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Management: Food and Drug Administration (FDA)
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Total 57 results found since Jan 2013.
The Effects of a National Recall on the Reports to the FDA Manufacturer and User Facility Device Experience Database of a Common Atherectomy Device
The HawkOne Directional Atherectomy System (Medtronic Inc., Minneapolis, MN) is a peripheral arterial disease management system that was recalled in December 2021 secondary to repeated guidewire prolapse. We set forth to analyze the patient problems and device issues that caused the device to be recalled and determine if the recall had a significant impact on the device reports utilizing the US Food and Drug Administration (FDA) database Manufacturer and User Facility Device Experience (MAUDE).
Source: Journal of Vascular Surgery - May 23, 2023 Category: Surgery Authors: Doug Hogan, Diana Otoya, Kedar Lavingia, Michael Amendola Tags: Poster Competition Source Type: research
Minnesota Settles Vaping Lawsuit Against Juul
MINNEAPOLIS — Minnesota announced a settlement Monday in its lawsuit against Juul Labs and tobacco giant Altria—the first of thousands of cases against the e-cigarette maker to reach trial—just ahead of closing arguments.
The terms will be kept confidential until formal papers are publicly filed with the court in 30 days, Minnesota Attorney General Keith Ellison said in a statement.
“After three weeks of trial highlighting and bringing into the public record the actions that JUUL and Altria took that contributed to the youth vaping epidemic, we reached a settlement in the best interest of Minnesotan...
Source: TIME: Health - April 17, 2023 Category: Consumer Health News Authors: STEVE KARNOWSKI/AP Tags: Uncategorized healthscienceclimate Vaping wire Source Type: news
Complications associated with PEAK PlasmaBlade from 2010 to 2020 from MAUDE
Proc (Bayl Univ Med Cent). 2022 May 19;35(5):615-620. doi: 10.1080/08998280.2022.2075686. eCollection 2022.ABSTRACTThe pulse-electron avalanche knife (PEAK) PlasmaBlade 3.0 and 4.0 (Medtronic, Minneapolis, MN) is an electrosurgical technology that is widely used in surgery. Our study aimed to summarize device malfunctions, patient injuries, and interventions related to PEAK PlasmaBlade 3.0 and 4.0. The US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of PlasmaBlade adverse events from June 6, 2010, to August 30, 2020. Data were extracted from report...
Source: Baylor University Medical Center Proceedings - August 22, 2022 Category: Universities & Medical Training Authors: Esther Lee Amir Elzomor Sameh Boulos Olivia Silva Luke J Pasick Daniel A Benito Jane Tong Philip Zapanta Arjun S Joshi Joseph F Goodman Punam G Thakkar Source Type: research
CBD Could Help Cops Get Relief From Stress, Insomnia, and Chronic Pain. But Using It Puts Their Job in Jeopardy
There were moments in the past few years when Police Sgt. Brian Vaughan would have tried almost anything to break the cycle of sleeplessness that wore him down—to wash away the images, sounds, and smells of violence that stuck to his memory, and ease the constant pain that was shooting through his back. At one point, he found himself tempted to try CBD, a widely available cannabis derivative that can offer relief from many ailments.
“It would have been great to be able to take it and see if it helps,” says Vaughan, a 14-year law enforcement veteran and training coordinator for the police department in Dal...
Source: TIME: Health - July 29, 2022 Category: Consumer Health News Authors: Katja Ridderbusch Tags: Uncategorized Drugs freelance healthscienceclimate Source Type: news
Effect of epidural spinal cord stimulation after chronic spinal cord injury on volitional movement and cardiovascular function: study protocol for the phase II open label controlled E-STAND trial
This study has been approved after full review by the Minneapolis Medical Research Foundation Institutional Review Board and by the Minneapolis VA Health Care System. This project has received Food and Drug Administration investigational device exemption approval. Trial results will be disseminated through peer-reviewed publications, conference presentations and seminars.
Trial registration number
NCT03026816.
