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Children's Hospital Los Angeles Opens New Cardiac Imaging Suite

Children's Hospital Los Angeles Opens New Cardiac Imaging Suite

First Pediatric Hospital in the United States to Feature Low-Field MRI Technology
Children's Hospital Los Angeles has opened its new Cardiac Imaging Suite, a 6,650-square-foot facility that will improve access, service and quality of care for cardiac patients featuring state-of-the-art technology that cannot be found at any other pediatric center in the United States. The suite houses the new, FDA-approved Siemens FreeMax 0.55 Tesla MRI system, a first-in-the-nation machine for pediatrics, that will allow for new ways to image children's hearts, lungs and more.
'Children's Hospital Los Angeles is committed to pioneering the latest research and innovations in the pursuit of advancing the standards of pediatric care. It's a commitment we take seriously as one of the top pediatric cardiology and heart surgery programs in the country that routinely treats some of the most complex cardiac patients,' said Paul F. Kantor, MBBCh, MSc, FRCPC, chief of the Division of Cardiology and co-director of the Heart Institute at Children's Hospital Los Angeles. 'We are thrilled to be the first in the U.S. offering this groundbreaking new technology to children and could not be more excited to harness this machine to further research and develop new applications in pediatric and fetal imaging.'
Low-field MRI offers diagnostic-quality images of the heart in a quieter, much more spacious environment with a magnet that is three to six times lower in strength than today's conventional clinical systems, making it safer and more comfortable for children. While stronger magnets provide a stronger signal, any movement or air can cause distortion in the image. The low-field MRI has a weaker signal and can accommodate motion, making it ideal for imaging fetuses, the heart, lungs and GI tract. In addition, because the patient does not need to be perfectly still, low-field MRI will reduce the need for general anesthesia in children as young as four or five years old; alternative methods of pain management with fewer side effects and preoperative restrictions can be used instead, such as virtual reality goggles. Low-field MRI is also excellent for patients who have metal implants, such as pacemakers or have a larger body size, which can make it difficult to get good ultrasound or computed tomography images.
'Low-field MRI opens up a world of possibilities that can improve care for children, including the development of real-time imaging capabilities,' said John Wood, MD, PhD, director of Cardiovascular MRI at Children's Hospital Los Angeles. 'This technology will allow Children's Hospital Los Angeles to pioneer novel MRI applications, such as using the 0.55T magnet to guide procedures, such as cardiac catheterizations. Using low-field MRI instead of X-ray would be a big deal for children, as limiting radiation exposure is key. The applications for lung imaging are also exciting, as there is no good way currently to monitor the progression of lung disease in babies and children. While it will take time to develop these techniques and translate them to the clinical environment, that is where we are headed thanks to this revolutionary machine.'
An international MRI expert, Dr. Wood and his team were the first in the world to perform real-time imaging of a human fetal heart – without the need for cardiac synchronization – using low-field MRI.
The Cardiac Imaging Suite also features the Siemens Sola 1.5 Tesla MRI machine, five patient prep and recovery bays, an anesthesia induction room and space for a future cardiac CT scanner. The 1.5T magnet is the current gold standard for advanced cardiac MRI and delivers exceptional image clarity, ensuring high-resolution imaging and faster scan times. The suite also offers specialized stress testing for myocardial perfusion, addressing blood flow issues in the heart. Children's Hospital Los Angeles is the only facility in California providing this advanced diagnostic service, setting a new standard for pediatric cardiac imaging.

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Beyond Air Submits FDA PMA Supplement for Next Generation LungFit® PH
Beyond Air Submits FDA PMA Supplement for Next Generation LungFit® PH

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Beyond Air Submits FDA PMA Supplement for Next Generation LungFit® PH

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The new system uses the same Smart Filter and accessories as the first-generation device, ensuring continuity, streamlined logistics, and minimal disruption for existing customers. The LungFit PH platform uses the Company's patented Ionizer™ technology to generate unlimited on-demand nitric oxide from ambient air, which is then able to be delivered directly to a ventilator circuit, regardless of dose or flow. The LungFit PH system uses the equivalent power of a 60-watt lightbulb to ionize the nitrogen and oxygen molecules, forming nitric oxide with low levels of nitrogen dioxide (NO2) created as a byproduct. The gas then passes through a Smart Filter, which removes the toxic NO2 from the internal circuit. For the treatment of PPHN, the novel LungFit PH system is designed to deliver NO doses consistent with the current standard of care for delivery of 20 ppm NO, with a range of 0.5 ppm – 80 ppm (low concentration NO), for ventilated patients. 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U.S. Food and Drug Administration Approves CSL's ANDEMBRY® (garadacimab-gxii), the Only Prophylactic Hereditary Angioedema (HAE) Treatment Targeting Factor XIIa with Once-Monthly Dosing for All Patients From the Start
U.S. Food and Drug Administration Approves CSL's ANDEMBRY® (garadacimab-gxii), the Only Prophylactic Hereditary Angioedema (HAE) Treatment Targeting Factor XIIa with Once-Monthly Dosing for All Patients From the Start

