The nominees for 2018 Best Medical Technology recently announced their participation in the 12th annual Prix Galien USA Awards.
The host of the award, the Galien Foundation, annually awards the Prix Galien Award to recognize outstanding achievements in biomedical and technological products aimed at improving the human condition.
Before candidates can qualify for this award, their products need to be approved by FDA within the past five years. They must also demonstrate significant potential to affect health care. The winners will be announced in October this year.
This year, the Foundation elected 20 nominees for “Best Drugs”, 13 nominees for “Best Biotechnology Products” and 10 nominees for “Best Medical Technologies”.
The best medical technology equipment includes glucose monitoring patches and sensors in pills. According to the Galien Foundation, these are the 10 most innovative medical devices in 2018.
FreeStyle Libre: Flash glucose monitoring system
Abbott’s FreeStyle Libre system is a glucose measurement system that does not require finger stick or finger stick calibration. It measures blood sugar level through a small sensor applied to the back of the user’s upper arm. According to the company, the sensor is a quarter of the size of two stacks and can provide real-time readings for up to 10 days. The sensor can also read glucose levels from clothing.
Each scan provides three data, including real-time glucose results, eight hour historical trends and trend arrows showing the direction of its glucose advance. The accompanying touchscreen reader can store up to 90 days of data so that people can track glucose levels over time.
Axios: bracket and electric cautery enhanced conveying system
Boston Scientific’s Axios stent and electrocautery enhanced delivery system are designed to provide therapeutic endoscopes with safety, accurately collecting fluid from the gastrointestinal tract into the pancreas and placing Axios stents. The system uses a cautery catheter with a therapeutic Axios stent for non exchange surgery.
Under the guidance of EUS, Axios catheter is powered through the tissue wall and enters the target structure. The conduit jacket retracts, allowing the bracket to unfold. The extraction system is then revoked.
Telescope
SpyGlass of Boston Scientific is a direct visualization system for cholangiopancreatoscopy. According to the company, it aims to optimize program efficiency and productivity because it improves ease of setup, ease of use and image quality.
It has a one-time use range, which can eliminate the reprocessing of optical probes, and reduce the risk of cross contamination and image quality degradation during multiple use. The integrated digital sensor has higher resolution image quality and 60% wider field of view, which can effectively evaluate pipes with consistent joint directions and attachment exit points. It also has special irrigation and suction connections, allowing doctors to better control and effectively clear vision. According to the company, the tip of the tapered catheter has a non-invasive design that can assist in intubation and through strict stenosis.
SpyGlass provides enhanced visualization and access for diagnostic and therapeutic applications, such as biliary system cancer, pancreatic cancer, carcinomatous duct cancer, gallbladder cancer, intraductal pancreatic mucinous tumors, intraductal papillary mucinous tumors of the pancreas, gallstones, primary sclerosing cholangitis, pancreatitis, pancreatic stones/fragments, biliary papillomatosis, and uncertain pancreatic strictures and masses.
Watchers
Boston Scientific’s Catcher is a left atrial appendage closure device that helps reduce the risk of stroke. For patients with non valvular atrial fibrillation, it can replace long-term warfarin treatment.
According to the company, Boston Science’s Watchman device is provided by way of a transfer road, which is designed to shut down the left atrial appendage to prevent thrombus migration. Because it prevents blood clots, the device can reduce the risk of stroke and systemic embolism.
BrainScope One
The BrainScope One system of BrainScope is an easy-to-use, non-invasive handheld platform that allows doctors to assess head injuries at the point of care.
The device is FDA approved and based on EEG technology. BrainScope One is non-invasive and painless, and can be used for patients aged between 18 and 85 years within three days after head injury. It measures and explains brain activity and neurocognitive function to help doctors make clinical diagnosis.
FoundationOne CDx
FoundationOne CDx is an FDA approved extensive concomitant diagnosis for solid tumors, including colorectal cancer, breast cancer, ovarian cancer and melanoma. According to the company, it aims to provide doctors with clinically actionable information.
Each test has the burden of microsatellite instability and tumor mutation, which is helpful for making immunotherapy decisions.
Omnigraft skin regeneration matrix
Omnigraft dermal regeneration matrix of Integra Lifesciences is an advanced double-layer dermal regeneration matrix, which can treat diabetic foot ulcers. According to the company, it is the only FDA approved product that can regenerate natural dermal tissue.
The patch has a built-in silicone layer, which can be used as a temporary skin layer to provide instant coverage for wound protection. It can be deleted within two to three weeks. Underneath the siloxane layer is the collagen/chondroitin-6-sulfate matrix, which serves as a real skin substitute layer. Omnigraft has bioengineered scaffold, which can promote skin regeneration, and has controllable porosity and degradation rate.
Omnigraft dermal regenerative matrix is designed to treat partial and full thickness neurodiabetic foot ulcers that last more than six weeks without capsules, tendons or bones.
KBCT 1000
Koning’s KBCT is a breast imaging device. It provides high contrast, real three-dimensional breast images with spatial resolution, no painful compression in 10 second exposure, and its radiation level is the same as that of normal mammograms.
Real 3D images have isotropic images in the 3D display to allow clinicians to evaluate tissues from any angle while eliminating overlapping structures. The 3D scan of KBCT is non contrast, and the contrast is enhanced, showing blood vessels and calcification.
Implantation system for Remodulin
Medtronic’s Remodulin implant system is designed to treat patients with pulmonary hypertension. The system uses the company’s SynchroMed II implantable drug infusion pump, equipped with a newly developed intravascular catheter, which can deliver Remodulin through the external infusion pump to the vein of patients who have previously received the drug.
Medtronic announced on July 31 that the system had been approved by FDA.
Abilify MyCite
Abilify MyCite is a prescription drug with sensors that are used to treat many diseases, including schizophrenia, type I bipolar disorder and major depression.
The Abilify MyCite system tracks whether drugs have been taken. Ingestion can usually be detected within 30 minutes, but it may take up to two hours for a smartphone application or Web portal to detect whether a drug has been taken.
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