Medtech approvals: FDA releases May 2015 PMAs

The FDA today released its list of the pre-market approvals it granted for medical devices in May 2015: Summary of PMA Originals &Supplements Approved Originals: 5 Supplements: 51 Summary of PMA Originals Under Review Total Under Review: 55 Total Active: 26 Total On Hold: 29 Summary of PMA Supplements Under Review Total Under Review: 547 Total Active: 379 Total On Hold: 168 Summary of All PMA Submissions Originals: 1 Supplements: 62 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 51 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 109.5 FDA Time: 86.4 Days MFR Time: 23.1 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, &ZIP DEVICE DESCRIPTION / INDICATIONS P130022 5/8/15 Nevro Senza Spinal Cord Stimulation (SCS) System Nevro Corporation Menlo Park, CA 94025 Approval for the Nevro Senza SCS System. This device is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, and leg pain. P140002 5/22/15 Misago Peripheral Self-Expanding Stent System Terumo Medical Corporation Elkton, MD 21921 Approval for the Misago Peripheral Self-expanding Stent System. This device is indicated to improve luminal diameter in symptomatic patients with de novo or restenotic native lesions or ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

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CONCLUSION On the whole, FDA seems very enthusiastic about the possibilities for AI to improve healthcare.  That’s gratifying to see. While progress in the development of a new regulatory approach is slow, that’s also not all bad. It would be worse in many ways for FDA to act precipitously.  These are complicated issues, and it will take time to develop an appropriate approach, in part because it will take time for FDA to acquire enough expertise. And most likely, whatever new approach we come up with will require new statutory authority. That said, it is incumben...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news
Source: Clinics - Category: General Medicine Source Type: research
CONCLUSION: Survival across the two time periods remained stable for oral SCC but showed a significant increase for oropharyngeal SCC, possibly because of improvements in the patients ’ response to radiotherapy, such as intensity-modulated radiation therapy, and the use of more accurate diagnostic imaging approaches.
Source: Clinics - Category: General Medicine Source Type: research
CONCLUSION: Roux-en-Y gastric bypass successfully reduced weight, BMI, and comorbidities and medication use and cost at 24 months in Brazilian patients treated in the public Unified Health System.
Source: Clinics - Category: General Medicine Source Type: research
ABSTRACT Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related mortality worldwide. The Brazilian Society of Hepatology (SBH) published in 2015 its first recommendations about the management of HCC. Since then, new data have emerged in the literature, prompting the governing board of SBH to sponsor a single-topic meeting in August 2018 in S ão Paulo. All the invited experts were asked to make a systematic review of the literature reviewing the management of HCC in subjects with cirrhosis. After the meeting, all panelists gathered together for the discussion of the topics and the elaboration o...
Source: Arquivos de Gastroenterologia - Category: Gastroenterology Source Type: research
Conclusions: Prediagnosis use of metformin dose ≤1500 mg/d is associated with longer overall survival of elderly diabetic HCC patients.
Source: Journal of Clinical Gastroenterology - Category: Gastroenterology Tags: LIVER, PANCREAS & BILIARY TRACT: Original Articles Source Type: research
No abstract available
Source: Diseases of the Colon and Rectum - Category: Gastroenterology Tags: Editorial Source Type: research
This study was conducted at the Radiation-Oncology Department of a tertiary center. PATIENTS: Patients with rectal cancer,
Source: Diseases of the Colon and Rectum - Category: Gastroenterology Tags: Original Contributions: Colorectal Cancer Source Type: research
BACKGROUND: Minimally invasive surgical techniques are routinely promoted as alternatives to open surgery because of improved outcomes. However, the impact of robotic surgery on certain subsets of the population, such as frail patients, is poorly understood. OBJECTIVE: The purpose of our study was to examine the association between frailty and minimally invasive surgical approaches with colon cancer surgery. DESIGN: This is a retrospective study of prospectively collected outcomes data. Thirty-day surgical outcomes were compared by frailty and surgical approach using doubly robust multivariable logistic regression ...
Source: Diseases of the Colon and Rectum - Category: Gastroenterology Tags: Original Contributions: Colorectal Cancer Source Type: research
CONCLUSIONS: Overall survival was good in both subgroups and comparable to literature. The mean costs per patient differ between the watch-and-wait subgroup (€6713) and the total mesorectal excision subgroup (€17,108). No comparison between the groups could be made. Based on the results of this study, the current strategy, where patients with a clinical complete response are treated in a watch-and-wait policy, and patients with an incomplete response are treated with total mesorectal excision, is likely to be (cost)saving. See Video Abstract at http://links.lww.com/DCR/B177. RESULTADOS ONCOLÓGICOS Y COS...
Source: Diseases of the Colon and Rectum - Category: Gastroenterology Tags: Original Contributions: Colorectal Cancer Source Type: research
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