Bracco Imaging and Subtle Medical obtain CE mark for AI-powered MRI software
Italy-based Bracco Imaging and Subtle Medical have obtained an EU CE mark for AiMIFY, a jointly developed software designed to enhance the imaging of contrast MRI brain scans using artificial intelligence (AI).
Developed through the application of Bracco's imaging and Subtle's software, clinical evidence has demonstrated that AiMIFY provides contrast enhancement for MRI brain scans up to twice the level typically achieved with a labelled dose of gadolinium-based contrast agents (GBCAs).
Consequently, AiMIFY enhances the visualisation of small and poorly enhanced lesions that are critical to the early detection of certain conditions.
US-based Subtle Medical's chief product officer, Ajit Shankaranarayanan, points out that in achieving imaging enhancements in contrast MRI scans, whereby a contrast agent is administered to a patient before an MRI is undertaken, the software requires no adjustments to these standard practices.
According to the companies, validation data for AiMIFY, which was granted software as a medical device (SaMD) clearance from the US Food and Drug Administration (FDA) in October 2024, has demonstrated the technology's efficacy across diverse patient demographics, pathologies, lesion sizes, scanner vendors, MRI sequences, and acquisition orientations.
Radiology platform leader at Bracco Imaging, Sascha Daeuber commented: 'With the CE Mark for AiMIFY, we're taking the next step in our shared mission to deliver innovative, AI-powered solutions that enhance diagnostic precision and support radiologists and patients worldwide."
Bracco and Subtle Medical stated that they will now initiate commercialisation activities for AiMIFY in select European markets, with a phased commercial rollout expected between late 2025 and early 2026.
According to a 2023 report by GlobalData, the use of AI across healthcare is burgeoning, with the market forecast to reach a valuation of around $19bn by 2027. Radiology has emerged as one of the most common areas in which AI is being applied – as a means to drive efficiencies and alleviate clinician burnout.
In a recent report by KPMG on AI's impact on healthcare, 86% of healthcare professionals expressed their belief that AI adoption would give their organisation a competitive edge over those who did not.
"Bracco Imaging and Subtle Medical obtain CE mark for AI-powered MRI software" was originally created and published by Medical Device Network, a GlobalData owned brand.
The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Wall Street Journal
6 minutes ago
- Wall Street Journal
The High Cost of Good Intentions in Medicaid
Jared Bernstein and Hannah Katch reply to my June 5 op-ed on Medicaid by arguing that the healthcare program's expansions have been of high value to its recipients (Letters, June 12). It's more accurate to say that Medicaid is an excellent example of the high cost of good intentions. The best research on the program's effect on health outcomes is from the Oregon experiment in which people were randomly assigned to Medicaid. Researchers found little evidence that the program improved health outcomes. They also found that recipients value Medicaid at only 20% to 50% of its cost to taxpayers. State lawmakers appear to place a similarly low value on the program. They have always had the option of expanding Medicaid to able-bodied adults at their own expense. Most chose not to do so until they were offered 100% federal subsidies.
Fast Company
9 minutes ago
- Fast Company
Kering bets on Renault boss Luca de Meo to revive Gucci
Francois-Henri Pinault, the billionaire heir who has headed up the French fashion house Kering Group for the past 20 years, has picked the CEO of automaker Renault to be his successor. The stock market's reaction? That's gucci. Shares of Kering jumped Monday after reports trickled out beginning Sunday that Kering planned to tap Luca de Meo as its new CEO. The stock closed 13.5% higher. The Paris-based company confirmed the news in a statement on Monday, indicating that de Meo will take the helm of the struggling fashion house as it 'enters a new phase of development.' Pinault will stay on as chairman of the board of directors after de Meo takes the helm in September. Pinault said in the statement that he first met de Meo a couple years ago when he 'launched a reflection on the evolution' of the company's governance. 'His experience at the helm of an international listed group, his sharp understanding of brands, and his sense of a strong and respectful corporate culture convinced me that he is the leader I was looking for to bring a new vision and steer this chapter in our Group's history.' The big jump in Kering shares suggests investors are at least hopeful about Kering's future, and Bernstein analysts noted that brand management and marketing are de Meo's forte, as reported by CNBC. Kering shares have fallen more than 72% in the past four years as the company has struggled to convince customers—and investors—of its appeal. Gucci's Struggles Much of Kering's problem rests with Gucci, the group's biggest brand by far, accounting for 44% of revenue in 2024. Gucci has been dragging down the rest of the company: In the first quarter, Gucci's sales fell 25%, while Kering's fell 14%. Gucci has fallen out of fashion among consumers, and particularly in China and the broader Asia-Pacific region. The brand closed two stores in Shanghai earlier this year, while other brands have gained traction among consumers there—and elsewhere. Attempts to breathe some new life into the brand—such as the March announcement of Demna as Gucci's new creative director following a decade-long stint at Balenciaga—didn't assuage investors. And consumers looking for a handbag that's nostalgic to Gucci's golden years might find a more attractive option with an independent collection of handbags by Alexandra Gucci Zarini, an heir to the Gucci family, While de Meo had a successful tenure at Renault—during which time the stock jumped nearly 90%—he faces a difficult road in his new role. 'De Meo has a titanic challenge ahead of him,' Luca Solca, analyst at Bernstein, told The Wall Street Journal.
