Medtech approvals: FDA releases June 2015 PMAs

The FDA today released its list of the pre-market approvals it granted for medical devices in June 2015: Summary of PMA Originals &Supplements Approved Originals: 5 Supplements: 80 Summary of PMA Originals Under Review Total Under Review: 53 Total Active: 22 Total On Hold: 31 Summary of PMA Supplements Under Review Total Under Review: 575 Total Active: 418 Total On Hold: 157 Summary of All PMA Submissions Originals: 4 Supplements: 72 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 80 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 115.2 FDA Time: 97.1 Days MFR Time: 18.1 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, &ZIP DEVICE DESCRIPTION / INDICATIONS P120024 6/11/15 activL® Artificial Disc Aesculap Implant Systems, LLC Center Valley, PA 18034 Approval for the activL® Artificial Disc. This device is indicated for reconstruction of the disc at one level (L4-L5 or L5- S1) following single-level discectomy in skeletally mature patients with symptomatic degenerative disc disease (DDD) with no more than Grade I spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. The activL® Artificial Disc is implanted using an anterior retroperitoneal approach. Patients receiving the activL® Arti...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

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AbstractInformation technology can be an important facilitator of social inclusion for people with disabilities into society. However, the goals specified in this area by organizations such as the European Commission have not yet been achieved in their totality. The aim of this paper is to explore which types of information communication technology-based applications and/or digital services have been suggested to facilitate the social integration of people who suffer from different types of disabilities. We performed a literature review that included studies published during a period of 6  years (2010–2016). The...
Source: Health and Technology - Category: Information Technology Source Type: research
Conclusions/Importance: Although HCV testing and positive status rates are high among PWID in our study, few have received HCV treatment. Innovative initiatives to increase access to HCV treatment for PWID are urgently needed. PMID: 29932800 [PubMed - as supplied by publisher]
Source: Substance Use and Misuse - Category: Addiction Tags: Subst Use Misuse Source Type: research
Journal Name: Journal of Pediatric Endocrinology and Metabolism Issue: Ahead of print
Source: Journal of Pediatric Endocrinology and Metabolism - Category: Endocrinology Source Type: research
CONCLUSION: First line management of infertility once a diagnosis of PCOS is made should include weight loss and exercise with goals to below class 2 obesity (BMI
Source: Journal of Obstetrics and Gynaecology Canada : JOGC - Category: OBGYN Tags: J Obstet Gynaecol Can Source Type: research
CONCLUSION: There was a trend towards an increase in latency interval between cases of PV-PROM managed by SR and expectant management in our institution. When combined with the existing literature data, there may be an improvement in latency. PMID: 29921428 [PubMed - in process]
Source: Journal of Obstetrics and Gynaecology Canada : JOGC - Category: OBGYN Tags: J Obstet Gynaecol Can Source Type: research
(MedPage Today) -- But GDM diagnosed after 26 weeks'gestation not associated with excess risk versus no diabetes
Source: MedPage Today Cardiovascular - Category: Cardiology Source Type: news
A new study adds evidence to the ongoing insulin price controversy in the US, finding that 25% of patients with diabetes underuse insulin on cost grounds, which adversely affects their glycemic control.Medscape Medical News
Source: Medscape Medical News Headlines - Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news
Journal Name: Clinical Chemistry and Laboratory Medicine (CCLM) Issue: Ahead of print
Source: Clinical Chemistry and Laboratory Medicine - Category: Laboratory Medicine Source Type: research
A Houston hospital that suspended its renowned heart transplant program for two weeks amid scrutiny following the deaths of two patients could lose federal Medicaid funding
Source: ABC News: Health - Category: Consumer Health News Tags: Health Source Type: news
(MedPage Today) -- This week's topics include the emotional consequences of gun violence, a single test to diagnose diabetes, use of medicines to help addiction after opioid overdose, and screening for abdominal aortic aneurysm
Source: MedPage Today Psychiatry - Category: Psychiatry Source Type: news
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