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U.S. Food and Drug Administration Approves CSL's ANDEMBRY® (garadacimab-gxii), the Only Prophylactic Hereditary Angioedema (HAE) Treatment Targeting Factor XIIa with Once-Monthly Dosing for All Patients From the Start

ANDEMBRY inhibits the top of the HAE cascade by targeting factor XIIa and provides sustained protection from attacks Once-monthly dosing reduced HAE attacks by a median of more than 99 percent and a least squares mean of 89.2 percent, compared to placebo ANDEMBRY approval expands CSL's HAE franchise and underscores the company's legacy of delivering transformational innovations to the HAE community for over four decades KING OF PRUSSIA, Pa., June 16, 2025 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced the U.S. Food and Drug Administration (FDA) approved ANDEMBRY® (garadacimab-gxii), the only treatment targeting factor XIIa for prophylactic use to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. By targeting factor XIIa, a plasma protein that plays a key role in attacks of swelling in people with HAE, ANDEMBRY inhibits the top of the HAE cascade to prevent HAE attacks. ANDEMBRY, the only treatment to offer once-monthly dosing from the start for all patients, is a subcutaneous self-injection delivered in 15 seconds or less via an autoinjector with a citrate-free formula. HAE is a rare, chronic, and potentially life-threatening genetic disorder characterized by recurrent and unpredictable attacks of angioedema. Attacks of HAE are often painful and can affect multiple sites of the body, including the abdomen, larynx, face, and extremities. HAE occurs in about 1 in 50,000 people of any ethnic group. "ANDEMBRY, the first monoclonal antibody discovered and developed entirely by CSL, offers people living with this life-threatening condition long-term control over their disease along with a convenient administration method," said Bill Mezzanotte, MD, Executive Vice President, Head of R&D, CSL. "ANDEMBRY underscores our long-standing and enduring commitment to better the lives of the patients we serve, including those suffering with HAE. I'd like to thank all the physicians, patients and my colleagues who contributed to this exciting milestone for HAE patients and CSL." The approval is supported by data from the pivotal placebo-controlled Phase 3 VANGUARD trial evaluating the efficacy and safety of ANDEMBRY. The pivotal study (The Lancet, April 2023) demonstrated that treatment with ANDEMBRY: Led to 62 percent of ANDEMBRY-treated patients remaining attack-free throughout the treatment period. Reduced HAE attacks by a median of more than 99 percent and a least squares mean of 89.2 percent, compared to placebo. Achieved more than 99 percent median reduction and an 88 percent mean reduction in HAE attacks requiring on-demand therapy, compared to placebo. Attained more than 99 percent median reduction and a 90 percent mean reduction in moderate or severe attacks, compared to placebo. The most common adverse reactions in the pivotal trial (incidence ≥7%) are nasopharyngitis and abdominal pain. A published interim analysis (Allergy, Oct 2024) of the ongoing open-label extension study (median ANDEMBRY exposure of 13.8 months) showed that ANDEMBRY has a favorable long-term safety profile and provides sustained reductions in HAE attacks. In the pivotal trial and the open-label extension study, injection-site reactions (e.g., injection-site bruising, injection-site erythema, injection-site hematoma, injection-site pruritus, injection-site urticaria) were reported in 23 (14%) patients. "We've made significant progress in treating hereditary angioedema, yet many patients still experience painful and sometimes life-threatening HAE attacks and require frequent injections to manage them," said Dr. Tim Craig, Professor of Medicine, Pediatrics and Biomedical Sciences at Penn State University. "We now have a new option to manage this condition through a new target, as it allows us for the first time to inhibit the top of the HAE cascade by targeting factor XIIa." "ANDEMBRY, a novel once-monthly subcutaneous treatment that inhibits factor XIIa, is a welcome addition to the HAE treatment landscape," said Anthony J. Castaldo, CEO and Chairman of the Board, US HAE Association and HAE International. "People with HAE now have another choice for lessening the burden associated with this lifelong condition and realizing the community's shared goal of experiencing life to the fullest." This regulatory approval for ANDEMBRY is another crucial step in building toward the global availability of ANDEMBRY, which was recently approved in Australia, the United Kingdon (UK), the European Union (EU), Japan, Switzerland, and United Arab Emirates. CSL Behring will launch ANDEMBRY commercially immediately, with availability before the end of June. Healthcare professionals and patients interested in learning more about ANDEMBRY or accessing the therapy are encouraged to utilize ANDEMBRY ConnectSM, designed to offer comprehensive support and assistance through various