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TMJ Health introduces TMJ NextGeneration Device

14 August 2014

US-based TMJ Health has launched TMJ NextGeneration, a FDA-cleared medical device that will be used to reduce temporomandibular joint disorder (TMJD) pain.

The two custom-made, hollow ear canal inserts featured in the device enable the full passage of sound, and are said to be invisible from the outside.

TMJD, which is a group of painful conditions, affects the jaw joint and surrounding muscles and nerves. Even though TMJD is not life threatening, the disorder can be detrimental to quality of life and the symptoms can become chronic and difficult to manage, the company said. “The symptoms of TMJD include jaw pain, stiffness, clicking and locking, chewing difficulty, and migraines.” The symptoms of TMJD include jaw pain, stiffness, clicking and locking, chewing difficulty, and migraines.

According to the National Institute of Health, TMJD could afflict more than 35 million people in the US, the majority of whom are women aged between 20 and 40. TMJD has often been treated with bite splints, which are plastic mouthpieces that fit over the upper or lower teeth to prevent them from coming together and reduce the amount of clenching or grinding.

LSCI president and board-certified toxicologist Roger Wixtrom said: “While bite splints have helped to reduce pain associated with TMJD, there are drawbacks with these devices. “For example, they cannot be worn while eating and they can also affect speech, and as such are typically only worn at night while sleeping.
“The TMJ NextGeneration device offers a safe and effective option that patients should discuss with their dentist or ENT.”

The TMJ NextGeneration hollow ear canal inserts are located very close to the temporomandibular joint, and the volume of the ear canal increases when the jaw is opened through movements such as chewing, smiling and speaking. The device uses this anatomical change to provide a unique near-field treatment for TMJD. In a three-month clinical study, patients wearing the device experienced a significant reduction in the pain and dysfunction associated with TMJD, to an extent at least as much as that experienced by patients wearing a bite splint, the company claimed.

Image: TMJ NextGeneration is a first-of-its-kind, FDA-cleared medical device that is a safe and effective aid in reducing TMJD pain. Photo: courtesy of TMJ Health, LLC.


Printed Electronics World – Flexible, printed batteries for wearable devices

A California startup is developing flexible, rechargeable batteries that can be printed cheaply on commonly used industrial screen printers. Imprint Energy, of Alameda, California, has been testing its ultrathin zinc-polymer batteries in wrist-worn devices and hopes to sell them to manufacturers of wearable electronics, medical devices, smart labels, and environmental sensors.

The company’s approach is meant to make the batteries safe for on-body applications, while their small size and flexibility will allow for product designs that would have been impossible with bulkier lithium-based batteries. Even in small formats, the batteries can deliver enough current for low-power wireless communications sensors, distinguishing them from other types of thin batteries.

The company recently secured $6 million in funding from Phoenix Venture Partners, as well as AME Cloud Ventures, the venture fund of Yahoo cofounder Jerry Yang, to further develop its proprietary chemistry and finance the batteries’ commercial launch. Previous investors have included CIA-backed venture firm In-Q-Tel and Dow Chemical.

The batteries are based on research that company cofounder Christine Ho began as a graduate student at the University of California, Berkeley, where she collaborated with a researcher in Japan to produce microscopic zinc batteries using a 3-D printer.

The batteries that power most laptops and smartphones contain lithium, which is highly reactive and has to be protected in ways that add size and bulk. While zinc is more stable, the water-based electrolytes in conventional zinc batteries cause zinc to form dendrites, branch-like structures that can grow from one electrode to the other, shorting the battery. Ho developed a solid polymer electrolyte that avoids this problem, and also provides greater stability, and greater capacity for recharging.

Brooks Kincaid, the company’s cofounder and president, says the batteries combine the best features of thin-film lithium batteries and printed batteries. Such thin-film batteries tend to be rechargeable, but they contain the reactive element, have limited capacity, and are expensive to manufacture. Printed batteries are nonrechargeable, but they are cheap to make, typically use zinc, and offer higher capacity.

Working with zinc has afforded the company manufacturing advantages. Because of zinc’s environmental stability, the company did not need the protective equipment required to make oxygen-sensitive lithium batteries.

“When we talk about the things that constrain us in terms of the development of new products, there’s really two that I lose the most sleep over these days. One is batteries and one is displays,” says Steven Holmes, vice president of the New Devices Group and general manager of the Smart Device Innovation team at Intel.

Despite demand for flexible batteries, Ho says no standard has been developed for measuring their flexibility, frustrating customers who want to compare chemistries. So the company built its own test rig and began benchmarking its batteries against commercial batteries that claimed to be flexible. Existing batteries failed catastrophically after fewer than 1,000 bending cycles, she says, while Imprint’s batteries remained stable.

