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MedicalDeviceLink.com 12/10/2019 10:07
C 2 N Diagnostics’s detection test for Alzheimer’s disease is showing off some strong data coming out of the 12 th Annual Clinical Trials in Alzheimer’s Disease conference. The St. Louis-based company said results from a study show the Aptus-Aβ test strongly predicts the presence of brain amyloidosis in a diverse population. C 2 N Diagnostics said its blood-based in vitro diagnostic is being developed to predict amyloid PET scan results. It combines into a ratio, the concentration of amyloid beta (Aβ) isoforms Aβ42 and Aβ40 in human plasma, as measured by mass spectrometry. Amyloid PET scans accurately detect amyloid plaques –“ one of the hallmarks of Alzheimer’s disease –“ and are used in the workup and management of people with cognit.
MedicalDeviceLink.com 12/10/2019 03:01
Whether you’ve been tasked with sealing an enclosure around electronics, or you’re a highly enthusiastic mechanical engineer and really curious about why electromagnetic compatibility (EMC) matters, this article is for you. It covers the following aspects:. The methods of how devices can be effectively sealed against electromagnetic interference (EMI). Strategies to rethink the problem from a systems level to create compliant devices. Let’s start with some jargon:. Electromagnetic Interference (EMI) is the disturbance (usually undesired) caused by an external source effecting an electrical circuit (e.g., within a medical device) by electromagnetic induction, electrostatic coupling, or conduction. The effect from EMI may degrade device perform.
MedicalDeviceLink.com 12/09/2019 15:52
 and machine learning continue to make a profound impact on the medical device and diagnostics industry. So what AI trends can medtech (along with many other industries) expect in 2020? Top AI experts at New York, NY-based Fractal Analytics, one of the largest AI providers in the world, shared the following predictions. 1. AI Will Be More Clearly Defined. "There have been numerous AI (or actually, ML) related use-cases in 2019 and lots of lessons learned, including that we are still at very early stages of ML usage, especially in business applications, and that we need to treat this phase as we did with many new methodologies that came before –“ identify the right problem, test a new approach, identify its applicability, iterate unti.
MedicalDeviceLink.com 12/09/2019 14:07
New bipartisan legislation is looking to improve the availability of breakthrough devices for Medicare beneficiaries. The Ensuring Patient Access to Critical Breakthrough Products Act of 2019 (H.R. 5333) was reintroduced by U.S. Rep. Suzan DelBene (D-Wash). She previously introduced the bill in 2018. The bipartisan legislation is being co-led by Rep. Jackie Walorski (R-IN), Rep. Tony Cárdenas (D-CA), Rep. Gus Bilirakis (R-FL), Rep. Terri Sewell (D-AL), and Rep. Roger Marshall (R-KS). Right now, Medicare does not automatically cover the latest advances in medical technology, even when the products are approved through FDA’s breakthrough pathway process. Medicare’s coverage determination for FDA approved products can take up to three years,
MedicalDeviceLink.com 12/09/2019 13:57
The Centers for Disease Control and Prevention (CDC) has medical devices used in the ICU as a major source of antibiotic-resistant infections. ’s CeraShield technology may help reduce such infections by preventing fouling and formation of bacterial and fungal biofilms on device surfaces. FDA has designated the company’s CeraShield Endotracheal Tube (ETT) as a “breakthrough” device, pursuant to the 21st Century Cures Act based on its potential life-saving properties. And N8 reported that Frost & Sullivan had selected it as the winner of a . The first in-human in mechanically ventilated ICU patients show that the device is able to prevent ESKAPE pathogens in endotracheal tube aspirates and on the device itself. In vitro data show that t.
MedicalDeviceLink.com 12/09/2019 04:00
During the holiday season, one tends to think of presents. But today’s designers, manufacturers and sellers tell us the product is but a commodity and what we really want is the experience. Engineers and scientists are really like most ordinary consumers except in their interest in experiences that deal with great technical achievements, failures and the future –“ technologies that are yet to be. So, rather than a set of catchy products, this list will focus on unique experiences with particular appeal to engineers and scientists.ÂI. BooksÂ. Reading is an experience unlike no other in that it can be done by any literate person at almost any time and in any place. Here is a very short list of science and engineering related books released in.