programs. For more information, call 844-423-4273 or visit About HAE HAE is a rare and potentially life-threatening genetic condition that occurs in about 1 in 10,000 to 1 in 50,000 people. HAE is caused by deficient or dysfunctional C1INH, a protein in the blood that helps to control inflammation. Inadequate amounts of properly functioning C1INH can lead to the accumulation of fluid in body tissues, causing considerable swelling referred to as angioedema. HAE attacks can affect many parts of the body, including the face, abdomen, larynx, and extremities. Patients who have abdominal attacks of HAE can experience extreme pain, diarrhea, nausea, and vomiting caused by swelling of the intestinal wall. HAE attacks that involve the face or throat can result in airway closure, asphyxiation and, if left untreated, death. About ANDEMBRYANDEMBRY is a novel monoclonal antibody inhibiting factor XIIa (anti-FXIIa mAb) that has completed the Phase 3 pivotal study as a new type of once-monthly subcutaneous prophylactic treatment for attacks related to HAE, a form of bradykinin-mediated angioedema. ANDEMBRY is CSL's first homegrown recombinant monoclonal antibody to gain FDA approval. It was discovered and optimized by scientists at CSL's Bio21-based research site, with formulation and manufacturing for the clinical programs completed at the CSL Broadmeadows Biotech Manufacturing Facility. ANDEMBRY uniquely inhibits the plasma protein, FXIIa. FXII is the first protein activated in the HAE pathway, initiating the cascade of events leading to an HAE attack. By targeting activated FXII (FXIIa), ANDEMBRY inhibits this cascade at the top as compared to other HAE therapies that target downstream mediators. About the VANGUARD Trial The multicenter, randomized, double-blind, parallel-group VANGUARD trial evaluated the efficacy and safety of ANDEMBRY, an investigational first-in-class monoclonal antibody, as a prophylactic treatment for patients with hereditary angioedema. Patients aged 12 years and older with HAE type I or II underwent screening and a run-in study period to verify a baseline attack rate. Patients were randomized 3:2 to receive a loading dose of 400 mg followed by 200 mg of ANDEMBRY monthly (n=39) or volume matched placebo monthly (n=25) subcutaneously. After the six-month treatment period, patients were given the opportunity to continue into the open-label extension study, which is currently ongoing. The ongoing open-label extension of the Phase 3 VANGUARD study is evaluating the long-term safety and efficacy of ANDEMBRY (200 mg monthly) for the prophylactic treatment of hereditary angioedema attacks. IMPORTANT SAFETY INFORMATION What is ANDEMBRY?ANDEMBRY® (garadacimab-gxii) injection, for subcutaneous use, is a prescription medication used to prevent attacks of hereditary angioedema (HAE) in people 12 years and older. It is not known if ANDEMBRY is safe and effective in children under 12 years of age. What should I tell my healthcare provider before using ANDEMBRY?Before using ANDEMBRY, tell your healthcare provider about any medical condition you may have, especially if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. It is not known if ANDEMBRY can harm your unborn baby or if ANDEMBRY passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby while using ANDEMBRY. Tell your healthcare provider about all medications you take, including prescription medicines, over-the-counter treatments, vitamins, and herbal supplements. How should I use ANDEMBRY? Use ANDEMBRY exactly as instructed by your healthcare provider. Detailed instructions for use can be found in the patient information section of the full prescribing information. ANDEMBRY is given as an injection under your skin (subcutaneous) by you or a caregiver. Your healthcare provider should show you or your caregiver how to prepare and inject your dose of ANDEMBRY before you inject yourself for the first time. Do not try to inject ANDEMBRY unless you have been trained by your healthcare provider. What are the possible side effects of ANDEMBRY?The most common side effects of ANDEMBRY include: Redness, itchiness, and bruising (injection-site reactions) Stomach (abdominal) pain Runny or stuffy nose, sneezing, watery eyes (nasopharyngitis) Please see full prescribing information for ANDEMBRY, including patient information and instructions for use. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You can also report side effects to CSL Behring's Pharmacovigilance Department at 1-866-915-6958. About CSLCSL (ASX:CSL; USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For more information about CSL, visit Media ContactsValerie BombergerCSLOffice: +1 610-291-5388 Mobile: +1 267-280-3829 Email: Etanjalie Ayala CSL Behring Mobile: +1 610 297 1069 Email: Greg HealyCSLMobile: +1 610-906-4564Email: In Australia: Kim O'DonohueCSLMobile: +61 449 884 603Email: Brett FoleyCSLMobile: +61 461 464 708 Email: Investors ContactChris CooperCSLMobile: +61 455 022 740Email: View original content to download multimedia: SOURCE CSL Sign in to access your portfolio