Imprint has also been in talks about the use of its batteries in clothes and “weird parts of your body like your eye,” Ho says. The company also recently began working on a project funded by the U.S. military to make batteries for sensors that would monitor the health status of soldiers. Other potential applications include powering smart labels with sensors for tracking food and packages.


Source and top image: MIT Technology Review

For more attend the forthcoming events:

Printed Electronics Asia 1-5 September 2014 Tokyo, Japan
Printed Electronics USA 19-20 November 2014 Santa Clara USA
Energy Harvesting and Storage USA 19-20 November 2014, Santa Clara, USA

Hospital Networks Are Leaking Data, Leaving Critical Devices Vulnerable

Hospital Networks Are Leaking Data, Leaving Critical Devices Vulnerable

Hospital Networks Are Leaking Data, Leaving Critical Devices Vulnerable

Two researchers examining the security of hospital networks have found many of them leak valuable information to the internet, leaving critical systems and equipment vulnerable to hacking.

The data, which in some cases enumerates every computer and device on a hospital’s internal network, would allow hackers to easily locate and map systems to conduct targeted attacks.

In at least one case, a large health care organization was spilling info about 68,000 systems connected to its network. At this and every other facility that was leaking data, the problem was an internet-connected computer that was not configured securely. Quite often, the researchers found, these systems also were using unpatched versions of Windows XP still vulnerable to an exploit used by the Conficker worm six years ago.

“Now we know all the targeted info and we know that systems that are publicly connected to the internet are vulnerable to the exploit,” says Scott Erven, one of the researchers, who plans to discuss their findings today at the Shakacon conference in Hawaii. “We can exploit them with no user interaction… [then] pivot directly at the medical devices that you want to attack.”

Attackers could, for example, infect one of these systems and use it as a launchpad to find and hack the control system that manages embedded pacemakers. Such systems, Erven says, generally require no authentication to administer test shocks to patients or to configure thresholds that determine when a shock is automatically administered. An attacker could therefore alter the settings that determine when a patient is going into cardiac arrest in order to administer shocks when they aren’t needed or prevent life-saving shocks from occurring.

The data leak that makes it possible for hackers to locate vulnerable systems is the result of network administrators enabling Server Message Block, or SMB, on computers facing the internet and configuring it in such a way that allows data to broadcast externally. SMB is a protocol commonly used by administrators to help quickly identify, locate and communicate with computers and equipment connected to an internal network. With SMB, each system is assigned an ID number or other descriptor to help distinguish, say, the PC in a doctor’s office from surgical systems in an operating room or testing equipment in a lab.

This kind of information should only be available to network staff. But the researchers found many hospitals had misconfigured the SMB service, allowing outsiders to see it as well.

“Health Care Organizations Are Very Sloppy”
“It goes to show that health care [organizations are] very sloppy in configuring their external edge networks and are not really taking security seriously,” Erven says.

The vulnerability was uncovered by Erven and Shawn Merdinger, an independent health care security researcher and consultant, expanding on work Erven has done identifying vulnerabilities in medical devices and hospital equipment.

Erven is head of information security for Essentia Health, which operates about 100 facilities––including clinics, hospitals and pharmacies––in four states. He and his staff recently completed a two-year investigation into the security of all of Essentia’s medical equipment.

Among other problems, they found drug infusion pumps—for delivering morphine drips, chemotherapy and antibiotics—that could be remotely manipulated to change dosages delivered to patients; Bluetooth-enabled defibrillators that could be manipulated to deliver random shocks to a patient’s heart or prevent a medically needed shock from occurring; and temperature settings on refrigerators storing blood and drugs that could be reset to cause spoilage.

At the time Erven’s team conducted their research, they didn’t know how many vulnerable medical devices were directly connected to the internet as opposed to simply being connected to internal networks accessible via the internet.

Erven and Merdinger set out to scan the internet to answer this question. They scanned for any systems using port 445—the port the SMB protocol uses to transmit data—and filtered for hospitals and other health care organizations while using keywords like “anesthesia” and “defibrillator.” Within half an hour, they discovered a health care organization that was leaking information on 68,000 systems. The organization, which Erven would not identify, has more than 12,000 employees, 3,000 physicians and large cardiovascular and neuroscience institutions associated with it.

Among the systems with exposed data, the researchers easily identified at least 32 pacemaker systems in the organization, 21 anesthesiology systems, 488 cardiology systems, and 323 PACS systems—radiology systems for reading X-Rays and other images. They also identified telemetry systems, high-risk systems that are often used in infant-abduction prevention systems as well as for monitoring the movement of elderly patients throughout a hospital to ensure they don’t wander off.

