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Source: MDDI
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Total 110 results found since Jan 2013.
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
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
Fitbit Takes Large-Scale AFib Study Virtual
Fitbit is launching a large-scale virtual study to validate the use of its wearable technology to identify atrial fibrillation in patients. The San Francisco, CA-based company said it plans to enroll hundreds of thousands of people in the Fitbit Heart Study.
Results from the study could help with regulatory submissions.
The company said its wearables have the potential to accelerate AFib detection because their 24/7 heart rate tracking is powered by long battery life, which allows users to wear their device for multiple days at a time.
To track heart rate, Fitbit’s devices use photoplethysmography (PPG) t...
Source: MDDI - May 6, 2020 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Source Type: news
Telemedicine Is Here to Stay
COVID-19 has prompted a rapid adoption of telemedicine, a trend that some experts say could have a significant and lasting impact on the medical device industry.
Jason Mills, a medtech analyst at Canaccord Genuity, shared conclusions earlier this week from three recent physician surveys that his firm conducted across the structural heart, robotic surgery, and stroke/venous thromboembolism fields. One of the key takeaways is that the overwhelming majority of doctors have "swiftly embraced" telemedicine during the crisis.
A look at some of the major telemedicine players' earnings projectio...
Source: MDDI - April 15, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Digital Health Source Type: news
COVID-19 Business Updates Provide Some Clarity
The unknowns still outnumber the knowns, but recent business updates provide some clarity around how the medical device industry is fairing during the COVID-19 pandemic. First and foremost, it is clear that companies are hurting in the areas of elective procedures, which are being deferred. But there may be some silver linings hidden amongst the bad news.
Needham & Co. medtech analyst Mike Matson estimates that medical device sales across the industry will continue to drop by an average of 40% to 50% until the economy begins to reopen and hospitals start to resume elective procedures.
Matson's e...
Source: MDDI - April 10, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Business Source Type: news
Boston Scientific Recalls Angiographic Catheters Due to Injuries
At least nine people have been injured by a faulty cateter tip on Boston Scientific's Imager II 5F Angiographic Catheters, FDA reported this week. The company initiated a recall of the device in February that includes 6,130 of the catheters distributed between July 16, 2018 and Nov. 26, 2019. Click here for a full list of affected lot numbers.
The catheters are used to provide a pathway to deliver contrast agents to blood vessels. FDA said there is a potential for the catheter tip to become detached during a patient procedure or during procedure preparation. According to the recall notice from FDA, use of the a...
Source: MDDI - April 7, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news
This Robot Gives Birth and We Can & #039;t Stop Watching
She bleeds, breathes, and births a baby that is as eerily lifelike as she is. But most importantly, Victoria takes labor-and-delivery training to the next level.
Victoria, first introduced in 2014, was developed by Miami, FL-based Gaumard Scientific, and is considered the most advanced childbirth simulation system on the market. In the latest version, Victoria's eyes can focus and interact with her caregivers, enabling users to conduct a neurological-assessment that evaluates impaired eye motion for warning signs of a stroke, head trauma, drug use, cranial nerve ...
Source: MDDI - March 4, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Design Source Type: news
Medtech in a Minute: Feeling the Coronavirus Pinch, J & amp;J & #039;s Apple Study, and More
Coronavirus Hurts Big Medtech's Bottom LineÂ
As the Chinese healthcare system focuses on containing the spread of the coronavirus, medical device companies doing business in China are seeing lower procedure volumes, which means lower-than-expected revenue in the first quarter. Boston Scientific, for example, expects the virus to lower first-quarter revenue by $10 million to $40 million.
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J&J and Apple Have Big Hopes for Heartline Study
Johnson & Johnson’s Janssen Pharmaceutical unit and Apple opened enrollment for the Heartline Study, which aims to ...
Source: MDDI - March 2, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
J & amp;J and Apple Begin Enrollment for Heartline Study
In the past few years, Apple has greatly increased its presence in healthcare. The Cupertino, CA-based company has received FDA nods for apps associated with its technology and has found itself in several clinical trials.
