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Ra Medical CEO Irwin aims for Feb 2018 IPO
In May, Ra Medical received a nod from the FDA for its Dabra arteriosclerosis laser, clearing it for use in the US. It was a decision the company had been waiting on for approximately 3 years, CEO Dean Irwin told MassDevice.com in an interview, and signaled a significant shift forward. “In 2014, we submitted to the FDA, and here in 2017, just on May 24th, we received the go ahead to begin marketing in the United States,” Irwin said. Ra Medical won CE Mark approval in the European Union last October, giving the company time to launch in the region, which it’s been operating in for several months, Irwin said. “Tha...
Source: Mass Device - August 24, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Regulatory/Compliance Ra Medical Source Type: news

Shockwave Medical touts Disrupt BTK lithoplasty system study results
Shockwave Medical today released results from the Disrupt below the knee study of its Shockwave Lithoplasty system designed to treat peripheral artery disease, touting low rates of residual stenosis and low vascular complications. Data from the study was presented at the annual Cardiovascular and Interventional Radiological Society of Europe congress in Copenhagen, Denmark. “Interventional procedures that involve moderate and severe calcium can be complex, unpredictable and costly. The previous Disrupt PAD Study demonstrated that Lithoplasty addresses many major concerns in the treatment of problematic calcium in fe...
Source: Mass Device - September 19, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Shockwave Medical Source Type: news

Urinary Stone Disease: Diagnosis, Medical Therapy, and Surgical Management.
Abstract Clinical suspicion of urolithiasis should be evaluated with low-dose computed tomography as the first-line imaging modality for nonpregnant, adult patients. A period of observation may be appropriate for ureteral stones less than 10 mm, and medical expulsive therapy may be beneficial for facilitating passage of distal ureteral stones. Regardless of stone type, patients should adhere to a low-sodium diet and attempt to achieve a urine volume of more than 2.5 L daily. Individuals with calcium stones should maintain a normal calcium diet, and if stones persist, citrate therapy or thiazide diuretics in the ...
Source: The Medical Clinics of North America - February 7, 2018 Category: General Medicine Authors: Ludwig WW, Matlaga BR Tags: Med Clin North Am Source Type: research

Zebra Medical wins CE Mark for brain-bleed detection algorithm
Israeli machine-learning radiology firm Zebra Medical Vision said today it won CE Mark approval in the European Union for an algorithm for detecting intracranial hemorrhages as part of its deep learning imaging analytics platform. Zebra Medical said that its algorithm is designed to identify brain bleeds to provide extra support for physicians in acute care settings, and that it plans to use the algorithm for point-of-care detection to identify bleeds accurately and with reduced delay. “This new algorithm is an important addition to Zebra’s Analytics Engine. The ability to alert radiologists and surgeons to the pr...
Source: Mass Device - March 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Neurological Regulatory/Compliance Software / IT Zebra Medical Vision Source Type: news

Zebra Medical Vision wins FDA nod for Coronary Calcium Scoring algorithm
Israeli machine-learning radiology firm Zebra Medical Vision said this week it won FDA 510(k) clearance for its Coronary Calcium Scoring algorithm. The company said the algorithm is designed to automatically calculate a patient’s Agatston equivalent coronary calcium score from ECG gated CT scans to improve assessments of patients at risk for coronary artery disease. “Identification of high-risk individuals is key to prevention Zebra’s algorithm could run on CT studies of the chest and potentially help identify people with cardiovascular risk sooner, allowing more effective treatment and overall reduction of ...
Source: Mass Device - July 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Imaging Regulatory/Compliance Zebra Medical Vision Source Type: news

Fine-tuned continuous renal replacement therapy with calcium-free dialysate to manage severe hypercalcemia refractory to medical and intermittent hemodialysis
AbstractMalignancy-related hypercalcemia is a leading cause of hypercalcemia among hospitalized patients that carries poor prognosis. Parathyroid carcinoma is a rare form of primary hyperparathyroidism that may be associated with PTH dependent hypercalcemia. Severe hypercalcemia is life-threatening and may require management in an intensive care unit by means of medical therapy consisting of volume expansion, loop diuretics, cinacalcet, calcitonin and bisphosphonates. Renal replacement therapy such as intermittent hemodialysis has been successfully used among patients with severe hypercalcemia who become refractory to medi...
Source: European Journal of Medical Research - June 8, 2022 Category: Research Source Type: research

FastWave Medical Secures Multi-Million Dollar Private Financing Within Weeks, Accelerating the Future of its IVL Systems for Cardiovascular Calcium Treatment
Significant interest in FastWave Medical leads to the rapid close of a private financing, with notable physician key opinion leaders (KOLs) and medical device industry stakeholders among the investors. MINNEAPOLIS, Sept. 6, 2023 /PRNewswire-PRWeb/ -- FastWave Medical, a pioneering medical...
Source: PRWeb: Medical Pharmaceuticals - September 6, 2023 Category: Pharmaceuticals Tags: FNC Source Type: news

