Medtech approvals: FDA releases November 2015 PMAs

The FDA today released its list of the pre-market approvals it granted for medical devices in November 2015: Summary of PMA Originals &Supplements Approved Originals: 3 Supplements: 69 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 30 Total On Hold: 27 Summary of PMA Supplements Under Review Total Under Review: 583 Total Active: 433 Total On Hold: 150 Summary of All PMA Submissions Originals: 4 Supplements: 75 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 69 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 193.4 FDA Time: 103.0 Days MFR Time: 90.4 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, &ZIP DEVICE DESCRIPTION / INDICATIONS P130018 11/24/15 ProACT™ Adjustable Continence Therapy for Men Uromedica, Inc. Plymouth, MN 55441 Approval for the ProACT Adjustable Continence Therapy for Men. This device is indicated for the treatment of adult men who have stress incontinence arising from intrinsic sphincter deficiency of at least twelve months duration following radical prostatectomy or transurethral resection of the prostate (TURP) and who have failed to respond adequately to conservative therapy. P130028 11/20/15 Algovita Spinal Cord Stimulation System Algostim, LLC Blaine, MN 55449 Approval for the Algovita Spinal Cord Stimulation System. This device is indicated as an aid in the management ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

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This study aimed to assess the relative safety and short-term efficacy of drug-eluting bead transarterial chemoembolization (DEB-TACE) and conventional transarterial chemoembolization (c-TACE) for treating peculiar anatomical sites of gastric cancer liver metastasis. MATERIAL AND METHODS Of the 68 patients with gastric cancer liver metastases confirmed by imaging and pathology, 35 were treated with DEB-TACE and 33 with c-TACE. The DEB-TACE group comprised 26 males and 9 females aged 28-75 years (56.8±6.3), and the c-TACE group included 19 males and 14 females aged 33-77 (60.2±9.4) years. Liver functions of th...
Source: Medical Science Monitor - Category: Research Tags: Med Sci Monit Source Type: research
CONCLUSIONS The network pharmacology analysis reveals the molecular biological mechanism of Artemisia annua anti-NSCLC via multiple active components, multi-channels, and multi-targets. This suggests that Artemisia annua might be developed as a promising anti-NSCLC drug. PMID: 32474568 [PubMed - in process]
Source: Medical Science Monitor - Category: Research Tags: Med Sci Monit Source Type: research
Optical scanning holography (OSH) is an attractive technique since 3D information can be obtained with a single pixel detector. However, ...
Source: Optics Letters - Category: Physics Authors: Source Type: research
Source: Journal of Clinical Investigation - Category: Biomedical Science Authors: Source Type: research
New J. Chem., 2020, Accepted Manuscript DOI: 10.1039/D0NJ01814G, PaperGurpreet Kaur, Monika Chaudhary, Kailash C Jena, Narinder Singh Abstract Environmental contamination due to increase in drug level is touching its alarming stage. There is an array of drugs such as antibiotics, antidepressants, analgesics, cancer chemotherapy drugs etc which... The content of this RSS Feed (c) The Royal Society of Chemistry
Source: RSC - New J. Chem. latest articles - Category: Chemistry Authors: Source Type: research
Analyst, 2020, Advance Article DOI: 10.1039/D0AN00627K, PaperJun Liu, Cheng Cao We propose a novel GSH-generating prodrug to be used with a sulfonamide-induced “integrative” platform for selective cancer therapy. To cite this article before page numbers are assigned, use the DOI form of citation above. The content of this RSS Feed (c) The Royal Society of Chemistry
Source: RSC - Analyst latest articles - Category: Chemistry Authors: Source Type: research
Publication date: Available online 31 May 2020Source: Environmental Toxicology and PharmacologyAuthor(s): Badmus O. Olufunto, Njan Anoka, Ologe M. Olufunmilayo, Olatunji A. Lawrence
Source: Environmental Toxicology and Pharmacology - Category: Environmental Health Source Type: research
Hi everyone! I’m looking for advice on which schools to apply to in this cycle. I qualify as Disadvantaged on AMCAS and have FAP so I am able to apply to 20 schools. I’ve left off the Philly schools for personal reasons but am open to any other suggestions for my school list. cGPA: 3.7, sGPA: 3.6 For additional context, I had a really rough first 3 semesters of undergrad which included loss of income for my family, a parent’s cancer diagnosis, and 2 hospitalizations for... WAMC/School List: 3.7 cGPA/3.6 sGPA/515 MCAT
Source: Student Doctor Network - Category: Universities & Medical Training Authors: Tags: What Are My Chances? WAMC Medical Source Type: forums
Publication date: Available online 31 May 2020Source: European Journal of RadiologyAuthor(s): Qi Zhang, Han Ouyang, Feng Ye, Shuang Chen, Lizhi Xie, Xinming Zhao, Xiaoduo Yu
Source: European Journal of Radiology - Category: Radiology Source Type: research
Defects occurring in the femoral–fibular–ulnar developmental field are believed to cause the cluster of anomalies seen with femoral, fibular and ulnar limb deficiencies. Upper limb function must be considered in the management of lower limb deficiencies. The purpose of this study is to determine the frequency and type of upper extremity anomalies found in children with femoral and/or fibular deficiency. A retrospective review of 327 consecutive patients with the diagnosis of femoral and/or fibular deficiency was performed using existing records and radiographs. Characteristics of those with and without upper ex...
Source: Journal of Pediatric Orthopaedics B - Category: Orthopaedics Tags: Upper Limb Source Type: research
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