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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Trabectedin is used routinely in the palliative management of patients with advanced soft tissue sarcoma. It is not generally considered to be cardiotoxic, and there is no specific caution for its use in patients with a history of cardiac disease or risk factors. Here, we report six cases from a single academic centre where life-threatening cardiotoxicity occurred acutely during treatment with trabectedin. These patients had a median age of 72.5 years (range: 68–81) at presentation with cardiotoxicity, significantly higher than the median ages of patients treated with trabectedin in clinical trials. Cardiotoxicity oc...
Source: Anti-Cancer Drugs - Category: Cancer & Oncology Tags: CASE REPORTS Source Type: research
Authors: Zewari S, Hadi L, van den Elshout F, Dekhuijzen R, Heijdra Y, Vos P Abstract COPD and obesity often coexist and there is a complex interaction between them. Our aim was to evaluate the prevalence of obesity in a secondary care COPD population. Furthermore, the presence of comorbidities in obese (COPDOB) and non-obese COPD (COPDNO) individuals was studied. In 1654 COPD patients (aged ≥18 years) who visited a pulmonologist between January 2015 and December 2015, patient characteristics, pulmonary function tests and comorbidities were obtained from the medical records. Subjects were categorized according t...
Source: COPD: Journal of Chronic Obstructive Pulmonary Disease - Category: Respiratory Medicine Tags: COPD Source Type: research
Cancer Network speaks with Dr. Leon Ptaszek about managing cancer patients who have atrial fibrillation and are being treated with BTK inhibitors.
Source: CancerNetwork - Category: Cancer & Oncology Authors: Source Type: news
Whether bleeding should be considered a sufficient sign to justify thorough cancer surveillance in atrial fibrillation (AF) patients receiving nonvitamin K antagonist oral anticoagulants (NOACs) remains unclear. We investigated the relationships between bleeding events and new-onset cancers in AF patients receiving NOACs in a prospective cohort (n  = 395, mean follow-up duration of 2.8 years). There were 18 patients who were diagnosed with new-onset cancers 584 ± 372 days after the initiation of NOACs.
Source: The American Journal of Cardiology - Category: Cardiology Authors: Source Type: research
Whether bleeding should be considered a sufficient sign to justify thorough cancer surveillance in atrial fibrillation (AF) patients receiving non-vitamin K antagonist oral anticoagulants (NOACs) remains unclear. We investigated the relationships between bleeding events and new-onset cancers in AF patients receiving NOACs in a prospective cohort (n=395, mean follow-up duration of 2.8 years). There were 18 patients who were diagnosed with new-onset cancers 584 ±372 days after the initiation of NOACs.
Source: The American Journal of Cardiology - Category: Cardiology Authors: Source Type: research
ConclusionsPreoperative asymptomatic PFO was independently associated with postoperative adverse events. Moreover, 11% of patients who had negative TCDs at baseline, presented asymptomatic PFOs at discharge. Larger prospective studies are needed to further investigate for a prognostic impact of PFO in thoracic surgery.
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
CONCLUSIONS:  Preoperatively calculated CHA2DS2-VASc score can predict POAF in patients undergoing pulmonary lobectomy. Age is the most statistically significant independent predictor, and patients with scores ≥5 have significantly increased risk. Trials for POAF prophylaxis should target this population. PMID: 30485896 [PubMed - as supplied by publisher]
Source: The Thoracic and Cardiovascular Surgeon - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Thorac Cardiovasc Surg Source Type: research
Conclusions Preoperatively calculated CHA2DS2-VASc score can predict POAF in patients undergoing pulmonary lobectomy. Age is the most statistically significant independent predictor, and patients with scores ≥5 have significantly increased risk. Trials for POAF prophylaxis should target this population. [...] Georg Thieme Verlag KG Stuttgart · New YorkArticle in Thieme eJournals: Table of contents  |  Abstract  |  Full text
Source: The Thoracic and Cardiovascular Surgeon - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Original Thoracic Source Type: research
ConclusionFluoroscopy dose could be significantly reduced using an optimized X-ray dosing program in a novel X-ray detector without increasing total fluoroscopy time and without alterations of the incidence of recurrences or complications.
Source: European Journal of Radiology - Category: Radiology Source Type: research
Conclusions: Zanubrutinib was shown to be highly active in patients with R/R MCL, as demonstrated by a high rate of CR documented by PET-based imaging. Zanubrutinib was generally well-tolerated, consistent with previous reports of zanubrutinib treatment in patients with various B-cell malignancies.DisclosuresSong: Peking University Cancer Hospital (Beijing Cancer Hospital): Employment. Zhou: Affiliated Cancer Hospital of Zhengzhou University: Employment; Health and Family Planning Commission of Henan Province: Patents &Royalties: Scientific and technological innovative talents "51282" Project leaders; Henan C...
Source: Blood - Category: Hematology Authors: Tags: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma-Clinical Studies: Prognostic Markers and Therapies in Mantle Cell Lymphoma and Waldenstrom ' s Macroglobulinemia Source Type: research
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