FDA proposes new path to 510(k) clearance

The U.S. Food and Drug Administration (FDA) has proposed a new pathway for...Read more on AuntMinnie.comRelated Reading: FDA authorizes ACR to accredit DBT devices FDA releases update on breast implant lymphoma risk FDA: Brain coils may cause artifacts on MRA images FDA clears blood test to assist concussion evaluation FDA updates policy for nixing 510(k) submissions
Source: AuntMinnie.com Headlines - Category: Radiology Source Type: news

Related Links:

ConclusionsMany parents are worried about concussion, and this worry is greatest among the most socioeconomically disadvantaged parents. Further research is needed to determine the cause of this difference. Such work can identify whether there are appropriate individual or community-level targets for intervention to improve the ability of parents to understand and address the potential threat of concussion to their child.
Source: Social Science and Medicine - Category: Psychiatry & Psychology Source Type: research
Authors: Wierda WG, Byrd JC, Abramson JS, Bilgrami SF, Bociek G, Brander D, Brown J, Chanan-Khan AA, Chavez JC, Coutre SE, Davis RS, Fletcher CD, Hill B, Kahl BS, Kamdar M, Kaplan LD, Khan N, Kipps TJ, Ma S, Malek S, Mato A, Mosse C, Neppalli VT, Shadman M, Siddiqi T, Stephens D, Wagner N, Dwyer MA, Sundar H Abstract Chronic lymphocytic leukemia (CLL) is generally characterized by an indolent disease course. Histologic transformation (also known as Richter's transformation) to more aggressive lymphomas, such as diffuse large B-cell lymphoma or Hodgkin lymphoma, occurs in approximately 2% to 10% of patients and is a...
Source: Journal of the National Comprehensive Cancer Network : JNCCN - Category: Cancer & Oncology Tags: J Natl Compr Canc Netw Source Type: research
AbstractThromboembolism (TE) is a major cause of morbidity and mortality in adult cancer patients; however, there is a lack of sufficient knowledge on TE in pediatric cancer patients. We aimed to determine the epidemiology of TE in Korean children with cancer. Between January 2000 and July 2015, we retrospectively analyzed pediatric patients newly diagnosed with cancer at six tertiary hospitals in Korea. Of 3611 children with cancer, 33 (0.91%) had TE. A higher number of patients with acute lymphoblastic leukemia (n  = 13), brain tumors (n = 6), lymphoma (n = 4), and bone/soft tiss...
Source: Journal of Thrombosis and Thrombolysis - Category: Hematology Source Type: research
We describe the significant technological leap from bench to bedside that was achieved through a strong academic-industry collaboration between dedicated clinicians and researchers at the University of Pennsylvania, the Children ’s Hospital of Philadelphia, and Novartis to commercialize the chimeric antigen receptor T cell (CAR-T) therapy tisagenlecleucel (CTL019; Kymriah®; Novartis Pharma AG, Basel, Switzerland).Recent FindingsTisagenlecleucel was the first CAR-T therapy and the first gene therapy to receive US Food and Drug Administration approval in 2017, with an initial indication for pediatric and young adul...
Source: Current Hematologic Malignancy Reports - Category: Hematology Source Type: research
Publication date: Available online 19 January 2019Source: The Veterinary JournalAuthor(s): K.C. Pinello, J. Niza-Ribeiro, L. Fonseca, A.J. de MatosAbstractLymphoma is one of the most common neoplasms in dogs and it is one of the top five causes of cancer-related deaths, similar to human lymphoma. Companion animal epidemiological studies define dogs as sentinels of potential risk factors for human health, mainly due to shared environments, shorter disease latencies, and spontaneous disease. The aims of this study were to describe human and canine epidemiologic features of non-Hodgkin’s lymphoma (NHL) and their similar...
Source: The Veterinary Journal - Category: Veterinary Research Source Type: research
This study aimed to investigate the protective effects of resveratrol on oxidative damaged RPE cells. MATERIALS AND METHODS: Human D407 cells were divided into normal control (NC), H2O2 treated (H2O2, treating with H2O2 at a final concentration of 200 mol/l) and resveratrol treatment groups (treating with resveratrol at a concentration of 12.5, 25, 50 and 100 mg/l). Malondialdehyde (MDA) and superoxide dismutase (SOD) activities were examined using enzyme-linked immunosorbent assay (ELISA). 3-(4,5-dimethyl-2-thiazolyl)-2,5-diphenyl-2-H-tetrazolium bromide (MTT) and cell count kit-8 (CCK-8) were used to examine cell via...
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
Authors: Bian KY, Jin HF, Sun W, Sun YJ Abstract OBJECTIVE: To investigate the effect of tauroursodeoxycholic acid (TUDCA) on neurological impairment induced by acute cerebral infarction (ACI) and its relevant mechanism of action. PATIENTS AND METHODS: A total of 60 male Sprague-Dawley (SD) rats were randomly divided into Sham group (n = 20), ACI group (n = 20), and TUDCA group (n = 20). The rat model of ACI in middle cerebral artery was established. TUDCA was intravenously injected into rats in the TUDCA group, while an equal amount of sodium bicarbonate solution was intravenously injected into the other two g...
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
CONCLUSIONS: Therapy with combined use of Scs and MSCs has a significant therapeutic effect in repairing optic nerve injury. PMID: 30657568 [PubMed - in process]
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
Authors: Guo LP, Zhang ZJ, Li RT, Li HY, Cui YQ Abstract OBJECTIVE:   To investigate the influences of long non-coding ribonucleic acid (lncRNA) small nucleolar RNA host gene 20 (SNHG20) on proliferation and apoptosis of glioma cells, and further explore the mechanism of SNHG20 in the incidence and development of glioma. PATIENTS AND METHODS: A total of 80 cases of glioma specimens and 80 cases of para-carcinoma specimens were collected, and the expression level of SNHG20 was detected via reverse transcription-polymerase chain reaction (RT-PCR). The human glioma U118 and U251 cell lines with the stable kno...
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
ConclusionsResults from a validated neck model suggest increased cervical muscle force does not influence short term (
Source: Journal of Science and Medicine in Sport - Category: Sports Medicine Source Type: research
More News: Brain | Concussion | Food and Drug Administration (FDA) | Lymphoma | Neurology | Plastic Surgery