Fractyl Seeks to Turn Diabetes On Its Ear with Revita DMR
Fractyl Laboratories is seeking to ‘turn back the clock’ in Type 2 diabetes progression with its disease-modifying therapy.
FDA granted the Lexington, MA-based company IDE to launch a pivotal trial of the Revita DMR, a which holds the potential to eliminate the need for insulin injections in patients suffering from Type 2 diabetes.
“Insulin is a challenging drug for patients with Type 2 diabetes because it can cause weight gain,†Harith Rajagopalan M.D. Ph.D., co-founder and CEO of Fractyl told MD+DI. “It can cause a risk of your bloo...
Source: MDDI - June 3, 2020 Category: Medical Devices Authors: Omar Ford Tags: Implants Regulatory and Compliance Source Type: news
Medical Device Developers to the Rescue
Conclusion
Medical device specialists want to help, but responding to pandemic shortages can be complicated. These takeaways come from our experience with building PPE, but they apply to any collaborative rapid response project. Use these tips as a framework to get you and your team on the path to meaningful progress. (Source: MDDI)
Source: MDDI - June 3, 2020 Category: Medical Devices Authors: Scott Thielman Tags: Design Source Type: news
Open-Source Release Allows Manufacturers Worldwide to Produce the UMN & #039;s Low-Cost Ventilator
There has been no shortage of innovation and collaboration across the industry to provide critical medical solutions in response to the coronavirus pandemic, but developing a much-needed device is only half the battle. To truly make an impact, innovators need to make their technology available to as many patients as possible.
With that end-goal in mind, some organizations are open-sourcing their designs in an effort to ramp up production and distribution. The latest example of this trend comes out of the University of Minnesota (UMN) Bakken Medical Device Center.
In early April, MD+DI reported that ...
Source: MDDI - June 3, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Contract Manufacturing Source Type: news
Dear Dentists, Spare Us the Bloody Pictures, Please
Traditionally, dentists (and other medical professionals, for that matter) didn't have to worry about a social media presence. Times have changed, however, and a recent DentaVox survey suggests that dentists who engage with patients on social media are perceived as more innovative and caring than their "traditionalists" counterparts. Not all content is suitable to share, however and, for most patients, images from bloody procedures are a hard pass.
While 97% of respondents say they favor the use of social media by dental specialists, with Facebook being considered the most im...
Source: MDDI - June 2, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Business Source Type: news
Consider the Promises and Challenges of Medical Image Analyses Using Machine Learning
Medical imaging saves millions of lives each year, helping doctors detect and diagnose a wide range of diseases, from cancer and appendicitis to stroke and heart disease. Because non-invasive early disease detection saves so many lives, scientific investment continues to increase. Artifical intelligence (AI) has the potential to revolutionize the medical imaging industry by sifting through mountains of scans quickly and offering providers and patients with life-changing insights into a variety of diseases, injuries, and conditions that may be hard to detect without the supplemental technology.
Images are the largest source...
Source: MDDI - June 2, 2020 Category: Medical Devices Authors: Partha S. Anbil and Michael T. Ricci Tags: Imaging Source Type: news
New EUA Places Abiomed Firmly in the COVID-19 Conversation
Sometimes when the discussion of tackling the novel coronavirus comes up, the use of medical devices gets lost in the shuffle. Most of the conversation surrounding COVID-19 comes from either the promise of a vaccine or the expansion of tests.
Abiomed is adding to the conversation surrounding medtech’s potential contribution to the treatment of COVID-19 patients. Monday, the Danvers, MA-based company by receiving Emergency Use Authorization for a device to treat COVID-19 related right heart failure patients.
The Impella RP is a temporary heart pump that provides circulatory support for patients who develop...
Source: MDDI - June 2, 2020 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular COVID-19 Source Type: news
Pool of Antibody Tests Continues to Grow
The number of antibody tests for COVID-19 issued emergency use authorization continues to swell. Siemens Healthineers adds to that numbers as it said it has been issued EUA from FDA for an antibody test to detect the presence of SARS-CoV-2.
The Erlangen, Germany-based company said the test data demonstrated 100% sensitivity and 99.8% specificity. Tests with a high level of specificity yield low false-positive rates, which is highly desirable especially when prevalence of disease is low.
The total antibody test SARS-CoV-2 Total (COV2T)is available on the largest installed base of high-throughput analyzers, including the Ate...
Source: MDDI - June 1, 2020 Category: Medical Devices Tags: COVID-19 IVD Source Type: news
Strategic National Stockpile Legislation May Not Address the Real Problem
In the wake of widely reported shortfalls and unexplained re-routing of material in the Strategic National Stockpile (SNS) throughout the most critical stages of the COVID-19 pandemic, Congressional Democrats wasted no time introducing legislation that would mandate better and more transparent management of the resource.
