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Prevencio Receives FDA Breakthrough Device Designation for HART CADhs, Its Artificial Intelligence-driven Blood Test for Obstructive Coronary Artery Disease
Prevencio Receives FDA Breakthrough Device Designation for HART CADhs, Its Artificial Intelligence-driven Blood Test for Obstructive Coronary Artery Disease

Business Wire

time13-05-2025

  • Health
  • Business Wire

Prevencio Receives FDA Breakthrough Device Designation for HART CADhs, Its Artificial Intelligence-driven Blood Test for Obstructive Coronary Artery Disease

KIRKLAND, Wash.--(BUSINESS WIRE)-- Prevencio, Inc., the leader in artificial intelligence-powered blood tests for cardiovascular diagnostics, announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its HART CADhs® test. This designation recognizes HART CADhs as an innovative technology for identifying obstructive coronary artery disease (CAD) —a condition responsible for significant morbidity and mortality. The designation is reserved for technologies that offer significant advantages over existing solutions and address unmet medical needs. HART CADhs is the only AI-based multi-protein blood test capable of accurately detecting blockage in the heart's arteries. By combining multiple cardiac proteins with proprietary machine learning algorithms, HART CADhs delivers actionable insight through a simple, non-invasive blood draw, bridging critical diagnostic gaps in current cardiovascular care. 'The FDA's Breakthrough Device Designation is a pivotal milestone in our mission to revolutionize the diagnosis and treatment of obstructive coronary artery disease,' said Rhonda Rhyne, President and Chief Executive Officer of Prevencio. 'We are committed to expanding the use of HART CADhs from outpatient settings into emergency care environments to ensure that patients receive earlier, more accurate, and potentially life-saving diagnoses.' HART CADhs is currently available as a Lab Developed Test (LDT) with a 2 to 10-day turnaround, making it ideal for evaluating stable, non-urgent patients. The Breakthrough Device Designation enables close collaboration with the FDA and an expedited review process, supporting Prevencio's goal to advance the test into a rapid, FDA-cleared in vitro diagnostic (IVD) with a one-hour result time —ideal for evaluating chest pain patients in emergency rooms. HART CADhs was developed using Prevencio's proprietary HART platform in collaboration with researchers at Massachusetts General Hospital (MGH). In clinical research, the test demonstrated high accuracy (0.86 AUC) in detecting obstructive CAD, significantly outperforming standard-of-care tests such as stress echocardiography and nuclear imaging, which yielded only 0.52 AUC. 'With nearly half of U.S. counties lacking access to a cardiologist and long wait times in urban centers, a simple, accurate blood test to diagnose obstructive CAD offers tremendous potential to improve access to early diagnosis and intervention,' said James L. Januzzi, MD, a practicing cardiologist at MGH, Professor of Medicine at Harvard Medical School, Chief Scientific Officer at the Baim Institute for Clinical Research and Principal Investigator for the HART test development and validation. 'Our studies show HART CADhs is informative in a broad range of patient types including those with acute symptoms as well as those not diagnosed with a heart attack yet may have dangerous arterial obstruction. This suggests usefulness in both acute and outpatient settings.' Cardiovascular disease remains the leading cause of death in the United States and worldwide. According to the American Heart Association, cardiovascular disease and stroke account for over $318 billion in annual U.S. healthcare costs, nearly 10% of total healthcare spending. Prevencio's HART blood tests are designed to improve patient outcomes and reduce costs through earlier, more accurate, and more accessible diagnostics. In addition to HART CADhs, Prevencio also offers HART CVE®, a second AI-driven, multi-protein blood test that assesses a patient's one-year risk of heart attack, stroke, or cardiovascular death. Both tests are currently available to healthcare providers. About Prevencio HART Tests: Powered by AI, Prevencio is revolutionizing cardiac diagnostics with AI-driven blood tests for cardiovascular disease and custom diagnostics for diagnostic, medical device and pharmaceutical companies. Using this novel approach, the company has developed seven blood tests that significantly improve diagnosis and risk assessment for a variety of heart and blood vessel-related complications. HART test results have been peer-reviewed published 35 times, including at leading cardiovascular meetings—(European Society of Cardiology Congress; American College of Cardiology Scientific Sessions; American Heart Association Scientific Sessions; American Diabetes Association Scientific Sessions; and Transcatheter Cardiovascular Therapeutics Sessions) and in top-tier journals—(Journal of American College of Cardiology; American Journal of Cardiology; Clinical Cardiology; Biomarkers in Medicine; Journal of American Heart Association; and European Journal of Preventive Cardiology). About Prevencio, Inc. Prevencio's vision is to revolutionize cardiac diagnostics with AI-driven blood tests—thereby improving care with highly accessible, accurate and cost-effective diagnosis and earlier treatment. Prevencio utilizes Machine Learning (Artificial Intelligence) + Multi-Proteomic Biomarkers + Proprietary Algorithms to deliver diagnostic & prognostic tests that are significantly more accurate than standard-of-care stress tests, genetic risk scores and coronary artery calcium. The company is headquartered in Kirkland, Washington. For additional information, visit Prevencio, Inc. Forward-Looking (Safe Harbor) Statement: Except for historical and factual information contained herein, this press release contains forward-looking statements, such as market need, acceptance, and size, the accuracy of which is necessarily subject to various uncertainties of development-stage companies. The company does not undertake to update disclosures contained in this press release.

