MassDevice Archives - Page 189 of 587 - Medical Design Sourcing

LivaNova LifeSparc ACS pump cleared for extended use

LifeSparc includes a sterile, on-patient pump. The reduced circuit surface area decreases inflammatory response and eliminates the need for a heater/cooler. [Image courtesy of LivaNova]LivaNova (Nasdaq: LIVN) says a new FDA clearance expands how long health providers can use its LifeSparc advanced circulatory support (ACS) pump for extracorporeal membrane oxygenation (ECMO).

The new clearance makes permanent some of the temporary emergency guidelines under which LifeSparc provided ECMO therapy during the height of the COVID-19 pandemic.

In a news release posted yesterday, London-based LivaNova said it used existing real-world evidence to receive the new indication. The evidence included data collected during the pandemic.

“The onset of the global pandemic elevated ECMO to the forefront as an effective treatment option for patients in need of emergent rescue who had limited, if any, options,” said Dr. Raymond Yau, director of Cardiogenic Shock at the Heart H…

Orthofix, SeaSpine announce CFO post-merger

SeaSpine CFO John Bostjancic [Image courtesy of SeaSpine]SeaSpine CFO John Bostjancic will continue as the top financial officer of the to-be-named orthopedic device giant created through a merger with Orthofix.

When the two companies announced their plans to merge last month, they said that Bostjancic’s present boss, SeaSpine CEO Keith Valentine, would be CEO.

“John has been a key leader of SeaSpine dating back to the successful spin-out of the organization in 2015. I am confident his background and experience in the medical device industry, coupled with his cultural influence, will benefit the newly combined company as we continue to grow,” Valentine said in today’s news release.

“I believe John is well positioned to help lead us through the successful integration of the two companies, ensuring accountability across all levels of the organization, as we focus on the key initiatives that will drive growth, scalability and shareholder value.” Read more

Philips’ respiratory devices recall has even more problems

The FDA says some Philips ventilators — reworked as part of the company’s massive respiratory device recall — have new problems.

The Dutch medtech giant has informed the FDA that reworked Philips Respironics Trilogy ventilators have two new potential issues, the FDA said yesterday.

First, the new silicone sound abatement foam could separate from the plastic backing. The separated foam could impact device performance. For example, the silicone foam could potentially block the air inlet, lowering the inspiratory pressure. A ventilator alarm, such as the Low Inspiratory Pressure alarm, could sound. Philips installed silicone foam in the reworked ventilators to replace the polyester-based polyurethane (PE-PUR) foam that could potentially deteriorate and get into air pathways.

In addition, the company reported trace amounts of particulate matter in the air pathway of some reworked ventilators. Particulate samples went to a third-party lab for evaluation…

Enovis introduces DynaNail Helix for hindfoot fusions

The DynaNail Helix’s threads allow for easy insertion like a screw. But it also has the dynamic compressive power and stability of a nail. [Image courtesy of Enovis]Enovis Corp. (NYSE: ENOV) has launched the DynaNail Helix —the latest addition to its DynaNail family and suite of foot and ankle products.

As with other DynaNail systems, DynaNail Helix uses proprietary, nitinol-based materials technology. The NiTiNOL tech provides sustained dynamic compression properties for subtalar fusion.

At the same time, Enovis sought to give it an anatomically friendly design and simple, screw-like insertion. As a result, the Helix’s threads also allow for easy insertion like a screw while also providing a nail’s dynamic compressive power and stability.

“It provides sustained compression across the fusion site, which traditional screws cannot do,” said Dr. Christopher Hirose, a foot and ankle orthopedic surgeon based in Boise, Idaho.

Hirose added in the Enov…

Conformis launches Made-to-Measure Imprint knee system

Conformis’ Imprint knee system [Image courtesy of Conformis]Conformis (Nasdaq:CFMS) today announced the full commercial launch of its new Imprint knee system.

The orthopedic company’s new Imprint system is made-to-measure and will become Conformis’ primary knee offering. The company is also offering a fully personalized iTotal Identity system as a deluxe services upgrade option for patients through its Image-to-Implant Platinum Services program.

“We have been pleased with the surgeon feedback that we’ve received to date, and we are excited to see continued adoption of our Imprint system which reflects our business model transition,” said CEO and President Mark Augusti. “By introducing the new Made-to-Measure category of TKA systems, we created a new standard for personalization with the lower manufacturing cost and faster delivery time of typical fully custom products.”

Imprint uses several features from the Conformis’ fully personal…

ResMed opens manufacturing plant in Singapore

[Image courtesy of Google]ResMed (NYSE: RMD, ASX: RMD) this week announced the grand opening of its new Advanced Manufacturing Center in Singapore’s Tuas area.

The new 270,000-square-foot facility doubles the respiratory care company’s presence in Singapore to serve its key manufacturing hub in Asia Pacific. The facility will employ nearly 1,000 people and has smart dashboards that integrate real-time data to monitor the performance of production lines.

ResMed’s new facility also has the manufacturing capacity and footprint to scale production for connected devices and mask systems. The company plans to use the new facility to produce its latest positive airway pressure (PAP) system, which allows users to monitor their own sleep apnea treatment.