The problem went beyond this one organization. Because the health care organization’s network was connected to third-party networks, data from those networks was exposed as well. Hospital networks often are connected to those of other providers, pharmacies and laboratories. Systems belonging to these other organizations can also be exposed to SMB data leaks if the hospital doesn’t configure its own systems properly.

Although this organization was the largest one they identified with problems, they soon found others.

A Global Healthcare Issue
“We started running organization searches to identify hospitals, clinics, and other medical facilities and we quickly realized this is a global health care organization issue,” Erven says. “This is thousands of organizations [that are leaking this information] across the world.”

Most hacks involve multiple stages of reconnaissance and varying levels of penetration to reach critical systems and identify vulnerabilities. But in this case, the SMB data would allow an attacker to home in on vulnerable machines quickly instead of having to scan a hospital’s entire network, searching for something interesting—an activity that runs the risk of getting them noticed.

On some of the networks that were leaking data, the system administrators had assigned names to the systems on their network—such as “Dr. Armstrong’s office,” or “cardiology defibrillator in OR1″ making it even easier for hackers to identify specific systems for attack.

Armed with this information, as well as the research Erven had previously done to identify vulnerable hospital equipment, an attacker could craft a custom payload to target a specific brand of defibrillators or oncology equipment and send it to a hospital worker via a phishing email. The payload could then seek out the equipment on the network—using the SMB data—and execute its attack only on these specific devices. The attack could even be conducted to target a specific patient.

“The doctor’s name doesn’t necessarily help an attacker,” Erven says. “But when you know that this patient has an appointment with this doctor and I know this doctor uses this system, you could build a case for a major targeted attack and have more certainty of where you want to target.”

Erven says the SMB problem is just one security issue that health care organizations are facing. He says the problems exist because the security teams at these organizations are too often focused solely on HIPAA compliance—checking off boxes to meet government regulations for protecting data—while failing to conduct penetration testing and vulnerability maintenance to really test their systems and secure them the way the security teams at banks and other financial organizations do.

In this case, the vulnerability could be easily fixed by simply disabling the SMB service on external-facing systems or reconfiguring it so that it only broadcasts data internally on the hospital’s local network instead of broadcasting it out to the internet for hackers to see.


Regenerative Medicine / a Leap of Faith

Regenerative Medicine / a Leap of Faith

A Leap Of Faith Recap: Dr. Macchiarini & Pioneering Regenerative Medicine (6/27/14)
Pioneers in the history of mankind have never been fully recognized until generations that came after them finally reaped the benefits of what they courageously started. Today’s NBC News Special had Meredith Viera tracking the people involved in treading a new frontier in science: regenerative medicine or what is also known as stem-cell tecnology. This new field is indeed a leap of faith, especially for Italian surgeon and scientist Dr. Paolo Macchiarini (photo in this recap) whose quest to save the lives of people prompted him to venture into what is otherwise the unthinkable.

The Man Who Defied Uncertainty

Dr. Macchiarini is considered a pioneer in regenerative medicine and tissue engineering who specializes in tracheal transplantation. Currently a Professor of Regenerative Surgery at the Karolinska Institutet in Stochkholm, Sweden, he has spent at least 26 to 27 years of experimental research in a field where skeptics abound. His work has given him the conviction that artificially grown organs can be transplanted to humans and let their stem cells regenerate. This is the biggest hope anyone could ever give to people who are left without any alternative from a medical perspective.

Described by others as a rogue and rebel, Dr. Macchiarini was willing to gamble his life and career because he believed that treatment is available; he only needed to take that one chance or simply let it pass away. For this surgeon, he couldn’t allow himself to simply give up and see human lives wither away.

Where The Critics Stand

A percentage of the population in the medical field have qualms about regenerative medicine simply because this is a gray zone (as quoted from Dr. Joseph Vacanti of the Massachusetts General Hospital for Children). They say that it his has a long way to go and it would take extensive research and tests before the risks are taken out and lives could actually be saved. They claim that regenerative transplant is impossible for whole organs and that Dr. Macchiarini is jumping the gun.

The Rebel’s Journey

2008 marked the year when Dr. Macchiarini first crossed a new frontier when he took on the case of Spanish mom Claudia Castillo who became a recipient of the first trachea radically grown in a laboratory. Six years after the surgery, Claudia is healthy and living her fresh lease on life. Claudia’s case also proved that Dr. Macchiarini’s medical breakthrough can avert a body’s rejection of an implant.

In 2010, the surgeon handled his first case on a child, then 10-year old Ciaran Finn-Lynch. Ciaran’s case showed that Dr. Macchiarini’s method was more promising for children with their ability to regenerate and heal faster. By 2011, Dr. Macchiarini embarked on the utilization of a man-made trachea entirely created from plastic. His first recipient was 36 year-old Eritrean Andermariam Beyene.

