Boston Scientific Archives - Page 5 of 6

OneProjects raises $17M to advance 4D cardiac imaging

OneProjects co-founders Fionn Lahart (left) and Christoph Hennersperger [Photo courtesy of OneProjects]

Irish-German cardiac imaging startup OneProjects today announced $8 million in Series A2 funding and two grants totaling $9 million.

The company will use the new funds to complete product development, conduct clinical trials, gain FDA clearance and prepare for U.S. commercialization of the first product developed from its proprietary 4D cardiac imaging platform, Verafeye.

The Series A2 financing was led by imec.xpand, with participation from the European Innovation Council (EIC) Fund and existing investors LSP and Atlantic Bridge Ventures, which led the startup’s Series A1 funding in 2020.

OneProjects said it secured a $6 million grant from the Irish government’s Disruptive Technologies Innovation Fund and a $3 million grant from the EIC Accelerator.

OneProjects aims to improve catheter a…

Women may have more adverse events with left atrial appendage occlusion devices than men

Left atrial appendage occlusion (LAAO) devices on the market include Abbott’s Amplatzer Amulet (left) and Boston Scientific’s Watchman (right). [Images courtesy of Abbott and Boston Scientific]

Women appear more likely than men to experience adverse events or lengthened hospital stays from left atrial appendage occlusion (LAAO) devices, the FDA announced today.

The FDA in its letter to health care providers said that researchers have yet to determine the reason for the difference — and that it is working with device makers to determine the cause.

For now, FDA officials still think that the benefits outweigh the risks when it comes to using LAAO devices such as Abbott’s Amplatzer Amulet and Boston Scientific’s Watchman and Watchman FLX to prevent people with atrial fibrillation from experiencing strokes.

The FDA advised health providers to continue monitoring people with LAA…

September 2021 Issue: Our latest Medical Device Handbook is out!

Making medical devices: Everything you need to know

The innovation-fueled evolution of drug eluting stents

Dexcom CEO Kevin Sayer says G7 will be ‘wonderful’

Getting the inside scoop behind top medtech innovations

Autumn is upon us, and it is once again time to sip a pumpkin spice latte — or a pumpkin beer — and crack open our latest Medical Device Handbook.

Once again, we’ve reached out to experts across the industry to curate dozens of “what is” and “how to” types of articles that cover a breadth of categories: components, drug delivery, manufacturing and machining, materials, product design and development, regulatory, software, sterilization services and tubing.

As the years go by, I’m proud that we’re including more insights from the major medical device companies in each succeeding issue. This time around, we spoke to experts involved in some of the major industry innovations of the past decade:

Now VP of R&D …

Medtronic, Boston Scientific and Abbott fund new University of Minnesota Center for Medical Device Cybersecurity

(Image courtesy of the University of Minnesota)

The University of Minnesota and medical device manufacturers have partnered to launch an organization for cybersecurity research, outreach and workforce training.

Medtronic (NYSE:MDT) , Boston Scientific (NYSE: BSX), Abbott Laboratories (NYSE:ABT) , Smiths Medical and UnitedHealth Group’s (NYSE: UNH) Optum contributed financial support as founding partners of the University of Minnesota Center for Medical Device Cybersecurity.

The Center for Medical Device Cybersecurity will be part of the College of Science and Engineering’s Technological Leadership Institute and also collaborate with the Earl E. Bakken Medical Devices Center and the University of Minnesota’s Office of the Vice President for Research. The center will host roundtables, a hackathon, industry networking, training and offer summer internships and a medical device cybersecurity short cours…

Abbott touts Amplatzer Amulet results in head-to-head trial with Boston Scientific’s Watchman

Abbott (NYSE:ABT) is claiming a big win for its Amplatzer Amulet device in a head-to-head trial with Boston Scientific’s (NYSE:BSX) Watchman.

Late-breaking data presented at the European Society of Cardiology Congress and simultaneously published in Circulation support the FDA’s recent approval for the Amplatzer Amulet, Abbott said in a news release.

Get the full story at our sister site, MassDevice.

Boston Scientific touts future of its MedSurg segment

Boston Scientific executive Dave Pierce sees a bright future for the company’s GI endoscopy and urology technologies.

As many companies did, Boston Scientific (NYSE:BSX) had to adapt during the COVID-19 pandemic and, with the lessons learned, it may be better for it.

Dave Pierce, the EVP of Boston Scientific’s MedSurg segment, certainly thinks so.

“Our team has really persevered and performed at a high level despite all the uncertainty of the past year,” Pierce told MassDevice following the release of the company’s second-quarter financial results. “We as a company are really proud of how we’ve worked to make a safe environment, give employees what they need from a mental health standpoint and help everyone navigate through the uncertainty of the pandemic.”

