Catheter-Directed Plan Improves Pulmonary Artery Occlusion Catheter-Directed Plan Improves Pulmonary Artery Occlusion
The Bashir endovascular catheter was designed to maximize thrombus reduction via a pharmacomechanical infusion.MDedge News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 18, 2023 Category: Consumer Health News Tags: Pulmonary Medicine Source Type: news

Don't get burned: Expert tips and tricks on MRI safety
How can MRI staff reduce the impact of radiofrequency-induced heating? Are tattoos and implantable medical devices safe? How can quenching be avoided? What are the special risks in 7-tesla MRI? A prize-winning RSNA 2023 exhibit addressed these and other questions. "While we are familiar with medical safety and ethics principles when errors occur, the culture of blaming parties is still prevalent," noted Ana Paula Santos Lima, MD, assistant professor of radiology at the University of Washington, and colleagues. "Everyone makes mistakes; it's crucial to minimize risks. It's not always direct staff at fault." System-wide vu...
Source: AuntMinnie.com Headlines - December 11, 2023 Category: Radiology Authors: Philip Ward Tags: MRI Source Type: news

Aria CV Wants to Offer a Device Option for Pulmonary Arterial Hypertension
Aria CV is venturing into a space that few medtech companies have gone before. The St. Paul MN-based company is developing an implantable device to tackle Pulmonary Arterial Hypertension (PAH), a disease that is mostly treated with pharmaceuticals. Earlier this week, the company raised $31 million in a series B round to help fund an early feasibility study in the U.S. for the Aria CV Pulmonary Hypertension System (Aria CV PH System). The series B round was led by Xeraya Capital. Also participating in the financing were Longview Ventures, Catalyst Health Ventures, BioStar Ventures, Cedar Point Capital, Frontcourt Group, and...
Source: MDDI - February 27, 2020 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

20 Private Medtech Companies to Watch in 2020
MD+DI has taken a hard look at the private medtech sector and developed this list of 20 private companies we will be paying particularly close attention to in the new year. It was not an easy task. There are so many interesting private companies in the industry right now that we started with a much longer list and whittled it down to the 20 companies that stood out most to us. So without further ado, here are the 20 companies that made the cut: 4C Medical is developing the AltaValve, a transcatheter mitral valve replacement (TMVR) platform designed to address mitr...
Source: MDDI - December 24, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

20 Private Companies to Watch in 2020
MD+DI has taken a hard look at the private medtech sector and developed this list of 20 private companies we will be paying particularly close attention to in the new year. It was not an easy task. There are so many interesting private companies in the industry right now that we started with a much longer list and whittled it down to the 20 companies that stood out most to us. So without further ado, here are the 20 companies that made the cut: 4C Medical is developing the AltaValve, a transcatheter mitral valve replacement (TMVR) platform designed to address mitr...
Source: MDDI - December 24, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

AI Beats Out Clinicians in Triaging Postoperative Patients for ICU
How good is artificial intelligence in decision-making? Not bad according to findings from a pilot study that was recently presented at the American College of Surgeons Clinical Congress 2019. Findings from the study show AI in the form of a machine-learned algorithm correctly triaged the vast majority of postoperative patients to the intensive care unit in its first proof-of-concept application in a university hospital setting. As it stands now surgical teams typically rely on clinical judgment to decide which patients need postoperative intense care because there is no single set of fixed criteria to make the determinati...
Source: MDDI - October 30, 2019 Category: Medical Devices Authors: MDDI Staff Tags: Digital Health Source Type: news

What Are Pulmonary Embolism Risk Factors?
Discussion Pulmonary embolism (PE) is potentially life-threatening but fortunately rare event especially in the pediatric population. It was first described in children in 1861. PE is likely underreported because of minimal or non-specific clinical symptoms. The incidence is estimated at 0.05-4.2% with the 4.2% based on autopsy reports. It is probably also increasing as more central venous catheters (CVC) are used, and more children are surviving previously poor prognostic diseases. There is a bimodal distribution with cases < 1 year (especially neonates which account for ~50% of this group) and in teenagers. Neonates a...
Source: PediatricEducation.org - September 23, 2019 Category: Pediatrics Authors: Pediatric Education Tags: Uncategorized Source Type: news

New System Could Hold Promise for Patients Suffering from Pulmonary Arterial Hypertension
SoniVie’s recent clinical trial of TIVUS (therapeutic intravascular ultrasound) shows encouraging results for patients with pulmonary arterial hypertension (PAH). “The TROPHY1 study was our first human study in patients with pulmonary arterial hypertension,” said Charles Carignan, MD, CEO of SoniVie, in an interview with MD+DI. The results are from a 6-month follow-up for the 23 enrolled WHO Class 3 patients in the United States, Europe, and Israel. TIVUS is a catheter that goes either through the jugular vein or the femoral vein into the right side of the heart and pas...
Source: MDDI - June 5, 2019 Category: Medical Devices Authors: Susan Shepard Tags: Business Source Type: news

