App Predicts Blood Glucose Levels 60 Minutes into the Future
There's a new, AI-powered diabetes app that claims to accurately predict blood glucose levels sooner than the industry-leading continuous glucose monitoring (CGM) systems, which currently tout 20-minute glucose value prediction capabilities. Bio Conscious Technologies said an in-house silico study of its Diabits AI algorithm demonstrated its ability to provide 60-minute blood glucose value predictions. The Vancouver, British Columbia-based company says the app is designed for people with diabetes who use a CGM to monitor their daily blood sugar fluctuations. “The ability to accurately predict ...
Source: MDDI - June 11, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health Source Type: news

RapidAI is Set to Acquire EndoVantage for an Undisclosed Sum
M&A is still a thing during the COVID-19 Pandemic. Advanced stroke imaging firm, RapidAI is acquiring EndoVantage, developer of the Find, Track, and Treat comprehensive cerebral aneurysm management platform. Menlo Park, CA-based RapidAI said this acquisition can help it expand its scope, from ischemic stroke to hemorrhagic stroke and now aneurysm. EndoVantage was started at Mayo Clinic and Arizona State University has developed a powerful award-winning computational platform that provides comprehensive cerebral aneurysm management, automating the entire workflow from initial assessment, growth monitoring, to treatment ...
Source: MDDI - June 10, 2020 Category: Medical Devices Tags: Business Cardiovascular Source Type: news

DoD Funds Clinical Trial of Seraph Blood Filter to Treat COVID-19
The Department of Defense is funding a clinical trial of a COVID-19 treatment using ExThera Medical’s Seraph 100 Blood filter. The device was selected to be in the multi-center randomized clinical trial because it showed encouraging preliminary results in critically ill COVID-19 patients at a military hospital in the U.S. and 14 other hospitals in Europe. Investigators at the Uniformed Services University in Bethesda will run the trial of the Martinez, CA-based company’s device. Initial reports indicate Seraph 100 stabilizes blood pressure and inflammatory biomarkers that correlate with ...
Source: MDDI - June 10, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 Business Source Type: news

Study Could Add More Depth to Bioelectronic Medicine
This study is one of several that we’re conducting and there are more coming out in the next few months,” he said. “I see this study and [the upcoming studies] as part of this big story that has to do with building the second generation vagus nerve stimulation therapies – that will be much more effective and much safer. It will allow a lot of flexibility to healthcare providers in individualizing the therapy to specific subjects.” (Source: MDDI)
Source: MDDI - June 9, 2020 Category: Medical Devices Authors: Omar Ford Tags: Digital Health R & Source Type: news

Devices Will Play A Greater Role in COVID-19
Up until now, medical devices have been in the background when it comes to the novel coronavirus. The bigger stories in the industry came from diagnostic firms either developing virus detection or antibody tests.   However, that all changed when Danvers, MA-based Abiomed was granted Emergency Use Authorization for the Impella RP to include patients suffering from COVID-19 related right heart failure or decompensation, including pulmonary embolism.   I give my take on why this lone EUA could be the start of more device-related solutions regarding symptoms associated with COVID-19.   &Acir...
Source: MDDI - June 8, 2020 Category: Medical Devices Tags: COVID-19 Source Type: news

Procedure Volumes Are Rebounding Faster than Expected —but Still Far from Normal
From a revenue perspective, the biggest hit on the medical device industry during the height of the global coronavirus pandemic was the fact that most non-emergency procedures were deferred. This was necessary both as a safety precaution for patients and to conserve hospital resources for COVID-19 patients. The good news, however, is that analysts are seeing positive signs of procedure volume recovery, particularly in orthopedics, which was by far the hardest hit sector. In a recent survey of 51 orthopedic practices, Canaccord Genuity analyst Kyle Rose measured the rates of patient volumes since the...
Source: MDDI - June 8, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Orthopedics Source Type: news

Medtronic Expands Indications for the Resolute Onyx DES in Europe
Medtronic has scored CE mark for a unique indication for the Resolute Onyx drug-eluting stent. The Dublin-based company said the approval was for a DAPT indication for high bleeding risk (HBR) patients. The firm said for HBR patients whose bleeding risk may be increased by taking longer DAPT regimens (a combination of aspirin and anti-clotting medication), this new, indication allows physicians to recommend a shorter, one-month regimen of DAPT, following a percutaneous coronary intervention (PCI) with Resolute Onyx. The indication is based on results from the Onyx ONE Global Study, a prospective, randomized, one-month DAPT...
Source: MDDI - June 8, 2020 Category: Medical Devices Authors: MDDI Staff Tags: Regulatory and Compliance Cardiovascular Source Type: news