Cucumber Recall Sparks Warning to Customers
Cucumber Recall Sparks Warning to Customers

Newsweek

time4 hours ago

  • Newsweek

Cucumber Recall Sparks Warning to Customers

Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. Fuentes Farms Inc. is recalling boxes of their fresh cucumbers due to fears of potential Salmonella contamination. Newsweek reached out to the company via email Monday for additional comment. Why It Matters Numerous recalls have been initiated in 2025 due to the potential of damaged products, foodborne illness, contamination and undeclared food allergens. Millions of Americans experience food sensitivities or allergies every year. According to the Food and Drug Administration (FDA), the nine "major" food allergens in the U.S. are eggs, milk, fish, wheat, soybeans, Crustacean shellfish, sesame, tree nuts and peanuts. The FDA also warns that Salmonella is an organism that could cause serious and sometimes fatal infections in frail or older people, young children and those with weakened immune systems. Healthy people infected with Salmonella could experience vomiting, diarrhea or abdominal pain, the FDA says. What To Know In its alert, the FDA says that the cucumbers were distributed at flea markets in McAllen and Alamo, Texas areas. The impacted product has a lot number of 357 and were sold in 40-pound boxes by 1-1/9 bushels. The cucumbers were sold from May 31 to June 3. The FDA alert says that as of Monday, there have been no reported illnesses and that "the recall is not part of any current food outbreaks." "However, out of an abundance of caution, Fuentes Farms LLC is notifying all customers and urging anyone who may have purchased the item at the flea market or sold cucumbers from Lot # 357," the FDA alert adds. The alert has additional photos of the recalled cucumbers for potential customers to reference. Fuentes Farms Inc. fresh cucumbers can be seen and are being recalled on Jun 16, 2025, due to potential Salmonella contamination. (Photo from the U.S. Food and Drug Administration) Fuentes Farms Inc. fresh cucumbers can be seen and are being recalled on Jun 16, 2025, due to potential Salmonella contamination. (Photo from the U.S. Food and Drug Administration) What People Are Saying The FDA alert in part: "The recall was as the result of a routine sampling program by the company which revealed that the finished products contained the bacteria. The company has ceased the production and distribution of the product as FDA and the company continue their investigation as to what caused the problem." In an email to Newsweek in January, the FDA said: "Most recalls in the U.S. are carried out voluntarily by the product manufacturer and when a company issues a public warning, typically via news release, to inform the public of a voluntary product recall, the FDA shares that release on our website as a public service. "The FDA's role during a voluntary, firm-initiated, recall is to review the recall strategy, evaluate the health hazard presented by the product, monitor the recall, and as appropriate alert the public and other companies in the supply chain about the recall," the FDA continued. It added: "The FDA provides public access to information on recalls by posting a listing of recalls according to their classification in the FDA Enforcement Report, including the specific action taken by the recalling company. The FDA Enforcement Report is designed to provide a public listing of products in the marketplace that are being recalled." Additional information on recalls can be found via the FDA's Recalls, Market Withdrawals, & Safety Alerts. What Happens Next Customers are urged to throw away the impacted cucumbers or return it to the original place of purchase, the FDA says. People with additional questions or concerns may contact the company at 1-956-340-8653 weekdays from 9 a.m. to 2 p.m. CT or by email at sales@

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