That effort, however, may be an example of inventorying trees without recognizing the entire forest is sparsely grown out, according to one expert on the medical supply chain.
“There’s a lot of misunderstanding about the stockpile, and people are using the stockpile as a...
Source: MDDI - June 1, 2020 Category: Medical Devices Authors: Greg Goth Tags: Regulatory and Compliance Source Type: news
Medtech in a Minute: Philips Regulatory Win, Eko ’s Telemedicine Play, and More
Philips Wins Regulatory Nod for Clinical Surveillance Biosensor
Philips won a nod from FDA and a CE mark for a next-generation wireless wearable biosensor to help monitor COVID-19 patients in hospital. The Amsterdam, Netherlands-based company touts its next-generation device as being able to enhance clinical surveillance in its patient deterioration detection solution to help clinicians detect risk so they can intervene earlier and help improve care in lower acuity care areas.
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Eko Moves Deeper into Telemedicine in the Age of Social Distancing
The digital health company is launching a platform that will combin...
Source: MDDI - May 30, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
Quest Wins EUA for COVID-19 Self-Collection Kit
Quest Diagnostics has won emergency use authorization for a self-collection kit for COVID-19. The Secaucus, NJ-based company said its test is for individuals to self-collect a nasal specimen at home or in a healthcare setting when determined to be appropriate by a healthcare provider.
The self-collection kit allows an individual to swab the front part of the nostril and may be used on children (supervised by an adult) as well as adults. Specimens are shipped overnight via FedEx at room temperature (without a frozen cold pack).
Specimens collected using the kit may be tested with the Quest Diagnostics SARS-CoV-2 RT-PCR test...
Source: MDDI - May 29, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 IVD Source Type: news
Medtronic Issues Recall for HVAD Pump Outflow Graft
Medtronic is recalling its HeartWare HVAD pump outflow graft and outflow graft strain relief because of the risk of breaks and tears during the pre-implant pump assembly process. FDA has identified this as a Class I recall. The Dublin-based company said it has received 92 complaints.
The recalled products according to FDA’s release are:
HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief
Model Numbers:HVAD Pump Outflow Graft: 1125
HVAD Pump Implant Kit: 1103
HVAD Implant Accessories Kit: 1153
Distribution Dates: March 1, 2018 to April 1, 2020
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Medtronic said the use of the affe...
Source: MDDI - May 29, 2020 Category: Medical Devices Tags: Cardiovascular Regulatory and Compliance Source Type: news
InspectIR Systems Launches Trial for Mobile Device to Detect COVID-19
InspectIR Systems has launched a clinical trial focused on using a mobile device for the detection of the novel coronavirus (COVID-19).
The Frisco, TX-based company began the trial on Wednesday and said it will test the InspectIR portable breathalyzer.
"As most of us have experienced, the world has changed due to the coronavirus pandemic. We challenged our development teams with a simple question: 'Can we help?' We quickly realized our devices could identify COVID-19 in the breath and help with the unique circumstances facing the U.S. and the world right now," InspectIR CEO Tim Wing, said in a release. "It provides detecti...
Source: MDDI - May 28, 2020 Category: Medical Devices Authors: MDDI Staff Tags: COVID-19 IVD Source Type: news
Supplier Stories for the Week of May 24
(Source: MDDI)
Source: MDDI - May 28, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Components Source Type: news
Eko Moves Deeper into Telemedicine in the Age of Social Distancing
Physicians and clinicians are facing the unique challenge of practicing social distancing with their patients during the COVID-19 pandemic. It seems almost impossible because the practice of healthcare is so hands-on.
However, Eko Health is hoping to overcome this challenge by marrying its technology with telemedicine. Last week, the digital health company launched Eko Telehealth, an artificial intelligence-powered telemedicine platform geared toward cardiac exams.
“As we think of the future of healthcare, the fact the clinician and the patient aren’t in the same room shouldnâ€...
Source: MDDI - May 28, 2020 Category: Medical Devices Tags: COVID-19 Digital Health Source Type: news
The New Normal of Workplace Safety
Just a couple of short months ago, workplace safety was a familiar concept. The potential hazards — exposure to chemicals, proximity to machinery, ladders, and so forth — and the preventive measures implemented by employers were straightforward and well-understood. What does that look like in the COVID-19 era? Social distancing . . . temperature checks . . . obsessive hand washing . . . face masks and shields . . . double and triple shifts to comply with strict capacity requirements. And that bulletin board where the company proudly touted the number of days without a workplace injury? N...
Source: MDDI - May 28, 2020 Category: Medical Devices Tags: Business Source Type: news
