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T2Candida Panel (2015 Prix Galien USA Winner)

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T2Candida Panel (2015 Prix Galien USA Winner)

T2 Biosystems (Lexington, MA) touts its T2Candida Panel as the only FDA-cleared test for sepsis that does not require a blood culture that could potentially take days to produce a result. Instead, the T2Candida Panel is able to identify the five clinically relevant species of Candida within 4.5 hours. The company's  T2Dx Instrument uses proprietary T2 Magnetic Resonance technology to measures how water molecules react in the presence of magnetic fields.

The groundbreaking nature of the technology is getting attention. As of June 30, 41 customers including multiple hospital systems had committed to adopt the T2Dx Instrument at U.S. and European sites, according to the company. Revenue for the first six months of 2016 was $2.1 million, about triple what it was a year before, and Canon U.S.A. this month spent $40 million to buy nearly a fifth of T2 Biosystems's stock. 

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[Image courtesy of T2 Biosystems]

The 6 Greatest Medical Technologies of the Past 10 Years

    Invention Innovation Light Bulb Medtech

Find out which devices the Prix Galien Foundation is considering for its "Discovery of the Decade" awards.

Chris Newmarker

The Prix Galien Foundation, which oversees U.S. activities of the international Prix Galien award, has a nine-person awards committee including four Nobel laureates reviewing its past annual Prix Galien USA award winners in order to declare a "Discovery of the Decade" in each of its three categories: medtech, pharmaceuticals, and biotech.

The Discovery of the Decade winners will be announced October 27 at an awards ceremony at the American Museum of Natural History in New York.

The past Prix Galien USA annual award winners that are nominees range from groundbreaking IVD to ICDs placed just under the skin. Read on to discover the medtech vying for the Discover of the Decade honor. (And who needs those Nobel laureates? Vote in our own Qmed survey.

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Learn about "How to Set Your Connected Health Solution Apart" at BIOMEDevice San Jose, December 7-8.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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[Image from Pixabay]

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New 3-D Printed Bone Can Grow With Kids

Northwestern University researchers formulated ink from calcium and biocompatible polymers.

Nancy Crotti

3-D Printed Bone NorthwesternResearchers at Northwestern University have developed 3-D printed bone implants that rapidly induce bone regeneration and growth, according to a statement from the university.

The 3-D printable ink they created produces hyperelastic bone-like material, whose shape can be easily customized. The research shows promise for treating bone defects in children, for whom bone implantation surgery is particularly painful and complicated.

The study, which evaluates the material with human stem cells and within animal models, was publishedby the journal Science Translational Medicine.

One current bone replacement solution has surgeons harvesting bone from elsewhere in the body, then shaping and molding it to exactly fit the area where it is needed. Researchers at the University of Nottingham, MIT, Tufts University, and elsewhere, have produced scaffolds made of natural and synthetic materials that create a frame for bone to grow on. Another alternative, metallic implants, cannot grow with the child.

Learn about "How to Set Your Connected Health Solution Apart" at BIOMEDevice San Jose, December 7-8.

With the new bio-ink, physicians would be able to scan the patient's body and 3-D print a personalized product, according to study leader Ramille Shah, assistant professor of materials science, engineering, and surgery at Northwestern. Its mechanical properties allow for easier and faster sizing and shaping during a procedure, and less pain for the patient, Shah said.

The biomaterial is a mix of hydroxyapatite (a calcium mineral found naturally in human bone) and a biocompatible, biodegradable polymer that is used in many medical applications, including sutures. It quickly mended spinal bones in rats and healed a monkey's fractured skull in just four weeks, with no signs of infection or other side effects, according to a report in Science.

The material's success in live animals lies in the printed structure's unique properties. It's majority hydroxyapatite yet hyperelastic, robust and porous at the nano, micro, and macro levels, according to the university.

"Porosity is huge when it comes to tissue regeneration, because you want cells and blood vessels to infiltrate the scaffold," Shah said in the statement. "Our 3-D structure has different levels of porosity that is advantageous for its physical and biological properties."

While hydroxyapatite has been proven to induce bone regeneration, it is also notoriously tricky to work with. Clinical products that use hydroxyapatite or other calcium phosphate ceramics are hard and brittle. To compensate for that, previous researchers created structures composed mostly of polymers, but this shields the activity of the bioceramic. Shah's bone biomaterial, however, is 90% hydroxyapatite by weight and just 10% polymer by weight, and maintains its elasticity because of the way its structure is designed and printed. The high concentration of hydroxyapatite creates an environment that induces rapid bone regeneration, according to the university.

"Cells can sense the hydroxyapatite and respond to its bioactivity," Shah said. "When you put stem cells on our scaffolds, they turn into bone cells and start to up-regulate their expression of bone-specific genes. This is in the absence of any other osteo-inducing substances. It's just the interaction between the cells and the material itself."

Because the 3-D printing process is performed at room temperature, Shah's team was able to incorporate other elements, such as antibiotics, into the ink, to reduce the possibility of infection after surgery. Growth factors could also be added to further enhance regeneration.

