FDA Compliance Boot Camp 2016

Imagine getting inside the head of a working FDA inspector ... receiving the same training the inspector gets ... knowing which problems face the most scrutiny ... all before your next inspection. Here's how. Are you confident you'll sail through your next inspection? You can be when you have the same training the FDA gives its own inspectors. Know what to expect when the next inspector walks through your door -- from what the agency trains its investigators to look for ... to which pr...
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Carbon Nanotube-Based Sensor Detects Toxins With a Mobile Phone

Researchers have developed a chemical sensing material consisting of a group of carbon nanotubes individually wrapped with supramolecular polymers that can be used with a mobile phone to detect toxins. Chemical sensors offer opportunities for improving personal security, safety, and health. To enable broad adoption of chemical sensors requires performance and cost advantages that are best realized from innovations in the design of the sensing (transduction) materials. Ideal materials a...
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SONON is world’s first wireless portable ultrasound equipment.

SONON is world's first wireless portable ultrasound equipment. It supports iOS and Android mobile phone or tablet. It seems like you can do anything with your smartphone these days. How about using it as a portable ultrasound scanner? South Korean start-up Healcerion wants to make that a reality with Sonon, a portable ultrasound system that runs on Android or iOS mobile devices. Currently targeted for ob/gyn applications, the Sonon linear probe wirelessly sends image data to an app running...
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University of California – New Injectable Hydrogel Encourages Regeneration and Improves Functionality After a Heart Attack

University of California, San Diego bioengineers have demonstrated in a study in pigs that a new injectable hydrogel can repair damage from heart attacks, help the heart grow new tissue and blood vessels, and get the heart moving closer to how a healthy heart should. The results of the study were published Feb. 20 in Science Translational Medicine and clear the way for clinical trials to begin this year in Europe. The gel is injected through a catheter without requiring surgery or general anesth...
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Harvard University – The first autonomous, entirely soft robot

A team of Harvard University researchers with expertise in 3D printing, mechanical engineering, and microfluidics has demonstrated the first autonomous, untethered, entirely soft robot. This small, 3D-printed robot — nicknamed the octobot — could pave the way for a new generation of completely soft, autonomous machines. In this video, see the octobot in action. It is the first entirely soft, autonomous robot, made by a combination of embedded 3D printing, modeling, and soft lithography. Credit:...
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Allergy Amulet brings food allergy sufferers a fast and portable allergen detection device

Allergy Amulet is a rapid, portable, point-of-consumption allergen detection device. Users will wear the device as a necklace, bracelet, or carry it in their pocket or purse. The first Amulet will detect peanut allergens; future Amulets will detect other common food allergens and ingredients. Amulet uses a molecularly imprinted polymer that can capture the presence of an allergen in seconds. The polymer has synthetic cavities that match specific allergens in shape, charge, and other molec...
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Cleveland Clinic – Mobile Stroke Treatment Unit

Each year in the United States, nearly 800,000 people suffer a stroke, or a brain attack. This occurs when an artery that supplies blood to part of the brain becomes blocked or ruptures and leads to bleeding in the brain. In ischemic strokes, a blood clot is the triggering event, while the remaining 10 percent of strokes are called hemorrhagic and a burst blood vessel or aneurysm is typically the cause. Strokes occur frequently: Once every 40 seconds, while every four minutes an American dies...
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Prep Pad : The Smart Scale

Prep Pad + Countertop Prep Pad is the smart food scale that gives real-time nutritional insight into your food through a customized Balance goal and beautiful visualizations of calories, carbs, protein, and more. Meet your kitchen nutritionist,skip the fads, get the facts. Get an accurate nutritional breakdown of the meals you make at home with the simple-but smart-food scale, Prep Pad, and its partner app, Countertop. Set nutritional goals, make and log your meals, and track your progress to h...
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MIT Optical Brush

Researchers at the MIT Media Lab have developed a new imaging device that consists of a loose bundle of optical fibers, with no need for lenses or a protective housing. The fibers are connected to an array of photosensors at one end; the other ends can be left to wave free, so they could pass individually through micrometer-scale gaps in a porous membrane, to image whatever is on the other side. Bundles of the fibers could be fed through pipes and immersed in fluids, to image oil fields, a...
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FDA Approves Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic valve stenosis

The U.S. Food and Drug Administration today approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery. These devices were previously approved only in patients at high or greater risk for death or complications during surgery. Edwards Lifesciences is an American medical equipment company specializing in artificial heart valves and he...
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Arineta’s New Innovative CT Scan using full beam intensity