“Singapore’s strategic location and support for business investment, coupled with ResMed’s world-leading devices and digital health offerings, provides the perfect opportunity to expand our manufac…

GE HealthCare investing $80M in contrast media ingredients plant in Norway

GE Healthcare says its contrast media products are used in more than 100 million procedures globally every year. [Image courtesy of GE Healthcare]GE Healthcare today announced it is investing $80 million to expand contrast media production capacity in Norway.

The investment will go toward increasing manufacturing capacity by 30% at its active pharmaceutical ingredients site in Lindesnes, Norway. It will create around 100 new jobs as part of GE Healthcare’s commitment to addressing significant future global demand for iodinated contrast media, used in X-ray and computed tomography (CT) procedures around the world.

GE Healthcare’s announcement comes after it announced a long-term agreement with Chile-based mining company SQM to secure its supply of iodine for vital imaging agents.

Iohexol and iodixanol APO are used in over 100 million patient doses of GE iodinated contrast media annually to enhance the visualization of organs, blood …

CMR Surgical hits 100 mark for Versius systems installed

The Versius system features freedom of port placement. [Image from CMR Surgical]CMR Surgical today announced that it has installed more than 100 Versius surgical robotic systems worldwide.

Count CMR among a host of companies, big and small, that are seeking to compete against surgical robotics pioneer Intuitive. Surgical robotics is a hot space. (Here are 16 robotic surgery companies to know. And here are eight more, including CMR.)

Since introducing Versius in 2019, Cambridge, U.K.–based CMR has scaled up rapidly. There are now Versius robots in operation across Europe, Asia, Australia, Latin America, and the Middle East.

To meet the growing demand, CMR Surgical is working on building a roughly 75,000-square-foot manufacturing facility in Cambridgeshire. The new facility will serve as CMR’s global manufacturing hub. The company also has plans for additional European offices in the coming months.

A ‘significant milestone’ for CMR Surgi…

FDA says Insulet Omnipod Dash batteries recall is Class I

The smartphone-like Personal Diabetes Manager [PDM] is supposed to enable an Omnipod Dash user to conveniently and discreetly communicate with their Podd. [Image courtesy of Insulet]The FDA has posted a notice that an Insulet recall related to Omnipod Dash batteries is Class I, its most serious level.

Insulet recently issued a voluntary global safety notice to warn about battery problems. The Omnipod Dash is Insulet’s previous-generation insulin pump. The company since launched its FDA-cleared and CE-marked Omnipod 5 next-generation automated insulin delivery system.

The Omnipod Dash includes a Personal Diabetes Manager (PDM) — a locked-down Android mobile device with features similar to a smartphone that controls the Pod delivering insulin. The FDA says Insulet has received Insulet 455 complaints involving these battery issues, including three fires. There have been no reports of injuries or deaths.

Reported problems include battery swelling, fluid leakage…

Axonics, Outset lead medtech space on Deloitte’s list of fastest growing companies

Deloitte today released its “North America Technology Fast 500” list of growing companies, including a handful of medtech firms.

The list, which ranking of the fastest-growing North American companies across a range of sectors, included several “Life Sciences” outfits. Immunology company Vir Biotechnology led the way in first place on the list.

Axonics (Nasdaq:AXNX) represented the highest-ranked medical device company at No. 4. According to Deloitte, the company registered 25,401% growth over a three-year period. Axonics reported $180.3 million in revenue in fiscal 2021, compared to $707,000 in fiscal 2018.

The company topped last year’s version of the list. Axonics develops novel products for adults with bladder and bowel dysfunction. Its sacral neuromodulation (SNM) systems provide adults suffering from overactive bladder and/or fecal incontinence with long-lived, easy-to-use, safe, clinically effective therapy. The compa…

Siemens Healthineers presents duo of new MRI scanners

The Magnetom Cima.X (left) and Magnetom Terra.X (right). [Image from Siemens Healthineers]Siemens Healthineers this week presented its two latest magnetic resonance imaging (MRI) tomographs for clinical and scientific use.

The company unveiled its Magnetom Cima.X with 3T field strength and Magnetom Terra.X with 7T at its Siemens Healthineers Shape 23 Keynote.

“Due to their high field strengths and strong gradient performance, both scanners will be optimal for detecting the finest structures in the body more clearly,” said Aruther Kaindl, head of MRI at Siemens Healthineers. “By introducing AI-based algorithms on these high-end scanners for the first time, we reduce the scanning time in MRI by up to 50%4, while improving image quality.”

About the 3T Magnetom Cima.X from Siemens

The 3T Magnetom Cima.X uses Siemens’ strongest gradient. It features an amplitude of 200 mT/m and a slew rate of 200 T/m/s. The company said this registers 2.5…

Abbott FreeStyle LibreLink app now pairs with Novo Nordisk insulin pens in UK

The NovoPen Echo smart insulin pen. [Image from Novo Nordisk]Novo Nordisk (NYSE:NVO) announced that users of the Abbott (NYSE:ABT) FreeStyle LibreLink app can connect to its smart insulin pens.

People living with diabetes in the United Kingdom can connect the app to the Novo Nordisk smart, connected pens. Users of the Abbott FreeStyle LibreLink app with FreeStyle Libre glucose sensing technology can see a range of information related to their diabetes. This includes dose timing and the amount of insulin taken, plus how those metrics impact their individual glucose patterns.

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