Human trials could begin within five years, according to the Science article. Shah imagines hospitals 3-D printing customized implants while the patient waits.

"The turnaround time for an implant that's specialized for a customer could be within 24 hours," Shah said. "That could change the world of craniofacial and orthopaedic surgery, and, I hope, will improve patient outcomes."

Nancy Crotti is a contributor to Qmed.

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This New Coating Could Take Endoscopes to the Next Level

Researchers at Harvard's Wyss Institute have developed a new antifouling surface coating for endoscopes that could help keep blood and other body fluids clear from the lens and reduce camera obstruction.

Kristopher Sturgis

Joanna Aizenberg Endoscopes Coating Wyss
Joanna Aizenberg (Image courtesy of Wyss Institute at Harvard)

One of the largest complications with camera-guided endoscopes is avoiding the buildup of blood and other bodily fluids around the camera lens, which can often obstruct the view during many critical procedures. In an effort to solve the issue, researchers from the Wyss Institute at Harvard have created a novel transparent surface coating designed to keep blood and other bodily fluids away from the camera as it is guided throughout the body.

For years endoscopes have been used to provide doctors and clinicians with a means to see inside the body to diagnose and treat a variety of different conditions. Over 20 million endoscopic procedures are performed each year in the U.S. alone, from procedures in the stomach, intestines, and colon to endoscopic procedures performed during pregnancy and surgery. 

"Endoscopes are used by many physicians around the world for a variety of procedures, and ironically, the moment when bleeding occurs and the optical field is blocked is also precisely when physicians most need to see what's happening," says Joanna Aizenberg, PhD, the Harvard material sciences professor who led the Wyss research team. 

To try and address the issue, the group turned to SLIPS (Slippery Liquid Infused Porous Surfaces) technologies, a former project at the institute designed to develop specialized coating substances that could repel blood and bacteria. The group aimed to adapt the SLIPS technology for endoscopic use by tailoring it to survive the harsh conditions of the human body. This meant they needed a substance that was transparent--so that it could coat the surface of the lens without obstructing view--and also be able to withstand the constant contact of soft tissue and corrosive human bodily fluids.

Learn about "How to Set Your Connected Health Solution Apart" at BIOMEDevice San Jose, December 7-8.

To bridge this gap, the group decided to work with silica nanoparticles and deposit them layer by layer onto the glass camera lens of an endoscope to create a porous surface. This porous surface would then be infused with a medical-grade silicone oil to create a self-replenishing liquid layer that could not only endure multiple procedures, but also the standard sterilization procedures that endoscopes go through between uses.

The team recently began testing the antifouling endoscope in vivo in bronchoscopy, a procedure performed on patients with pathological lung conditions. They decided to test the effectiveness of the new SLIPS coating an anesthetized pig by performing a bronchoscopy procedure with one of their modified endoscopes coated with the new material. The lens proved able to repel blood and mucus from start to finish, providing unprecedented clarity that saved time and reduced the overall complexity of the procedure.

With conventional scopes requiring repeated breaks to stop and clean the lens to wipe away blood and fluids, the new coating material could prove to be rather revolutionary for a procedure so widely used in the world of medicine. As the group moves forward with their research they intend to explore other uses for their slippery lens coating in other instruments that require an unobstructed optical field such as robotics, marine exploration, and pipe maintenance.

However, for now, they plan to continue to refine the technology in an effort to make endoscopic procedures easier for clinicians, as well as improve patient treatment and procedural outcomes.

Kristopher Sturgis is a contributor to Qmed.

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Diabetes Device a Step Closer to Artificial Pancreas

Diabetes Device a Step Closer to Artificial Pancreas

In a leap forward for diabetes management, FDA approved Medtronic's MiniMed 670G system, the first hybrid closed loop system for insulin delivery. The device approval is another sign of incremental progress toward a full closed loop system, often referred to as an artificial pancreas. 

The 670G system uses the SmartGuard HCL algorithm and the Guardian Sensor, which can be worn for seven days and is more accurate than prior Medtronic sensors. Patients do still need to perform some tasks for insulin management, including entering mealtime carbohydrates, calibrating the sensor at times, and accepting bolus correction recommendations, according to the company press release. The system's algorithm is designed to keep patients within a target glucose level range for as much time as possible throughout the entire day.

"With SmartGuard HCL, the ability to automate basal insulin dosing 24 hours a day is a much-anticipated advancement in the diabetes community for the profound impact it may have on managing diabetes--particularly for minimizing glucose variability and maximizing time in the target range," Richard M. Bergenstal, M.D., principal investigator of the pivotal study and executive director of the Park Nicollet International Diabetes Center in Minneapolis, said in the release. "The data from the pivotal trial were compelling and I am confident that this therapy will be well-received by both the clinical and patient community."

Hear from an Abbott diabetes executive during a panel on "Reimbursement Trends Impacting Connected Devices: What Engineers Need to Know!"   at BIOMEDevice San Jose, December 7-8.

According to Medtronic, the company plans to release the MiniMed 670G system commercially in spring 2017 and will broaden the launch gradually in order to ensure proper training on how to use the device. The device is approved for patients with type 1 diabetes who are 14 years old and older. Approval for the system outside the United States is anticipated in summer 2017. 