Medtech in a Minute: Bigfoot Steps Up the Funding Game, Fitbit Flow, and More
Fitbit Dives Deeper Into Medtech with Ventilator FDA granted an emergency use authorization for the Fitbit Flow, a low-cost ventilator, for use during the COVID-19 pandemic. The company said the device builds on standard resuscitator bags, like those used by paramedics, with sophisticated instruments, sensors, and alarms that work together to support automated compressions and patient monitoring.   Advamed Takes a Stand Against Racial Injustice It's rare that the head of one of the industry's most prominent trade associations takes a stand on a controversial social issue, but as the father of a blac...
Source: MDDI - June 7, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Digital Health Source Type: news

Abiomed Granted IDE to Evaluate ‘World’s Smallest Heart Pump’
Abiomed said it has received approval for an IDE to start an early feasibility study of what it is calling the “world’s smallest heart pump.”   The Danvers, MA-based company said the first-in-human trial will look at the 9 French Impella ECP heart pump in high-risk percutaneous coronary intervention (PCI) patients.   The primary endpoint of the study is successful delivery, initiation, and maintenance of adequate hemodynamic support and a composite rate of major device-related adverse events during high-risk PCI.   The stu...
Source: MDDI - June 6, 2020 Category: Medical Devices Tags: Cardiovascular Regulatory and Compliance Source Type: news

Supplier Stories for the Week of May 31
(Source: MDDI)
Source: MDDI - June 5, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Assembly and Automation Source Type: news

Fitbit Continues its Race into Medtech with New EUA
Fitbit is continuing its rapid trajectory into the medtech industry with a new Emergency Use Authorization from FDA. The San Francisco, CA-based company said the EUA is for a low-cost emergency ventilator to help address patients’ needs during the COVID-19 pandemic. The company said after seeing the need for ventilators, it applied its deep in-house expertise in advanced sensor development and hardware design to quickly create Fitbit Flow, an automatic resuscitator inspired by the MIT E-Vent Design Toolbox and based on specifications for Rapidly Manufactured Ventilation Systems. Fitbit said during develop...
Source: MDDI - June 5, 2020 Category: Medical Devices Tags: COVID-19 Business Source Type: news

How Ready Are You for the Next Crisis?
During the COVID-19 pandemic, medical device and diagnostics companies and their partners have been responding with rapid solutions to meet urgent healthcare needs. Much has been learned from the quick response that could help the medical device industry prepare for future pandemics, disasters, and other potential supply-chain disruptions. MD+DI will be exploring such lessons in the webinar series, How the Medtech Industry Can Respond to Crisis. The six individual webinars held the week of June 22 include: June 23, 11 am EDT: Respond and Restore: Best Practices for Responding to a Pandemic (and Other Crises) June 23, 2 pm ...
Source: MDDI - June 4, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Business Source Type: news

AdvaMed CEO: We Can and Must Stand for the Cause of Equal Justice for All
As a journalist covering the medical device industry for more than a decade, I cannot recall the last time AdvaMed took a stand on a controversial social or political issue. The trade association is known for advocating on a range of policy issues impacting the industry but tends to avoid the really hot-button topics such as gun violence and police brutality. Until now. "For too many in this country, the fear of a similar fate [to that of George Floyd] has led to outrage, anger, and hopelessness. We are seeing this expressed in cities across the nation, and for good reason. We are proud of our indus...
Source: MDDI - June 4, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

LaunchPad Lands Coveted Grant for Dental Bone Graft
In more than 30% of dental implant cases, existing bone graft materials fail to achieve the desired clinical results, and another bone graft procedure must be conducted, increasing the overall time and cost of the treatment. That's where LaunchPad Medical could potentially change the game with its new dental bone graft solution based on the company's Tetranite technology. The Lowell, MA-based company won a $1.8 million grant from the Michigan-Pittsburgh-Wyss Regenerative Medicine Resource Center to initiate a pivotal animal study of its technology. The grant was funded by the National Institutes of Health's Nat...
Source: MDDI - June 4, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: R & D Implants Source Type: news

Bigfoot Takes a Big Step Closer to Market with $55M Financing
Bigfoot Biomedical hasn't let the coronavirus pandemic stand in the way of bringing its injection-based digitized insulin dosing platform to the U.S. market. If anything, CEO Jeffrey Brewer says the pandemic has "only crystalized the need for medical solutions like ours that facilitate remote care, remote support, and home delivery." The company has raised a total of $55 million to close its series C equity financing. Abbott led the round with support from existing investors, including Quadrant Capital Advisors, Senvest Capital, Janus Henderson, and Cormorant Asset Management, along with new investo...
Source: MDDI - June 3, 2020 Category: Medical Devices Tags: Business R & D Source Type: news