MAAS Group Holdings Ltd. (MGH) Gets a Buy from Wilsons
MAAS Group Holdings Ltd. (MGH) Gets a Buy from Wilsons

Business Insider

time12-05-2025

  • Business
  • Business Insider

MAAS Group Holdings Ltd. (MGH) Gets a Buy from Wilsons

In a report released on May 8, James Ferrier from Wilsons maintained a Buy rating on MAAS Group Holdings Ltd. (MGH – Research Report), with a price target of A$4.75. The company's shares closed last Friday at A$4.40. Protect Your Portfolio Against Market Uncertainty Discover companies with rock-solid fundamentals in TipRanks' Smart Value Newsletter. Receive undervalued stocks, resilient to market uncertainty, delivered straight to your inbox. According to TipRanks, Ferrier is an analyst with an average return of -0.9% and a 40.38% success rate. Ferrier covers the Consumer Cyclical sector, focusing on stocks such as G.U.D. Holdings, ARB Corporation , and Collins Foods . The word on The Street in general, suggests a Strong Buy analyst consensus rating for MAAS Group Holdings Ltd. with a A$4.90 average price target. The company has a one-year high of A$5.05 and a one-year low of A$3.30. Currently, MAAS Group Holdings Ltd. has an average volume of 718.7K. Based on the recent corporate insider activity of 6 insiders, corporate insider sentiment is positive on the stock. This means that over the past quarter there has been an increase of insiders buying their shares of MGH in relation to earlier this year.

Some Harvard doctors worry Trump's anti-DEI push will harm health care
Some Harvard doctors worry Trump's anti-DEI push will harm health care