Most recently, the tech giant is seeing some movement in its partnership with Johnson & Johnson’s Janssen Pharmaceutical unit.
The companies just opened enrollment for the Heartline Study, which is designed to explore if the Heartline Study app on iPhone and heart health features on Apple Watch can improve health outcomes, including reducing the risk of stroke, with earlier detection...
Source: MDDI - February 26, 2020 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Cardiovascular Source Type: news
ICDs Have Come a Long Way in 40 Years
Michel Mirowski and his colleagues gave the field of implantable cardioverter-defibrillators (ICDs) a pretty good start, but what's more impressive is how far the technology has advanced since that first human ICD implant in February 1980. In the past 40 years we've seen ICDs become dramatically smaller, longer lasting, more capable, more personalized, subcutaneous (non-transvenous), and even MRI-firendly. And that's not to mention the advanced data connectivity and monitoring capabilities that the latest technologies offer. So without further ado, let's take a look at the current ICD landscape and the companie...
Source: MDDI - February 4, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Source Type: news
Abbott Wins Approval for CATALYST Trial for At-Risk Stroke Patients
This study is an extremely important step in assessing the Amplatzer Amulet as an effective non-prescription drug alternative for patients with AFib who are at an increased risk for ischemic stroke."
In an email sent to MD+DI, Abbott wrote, “We already have an Amulet IDE trial underway that is intended to support our submission for approval in the U.S. for Amplatzer Amulet. The newly announced CATALYST trial will support our submission for an expanded indication for Amulet as a safe and effective alternative to NOAC drugs for patients with atrial fibrillation and at risk of stroke.â€
Abbo...
Source: MDDI - February 3, 2020 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Regulatory and Compliance Source Type: news
What to Expect in Neuromodulation This Year
The spinal cord stimulation (SCS) market growth should improve in 2020 as leaders in the space launch new products and benefit from recent acquisitions and invest in potential indication expansions, according to Needham & Co.'s Mike Matson. The medtech analyst published a report Monday sharing his takeaways from the North American Neuromodulation Society (NANS) meeting in Las Vegas, NV over the weekend.
Matson noted that SCS device market growth should continue to improve in 2020 and beyond, thanks to a number of factors. The analyst estimates that SCS currently represents about $2.5 billion, wh...
Source: MDDI - January 27, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
What ’s the Big Deal about Data in Medtech?
Discussion, “Top 5 Things You Need to Know about the Implantable Internet of Things."
Brian Chapman, partner and leader of ZS’s medtech practice of ZS, attributes today’s focus on data to the intersection of two important things:
"A general recognition that understanding more and connecting actions with outcomes will provide feedback and understanding that will drive standards of care. This is not new, but as capabilities rise in data collection, aggregation, and synthesize rise, and coupled with machine learning, the promise of data in healthcare is becoming even more ...
Source: MDDI - December 20, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Digital Health Source Type: news
Medical Device Recalls Were Way Up in 2019
There have been 48 medical device recalls issued in 2019, according to FDA, and the agency reported on four of those recalls just in the past week.
On Monday, MD+DI reported that Medtronic has recalled its SynchroMed II implantable drug infusion pump after receiving reports of early motor stall due to the potential presence of foreign particles inside the pump motor assembly. Since then, FDA has posted three more device recall notices, including one from Cook Medical,  one from GE Healthcare, and one from Smiths Medical.
The most serious of these recent recalls is...
Source: MDDI - December 20, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news
Medtronic Gives Heart Docs Something to & #039;MARVEL & #039; At
Study results published this week in the Journal of the American College of Cardiology: Clinical Electrophysiology show that an investigational set of algorithms in Medtronic's Micra transcatheter pacing system (TPS) significantly improves synchrony and cardiac function in patients with impaired electrical conduction between the chambers of the heart, a condition called atrioventricular (AV) block.
The results from the MARVEL 2 study are expected to be presented Nov. 16 at the American Heart Association's annual scientific sessions.
Medtronic said that based on positive results from both...
Source: MDDI - November 11, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Source Type: news
