Medtech approvals: FDA releases September 2015 PMAs

The FDA today released its list of the pre-market approvals it granted for medical devices in September 2015: Summary of PMA Originals &Supplements Approved Originals: 4 Supplements: 53 Summary of PMA Originals Under Review Total Under Review: 55 Total Active: 31 Total On Hold: 24 Summary of PMA Supplements Under Review Total Under Review: 611 Total Active: 461 Total On Hold: 150 Summary of All PMA Submissions Originals: 3 Supplements: 84 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 53 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 127.6 FDA Time: 90.9 Days MFR Time: 36.9 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, &ZIP DEVICE DESCRIPTION / INDICATIONS P100006 9/1/15 Augment® Bone Graft Biomimetic Therapeutics, LLC Franklin, TN 37067 Approval for Augment® Bone Graft. This device is indicated for use as an alternative to autograft in arthrodesis (i.e., surgical fusion procedures) of the ankle (tibiotalar joint) and/or hindfoot (including subtalar, talonavicular, and calcaneocuboid joints, alone or in combination), due to osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, psoriatic arthritis, avascular necrosis, joint instability, joint deformity, congenital defect, or joint arthropathy in patients with preoperative or intraoperative evidence indicating the need for supplemental graft material. P1400...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

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Authors: Genovese G, Moltrasio C, Garcovich S, Marzano AV Abstract Pyogenic arthritis, pyoderma gangrenosum (PG) and acne (PAPA) syndrome is an autosomal dominant autoinflammatory syndrome due to mutations in proline-serine-threonine phosphatase interacting protein 1 (PSTPIP1) gene and presenting with cutaneous and articular manifestations. Other autoinflammatory syndromes caused by mutations in PSTPIP1 gene or characterized by clinical findings overlapping with those found in PAPA syndrome have been recently included in the group of PAPA spectrum disorders. These disorders are PASH (PG, acne and hidradenitis suppu...
Source: Giornale Italiano di Dermatologia e Venereologia - Category: Dermatology Tags: G Ital Dermatol Venereol Source Type: research
Authors: Ye J, Zheng Q, Zou L, Yu Q, Veronese N, Grabovac I, Stefanac S, Tzeng HM, Yu JJ Abstract Background: The postural stability is a major factor that helps prevent developing knee osteoarthritis with aging. The aim of this study was to investigate the effects of Baduanjin qigong on postural control and physical function in older adults with knee osteoarthritis. Methods: Fifty-six individuals over 60 years of age with knee osteoarthritis were randomly assigned to either an experimental group (n = 28) or a control group (n = 28). Participants in the experimental group received a ...
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
Conclusions: The present study suggests that a method of SPA combined with higher-order Markov-SPA is relatively effective and can be applied to the clinical prediction of diabetic ulcers, which has higher accuracy than traditional first-order curative effect prediction model. PMID: 32617110 [PubMed]
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
Conclusion: Concomitant use of herbal and conventional antidiabetic medicines was a common practice. Cognizant of its potentially serious herb-drug interactions, efforts should be made to improve awareness and knowledge of healthcare providers about HM potential effects. Further studies on dose, frequency, duration, and modes of interaction are recommended. PMID: 32617109 [PubMed]
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
Authors: Momeni M, Arab M, Dehghan M, Ahmadinejad M Abstract Materials and Methods: This randomized, parallel, single-blind controlled trial study was performed on 75 ICU patients. Patients were allocated into three groups (massage by a nurse, massage by the patient's family, and control group) by the minimization method. Swedish massage was provided for the patients in experimental groups (each foot for 5 minutes) once a day for six days. The pain was examined in all three groups before, immediately, and one week after the intervention. Results: The mean scores of pain in the groups of foot massage by the pati...
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
Conclusion: Overall, our study suggests that strength training through virtual reality training protocol improves pain and sports performances than isokinetic training and other conventional trainings in university football players with chronic low back pain. PMID: 32617104 [PubMed]
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
Isolation of Oxyberberine and β-Sitosterol from Berberis lycium Royle Root Bark Extract and In Vitro Cytotoxicity against Liver and Lung Cancer Cell Lines. Evid Based Complement Alternat Med. 2020;2020:2596082 Authors: Anwar MA, Tabassam S, Gulfraz M, Sheeraz Ahmad M, Raja GK, Arshad M Abstract Berberis lycium Royle has been traditionally used to cure rheumatism, eye and ear diseases, malarial fever, diabetes, stomach disorders, and skin diseases. There is a least amount of data available on cytotoxic capacity of Berberis lycium from Pakistani origin, so on this basis, the present study was aimed ...
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
Conclusion: Tetrapanax papyriferus and hederagenin relieved sciatica by reducing inflammation levels, inhibiting p38 MAPK phosphorylation, and decreasing the levels of dorsal root ganglion proteins. PMID: 32617100 [PubMed]
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
Publication date: Available online 4 July 2020Source: Best Practice &Research Clinical AnaesthesiologyAuthor(s): Kyle Gress, Karina Charipova, Daniel An, Jamal Hasoon, Alan D. Kaye, Antonella Paladini, Giustino Varrassi, Omar Viswanath, Alaa Abd-Elsayed, Ivan Urits
Source: Best Practice and Research Clinical Anaesthesiology - Category: Anesthesiology Source Type: research
Publication date: Available online 3 July 2020Source: Best Practice &Research Clinical AnaesthesiologyAuthor(s): Ivan Urits, Cynthia Pham, Daniel Swanson, Kevin Berardino, Prudhvi Bandi, Ariunzaya Amgalan, Rachel J. Kaye, Jai Won Jung, Alan D. Kaye, Antonella Paladini, Giustino Varrassi, Adam M. Kaye, Laxmaiah Manchikanti, Omar Viswanath
Source: Best Practice and Research Clinical Anaesthesiology - Category: Anesthesiology Source Type: research
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