Medtech approvals: FDA releases August 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015: Summary of PMA Originals &Supplements Approved Originals: 2 Supplements: 70 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 28 Total On Hold: 29 Summary of PMA Supplements Under Review Total Under Review: 569 Total Active: 422 Total On Hold: 147 Summary of All PMA Submissions Originals: 5 Supplements: 90 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 70 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 229.0 FDA Time: 130.3 Days MFR Time: 98.7 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, &ZIP DEVICE DESCRIPTION / INDICATIONS P140008 8/5/15 Orbera™ Intragastric Balloon Apollo Endosurgery, Inc. Austin, TX 78746 Approval for the Orbera Intragastric Balloon. The ORBERA™ Intragastric Balloon System is indicated for use as an adjunct to weight reduction for adults with obesity with Body Mass Index (BMI) of ≥ 30 and ≤ 40 kg/m2 and is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of significant long-term weight loss and maintenance of that weight loss. ORBERA™ is indicated for adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and beha...
Three women describe living with the intense pain and heavy periods caused by adenomyosis.
Taking a closer look at PROTEUS, an intriguing study in patients with high-risk proliferative diabetic retinopathy.Medscape Ophthalmology
The objective of this study was to evaluate the distance of the crest of alveolar ridge to the cementoenamel junction (CEJ) of the lower second molars and the bone density of the third molar socket filled with Gen-Tech ®, 5 years after an exodontia using cone beam computed tomography (CBCT) to visualize the central region of the sockets, without overlapping of the buccal and lingual cortical bones. Material and Methods A total of 12 individuals from an initial group of 39 patients submitted to extraction of the unruptured lower third molars and grafting of an association of inorganic bovine bone matrix, organic bovine ...
(MedPage Today) -- U-shaped association for girls, while boys saw more obesity with less self-regulation
A 58-year-old man presents with a cough, dyspnea, and chest pain. Chest imaging shows the presence of pleural effusion, and a biopsy is obtained. What is your diagnosis?
DIABETES symptoms aren ’t always obvious and can take a long time to develop - particularly with type 2 diabetes people with the condition won’t show any signs at all. For many people a few drinks is part of ever day life, but when you have diabetes or you’re trying to prevent it, it’s a bit more complicated. Ther e are four things you should make sure to do after a night of alcohol.
The Johnson &Johnson Institute has recently launched a virtual reality training program designed to prepare orthopedic surgeons and nurses for a couple common procedures. The program will expand to other surgeries, but for now it’s focusing...
Researchers at the UAB ’s comprehensive Diabetes Center have discovered a safe and effective therapy to reduce insulin requirements and hypoglycemic episodes in adult subjects with recent onset Type 1 diabetes by promoting the patient’s own beta cell function and insulin production – the first such discovery to targ et diabetes in this way. The findings reveal that regular oral application of verapamil, a common blood pressure medication, also enabled patients to produce higher levels of their…
Scientists believe the results say it’s likely that dogs make bacteria in the home and the body more diverse, and therefore help strengthen the immune system.
Putting in long hours at the office could make you more likely to get diabetes, heart disease and psychiatric disorders, research suggests.
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