Mp31-14 does dietary assessment aid in decision-making for medical management of hypercalciuria?
Management of hypercalciuria (=250 mg/d) to reduce stone risk may require dietary and/or medical therapy. Dietary advice is often based on 24-h urine results alone, without quantifying dietary calcium and/or other dietary factors. We quantified dietary contributors to hypercalciuria in our patients.
Source: The Journal of Urology - April 1, 2018 Category: Urology & Nephrology Authors: John Roger Bell, Mark E Ehlers, Amy Schweitzer, Stephen Y Nakada, Kristina L Penniston Tags: Stone Disease: Medical & Dietary Therapy II Source Type: research

CNS Summit 2017 Abstracts of Poster Presentations
Conclusion: This novel technology discriminates and quantifies subtle differences in behavior and neurological impairments in subjects afflicted with neurological injury/disease. KINARM assessments can be incorporated into multi-center trials (e.g., monitoring stroke motor recovery: NCT02928393). Further studies will determine if KINARM Labs can demonstrate a clinical effect with fewer subjects over a shorter trial period. Disclosures/funding: Dr. Stephen Scott is the inventor of KINARM and CSO of BKIN Technologies.   Multiplexed mass spectrometry assay identifies neurodegeneration biomarkers in CSF Presenter: Chelsky...
Source: Innovations in Clinical Neuroscience - November 1, 2017 Category: Neuroscience Authors: ICNS Online Editor Tags: Assessment Tools biomarkers Cognition Current Issue Drug Development General Genetics Medical Issues Neurology Patient Assessment Psychopharmacology Scales Special Issues Supplements Trial Methodology clinical trials CNS Su Source Type: research

Medical and dietary interventions for preventing recurrent urinary stones in children.
CONCLUSIONS: Oral potassium citrate supplementation may reduce recurrent calcium urinary stone formation in children following SWL; however, our confidence in this finding is limited. A substantial number of children stopped the medication due to adverse events. There is no trial evidence on retreatment rates. There is a critical need for additional well-designed trials in children with nephrolithiasis. PMID: 29117629 [PubMed - as supplied by publisher]
Source: Cochrane Database of Systematic Reviews - November 9, 2017 Category: General Medicine Authors: Kern A, Grimsby G, Mayo H, Baker LA Tags: Cochrane Database Syst Rev Source Type: research

Psychosis in a Child with Atypical Autism: A Case Report and a Brief Review of the Association of Psychosis and Autism
Conclusion In cases of childhood psychosis, the clinician should maintain a high suspicion of COS. In cases of ASD, a careful and detailed history of early development and course of illness should be obtained to identify or rule out any symptoms of psychosis, as there is a strong link between schizophrenia and ASD. Distinguishing symptoms of psychosis from other symptoms of ASD is critical for optimal treatment in this challenging group of pediatric patients. References Kraepelin E. Psychiatrie. 8 Auflage Leipzig, Austria: Barth; 1909. English translation and adaptation by Barclay RM, Robertson GM. Dementia Praecox and Pa...
Source: Innovations in Clinical Neuroscience - April 1, 2018 Category: Neuroscience Authors: ICNS Online Editor Tags: Case Report Current Issue ASD association autism autism spectrum disorder psychosis Source Type: research

Comparison of current guidelines on medical management of stone disease.
CONCLUSIONS: Despite methodological heterogeneity and subjective rating of recommendations, an acceptable degree of consensus was noted on Guidelines regarding medical management of stone disease. PMID: 33459633 [PubMed - in process]
Source: Archivos Espanoles de Urologia - January 21, 2021 Category: Urology & Nephrology Tags: Arch Esp Urol Source Type: research

Randomized Controlled Trial of Storytelling vs Didactic Education Effects on Dietary Colorectal Cancer Risk Behaviors among Latinxs
J Health Care Poor Underserved. 2021;32(3):1531-1553. doi: 10.1353/hpu.2021.0148.ABSTRACTDietary patterns associated with risk for colorectal cancer (CRC) may contribute to continuing health disparities in Latinx populations. Latinx from low-income communities, aged 25-65, were randomized to a 12-week storytelling-based intervention (ST) (n = 300) or didactic learning (DL)(n = 285) classes on cancer screening and dietary changes related to CRC risk facilitated by Latinx lay health workers (promotora/es de salud). Dietary intake was assessed pre-and post-intervention (24-hour dietary recall) with no significant differences ...
Source: Journal of Health Care for the Poor and Underserved - August 23, 2021 Category: International Medicine & Public Health Authors: Linda K Larkey Lisa L Smith Wonsun S Kim Julie Gonzalez Cynthia A Thompson Source Type: research