Medtech approvals: FDA releases August 2015 PMAs

The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015: Summary of PMA Originals &Supplements Approved Originals: 2 Supplements: 70 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 28 Total On Hold: 29 Summary of PMA Supplements Under Review Total Under Review: 569 Total Active: 422 Total On Hold: 147 Summary of All PMA Submissions Originals: 5 Supplements: 90 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 70 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 229.0 FDA Time: 130.3 Days MFR Time: 98.7 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, &ZIP DEVICE DESCRIPTION / INDICATIONS P140008 8/5/15 Orbera™ Intragastric Balloon Apollo Endosurgery, Inc. Austin, TX 78746 Approval for the Orbera Intragastric Balloon. The ORBERA™ Intragastric Balloon System is indicated for use as an adjunct to weight reduction for adults with obesity with Body Mass Index (BMI) of ≥ 30 and ≤ 40 kg/m2 and is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of significant long-term weight loss and maintenance of that weight loss. ORBERA™ is indicated for adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and beha...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news

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CONCLUSION: Initial results illustrate how a shift from paper-based documentation to an integrated eHealth service can improve communication and documentation in an independent therapy network. PMID: 31118341 [PubMed - in process]
Source: Studies in Health Technology and Informatics - Category: Information Technology Tags: Stud Health Technol Inform Source Type: research
Authors: Jung O, Glachs D, Strohmeier F, Mulrenin R, Huisman S, Smith I, van Keulen H, Sont J, Ploessnig M Abstract The number of people with diabetes is increasing in every European country and like all chronic diseases it cannot be cured. However, patient empowerment is an acknowledged strategy for improving the patients' health situation. This paper describes the Action Plan Engine developed as a tool for diabetes patients in the POWER2DM project. The Action Plan Engine offers a guided workflow based on treatment goals and activities. A periodic review evaluates how successful a patient has fulfilled these goals...
Source: Studies in Health Technology and Informatics - Category: Information Technology Tags: Stud Health Technol Inform Source Type: research
Authors: Denecke K, Jolo P, Sevinc B, Nüssli S Abstract Diabetes mellitus (DM) is a chronic disease that affects many people in Switzerland and around the world. Once diagnosed, a patient has to continuously monitor blood glucose, manage medications or inject insulin. Technical skills and competencies as well as knowledge on disease management have to be acquired right after being diagnosed. Diabetes consultants support patients in this process and provide educational material. While the process of generating patient-tailored material is currently complex and time consuming, in future, the eDiabetes platform c...
Source: Studies in Health Technology and Informatics - Category: Information Technology Tags: Stud Health Technol Inform Source Type: research
CONCLUSION: Hearing performance was significantly better with ADHEAR under all test conditions except those where maximum perception was already achieved without ADHEAR. PMID: 31119336 [PubMed - as supplied by publisher]
Source: HNO - Category: ENT & OMF Tags: HNO Source Type: research
Authors: Daida H, Dohi T, Fukushima Y, Ohmura H, Miyauchi K Abstract Enormous effort has been put into the prevention of atherosclerosis through risk modification, especially with lipid-lowering therapies. Regression, that is, the reversal of the atherosclerosis process, has long been a goal of atherosclerosis research among basic and clinical investigators. Intravascular ultrasound (IVUS) was developed in the 1990s as an intracoronary imaging technique to observe the details of the vessel walls and to measure the vessel lumen and plaque area with high reproducibility. Compared with the coronary angiogram, IVUS pro...
Source: Journal of Atherosclerosis and Thrombosis - Category: Cardiology Tags: J Atheroscler Thromb Source Type: research
This study aimed to investigate if hyperinsulinemia and/or insulin resistance was correlated with the occurrence of papillary thyroid cancer (PTC) in a group of Chinese patients. 258 inpatients were included in the study. According to the postoperative pathology results, all subjects were divided into PTC (n = 153) and control groups (with benign thyroid nodules, n = 105). Body mass index (BMI), fasting glucose, fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR), thyroid-stimulating hormone (TSH), FT4, FT3, thyroid peroxidase antibody (TPOAb), thyroglobulin antibody (TGAb), serum uric acid (UA), ...
Source: Endocrine Journal - Category: Endocrinology Tags: Endocr J Source Type: research
Double-wedge prism scanners are typically used for one-dimensional (1D) scanning in imaging systems. This type of scanner operates on the principle of two identical wedge prisms counter-rotating around the optical axis with identical angular velocity in order to move the image formed by the optical ...
Source: Applied Optics - Category: Physics Authors: Source Type: research
Authors: Dhamane AD, Baker CL, Rajpura J, Mardekian J, Dina O, Russ C, Rosenblatt L, Lingohr-Smith M, Lin J Abstract Objective: To compare the risk of hospitalization and costs associated with major bleeding (MB) or stroke/systemic embolism (SE) among elderly patients with nonvalvular atrial fibrillation (NVAF) who initiated apixaban then switched to another oral anticoagulant (OAC) vs. those who continued with apixaban treatment. Methods: NVAF patients (≥65 years) initiating apixaban were identified from the Humana database (1/1/2013-9/30/2017) and grouped into Switcher and Continuer cohorts. For Switchers, the...
Source: Current Medical Research and Opinion - Category: Research Tags: Curr Med Res Opin Source Type: research
Authors: Nishiyama A, Wakabayashi H, Nishioka S, Nagano A, Momosaki R Abstract Our aim was to clarify the nutritional status and energy intake needed for activities of daily living (ADL) improvement among convalescent stroke patients. This retrospective cohort study of stroke patients used data from the Japan Rehabilitation Nutrition Database. Mean energy intake per ideal body weight was 26 kcal/kg/day at 1 week after hospitalization. Patients were divided into two groups according to energy intake: ≥26 kcal/kg/day (high) and
Source: Neurologia Medico-Chirurgica - Category: Neurosurgery Tags: Neurol Med Chir (Tokyo) Source Type: research
Publication date: Available online 24 May 2019Source: Life SciencesAuthor(s): Feng-Ling Yu, Jun-Wen Wu, He ZhuAbstractAimAcetaminophen (APAP) overdose is the most frequent cause of drug-induced liver damage. Magnolia officinalis is a traditional hepatoprotective Chinese medicine and Honokiol (HO) is the major active constituent. The present study was to investigate the effect of HO on APAP-induced hepatotoxicity and related mechanisms.Main methodsFour groups of mice were subjected to treatment as vehicle, APAP, APAP + HO and APAP + HO + NRF2 inhibitor. The morphological and biochemical assessments were used to ...
Source: Life Sciences - Category: Biology Source Type: research
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