Get the full story at our sister site, MassDevice.

5 challenges Boston Scientific overcame to make single-use scopes work

FDA wanted single-use scopes to reduce potentially deadly superbug infections. Here’s how Boston Scientific made it happen.

The Exalt Model D [Image courtesy of Boston Scientific]

Boston Scientific’s Exalt Model D Single-Use Duodenoscope received FDA clearance in December 2019. It was the first device of its kind to hit the medical market. Just five months earlier, the FDA urged device manufacturers to move away from re-usable duodenoscopes with endcaps that were more difficult to clean and led to “superbug” infections in 1 in 20 cases. As it so happened, Boston Scientific was already working on a single-use scope.

Now on the market, Exalt is making its way into physician’s offices, but it was a complicated journey.

Boston Scientific’s chief medical officer Dr. Brian Dunkin recently told Medical Design & Outsourcing that the company overcame five challenges to make Exalt a reality:

1. Predicting …

The 18 most innovative medical devices of 2021

[Images from BD, Edwards, Alcon and CVRx]

The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards.

The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition.

“The Awards Committee is excited to introduce the nominees for the 2021 Prix Galien USA Awards. These products have been created by scientists who have dedicated their lives to discovering, developing and distributing life-saving answers for patients,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Award committees and former CEO of the Bill & Melinda Gates Foundation.

“We appreciate the opportunity to honor these researchers and their tireless efforts,” Desmond-Hellmann said in a news releas…

DTW Podcast: Getting to the heart of Boston Scientific’s peripheral business; How Hologic sees trials changing

In this week’s episode of the DeviceTalks Weekly Podcast, Boston Scientific peripheral business EVP Jeff Mirviss explains why the specialty’s name doesn’t really reflect the importance of arteries, veins and other critical “highways” in the body.

Mirviss explains where the peripheral business is headed, and why Boston Scientific is uniquely positioned to address the business.

He also shares lessons learned over his 20-plus years at Boston Scientific including the challenges presented by the Guidant acquisition and the necessary spirit infused by CEO Michael Mahoney.

Also on this week’s podcast, Eric Kolodziej, corporate VP and global head quality and regulatory affairs at Hologic, about how clinical trial management is changing. What role will real-world evidence play going forward, and how will Hologic and others follow up on the record number of EUA’s issued over the past year by the FDA.

Kolodziej will be part of a panel of regulato…

BWXT Medical to make TheraSphere microspheres for Boston Scientific

BWXT Medical announced today that it entered into a long-term, mutually exclusive agreement to manufacture Boston Scientific’s TheraSphere.

Ottawa, Ontario-based BWXT’s new deal with Boston Scientific covers manufacturing of the TheraSphere Y-90 glass microspheres from the Marlborough, Mass.-based medtech company.

Get the full story at our sister site, MassDevice.

4 innovative devices delivered through catheters

[Images from Boston Scientific, Abbott, Edwards Lifesciences and Medtronic]

Physicians use catheters to deploy numerous life-saving devices across the healthcare realm, from cardiovascular to neurovascular.

They typically insert the thin, flexible tubes in a process called catheterization to deploy devices such as left ventricular assist devices (LVADs), transcatheter aortic valve replacements (TAVRs) and occluders to stop bleeding. The catheter industry is regularly innovating to keep up with the medtech industry’s growing demand for smaller devices for larger patient populations.

Throughout 2020, we saw a number of FDA clearances and approvals for catheter-based technologies, including ones designed for conditions renal denervation and heart failure. Just a few months into 2021, the FDA has approved catheter-based innovations by two major medtech companies. Two others developed for high-risk patients a…

8 medical device companies that beat the COVID-19 pandemic and prospered

[Image from unsplash.com]

Some medical device businesses not only survived the COVID-19 pandemic but actually thrived — with many producing the medtech needed to fight the coronavirus’s spread.

Medical Design & Outsourcing recently analyzed financials for 20 of the largest medical device businesses in the world. Not only was revenue only slightly down for the 20 during 2020, but it was actually up for eight of the 20 companies.

For many of the eight companies that saw sales increase, there was a common theme: They pivoted their focus to the diagnostics imaging and personal protective equipment needed to against COVID-19.

“We had different kinds of companies that were able to benefit on some level from COVID and shutdowns,” Richard Newitter, senior research analyst at SVB Leerink, told MDO.

Overall, medtech sales declined in Q1 and Q2 but then bounced back in a V-shaped recovery fo…