MedicalDeviceLink.com 12/06/2019 14:46
A major server outage rattled Dexcom customers –“ particularly parents of diabetic children –“ over the U.S. Thanksgiving holiday weekend. But most were not as mad about the technology glitch as they were about the company's lack of communication about the issue. Dexcom has since fixed the problem and promised to communicate better with customers going forward. ÂVicarious Surgical is now the first to receive a breakthrough device designation from FDA for a robotically-assisted surgical device. What makes this new robot so special? Virtual reality. ViewRay has signed a non-binding memorandum of understanding with both Elekta and Medtronic. Elekta has committed to invest capital for up to a 9.9% minority interest in ViewRay, and Medtronic
MedicalDeviceLink.com 12/06/2019 13:55
3DBio Therapeutics has won a unique designation from FDA. The New York-based company was granted a Rare Pediatric Disease designation for AuriNovo, an investigational combination product for reconstruction of the outer ear in patients with microtia. Microtia is a rare congenital disorder causing the outer ear (auricle) to be smaller than typical, misshapen, and sometimes missing at birth; most cases only affect one ear. The firm’s AuriNovo combination product incorporates the patient's own auricular cartilage cells into a 3D-bioprinted, living, full-sized ear construct designed to replace the patient's microtia-affected ear. AuriNovo is then implanted under the patient's skin. FDA’s Rare Pediatric Disease designation provides incentives to
MedicalDeviceLink.com 12/06/2019 10:22
W.L. Gore & Associates is setting its sights on helping to improve insulin therapy in patients with type 1 diabetes. To do this the Flagstaff, AZ-based company is investing in PhysioLogic Devices, a startup developing an implantable intraperitoneal insulin delivery system. The investment is set to provide supplemental funding to allow Elkton, MD-based PhysioLogic to reduce key challenges associated with implantable micropumps and actuators and enable the startup's development goals for the upcoming years. An essential part of the system that PhysioLogic is developing is an implanted catheter for intraperitoneal insulin delivery. Independently, Gore will apply its material science expertise to resolve obstructions that can occur in these cat.
MedicalDeviceLink.com 12/05/2019 11:05
Personal Genome Diagnostics (PGDx) and Merck are looking to find the right combination to enhance and improve cancer therapy. Both companies hope to achieve this goal through an IDE FDA recently granted to Baltimore-based PGDx. The IDE gives PGDx approval for the use of its elio tissue complete assay in a Merck trial of pembrolizumab-base combination therapy. The elio assay will be used during the trial to analyze genomic markets to direct patient enrollment and stratification. PGDx’s elio tissue complete panel is a 500+ gene test for somatic alterations that detect single nucleotide variants (SNVs), small insertion/deletions, amplifications, rearrangements, microsatellite instability (MSI) and tumor mutation burden. PGDx provides genomic s.
MedicalDeviceLink.com 12/04/2019 14:32
A medtech startup is shaking up the surgical robotics space by adding virtual reality to the equation. Vicarious Surgical is developing the technology and has been granted breakthrough device designation from FDA. The firm said it is the first company to receive this designation for a surgical robotics solution. The Boston-based company’s CEO and co-founder Adam Sachs spoke with MD+DI about the technology on Wednesday, a few hours before speaking at . “It starts with a paradigm shift in computer/human interaction driven by virtual reality,” Sachs told MD+DI . “We have a natural user interface with visual immersion that is so convincing, it makes the surgeon actually feel as if they have been shrunk down and placed inside of their patient. T.
MedicalDeviceLink.com 12/04/2019 13:43
A major server outage rattled Dexcom customers –“ particularly parents –“ over the U.S. Thanksgiving holiday weekend. But most were not as mad about the technology glitch as they were about the company's lack of communication about the issue. Dexcom said it became aware of an issue with Dexcom Follow early Saturday morning that caused some followers to not receive continuous glucose monitoring data or alerts. Dexcom Follow is an important feature of the company's product that many users have come to rely on as part of their diabetes management. James McIntosh, senior public relations manager at Dexcom, told MD+DI Wednesday afternoon that Dexcom Follow Services have been restored to full-service levels but that the company continues to m.
