The Surveillance Heartcare Outcomes Registry trial demonstrated that Caredx Inc.’s Heartcare test identifies acute cellular rejection in heart transplant patients better than donor-derived cell-free DNA (dd-cfDNA) alone, while reducing biopsies and improving clinical outcomes. Heartcare combines two non-invasive tests, dd-cfDNA and Allomap Heart gene-expression profiling.
The Surveillance Heartcare Outcomes Registry trial demonstrated that Caredx Inc.’s Heartcare test identifies acute cellular rejection in heart transplant patients better than donor-derived cell-free DNA (dd-cfDNA) alone, while reducing biopsies and improving clinical outcomes. Heartcare combines two non-invasive tests, dd-cfDNA and Allomap Heart gene-expression profiling.
Wubin Bai, assistant professor of applied physical sciences at UNC-Chapel Hill, is seeking protection for morphable 3D-folded microelectronic mesostructures, including epicardial bioelectronic probes, made using concepts borrowed from origami.
The recent cyberattack on Change Healthcare, a part of the Unitedhealth Group, crippled reimbursement claims processing for thousands of providers for several weeks and potentially exposed troves of patient data. Congressional committees are investigating the attack, its scope, and Unitedhealth’s response. Please take a few minutes to fill out this short survey to help BioWorld understand how your company is responding to these threats. You can click through to the questions here.
The U.S. FDA has several methods for signaling its enforcement intentions regarding medical devices and drugs, but there are times when warning letters are the vectors for communicating the agency’s current thinking.
Citing the need to protect the public interest, the U.S. Department of Health and Human Services ordered an immediate government-wide funding suspension May 15 of Ecohealth Alliance Inc. while formal debarment proceedings are pending against the New York-based nongovernmental organization.
Denver-based Arcscan Inc. gained Chinese approval of its computer-controlled, ultra-high frequency ultrasound diagnostic imaging solution for myopia called Insight 100, expanding its reach beyond the U.S. and Europe.
Medtronic plc said its investigational Omniasecure defibrillation lead met its primary safety and effectiveness endpoints and exceeded prespecified performance goals, in the global Lead Evaluation for Defibrillation and Reliability (LEADR) pivotal trial.
Imaging is the number one way physicians track cancer progression and burdens within neurology and cardiology, but the ability to take imaging information and interact with it to make better decisions is becoming ever more complicated.
The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) is among the regulators across the globe that are scrambling to keep pace with artificial intelligence (AI) in medical devices, releasing an April 30, 2024, paper on its own approach. One of the key considerations in this paper is...
The U.K. National Institute for Health and Care Excellence has posted an early value assessment review of digital technologies for the management of chronic obstructive pulmonary disease, giving the conditional nod to only one technology — the Mycopd app by London-based My Mhealth Ltd.
Apple Inc. said the U.S. FDA has approved the Apple Watch's atrial fibrillation (AF) history feature under its rigorous Medical Device Development Tools (MDDT) program that specifies what devices health professionals can rely on.
May Health SAS closed a $25 million series B financing round to advance its Ovarian Rebalancing therapy for polycystic ovary syndrome (PCOS)-related infertility. The round brings the total funds raised by the Paris-based company to date to $35 million, May Health CEO Anne Morrisey told BioWorld.
Singapore- and U.S.-based Sunbird Bio Pte Ltd. is advancing its blood-based diagnostics platform for neurological diseases like Alzheimer’s and Parkison’s disease (AD/PD), amidst new breakthroughs in the AD drug therapies and diagnostics space.
Butterfly Network Inc. expanded its collaboration with the Clinton Health Access Initiative, Global Ultrasound Institute and the Bill & Melinda Gates Foundation to increase access to maternal/fetal ultrasound technology. The program will bring 500 IQ+ systems and ultrasound training to six...
Alzheimer’s disease (AD) is recognized worldwide for its debilitating symptoms of declining cognitive function and gradual memory loss. What remains less clear is exactly what causes the neurodegenerative disease, and how to treat it. “Alzheimer’s disease is characterized by two key pathologies –...
Stereotaxis Inc. said it is buying electrophysiology catheter maker Access Point Technologies EP Inc. to enhance its minimally invasive endovascular surgical robotics technology offerings.
Med-tech deal value increased in April, reaching $172.37 million, a 538% bump from March’s $27 million. However, the monthly average for deal value in 2024 stands at $140.68 million, reflecting an 84% decline from the 2023 monthly average of $886.13 million.
By now, the story of last year’s dismal U.S. capital markets is hardly news. But when combined with increasing regulatory stresses, especially for biopharma and med-tech startups, there are elements of that story giving some Street-watchers pause, even as the market begins to show a few signs of...
Hologic Inc. moved to expand its breast surgery line with the acquisition of Endomagnetics Ltd. (Endomag) for a proposed $310 million. Endomag offers a magnetic system that allows precise localization of tumors in the breast and lymph nodes without the use of radioactive materials or wires,...
Bruker Corp. shows no sign of slowing its buying binge, picking up Nanostring Technologies Inc. for $392.6 million in cash plus the assumption of certain liabilities in its seventh deal so far this year.
Nanostring entered bankruptcy in February and received a “stalking horse” bid of $220 million...
Elixir Medical Corp. revealed that data from the Pinnacle I study has validated the safety and effectiveness of its Lithix Hertz contact intravascular lithotripsy system to treat moderate to severe calcified coronary artery lesions by percutaneous transluminal coronary angioplasty.
Australia is poised to play a leading role in the rise of the global radiopharmaceutical industry, as advanced therapies drive significant investment and rapid expansion, according to a new discussion paper from industry accelerator Mtpconnect.
The EU has declared that it will investigate the anticompetitive practices of the People’s Republic of China where medical devices are concerned, a clear sign that device makers in the European Union succeeded in persuading Brussels that the Made in China 2025 initiative represents an intolerable...
South Korean med-tech companies Nunaps Co. Ltd. and Share & Service are the latest to clear domestic approvals for digital therapeutics as the government ramps up R&D funding for artificial intelligence-based medical technologies.
Data from the transcatheter valve and vessel trial showed that percutaneous interventions in patients with aortic stenosis and coronary disease resulted in significantly lower mortality rates than those receiving surgical treatment.
Less than a week ago, executives at Lyra Therapeutics Inc. were looking ahead to “imminent” data from its first phase III study in chronic rhinosinusitis (CRS), testing drug-device candidate LYR-210, a drug-device candidate largely expected to...
Lindis Blood Care GmbH recently revealed excellent data from the Remove study that showed that its Catuvab device was safe and effective in removing tumor cells from intraoperative blood during high blood loss cancer surgeries.
Precision medicine holds exciting promise for the medical device industry as it offers a range of solutions within diagnostics, digital devices and imaging, which could transform patient care, delegates heard at the LSX World Congress in London....
Acrivon Therapeutics Inc.’s $130 million financing disclosed April 9 hiked confidence in then-pending data with ACR-368 (prexasertib), the selective small-molecule inhibitor that targets checkpoint kinase 1 (CHK1) and CHK2. Undergoing tests in a...
Researchers have developed and validated a new technique that allows them to measure the lipid compounds in live cancer cells, one by one, according to a study published in the journal Analytical Chemistry. The new method paves the way for...
Breakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.