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...
by Christian Sinclair (@ctsinclair)We used to publish a lot more article reviews here on Pallimed. Sometimes the analysis would be quite deep and sometimes we would just lump together a while bunch of snippets from key articles. I have been keeping an ever-growing list of articles I would love to write up for the site*, but never seemed to have the time to get to them, and then new ones would come out, that I would want to write about, but they too would just get added to the list. At the end of the year, I would look back on key articles for our field and be pretty bummed out that I never got anything published here about...
This study determined if there are observable patient-, tooth- and crack-level characteristics markedly associated with whether a tooth with an external crack also has an internal crack. METHODS: Two hundred nine dentists in The National Dental Practice-Based Research Network enrolled 2,858 adults with a vital permanent posterior tooth having at least 1 observed external crack. Presence and characteristics of internal cracks were recorded for 435 cracked teeth that were treated. Generalized estimating equations were used to identify significant (P
Researchers at the University of Guelph in Ontario, Canada claim the whey and casein proteins in cow's milk make people feel full and release hormones which reduce blood sugar.
DIABETES type 2 symptoms can be hard to spot and many people with the condition won ’t realise they have it. But if this type of diabetes is left untreated it can lead to more serious health problems. Drinking certain types of alcohol can cause blood sugar levels to spike.
Xiuqing Ji, Qiong Pan, Yan Wang, Yun Wu, Jing Zhou, An Liu, Fengchang Qiao, Dingyuan Ma, Ping Hu, Zhengfeng Xu
In an intriguing study, black patients were far more likely to agree to certain health tests if they discussed them with a black male doctor.
CONCLUSION: Having a spouse who is depressed may increase one's risk of cognitive decline as well as one's risk of depression. Interventions for preventing cognitive decline and depression among older adults may be enhanced by considering the marital context. PMID: 30120019 [PubMed - as supplied by publisher]
ConclusionOur study revealed that early and multiple doses of systemic baicalein attenuated neuropathic pain and improved sciatic nerve function by inhibiting pro-inflammatory cytokine expression and attenuating the activation of astrocytes in the spinal cord.
Authors: Urdaneta J, Arroyo D, Mon C, Abadal J, Gálvez E, Ortiz M, Camacho R, Herrero JC PMID: 30119947 [PubMed - as supplied by publisher]
A new study evaluates the management of emergency situations in patients with chronic adrenal insufficiency.Clinical Endocrinology
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