On February 5th, @US_FDA identified a Class I Recall, the most serious type of recall: Edwards Lifesciences Recalls Swan-Ganz Thermodilution Catheter Due to Incorrect Assembly Causing Reversal of Lumens. Find out more about the recall: https://go.usa.gov/xER5f   #FDA #MedicalDevicepic.twitter.com/6adzC2txTv
On February 5th, @US_FDA identified a Class I Recall, the most serious type of recall: Edwards Lifesciences Recalls Swan-Ganz Thermodilution Catheter Due to Incorrect Assembly Causing Reversal of Lumens. Find out more about the recall: https://go.usa.gov/xER5f  #FDA #MedicalDevice pic.twitter.com/6adzC2txTv (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 8, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA labels Edwards Lifesciences ’ recall of Swan Ganz thermodilution caths as Class I
The FDA has labeled a select recall of Edwards Lifesciences‘ (NYSE:EW) Swan-Ganz Thermodilution catheters over issues with the lumen assembly as Class I. Class I designations, the FDA’s most severe, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. The Irvine, Calif.-based company’s Swan-Ganz Thermodilution catheters function as a diagnostic tool to determine hemodynamic pressures and cardiac output and are intended for use with a compatible cardiac output computer. The catheters have indications for measuring hemodynamic conditions th...
Source: Mass Device - February 4, 2019 Category: Medical Devices Authors: Fink Densford Tags: Catheters Featured Food & Drug Administration (FDA) Recalls Vascular Edwards Lifesciences Source Type: news

Edwards wins FDA nod for next-gen HemoSphere platform
Edwards Lifesciences (NYSE:EW) said yesterday that it won FDA 510(k) clearance for its Hemosphere platform with the Acumen suite of decision-support solutions intended for hemodynamic monitoring. The Irvine, Calif.-based company touted that the newly cleared HemoSphere platform is the first to include predictive monitoring for moderate to high-risk surgical patients. The system now includes the Acumen hypotension prediction index, a machine-learning powered algorithm intended to indicate the likelihood of a hypotensive event, and the Acumen IQ sensor, which allows the HPI software to update parameters every 20 seconds, Edw...
Source: Mass Device - December 4, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Blood Management Food & Drug Administration (FDA) Regulatory/Compliance Edwards Lifesciences Source Type: news

Lauren ’s story: How roller derby saved my life
I wasn’t a particularly athletic child. The second day of soccer practice, in sixth grade, we had to run laps around the soccer field, and 10-year-old me said, “I feel like I’m going to have a heart attack!” My coach disagreed. I quit. That much running was not for me. Fifteen years later, at age 25, I had not only joined a roller derby league, but had also worked my way up to doing contact drills at practice in just three months. I felt incredible! I felt powerful! I felt unstoppable… until I went into cardiac arrest at a Thursday night practice this past July. A lost two days I woke up the following Sunday at D...
Source: Thrive, Children's Hospital Boston - December 6, 2017 Category: Pediatrics Authors: Lauren Simano Tags: Diseases & Conditions Our Patients’ Stories ALCAPA Boston Adult Congenital Heart Program Coronary Artery Program Dr. Luis Quinonez Source Type: news

Abbott maintains Nanostim halt on docking button issue
Abbott (NYSE:ABT) said this month that it’s maintaining the worldwide halt on implantations of the Nanostim leadless pacemaker made by its St. Jude Medical subsidiary after reports surfaced of problems with the device’s docking button. The 3.6mm docking button is designed to allow the Nanostim device to be retrieved after implantation; it’s meant to connect with the retrieval catheter during removal. In a Nov. 17 letter to physicians, Abbott said it received three reports of docking buttons detaching, out of 1,423 Nanostim implantations (0.002%), with no serious injuries reported. One of the cases occur...
Source: Mass Device - December 5, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Recalls Wall Street Beat Abbott Cardiac Rhythm Management stjudemedical Source Type: news

Edwards wins FDA nod for HemoSphere monitoring platform
Edwards Lifesciences (NYSE:EW) shares rose this morning after the company said it won FDA clearance for its HemoSphere advanced monitoring platform. Hemodynamic monitoring, the measurement of a patient’s blood circulation and cardiac function, enables clinicians to evaluate whether a patient is receiving enough oxygen to their organs and tissues. The Irvine, Calif.-based company’s blood monitoring device is wireless and incorporates visual clinical support screens and a touchscreen. The HemoSphere monitor is compatible with the company’s Swan-Ganz pulmonary artery catheter and Oximetry catheters, according ...
Source: Mass Device - April 19, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Blood Management Hospital Care Patient Monitoring Regulatory/Compliance Wall Street Beat Edwards Lifesciences Source Type: news

Edwards Lifesciences wins CE Mark for HemoSphere blood flow monitor
Edwards Lifesciences (NYSE:EW) said yesterday that it won CE Mark approval in the European Union for its HemoSphere blood flow monitor. Hemodynamic monitoring, the measurement of a patient’s blood circulation and cardiac function, enables clinicians to evaluate whether a patient is receiving enough oxygen to their organs and tissues. The device includes visual clinical support screens and is compatible with the Edwards Swan-Ganz pulmonary artery catheter and Oximetry catheters. “The HemoSphere advanced monitor enables simplified visual clinical support, which is particularly important in the care of our most c...
Source: Mass Device - January 18, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Blood Management Hospital Care Regulatory/Clearance Wall Street Beat Edwards Lifesciences Source Type: news