Boston Globe

time05-04-2025

  • Health
  • Boston Globe

Some Harvard doctors worry Trump's anti-DEI push will harm health care

Dr. Bruce Fischl, a professor of radiology at Harvard Medical School who runs a neuroimaging lab at MGH, fears the ultimatum might imperil programs designed to help young students from disadvantaged backgrounds enter the biomedical field. He's seen the power of such initiatives, citing one local lab's internship program for high school and undergraduate students in which they get to observe and participate in brain research on Alzheimer's and other diseases. Advertisement The goal of the internship program, he said, is to 'demystify biomedical research' and provide opportunities to young people who have limited opportunities to pursue science careers. More than half of the roughly 50 students who have participated are children of first-generation immigrant families. One of the students was recently hired as a research associate in the lab. Advertisement 'The program has been freaking amazing,' Fischl said. 'It gives young people an opportunity to be seen and heard and flourish in an environment that they wouldn't have access to otherwise. It's not an alternative to meritocracy, it's a way to broaden the pool of people who have access to be considered for meritocracy.' In its The demands also included that Harvard crack down on programs and departments that stoke antisemitism and report on disciplinary actions taken against people who violated antisemitism rules since the Oct. 7, 2023, Hamas-led attack on Israel. The letter from the Trump administration's antisemitism task force accused Harvard of failing to protect students and faculty from antisemitic violence and harassment. The administration had said on Monday that it was reviewing $9 billion in federal grants and contracts destined for the university and its affiliated institutions, including such renowned hospitals as MGH, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Boston Children's Hospital, and Dana-Farber Cancer Institute. Several Jewish doctors who teach at Harvard Medical School said that meeting the demand by the administration's antisemitism task force could actually fuel hatred of Jews and undermine merit-based programs while imperiling research at Harvard's hospitals. Advertisement 'The tragedy of all this is that the professed rationale for these demands is to reduce antisemitism, and this will absolutely have the opposite effect,' said a Jewish physician and researcher at Brigham, who insisted on anonymity because of the sensitivity of the matter. '[Administration officials] are demanding that Harvard take a wide range of actions that will be very unpopular.' Rachel Petherbridge, a doctoral student in systems biology at Harvard Medical School, exclaimed 'damn, damn, damn!' on Friday as she read through the list of demands in Petherbridge has spent much of the past five years studying maternal health, including In June 2020, a Black Lives Matter sign was displayed on the window of a business in Boston. John Tlumacki/Globe Staff 'The Trump administration wants us to be color blind,' Petherbridge said. 'But how far does that go when we are considering differences between people in our research and trying to be careful and conscientious? . . . It's Kafkaesque. Because no one knows what the crime is and what the rules are, then everyone is afraid.' In 2023, Harvard received about 10 percent of its revenue from federal grants and contracts, and its affiliated hospitals rank among the nation's top hospital recipients of federal health research grants. Last year, two hospitals, MGH and Brigham, together Advertisement A spokesperson for Beth Israel Lahey Health declined to comment on the demands but said 'research and innovation are at the center of our mission as an academic health system, and federal funding is critical in supporting the work of our researchers. Any changes to federal research funding will have a significant impact on our ability to recruit talented clinicians.' Spokespersons for Mass General Brigham, Dana-Farber, and Children's declined to comment. The crackdown on diversity programs drew particularly fierce criticism from several physicians and researchers. Scott Delaney, a research scientist in environmental health at the Harvard T.H. Chan School of Public Health, said he is concerned that the Trump administration is using diversity programs as a pretext for gutting university funding and undermining scientific research. 'DEI is a slur that they use for anything they don't like — and generally, that's research that is not specifically tailored to straight, white men,' he said. He said the targets of the administration's review of Harvard likely will widen over time, much as they have with the review of NIH research grants. At first, the NIH 'It feels a little bit like we're standing on a train track and we can see the train coming,' Delaney said. One veteran physician-scientist at MGH said he hopes Harvard refuses to bow to the ultimatum from the Trump administration. But in a telling sign of the fear sweeping the school and other Ivy League universities, the doctor insisted on anonymity. Advertisement 'This is absolute bullying, and capitulating to a bully never works out,' he said of President Trump. 'I hope that not only Harvard but the combined academic enterprise gets a backbone and resists as best as they possibly can. This autocratic approach is what leads to fascism.' Tiana Woodard of the Globe staff contributed reporting. Jonathan Saltzman can be reached at

Mass General Brigham said layoffs wouldn't affect patient care. Some disagree.
Mass General Brigham said layoffs wouldn't affect patient care. Some disagree.

Boston Globe

time02-04-2025

  • Health
  • Boston Globe

Mass General Brigham said layoffs wouldn't affect patient care. Some disagree.

