It Seems To Me The TGA Has A Lot Of Catching Up To Do As A Medical Device Regulator.

This appeared a few days ago:TGA to reform regulation for software as medical devices as apps, AI and 3D printing in healthcare boomLynne Minion | 11 Oct 2018 Health apps, diagnostic AI systems and the 3D printing of body parts are among the tech innovations that could soon be subject to strengthened oversight, with the Therapeutic Goods Administration planning to put forward regulatory amendments for the emerging technologies.Within its new business plan for 2018-19, the TGA said software as a medical device – such as the recently announced Apple Watch 4, which includes an atrial fibrillation-detecting algorithm and an ECG – will soon need to jump through custom-fit hoops.In response to the “complicated and dynamic” healthcare landscape, the TGA is chasing the health tech pioneers to put in plac e rules that manage risk and weed out the cowboys.“Scientific advancements such as new cancer treatments and new technologies such as 3D bio-printing continue to bring opportunities for... This is the initial part of the post - read more by clicking on the title of the article. David.
Source: Australian Health Information Technology - Category: Information Technology Authors: Source Type: blogs

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Giuseppe Ristagno1*, Francesca Fumagalli1, Barbara Bottazzi2, Alberto Mantovani2,3,4, Davide Olivari1, Deborah Novelli1 and Roberto Latini1 1Department of Cardiovascular Research, Mario Negri Institute for Pharmacological Research IRCCS, Milan, Italy 2Humanitas Clinical and Research Center-IRCCS, Milan, Italy 3Humanitas University, Milan, Italy 4The William Harvey Research Institute, Queen Mary University of London, London, United Kingdom The long pentraxin PTX3 is a member of the pentraxin family produced locally by stromal and myeloid cells in response to proinflammatory signals and microbial moieties. The p...
Source: Frontiers in Immunology - Category: Allergy & Immunology Source Type: research
Conclusions: CG-FAST scale could be an effective and simple scale for accurate identification of LVOS among AIS patients. Introduction Large vessel occlusion stroke (LVOS) often leads to severe disability and mortality. Although endovascular therapy (EVT) has been proved to be effective for LVOS patients (1–9), especially in anterior circulation, its benefit is highly time-dependent (10, 11). As hospitals with around-the-clock endovascular capability are scarce in many parts of the world and patients admitted directly to a CSC would have better outcomes than those receiving drip and ship treatment (12, 13), thi...
Source: Frontiers in Neurology - Category: Neurology Source Type: research
Siriluck Ponsuksili1, Nares Trakooljul1, Frieder Hadlich1, Karen Methling2, Michael Lalk2, Eduard Murani1 and Klaus Wimmers1,3* 1Leibniz Institute for Farm Animal Biology (FBN), Institute for Genome Biology, Functional Genome Analysis Research Unit, Dummerstorf, Germany 2Institute for Biochemistry – Metabolomics, University of Greifswald, Greifswald, Germany 3Faculty of Agricultural and Environmental Sciences, University of Rostock, Rostock, Germany Given the central metabolic role of the liver, hepatic metabolites and transcripts reflect the organismal physiological state. Biochemical-clinical plasma bio...
Source: Frontiers in Genetics - Category: Genetics & Stem Cells Source Type: research
(CNN) — Hey, sleepyheads. What you believe about sleep may be nothing but a pipe dream. Many of us have notions about sleep that have little basis in fact and may even be harmful to our health, according to researchers at NYU Langone Health’s School of Medicine, who conducted a study published Tuesday in the journal Sleep Health. “There’s such a link between good sleep and our waking success,” said lead study investigator Rebecca Robbins, a postdoctoral research fellow in the Department of Population Health at NYU Langone Health. “And yet we often find ourselves debunking myths, whether ...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - Category: Consumer Health News Authors: Tags: Health Healthwatch News CNN Sleep Source Type: news
in N, Serrano I, Midwinter W, Wilk A, Bardaji A, Ingold N, Buchan R, Tayal U, Pascual-Figal DA, de Marvao A, Ahmad M, Garcia-Pinilla JM, Pantazis A, Dominguez F, Baksi AJ, O'Regan DP, Rosen SD, Prasad SK, Lara-Pezzi E, Provencio M, Lyon AR, Alonso-Pulpon L, Cook SA, DePalma SR, Barton PJR, Aplenc R, Seidman JG, Ky B, Ware JS, Seidman CE Abstract BACKGROUND: Cancer therapy-induced cardiomyopathy (CCM) is associated with cumulative drug exposures and pre-existing cardiovascular disorders. These parameters incompletely account for substantial inter-individual susceptibility to CCM. We hypothesized that rare variants ...
Source: Circulation - Category: Cardiology Authors: Tags: Circulation Source Type: research
Conclusion: In ischemic stroke or TIA patients with platelet count within normal range, platelet count may be a qualified predictor for long-term recurrent stroke, mortality, and poor functional outcome. Introduction Platelets exert a critical role in the pathogenesis of atherosclerotic complications of cardio-cerebrovascular disease, contributing to thrombus formation, and embolism (1, 2). Previous literature reported that platelets of various size and density are produced by megakaryocytes of different size and stages of maturation in different clinical conditions, suggesting various platelet patterns in differen...
Source: Frontiers in Neurology - Category: Neurology Source Type: research
Conditions:   Atrial Fibrillation;   Cancer Intervention:   Sponsor:   Heart Care Foundation Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
This study was approved by the ethics committee of the medical faculty of the Ruhr University Bochum. FIGURE 1 Figure 1. Flow chart showing the selection of the study population. Results A total of 59 patients underwent emergency CCTA (Figure 2A) for suspected stroke, of which 44 received the final diagnosis ischemic stroke. There were 17 patients who had ischemic stroke or TIA and known or newly diagnosed atrial fibrillation (Table 1; mean age: 77.5 years, standard deviation: 8.4 years; 53% female). As hypothesized, intracardiac thrombi could be visualized: once in an artificially occluded left atrial appe...
Source: Frontiers in Neurology - Category: Neurology Source Type: research
ntaro Inamura Lung cancer is the leading cause of cancer-related deaths worldwide. Although molecular therapies have emerged as efficacious strategies for the treatment of lung cancer, surgical resection is still recommended as a radical therapeutic option. Currently, lobectomy is regarded as the most reliable radical treatment of primary lung cancer. Among the various complications after lobectomy, cerebral thromboembolism requires attention as a life-threatening complication during the early postoperative period. It occurs in 0.2–1.2% of surgical cases of lung cancer and typically develops following left up...
Source: Cancers - Category: Cancer & Oncology Authors: Tags: Review Source Type: research
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