MedicalDeviceLink.com 12/04/2019 10:42
Researchers are using artificial intelligence to measure a common marker of heart disease via lung cancer screenings. The research was presented at the annual meeting of the Radiological Society of North America (RSNA). Low-dose chest CT is approved for lung cancer screening in high-risk people, such as long-time smokers. While these CT scans are intended to diagnose lung cancer, coronary artery calcium, a measure of plaque in the arteries, is also visible on CT. The coronary artery calcium score derived from CT is a well-established measure that helps doctors decide who should get cholesterol-lowering preventive medications called statins. The research team, which represents a close collaboration between MGH's CIRC and AIM at BWH, recently.
MedicalDeviceLink.com 12/03/2019 23:23
Is widespread adoption of surgical robots around the corner? The question is certainly timely given the recent developments in the sector. To name a few, in mid-September, announced it raised $243 million in a Series C round, while reaching unicorn status. Two weeks later, was unveiling Hugo to investors, its long-awaited robotic surgery system. Meanwhile, , the joint venture between Johnson & Johnson and Verily, took on a new CEO ahead of market launch. As the range of offerings continue to expand, should we expect to see surgical robots in every OR soon? The answer is not quite yet. On one hand, a lot has happened since Intuitive Surgical came to existence and launched the da Vinci. Today more than five million patients have benefited fro.
MedicalDeviceLink.com 12/03/2019 15:37
Investors are getting behind Impulse Dynamics’s implantable device that helps treat heart failure. The Mount Laurel, NJ-based company raised $80.3 million in a series D round –“ that will help give the Optimizer Smart a huge commercialization push. Impulse Dynamics said the financing round was led by investor Amzak Health Investors, the round also included Wellington Management, Kennedy Lewis Investment Management, Acorn Biosciences, and Minth Holdings Limited; strategic investors Zoll Medical Corporation, Abiomed and one additional corporate investor; and the company’s chief executive and chief financial officers. “This financing will be used to roll out the product commercially in the U.S.,” Simos Kedikoglou, CEO of Impulse Dynamics, told.
MedicalDeviceLink.com 12/03/2019 15:34
Campbell, CA-based VivaLNK has received Class IIa medical device CE mark for its multi-vital medical wearable sensor and software development kit.ÂÂAt 7.5 grams, the reusable patch is the smallest of its kind, VivaLNK said. The company also noted that the reusability factor can increase the economic value of using the patch 10-times or more than single-use devices. Also, VivaLNK said the combination of a wearable sensor and an associated software development kit enables any application developer to build medical wearable solutions without the need to become experts in hardware and sensor networks. The multi-vital wearable sensor can generate a continuous stream of ECG rhythm, respiratory rate, heart rate, RR interval, and three-axis a.
MedicalDeviceLink.com 12/03/2019 13:43
There could soon be an eye test to aid in the assessment of Parkinson’s disease. FDA has recently granted breakthrough device designation to a technology designed by RightEye that uses objective eye movement measurements to help detect the neurological disease. If the RightEye Vision System could gain a nod from FDA for detection, it would be a gamechanger because currently, no single test is capable of definitively diagnosing Parkinson's disease. Doctors instead rely on a variety of neurological examinations designed to confirm the clinical diagnosis, and misdiagnosis remains a continuing issue for the health community. "With this FDA Breakthrough Device Designation, RightEye has an opportunity to address a critical unmet need in the figh.
MedicalDeviceLink.com 12/02/2019 19:57
Advances in 3D printing have been driving medtech innovation for some time, and every new technological advance offers new potential for progress. Cynthia Star is helping drive such innovation as director, technology transfer, Johnson & Johnson, 3D Printing Center of Excellence. Inspired by the opportunities offered by 3D printing, Star is helping R&D, marketing, supply chain, and partners around the world work together to bring about medtech advances. MD+DI asked Star a few questions about 3D printing’s current role in healthcare innovation, the challenges engineers face, what steps the medtech industry should take next, and more. ÂAs director of technology transfer for Johnson & Johnson’s 3D Printing Center of Excellence, can you expla.

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