CNBC
10 minutes ago
- CNBC
Eaton makes a move outside of the data center — plus, what's new with Abbott Labs
Every weekday, the CNBC Investing Club with Jim Cramer releases the Homestretch — an actionable afternoon update, just in time for the last hour of trading on Wall Street. Markets: Stocks were higher in afternoon trading Monday, with the S & P 500 adding nearly 1% and the tech-heavy Nasdaq Composite advancing around 1.5%. The action across Wall Street — and not just in stocks, but also in areas like gold and oil — suggest the market is betting that the Israel-Iran attacks will not lead to a broader conflict in the Middle East. As we highlighted in a story earlier Monday , investors view geopolitical events through the lens of, "What does this mean for global economic growth?" On Monday, at least, the belief is that growth will not be derailed by the attacks. Defense deal: Club holding Eaton is making a move outside of its high-profile data center business. On Monday, the electrical equipment company announced a $1.55 billion acquisition of aerospace and defense firm Ultra Precision Control Systems, expanding Eaton's presence in two fast-growing end markets amid rising global defense spending driven by geopolitical uncertainty and conflict overseas. Ultra PCS makes products like ejection systems that help drop missiles, along with noise and vibration control for aircraft interiors. The deal is expected to be accretive to Eaton, given Ultra PCS's "strong growth position on high-margin business," according to the Monday announcement. Ultra PCS is projected to generate sales of roughly $240 million in 2025, which would be equal to nearly 6% of Eaton's expected aerospace revenues of $4.08 billion. In the company's first quarter, aerospace was about 15% of sales. The acquisition, while small, speaks to a key concern Jim Cramer now has with Eaton's stock: its close linkages to the AI data center trade. With the way our own stock portfolio has evolved, Jim worries that shares of Eaton are too closely tied with the spending patterns of hyperscalers like Amazon and Microsoft. Even if the "data center and distributed IT" end market is only expected to contribute 17% of Eaton's total sales this year, it can sometimes feel like that's the only thing that moves the stock. And now that we have other AI industrial names like Dover and GE Vernova in the portfolio, Jim has even speculated if the Club should exit Eaton all together. "I am concerned and think that we might have to take one of these off out of that concern," he said of Eaton and Dover during the May Monthly Meeting . "I like the data center [story] but I do not want to be the data center fund." Therefore, adding Ultra PCS to the fold at Eaton should help boost its budding aerospace business and, hopefully, broaden the way Wall Street views the stock. Jim has described the aerospace division as "a very solid business that is really coming on." Shares of Eaton are up more than 4%, outperforming the rebounding market. A few other stocks in the AI data center trade such as Vertiv also are having a strong day. Abbott roundup: There are a few headlines involving Club name Abbott Laboratories on our radar Monday, including an initiation over at Leerink Partners. Analysts began coverage of the medical devices company with a hold-equivalent rating and target price of $143, implying less than 6% upside from where the stock closed Friday. While noting Abbott's strong position in the industry, Leerink analysts said they believe "potential upside growth drivers and strong execution" is largely baked into the company's "stock at current peak valuation levels," without any compelling near-term catalysts. We do have a hold-equivalent 2 rating on the name, as well, so it's difficult to push back on claims of a full valuation. Better news for Abbott came out of Canada, where the company got government approval of a rapid blood test to help clinicians assess suspected concussions. While we're not sure this is a major needle-mover right now, it is an interesting product with use cases that include sporting events. For example, the motorcycle road racing series MotoAmerica will have the test on hand at all of its races this year . Lastly, we came across a story in The New York Times from late last week that took a closer look at claims around baby formula. Earlier this month, Health Secretary Robert F. Kennedy Jr. ordered the Food and Drug Administration to review infant formula ingredients, the first such review in decades. Abbott, the maker of Similac baby formulas, has faced lawsuits related to its specialized formula business, though the company defends the safety of its product. Separately, Abbott also had issues with a manufacturing plant in 2022 . Shares of Abbott Labs have been one of the best-performing stocks in our portfolio this year, though the stock hasn't done much since early March. Up next: Homebuilder Lennar is set to report earnings after the closing bell Monday, and we'll be listening to commentary on the conference call around overall housing market activity, which carries implications for Club name Home Depot. Before Tuesday's opening bell, we'll hear from Jabil, which makes electronic components and is a supplier to Club holding Apple . Also out Tuesday morning is a handful of notable economic reports. We'll get retail sales for May; the latest import/export prices index; and the Federal Reserve's industrial production and capacity utilization report. Combined, all three releases will shed light on the health of the U.S. economy ahead of the Fed's interest rate decision on Wednesday afternoon. (See here for a full list of the stocks in Jim Cramer's Charitable Trust.) As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. Jim waits 45 minutes after sending a trade alert before buying or selling a stock in his charitable trust's portfolio. If Jim has talked about a stock on CNBC TV, he waits 72 hours after issuing the trade alert before executing the trade. THE ABOVE INVESTING CLUB INFORMATION IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY , TOGETHER WITH OUR DISCLAIMER . NO FIDUCIARY OBLIGATION OR DUTY EXISTS, OR IS CREATED, BY VIRTUE OF YOUR RECEIPT OF ANY INFORMATION PROVIDED IN CONNECTION WITH THE INVESTING CLUB. NO SPECIFIC OUTCOME OR PROFIT IS GUARANTEED.