They include six full-time chaplains — at least half of whom worked directly with patients and families facing health crises and end-of-life decisions. Also laid off: the director of domestic violence programs at Brigham and Women's Hospital who counseled patients who had survived human trafficking and other abuse; and an employee in Massachusetts General Hospital's Living Tobacco-Free program who helped hundreds of patients quit smoking each year. Advertisement Tara Deonauth, a board-certified chaplain and graduate of Harvard Divinity School who served as spiritual care manager at Faulkner Hospital, said she was 'shocked and heartbroken' when she was laid off on March 10. 'I could not have worked more closely with patients,' said Deonauth, who estimated she saw about 25 patients a week and spent up to an hour with each, listening to stories of grief and hopelessness. Most were in intensive care or a secure psychiatric unit for patients at risk for harming themselves or others. Deonauth said she was 'on call 24-7″ and responded to requests in the middle of the night, including arranging for a Catholic priest to deliver last rites. A number of employees who were laid off signed confidentiality agreements and declined to comment out of fear of jeopardizing severance packages. However, the Boston Globe confirmed the layoffs from co-workers who kept their jobs. Advertisement Jessica Pastore, a spokesperson for MGB, said the job cuts focused on nonclinical managers and administrators and that Klibanski never said all employees who worked with patients would be excluded from layoffs. Individual hospitals, she said, made decisions 'to ensure there would be no negative impacts to patient care.' Six weeks ago, MGB announced it would make Mass General Brigham announced the most layoffs in its history in February. David L. Ryan/Globe Staff Klibanski said in her email the system would streamline its administration by making cuts 'focused on non-clinical and non-patient facing roles' and complete The Globe MGB declined to specify how many people have been laid off. Among those who have been especially hard hit were MGB's chaplains. The system laid off two of its nine chaplains at MGH and the hospital's head of spiritual care, the Rev. Donna Blagdan, who oversaw them and is a board-certified chaplain. She declined to comment, but multiple remaining MGB chaplains confirmed her departure. By the end of August, the system also plans to end the Clinical Pastoral Education program at MGH, which for about 90 years trained people to work as chaplains at hospitals, prisons, fire departments, and other settings inside and outside of Massachusetts. The program is said to be the first at a general hospital in the country. Advertisement MGB is laying off Rabbi Shulamit Izen, director of the program, in August when the last five students complete their training. The program will then close, according to multiple current hospital employees and graduates of the program. Izen declined to comment. During the yearlong program, trainees work 27 hours a week as chaplains 'in residency' at MGH, counseling sick or dying patients, helping families navigate the decision to take loved ones off life support, and comforting employees struggling with traumatic situations at the hospital. Jonathan DeWeese, a psychiatric nurse practitioner and psychotherapist in Cambridge who completed the program a decade ago, said he worked overnight shifts, supporting patients and families as they grappled with terminal illnesses and agonizing loss. 'Doctors don't have the time or the skill to sit with the distressed family that just lost their teenager or 20-year-old son in a car accident,' said DeWeese, who serves as an adviser to the program. 'That's one of the many scenarios in which a chaplain is really needed.' Meanwhile, Brigham laid off one of its two educators of chaplains at that hospital's residency program who also worked directly with patients, according to the Rev. Jennie Gould, the remaining educator and a chaplain. Ruth Delfiner, a part-time chaplain at MGH, said the job cuts by MGB 'shows their absolute lack of sympathy for what it is that we do.' 'These are programs which they put in place for appearances, but when they're concerned about the bottom line, they're going to be the first to go,' she said. Pastore, the MGB spokesperson, said 'patients and families will continue to have access to chaplains from a variety of religious backgrounds and especially in instances of emergent care, which is available every day of the week, at all times.' She also said the system is merging MGH's and Brigham's chaplain residency programs. Advertisement With the layoffs, Gould said she doubted Brigham will be able to have a chaplain on site at all times, as it had before, or be able to respond to every cardiac arrest, respiratory arrest, and request by relatives of deceased patients to view bodies in a room near the morgue. A photo shows Tara Deonauth, a chaplain who was recently laid off, with Faulkner ICU Clinical Leader Ellen McCarthy, left, who nominated her for an I Care Award when Tara worked in the hospital. John Tlumacki/Globe Staff Multiple employees said Loftus provided direct therapy services to nearly a dozen victims of human trafficking. Loftus also provided training on how to care for survivors of trauma and violence to more than 900 front-line clinicians last year alone. About 100 health care providers were so alarmed by Loftus's dismissal that they signed a petition urging leadership to rehire her. 'While her official title is Clinical Program Director, Jessica provides direct patient care to hundreds of patients throughout our system,' said the letter. Loftus said patient care 'inevitably suffers' when clinicians are 'seen as job titles rather than humans.' Pastore, the MGB spokesperson, said Loftus had a 'management role that was consolidated from two managers managing a group of social workers down to one manager. This was a reduction of a management layer, not the elimination of a clinical care role.' In response, Loftus said, 'They can classify it however they want, but my role in our human trafficking program was direct patient care.' Advertisement MGB has also laid off both employees of the Mass General Living Tobacco-Free program, which the health system decided last year to end in 2025, Pastore confirmed. One of the employees was a tobacco treatment specialist who helped several hundred smokers a year try to quit, according to a staffer at a community health center and another person familiar with the program. Both sources insisted on anonymity because of the sensitivity of the topic. The other laid-off employee was the program manager. The program operated at community health centers in Charlestown, Chelsea, Revere, and Everett, and featured one-on-one coaching, support groups, yoga, and other tools. Pastore said there are still multiple tobacco treatment programs in Boston run by other groups. Dr. Mark Eisenberg, who worked for 37 years as a primary care physician at MGH Charlestown and now works part time helping patients with addictions at the hospital, said he often referred patients to Tobacco-Free. 'It was a great resource for a physician who didn't have the time during a 15-minute appointment to effectively counsel patients,' he said. Dr. Michael Barnett, a primary care physician at Brigham and associate professor of health policy and management at Harvard T.H. Chan School of Public Health, said he was dismayed by the layoffs of staffers who worked with patients, but he wasn't particularly surprised. 'As primary care doctors, we know that MGB doesn't invest in interventions that improve public health unless they generate huge profits,' said Barnett, Advertisement In March, Pastore did not respond to Barnett's criticism. Gould, the Brigham chaplain, said layoffs of employees who dealt directly with patients was short-sighted and often affected workers with relatively modest salaries. 'Look,' she said, 'chaplains are not breaking the MGB bank.' Jonathan Saltzman can be reached at

