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...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news

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We report energy band bending of methylammonium lead halide (MAPbI3) perovskite film in contact with indium-tin-oxide (ITO) surface using photoelectron spectroscopy in air (PESA) and ultraviolet photoelectron spectroscopy (UPS) measurements. MAPbI3 perovskite films were vacuum-deposited using co-evaporation of methylammonium iodide (CH3NH3I, MAI) and lead iodide (PbI2) powders. Using PESA and UPS, the highest occupied molecular orbital levels were measured varying the thickness of the perovskite films. Substantial energy band bending close to the ITO surface was not observed. The vacuum-deposited perovskite films feature a...
Source: Results in Physics - Category: Physics Source Type: research
Publication date: Available online 21 September 2018Source: Results in PhysicsAuthor(s): H.H. Zhang, Y. Chen, Z. ZhangAbstractTwo benzaldehyde thiosemicarbazone derivatives namely 3-methoxy,4-hydroxyl-benzaldehyde thiosemicarbazone (MHBT) and 2-hydroxyl,3-methoxy-benzaldehyde thiosemicarbazone (HMBT) were synthesized and their inhibition behavior for mild steel in 1.0 M HCl solution was investigated using gravimetric measurements and electrochemical tests. Weight loss measurements suggested that these two compounds acted as efficient inhibitors for mild steel in 1.0 M HCl solution and the inhibition efficiency reached a ma...
Source: Results in Physics - Category: Physics Source Type: research
Publication date: Available online 21 September 2018Source: Journal of Sound and VibrationAuthor(s): Mou Li, Yao Zhang, Youyi Wang, Quan Hu, Rui QiAbstractA pointing and vibration isolation integrated control method for optical payload in the satellite system with a Pointing and Vibration Control Platform(PVCP) is developed and verified. Firstly, the dynamic model of the satellite system is formulated. This satellite system contains a payload, a PVCP and a satellite body. Three pointing control methods are proposed depending on different measurement information. By comparing the three methods, one reasonable control method...
Source: Journal of Sound and Vibration - Category: Physics Source Type: research
We present a rapid and label-free method for hematologic screening for diseases and syndromes, utilizing quantitative phase imaging (QPI) and machine learning. We aim to establish an efficient blood examination framework that does not suffer from the drawbacks of conventional blood assays, which are incapable of profiling single cells or require labeling procedures. Our method involves the synergistic employment of QPI and machine learning. The high-dimensional refractive index information arising from the QPI-based profiling of single red blood cells is processed to screen for diseases and syndromes using machine learning...
Source: Biosensors and Bioelectronics - Category: Biotechnology Source Type: research
ConclusionThese findings indicate that acute aerobic exercise elicits a higher elevation in plasma level of inflammatory ci-miRNAs in obese than normal-weight individuals, irrespective of cardiorespiratory fitness and indicator of metabolic syndrome (HOMA-IR).
Source: Physiology and Behavior - Category: Physiology Source Type: research
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Source: Physiology and Behavior - Category: Physiology Source Type: research
ConclusionsThe established genetic/mass spectra relatedness between the three post-surgery isolates suggests that these cases may be considered a healthcare-associated mucormycosis outbreak.
Source: Journal of Medical Mycology - Category: Biology Source Type: research
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Source: Sensors and Actuators B: Chemical - Category: Chemistry Source Type: research
In this study, a cheaper, rapid-prototyping, high-sensitivity angle-scanning surface plasmon resonance (SPR) was developed by fused deposition modeling (FDM) 3D printing technology for HbA1c detection. The sensor chip is based on an aptamer that has high affinity and high specificity to HbA1c. The results showed that this HbA1c-specific aptamer had high specificity for HbA1c, and the calculated KD was 6.13 × 10-8 M. The linear detection response of HbA1c appeared in the range of 18 to 147 nM, with a detection limit of 1 nM. This SPR HbA1c detection system could be a promising platform for ...
Source: Sensors and Actuators B: Chemical - Category: Chemistry Source Type: research
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Source: Sensors and Actuators B: Chemical - Category: Chemistry Source Type: research
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