Not all of Dr. Macchiarini’s cases can be said as success stories, but the process he went through encouraged him to review and enhance his methods.

Stumbling Blocks

Christopher Lyles was the first American to undergo Dr. Macchiarini’s method. Since regenerative surgery was still unauthorized in the US, Chris travelled all the way to Stockholm in the hopes of a solution to the threat of his inoperable throat tumor. His doctors in Baltimore may have been doubtful of the operation’s success but Chris and his family had faith in the procedure. For Chris, his venture may or may lead to success but his desire to bring elevated awareness on regenerative medicine in the US was more than enough to take the risks with Dr. Macchiarini. The operation was a success but Chris only lived for another 4 months due to pneumonia.

Hannah Warren became Dr. Macchiarini’s youngest patient who paved way for a major shift in regenerative surgery outlook in the US. Hannah had to go through a difficult time waiting for a hospital that would allow the procedure even if Dr. Macchiarini was ready to work on her case. She found emotional, moral and financial support from the nuns and medical staff (particularly Dr. Mark Holterman and Dr. Rick Pearl) of the Children’s Hospital of Illinois. Hannah’s case became the turning point to gain an FDA approval.

When Dr. Macchiarini finally got to evaluate Hannah’s case, he knew that the procedure would become very risky due to the problems posed by Hannah’s missing windpipe and a complex congenital problem. Hannah’s parents were undaunted; by taking a chance on Dr. Macchiarini, they had hopes that their little girl has a chance of living a life outside the confines of a hospital where she practically lived all her life. Unfortunately, the complications that came with the risks only provided the 2-year old another 3 months to live after her first surgery.

The Road Ahead

Among his patients, Hannah had the biggest impact on Dr. Macchiarini from an emotional, professional and ethical standpoint. His empathy for Hannah fuelled him to do everything he could but her death made him question the decisions he’s made so far. It came to a point that he wanted to stop as losing lives didn’t make sense anymore.

Dr. Macchiarini never saw the support that came pouring in: from the families of Chris Lyles and Hannah as well as people who were critical of his ventures. Dr. Vacanti finally yielded that Dr. Macchiarini may have done experiments that were risky and dangerous but he did the right thing for surgical innovation.

Dr. Macchiarini’s experience with Chris and Hannah energized him to enhance his technology and better his success rate on his patients.

That’s our recap of A leap of Faith: A Meredith Viera Special today, 06/27/14.We’ll be back next week as we recap Dateline NBC. Until then, please check out our Dateline NBC archives HERE.

Image credit: NBC News


Aenor Sawyer MD – From Promise to Power of Digital Health.

Dr Sawyer is a leader in Digital Health innovation at UCSF as the Associate Director of Strategic Relations for the Center for Digital Health Innovation (CDHI) and the Associate Director of the Digital Health track in the CTSI Catalyst accelerator. She is a Clinical Adviser to Rock Health, an Adviser to Open Placement and 1eq, and is on the Clinical Advisory Board for Epocrates. Dr. Sawyer co-founded Trinity, a HIPAA compliant, web-based collaboration technology for virtual Tumor Board and multidisciplinary management (MDM) of complex patients, now in pilot at UCSF. Dr. Sawyer has served on UCSF IT committees for Telemedicine, and Web-based/ mobile technology, and is a member of the NIH CTSA TSIG Telehealth Committee. As an ‘Expedition Medic’ for world-record ocean rowers, she has employed remote sensing/communication to provide remote medical coverage and co-developed WEARHUB with Archinoetics. She is faculty advisor to the UCSF Pediatric Device Consortium, Project Director for Roboimplant.

She is co-developing a safe early-mobility device for in-patients (Mobi-us). As an Assistant Clinical Professor in the UCSF Dept of Orthopaedic Surgery, Dr Sawyer combines her interest in innovation with her clinical expertise in Orthopaedics, Physical Therapy, and Exercise Physiology to provide comprehensive musculoskeletal care. She is Director of the UCSF Skeletal Health Service and Director of the Pediatric Bone Health Consortium, helping Pediatric to Geriatric patients optimize their bone health across their lifespans. Dr Sawyer’s career includes 10 years as a Physical Therapist, after which she received an M.S. in Human Physiology and her M.D. from the University of California, Davis. In the Sutter system she Co-Directed a Cardiac Rehab program for 5 years. Upon completion of her Orthopaedic Surgery residency at Stanford University, she completed fellowship training in Paediatric Orthopaedic Surgery and Paediatric/Adolescent Sports Medicine, both at Boston Children’s Hospital, in the Harvard Orthopaedic program.

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