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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Authors: Kashfi SA, Ghoreishi M, Abtahi SH PMID: 31005283 [PubMed - as supplied by publisher]
Source: Journal Francais d Ophtalmologie - Category: Opthalmology Tags: J Fr Ophtalmol Source Type: research
Source: Journal of Pain and Symptom Management - Category: Palliative Care Source Type: research
Source: Journal of Pain and Symptom Management - Category: Palliative Care Source Type: research
Abstract Cystoscopy and histology are the gold standards for detection of bladder cancer. However, these methods are highly subjective, expensive, and invasive. We have developed a non-invasive method for the diagnosis of bladder cancer by detecting telomerase activity in human urine. Telomerase substrate (TS) primer is elongated with repeating sequences of (TTAGGG)n in the presence of telomerase. The elongated primer can trigger hybridization chain reaction between two hairpins H1 and H2, result in the aggregation of AuNPs due to the hybridization between the tail sequence on H1 (or H2) and DNA-AuNPs probe, and a...
Source: Analytica Chimica Acta - Category: Chemistry Authors: Tags: Anal Chim Acta Source Type: research
Conclusions: Limberg flap reconstruction for pilonidal sinus in the setting of acute abscess is a viable option with outcomes comparable to that for disease without acute abscess. This practice will avoid the pain and cost associated with a prolonged local wound care regimen involved in drainage of the abscess prior to flap reconstruction. PMID: 31006184 [PubMed - as supplied by publisher]
Source: Archives of Plastic Surgery - Category: Cosmetic Surgery Tags: Arch Plast Surg Source Type: research
We describe a case of a patient with severe intellectual disability and an open fracture of the distal lower limb. After fracture management and debridement of devitalized tissues, the resultant soft tissue defect was covered with a free gracilis flap. On postoperative day 7, the patient ripped out the newly transplanted flap. The flap was too traumatized for salvage, so a contralateral free gracilis muscle flap was used. The patient showed good aesthetic and functional outcomes at a 1-year follow-up. When planning the postoperative management of patients with psychiatric illness, less complex and more robust procedures ma...
Source: Archives of Plastic Surgery - Category: Cosmetic Surgery Tags: Arch Plast Surg Source Type: research
Bacteria that are difficult or impossible to treat are being spread around the world, fueled by everything from flippant doctors to lax regulation, sewage, anti-vaxxers and international travel, experts warn.
Source: the Mail online | Health - Category: Consumer Health News Source Type: news
ConclusionsCase series and case reports suggest that neuromodulation therapies can abort SE in 80-100% of patients (Oxford scale and GRADE were level 4 and D) with a wide range of adverse effects, which claims for prospective studies on the relationship be-tween efficacy and safety.
Source: Brain Stimulation - Category: Neurology Source Type: research
AbstractNumerous attempts to develop an early diagnosis of Parkinson ’s disease (PD) by searching biomarkers in biological fluids were unsuccessful. The drawback of this methodology is searching markers in patients at the clinical stage without guarantee that they are also characteristic of either preclinical stage or prodromal stage (preclinical–prodromal stage) . We attempted to upgrade this methodology by selecting only markers that are found both in patients and in PD animal models. HPLC and RT-PCR were used to estimate the concentration of amino acids, catecholamines/metabolites in plasma and gene expressi...
Source: Molecular Neurobiology - Category: Neurology Source Type: research
AbstractBioactive sphingolipids: sphingosine, sphingosine-1-phosphate (S1P), ceramide, and ceramide-1-phosphate (C1P) are increasingly implicated in cell survival, proliferation, differentiation, and in multiple aspects of stress response in the nervous system. The opposite roles of closely related sphingolipid species in cell survival/death signaling is reflected in the concept of tightly controlledsphingolipid rheostat. Aging has a complex influence on sphingolipid metabolism, disturbing signaling pathways and the properties of lipid membranes. A metabolicsignature of stress resistance-associated sphingolipids correlates...
Source: Molecular Neurobiology - Category: Neurology Source Type: research
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