‘We were the lucky ones', says Burmese student after home damaged in earthquake
‘We were the lucky ones', says Burmese student after home damaged in earthquake

The Independent

time31-03-2025

  • Health
  • The Independent

‘We were the lucky ones', says Burmese student after home damaged in earthquake

A Burmese student in the UK, whose home was damaged in the Myanmar earthquake, says his family consider themselves lucky compared to others. Aung Kaung Myat, a mechanical engineering student at the University of Sussex, was unable to contact his parents for several hours after he first heard the news of the 7.7 magnitude earthquake that hit his country on Friday. Mr Kaung Myat, from Mandalay, Myanmar's second-largest city near the epicentre where hundreds of buildings have collapsed, said the real concern is for those who have lost everything. 'My family is safe right now, which I'm incredibly grateful for, but like many others, they've been deeply affected,' the 23-year-old student told the PA news agency. 'Our home has been damaged but compared to what others are going through, we would consider ourselves lucky. 'The real concern is for those who have lost everything and those who've been injured, displaced and struggling to get even basic medical care and also food and even water.' According to state media, more than 2,000 people have been killed so far, with more than 3,900 injured and about 270 missing. Aid agencies have warned that the earthquake could exacerbate hunger and disease outbreaks in a country already wracked by food shortages, mass displacement and civil war. 'The earthquake itself is devastating, but what makes it even worse is that Mandalay, like the rest of Myanmar, is already in crisis,' said Mr Kaung Myat. 'Since the military coup in 2021, public services have collapsed, including healthcare. 'Hospitals are severely underfunded and understaffed and they even lack basic medical supplies. 'The military, the current regime, prioritises its own power and survival over the needs of the people. So there's no real aid coming from them. 'That means victims, especially those in public hospitals, who are really less fortunate, are left to save themselves right now.' Mr Kaung Myat, who had been feeling helpless so far away from home, has set up a fundraiser to help buy medical supplies for local hospitals in the area. His parents, who both work in the medical industry, have been organising supplies on the ground. So far they have co-ordinated donations to Mandalay General Hospital (MGH) and 550 Bedded Children's Hospital. They will be donating to additional hospitals including Mandalay Orthopaedic Hospital (MOH) and those in the Sagaing region, where conditions are believed to be even worse. Mr Kaung Myat, who left Myanmar for the UK in 2022, has said it is unsafe for him to return to his country after being involved in student demonstrations against the military coup and due to the country's conscription law. The military seized power from Aung San Suu Kyi's government in February 2021, triggering a civil war and a series of anti-coup protests. 'I went back home in 2023 after my first year, and at the time, the situation had not escalated as much. But now, it has gotten worse and worse, and it's not really safe for students to return to our country,' he said. 'Especially for those students who've been involved in the massive protest, the military coup and demonstration.' To learn more about Aung Kaung Myat's fundraiser you can visit his fundraising page at

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