Source: BMJ Open - July 18, 2022 Category: General Medicine Authors: Darrow, D. P., Balser, D. Y., Freeman, D., Pelrine, E., Krassioukov, A., Phillips, A., Netoff, T., Parr, A., Samadani, U. Tags: Open access, Neurology Source Type: research
Can Cannabis Help Your Gut?
When Joe Silverman developed Crohn’s disease at age 21, the symptoms started out mild. While the sight of blood in his stools initially freaked him out, what really bothered him was the frequent abdominal pain and bloating that occurred as his condition progressed to moderate and then severe. Dietary changes didn’t make a difference, so he began taking prescription oral anti-inflammatory drugs that are often used to treat certain bowel diseases, which alleviated but didn’t eliminate his discomfort. He started using prescription steroid suppositories to cope with flare-ups of the inflammatory bowel disease...
Source: TIME: Health - September 23, 2021 Category: Consumer Health News Authors: Stacey Colino Tags: Uncategorized Source Type: news
Fecal Transplants: a New Treatment for IBD
Linda Ann Sasser has had ulcerative colitis since she was 20, but it wasn’t until May 2019, about 30 years later, that her condition hit a low point: not only did she have a major flare-up of chronic inflammatory bowel disease (IBD), but on top of it, she had Clostridioides difficile (or C. diff), a highly contagious bacterial infection that causes severe diarrhea and inflammation of the colon. “I became really, really sick with bloody diarrhea 30 times a day and chronic stomach pain,” Sasser says. While hospitalized for 12 days, she was given oral steroid medications, which didn’t help, then IV ste...
Source: TIME: Health - September 9, 2021 Category: Consumer Health News Authors: Stacey Colino Tags: Uncategorized Disease feature Source Type: news
Imbio Receives FDA 510(k) Clearance for New Cardiothoracic Imaging Algorithm
MINNEAPOLIS, March 16, 2021 -- (Healthcare Sales & Marketing Network) -- Imbio, a leading provider of artificial intelligence (AI) solutions for medical imaging analysis, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its RV/LV ... Devices, Cardiology, Radiology, FDA Imbio, RV/LV Analysis, pulmonary embolism
Source: HSMN NewsFeed - March 16, 2021 Category: Pharmaceuticals Source Type: news
FDA grants clearance for NightWare app designed to reduce PTSD-related nightmares
FDA grants De Novo clearance to prescription Apple Watch app for nightmare disorder (MobiHealth News):
The FDA granted Minneapolis-based NightWare a De Novo clearance on Friday for its Apple Watch and iPhone app designed to improve the sleep quality of those experiencing nightmare disorder and nightmares related to PTSD.
The digital therapeutic – which received breakthrough designation from the agency last year – uses the Watch’s sensors to track the heart rate and movement of users as they sleep. After establishing a baseline profile for the patient within one or two nights’ sleep, the machine learning algorithm s...
Source: SharpBrains - November 16, 2020 Category: Neuroscience Authors: SharpBrains Tags: Brain/ Mental Health Technology & Innovation Apple Watch De Novo clearance digital therapeutic FDA heart-rate iPhone app machine-learning nightmares NightWare prescription PTSD sleep quality Source Type: blogs
Inspire Medical scores reimbursement win from UnitedHealth
Inspire Medical Systems (NYSE:INSP) logged another reimbursement win, this time with the nation’s largest private insurer, UnitedHealth.
Minneapolis-based Inspire makes an eponymous device designed to treat obstructive sleep apnea using hypoglossal nerve stimulation. UnitedHealth has about 41 million lives under coverage, Inspire said.
“We are very pleased to receive this positive coverage decision from UnitedHealthcare. As health plans continue to update their coverage policies to include Inspire therapy, an increasing number of patients and physicians will have access to our innovative therapy,” preside...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Neuromodulation/Neurostimulation Respiratory Wall Street Beat Inspire Medical Systems Inc. Reimbursement UnitedHealth Group Source Type: news
