following “widowmaker” heart attacks, aka left anterior descending ST-elevation myocardial infarction (LAD STEMI) chronic total ob (Read more...)
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 m (Read more...)
BardyDx Patch for Ambulatory Cardiac Monitoring: Interview with Chief Commercial Officer Ken Nelson
Many cardiac arrhythmias are episodic and only detectable after continuously monitoring the heart’s rhythm for several days or weeks. In particular, atrial arrhythmias can be a diagnostic challenge due to the difficulty in clearly visualizing the P wave on an ECG. The two main monitoring options are either Holter monitors, which capture high- (Read more...)
INVU Receives FDA Clearance for Remote Pregnancy Monitoring System
Nuvo Group announced that it has received 510(k) clearance from the FDA to market INVU, a wearable device that remotely monitors fetal and maternal heart rates. Fetal and maternal heart rates are important measurements late in pregnancy, and an elevated fetal heart rate can be one of the first signals of fetal distress. Currently, obtaining [&helli (Read more...)
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 neo (Read more...)
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 Cove (Read more...)
Highly Sensitive Wearable Strain Sensor Uses Light for Detection
Stick-on strain sensors that can accurately measure the flexion of joints, big and small, have turned out hard to make. Piezoresistive devices tend to have a delayed response and are not stable in the long-run, while capacitive sensors are not very sensitive and nearby electromagnetic fields tend to interfere with them. Now researchers at South [&h (Read more...)
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 [&helli (Read more...)
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 patie (Read more...)
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 au (Read more...)