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 ...
Source: Mass Device - August 20, 2015 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
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 D...
Source: Mass Device - August 6, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
UPDATE: NuVasive beats The Street, closes DoJ probe
UPDATED July 30, 2015, with details on Justice Dept. probe.
NuVasive Inc. (NSDQ:NUVA) posted 2nd-quarter earnings that topped expectations on Wall Street and closed out its $14 million settlement with the U.S. Justice Dept.
San Diego-based NuVasive reported profits of $10.3 million, or 20¢ per share, on sales of $202.9 million for the 3 months ended June 30, marking a swing to profits from losses of -$4.1 million and 6.4% sales growth, compared with Q2 2014.
Adjusted to exclude 1-time items, earnings per share were 31¢, a full 6¢ ahead of expectations on The Street.
“We are pleased to report another strong quar...
Source: Mass Device - July 30, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Legal News MassDevice Earnings Roundup Regulatory/Compliance Nuvasive Source Type: news
Spinal surgery diminishes low back pain, improves sexual function
Chronic low back pain can limit everyday activities, including sex. 70 percent of patients consider sexual activity "relevant" to their life quality, and patients who receive surgical treatment for spinal spondylolisthesis (DS) and spinal stenosis (SS) -- common degenerative conditions most often occurring in older adults -- were twice as likely to report no pain during sex. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - March 24, 2015 Category: Science Source Type: news
How Do You Diagnose Hypermobility?
Discussion
Hypermobility can be seen in several different clinical entities. These include generalized joint hypermobility, joint hypermobility syndrome, Marfan syndrome, Ehlers-Danlos syndrome and Osteogenesis Imperfecta. For adults, a Beighton score of at least 4 or 5 is used as a definition of hypermobility. For children a score of 5 or 6 is used as a definition. (see scoring system below).
Generalized joint hypermobility is hypermobility with few or no symptoms. If they occur, knee symptoms are the most common.
Joint hypermobility syndrome has hypermobility along with other symptoms such as pain, reduced muscle stren...
Source: PediatricEducation.org - February 23, 2015 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news
Spinal Surgery for Patients Over 80
A new study appearing in the February 4th issue of the Journal of Bone & Joint Surgery (JBJS) found significant benefit from surgical treatment for lumbar spinal stenosis with and without degenerative spondylolisthesis - debilitating spinal conditions causing leg and back pain, numbness and weakness - and no higher overall complication rate and no higher mortality for patients age 80 and older when compared to patients younger than age 80. (Source: Disabled World)
Source: Disabled World - February 9, 2015 Category: Disability Tags: Surgery and Operations Source Type: news
Promising results from minimally invasive back surgery
Beaumont research findings published in the February online issue of Spine shows that patients who have a low back surgery called minimally invasive transforaminal lumbar interbody fusion, end up better off in many ways than patients who have more invasive surgery to alleviate debilitating pain."About 90 percent of adults experience low back pain in their lifetime, which can be caused by spinal instability, stenosis, spondylolisthesis, and symptomatic degenerative disc disease," says Mick Perez-Cruet, M.D. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - March 6, 2014 Category: Consumer Health News Tags: Back Pain Source Type: news
Single vs Multilevel Fusion for Spondylolisthesis, StenosisSingle vs Multilevel Fusion for Spondylolisthesis, Stenosis
Which is the best surgical option for single-level degenerative spondylolisthesis with multilevel lumbar stenosis? The SPORT study reports. Spine (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 3, 2013 Category: Consumer Health News Tags: Orthopaedics Journal Article Source Type: news
If Degenerative Cervical Spine Disease Doesn't Progress, Is Surgery Necessary?
Follow-up data on patients with degenerative disease of the upper (cervical) spinal vertebrae show little or no evidence of worsening degeneration over time, according to a study in the journal Spine. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health. For many patients with "unstable" cervical degenerative spondylolisthesis, observation may be a better choice than surgery, according to the new research by Dr Moon Soo Park and colleagues of Medical College of Hallym University, Republic of Korea... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - February 21, 2013 Category: Consumer Health News Tags: Neurology / Neuroscience Source Type: news