Derek Rapp, president and CEO of type 1 diabetes research organization JDRF, said in the release, "This significant milestone represents an important step forward in the management of type 1 diabetes and will improve the quality of life for those living with this chronic disease." He added, "We are very encouraged by the speed in which this groundbreaking technology was approved by the FDA, and we are proud of the role JDRF played in achieving this exciting breakthrough." 
 
FDA approved the MiniMed 670G system earlier than originally expected.
 
In a JDRF press release about the approval, Aaron Kowalski, PhD, JDRF chief mission officer, applauded the announcement and looked forward to future innovation. "This is a fantastic step forward, but we are not done, JDRF will continue supporting other artificial pancreas advancements and advocating for broad access to this life-changing technology." He went on to say, "Next generation systems are in the pipeline that could provide even better outcomes with less burden. And our work will not be finished until we cure and prevent T1D."

In a September 15 research note, Joanne Wuensch, analyst at BMO Capital Markets, wrote that a future system "will shift to a completely closed loop system that will include auto bolus correction, biometric sensing, smaller on-body experience, and smartphone connectivity."

Also on Wednesday, FDA approved Abbott's FreeStyle Libre Pro continuous glucose monitoring system, intended to be used by professionals. According to a company press release, patients will wear a sensor on the back of their upper arm for up to 14 days. The sensor will continuously measure glucose levels and record these levels every 15 minutes. Patients must go back to their physician, who will use the system's reader to retrieve the glucose level readings and analyze them. This system does not require fingerstick calibrations and is expected to be priced lower than other CGMs.

A consumer version of the system, which would allow patients to download their own glucose levels, is being reviewed by FDA. 

These developments are a boon for patients with diabetes. Wuensch pointed out in a September 28 research note that "the diabetes market is large, underpenetrated, and underserved . . . In other words, there is ample opportunity for many products to treat this population."

[Image courtesy of MEDTRONIC]

10. Massachusetts Institute of Technology

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Massachusetts Institute of Technology (Cambridge, MA)

Avg. starting salary for BME grads: $60,800

Undergraduate Acceptance Rate (campuswide): 8.2%

Total Enrolled Students (campuswide): 10,894

Tuition: $45,016

Recent Qmed stories about MIT research:

These 3-D Printed Polymers Have Shape-Memory Abilities

The Amazing Water Adhesive Developed at MIT

These Researchers Have Skin in the Game

New Technique Could Lead to Enhanced Biomedical Imaging

How to Turn Human Cell DNA Into a 'Tape Recorder'

Runners-up Schools

Georgia Institute of Technology

Avg. starting salary for BME grads: $63,000

University of California, Los Angeles

Avg. starting salary for BME grads: $60,000

University of Southern California

Avg. starting salary for BME grads: $53,100

University of Texas, Austin

Avg. starting salary for BME grads: $51,000

University of Michigan

Avg. starting salary for BME grads: $40,000

 The Toughest Medtech Interview Questions>>

[Image by PeterDandy - Own work, CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=25393968]

9. University of Wisconsin, Madison

    Arrow  backUniversity of Wisconsin Madison

University of Wisconsin, Madison (Madison, WI)

Avg. starting salary for BME grads: $62,000

Undergraduate Acceptance Rate (campuswide): 57.2%

Total Enrolled Students (campuswide): 41,946

Tuition: $10,410

Recent Qmed stories about University of Wisconsin research:

This Sensor Can See in the Dark

These Might Be the Best Stretchy Circuits Yet

A Biodegradable Microchip Made of Wood

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[Image by Vonbloompasha at English Wikipedia, CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=6750226]

8. University of Pennsylvania

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University of Pennsylvania (Philadelphia)

Avg. starting salary for BME grads: $62,500

Undergraduate Acceptance Rate (campuswide): 12.5%

Total Enrolled Students (campuswide): 24,832

Tuition: $47,668

Recent Qmed stories about Penn research:

New Gene Editing Tool Moves to Human Trial

TAVR Could Have a Blood Flow Problem

Placenta-on-a-Chip Could Help Preemie Babies

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[Image by Bryan Y.W. Shin at the English language Wikipedia, CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=1796242]

7. University of California, Berkeley

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University of California, Berkeley (Berkeley, CA)

Avg. starting salary for BME grads: $64,800

Undergraduate Acceptance Rate (campuswide): 14.2%

Total Enrolled Students (campuswide): 36,137

Tuition: $12,972

Recent Qmed stories about UC Berkeley research: 

These New Smart Threads Can Share Data

The Latest Graphene Advance

New Tiny Implantable Devices Are Powered by Ultrasound

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6. Northwestern University (Tie)

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Northwestern University (Evanston, IL)

Avg. starting salary for BME grads: $65,000

Undergraduate Acceptance Rate (campuswide): 13.9%

Total Enrolled Students (campuswide): 20,959

Tuition: $47,251

Recent Qmed stories about Northwestern research:

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[Image by Madcoverboy at English Wikipedia, CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=7036889]