Arineta provides innovative imaging solutions for improved cardiac care. They are have developed a unique CT scanner for cardiovascular imaging. Clinical In-hospital Evaluation of the Usefulness of a New Multi-detector Computed Tomography Scanner. Israel-based imaging equipment manufacturer Arineta said it has received U.S. Food and Drug Administration (FDA) clearance for its SpotLight CT cardiovascular scanner. The proprietary design of the dedicated cardiovascular scanner is very diff...
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FDA approves first intraocular lens with extended range of vision for cataract patients

The U.S. Food and Drug Administration today approved the first intraocular lens (IOL) that provides cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision (visual acuity) at near, intermediate and far distances. Intraocular lens (IOL) is a lens implanted in the eye used to treat cataracts or myopia. The most common type of IOL is the pseudophakic IOL. These are implanted during cataract surgery, after the cloudy crystalline lens (otherwise known as a ...
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University of Alabama at Birmingham Research – Amount of proteins excreted in the Infant’s urine determines kidney state

Researchers at the University of Alabama at Birmingham have found that the amount of proteins excreted in the urine of preterm infants with acute kidney injury, or AKI, is different from that excreted by infants with healthy kidneys. The study, led by principal investigator David Askenazi, M.D., was published in the Clinical Journal of the American Society of Nephrology. “The findings in this study could help physicians better diagnose kidney health in newborns,” said Askenazi, associa...
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The world’s first non-contact sleep sensor

S+, the non-contact sleep sensor that helps you sleep better from the very first night. S+ combines a bedside sleep monitor, smartphone app and web-based app to help you track and better understand your sleeping patterns, and then creates personalized feedback and suggestions to help improve your sleep. Using advanced bio-motion technology and rigorous sleep science, S+: Measures your breathing and body movements throughout the night Analyzes light, noise and temperature levels in y...
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Hearing challanged can now experience music

Bezalel Academy of Arts and Design graduate Liron Gino has designed a set of jewellery-like devices that allow people that have challenge hearing to experience music through vibration. The Vibeat collection is an alternative to headphones that features a necklace, bracelet and pin with circular modules attached to them. What is music like when you can't hear it? It's a question that sounds like a philosophical debate on par with trees falling in the woods and single hands clapping, but thi...
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‘Audio Bone’ listening technology that allows you to hear stereo music directly to cochlea (inner ear)

Audio Bone is a breakthrough in listening technology that allows you to hear stereo music without blocking your ears. Audio Bone transmits music through your bones directly to your inner ear – so you can still hear everything around you. Audio Bone is available in two different editions: Audio Bone 1.0 and Audio Bone Adjustable. Audio Bone 1.0 is our most popular product. It provides the best quality sound, and a stylish design. Scroll down to learn more about bone conduction and for information...
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IKEA launches indoor garden

IKEA is introducing an indoor gardening series that lets you grow your own tasty lettuce and herbs in water. Developed in collaboration with agricultural scientists in Sweden, KRYDDA/VÄXER series includes everything you need to get sprouting and keep your garden growing - even in the winter! How it works? Just keep an eye on the water level. Hydroponics simply means growing plants in water without soil. With added nutrients and the right light, it allows you to garden in any small space all y...
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Mixing solids and liquids enhances optical properties of both

New approach can dramatically change the extent to which optical devices scatter light. Shine a torch through a window and then a glass of water and you'll notice how the light changes as it passes through these two substances. Researchers at MIT and Harvard have now discovered what happens when you mix regular liquid and glass (which, as all pedants know, is also sort of a liquid) together and stick it on a stove. The team suspended glass particles in a fluid and found that, when warmed up, it...
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BioRing Wearable Brings A Personal Trainer To Your Fingers

Smart ring claims to measure calorie and protein intake and a whole lot ... bio-impedance sensor and optical heart rate sensor to capture data The BioRing utilizes three sensors - 3-axis accelerometer, bio-impedance and optical HR sensor give you an unique insight into your body and diet. When you eat, your food consists of primarily carbohydrates, fats and proteins. Carbs are broken down into glucose, which is transported into your cells with the help of insulin. When glucose enters yo...
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3D Printed Jaw

Media Arts and Science faculty member Zebulun Wood and his student researcher, 2016 graduate Cade B.T. Jacobs, created a prosthetic mandible utilizing digital scanning and 3-D sculpture and printing technology—revolutionizing a field that has long relied on more cumbersome materials and techniques. The subject for the project is a retired maintenance worker named Shirley Anderson, who had recurring tongue cancer. Radiation treatments resulted in osteoradionecrosis, also known as “bone death.”...
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New Bluetooth-Connected Insulin Pen

Emperra GmbH has launched a new Bluetooth insulin pen model. The new ESYSTA BT pen is equipped with a Bluetooth interface and transfers the injected insulin doses directly to the patient’s digital blood glucose diary. The smart insulin pens are automatically connected via the 868 MHz interface (similar to the ISM band), which are already being successfully used in medicine in combination with a wireless transmission blood glucose meter as an integrated diabetes management system, ESYSTA. Both...
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iBaby is a smart Wi-Fi air monitor that detects VOCs & purifies the air for a healthier life.

A smart Wi-Fi air monitor that detects VOCs & purifies the air for a healthier life. iBaby Air is a smart Wi-Fi air quality monitor and the world’s smallest air purifier that is surprisingly powerful. iBaby Air detects dangerous VOCs, alerts the user of changes in air quality and sends suggestions and tips on how to improve the air quality. This makes iBaby’s second Indiegogo campaign, the first being iFamCare’s Helmet. We were able to successfully raise over 300% of our desired go...
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MIT research – Ingestible sensor measures heart and breathing rates from within the digestive tract.

Using technology invented at MIT, doctors may one day be able to monitor patients’ vital signs by having them swallow an ingestible electronic device that measures heart rate and breathing rate from within the gastrointestinal tract. This type of sensor could make it easier to assess trauma patients, monitor soldiers in battle, perform long-term evaluation of patients with chronic illnesses, or improve training for professional and amateur athletes, the researchers say. The new sensor calc...
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MIT research identifies mechanism that allows the brain to strengthen links between neurons

Neuroscientists reveal how the brain can enhance connections Newly identified mechanism allows the brain to strengthen links between neurons. When the brain forms memories or learns a new task, it encodes the new information by tuning connections between neurons. MIT neuroscientists have discovered a novel mechanism that contributes to the strengthening of these connections, also called synapses. At each synapse, a presynaptic neuron sends chemical signals to one or more postsynaptic receiv...
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‘Bite Counter’ is a watch that counts bites to help watch weight

Researchers at Clemson University have been working for several years on the relationship between the number of bites you take and caloric intake. They designed and have run extensive studies with a bite-counting wristband that they now sell as a separate business. https://youtu.be/G8BfxRz-J8I The Bite Counter is a watch that also counts bites based on pattern recognition of wrist movements. The Bite Counter comes with PC software for configuring the device and connects via a micro USB por...
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FDA Approved – ‘Transcranial Magnetic Stimulation’ to treat variety of brain-related disorders

Israeli medical device maker Brainsway has developed a helmet-like device that uses Transcranial Magnetic Stimulation (Deep TMS) to treat a variety of brain-related disorders. Deep TMS is a noninvasive procedure that uses magnetic pulses to stimulate nerve cells in the brain. The pulses are sent through an electromagnetic coil (H-coil) placed near the patient's scalp in the area a therapist wants to treat for 20 minutes at a time. According to the company, the treatment has no side effects. P...
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Google’s DeepMind helping detect early signs of sight-threatening diseases.

Google’s DeepMind is initiating a new research project to aid doctors spot the early signs of sight-threatening diseases. The team uses machine learning to analyze more than a million eye scans and thereby creating algorithms that can detect early symptoms that humans might miss. The research project is DeepMind’s second collaboration with the UK’s National Health Service (NHS). https://youtu.be/d58_mb95oVY Moorfields Eye Hospital in London will partner with Google and DeepMind for a fi...
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Airing Promises to Transform Sleep Apnea Treatment

Airing is designed to be the world’s first maskless, hoseless, cordless micro-CPAP device to combat obstructive sleep apnea. Obstructive Sleep Apnea (OSA) is usually caused by a blockage of the airway in which soft tissue in the rear of the throat collapses during sleep. If OSA is untreated, it has the potential to lead to serious health problems from high blood pressure to cardiovascular disease to memory impairment. Typically, OSA is treated with “Continuous Positive Airway Pressure,” o...
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Livia: The Wearable, Drug-Free Solution To Cramp Pain

Cramps plague women around the world; Livia, an instant pain relief solution, is a device which has the potential to end them. The “off switch” for your cramps, Livia is a drug-free solution for menstrual pain. With a single touch, the wearable device closes the "pain gates" by stimulating the nerves and blocking the pain from passing to the brain. The technology itself relies on the “Gate Control Theory.” Livia transmits a pulse that keeps the nerves “busy” so they are unable to transmit ...
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‘Eve’ – Wireless indoor air quality monitoring

Live smarter by knowing more about the place you care about most. With Eve, see your home at a glance, right on your iPhone and iPad. The Eve family of HomeKit accessories gathers data on air quality, temperature, humidity, air pressure, energy consumption and more. Gain insights that help you improve your comfort, and make your home a smarter place.   https://youtu.be/CEHBGoG60mU   With Eve Room, Eve senses indoor air quality, temperature, and humidity. Eve Room is...
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