AstraZeneca’s IMFINZI® (durvalumab) plus chemotherapy has been approved by the US Food and Drug Administration (FDA) for the treatment of adult patients struggling with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer. According to the company’s announcement on Monday, June 18, its latest therapy, IMFINZI® (durvalumab), combined with paclitaxel and carboplatin, followed by the latest IMFINZI monotherapy, have been approved based on prespecified exploratory subgroup results analysis in the DUO-E Phase III. The results, which were published in the Journal of Clinical Oncology in October 2023, showed that administering IMFINZI plus after treating the patient with a combination of carboplatin can minimize the…
Author: Daniel Onyango
The US Supreme Court has unanimously rejected the petition seeking to restrict the FDA’s approval and relaxed regulation of the medical abortion pill mifepristone, granting nationwide access to the controversial drug. In the unanimous ruling rendered on Thursday by Justice Kavanaugh on behalf of the court, the judges determined that the anti-abortion doctors, petitioners, and associations did not have the legal right to file the petition, maintaining a status quo on access to mifepristone. Concerns about FDA’s Under-regulation of Mifepristone The plaintiffs in the abortion case mainly focused on two main grounds, which they cited to pose potential risks of…
Brightside Health, the provider of a mental care delivery platform, has launched a new service focusing on helping those struggling with substance use disorder through a new acquisition deal. According to the latest announcement, Brightside Health has extended its services to virtual intensive outpatient programs (IOP) for people with substance use disorder (SUD) through the acquisition of Lionrock Recovery—a pioneer in online substance abuse counselling platform founded in 2010. The acquisition enables Bright Health to offer a comprehensive telemental health treatment for diverse mental health conditions that are devastating to individuals and families. The platform targets individuals experiencing anxiety, suicidal…
FloPatch, the world’s first wireless wearable ultrasound device developed by a Canadian medical device company, Flosonic Medical, has been deployed in two critical care units at Toronto-based St. Michael’s Hospital for sepsis care, according to the company’s announcement. The revolutionary device, which has US FDA and Health Canada clearance, features a wearable Doppler ultrasound patch, which enables doctors to assess real-time blood flow and guide fluid resuscitation in critically sick patients, including those suffering from shock and sepsis. According to the Centers for Disease Control and Prevention (CDC), Sepsis is the third most commonly known cause of patient death in…
LungVision®, a breakthrough AI-powered medical technology developed by Body Vision Medical, was named the winner of “Best New Technology Solution—Biopsy” in the 2024 MedTech Breakthrough Awards program, which concluded last week. As announced by Body Vision Medical, the LungVision® system was selected as the winner of the prestigious award in the 8th annual award program. MedTech Breakthrough is a market intelligence organization that recognizes top companies, best products, and breakthrough technologies in the digital health space and medical technology market. MedTech Breakthrough Awards honor the efforts of MedTech companies in transforming healthcare using advanced and innovative approaches. It also recognizes…
Danish medical technology firm °MEQU has received 510(k) regulatory clearance from the US Food and Drug Administration (FDA) for its innovative portable blood and IV fluid warmer system, °M Warmer System, designed for both civilian and military use. According to Ulrik Krogh Andersen, Founder & CEO of °MEQU, the approval of the company’s product is a significant milestone attributed to more than a decade of research and product development. The approval paves the way for °MEQU’s presence in one of the world’s largest markets, aiding healthcare professionals in saving more lives. °MEQU’s °M Warmer System is a single-patient use blood…
A leading radiopharmaceutical tech startup, Nucleus RadioPharma, has secured additional capital in a Series A funding round led by AstraZeneca to make targeted theranostics and radiotherapies more accessible for personalized cancer therapy worldwide. Through the latest funding round, AstraZeneca joined the list of existing investors at Nucleus RadioPharma, including Mayo Clinic, GE Healthcare, Eclipse Ventures, the University of Missouri, Echo Global Granger Management Mercy Health, and Fox Chase Cancer Center. According to the company’s announcement on Wednesday, June 5, 2024, this financing round will help expand the development, supply, and commercial manufacturing capabilities of Theranostic radiopharmaceuticals, paving the way for…
BMI OrganBank, a North Carolina medical technology startup developing novel organ preservation and reconditioning technology, has announced promising results in organ preservation using its platform, which could potentially reduce the waitlist for organ transplants. The company announced on Monday, June 3, that pre-clinical data about their OrganBank Transport device generated and published in Transplantation Direct by the Duke University Ex Vivo Organ Laboratory (DEVOL) highlighted BMI OrganBank technology’s potential to significantly increase the possibilities of preserving and reconditioning organs for an extended time. With extended preservation and organ reconditioning, BMI OrganBank’s innovative warm perfusion platform can help reduce the number…
Novant Health has unveiled revolutionary High-tech robotics equipment that could make early lung cancer detection possible, improving diagnostics and therapy outcomes for cancer patients. As reported earlier by Charlotte Business Journal, the North Carolina-headquartered healthcare system has installed cutting-edge robotic equipment at its Agnes B. and Edward I. Weisiger Cancer Institute to help detect lung cancer at its early stages, increasing the likelihood of the patient’s survival. This is a pivotal milestone in cancer detection and treatment as traditional technologies can detect lung cancer only at stage III or stage IV, making the patient’s survival next to impossible. Novant’s less…
Massive Bio, a New York-based developer of an AI-driven oncology platform focusing on connecting cancer patients to available biopharmaceutical clinical trials, has partnered with Un Ensayo Para Mi (UEPM), a developer of a clinical trial search platform to extend better access to clinical trials by cancer patients in Latin America. The partnership announced during ASCO24, will help extend Massive Bio’s presence to nine Latin American countries, including Argentina, Brazil, Mexico, and Colombia, improving access to clinical trials and patient care. By leveraging UEPM’s AI-backed technology and vast network, Massive Bio aims to ensure more clients in LATAM access its cutting-edge…
German Trias i Pujol, a pioneering hospital serving nearly 1 million people in northern Barcelona, Spain, has launched an initiative backed by Masimo technology that combines telehealth and remote patient management to improve therapy outcomes. The initiative, launched on Monday under Masimo’s SESHAT project, will leverage advanced wearables technology and wireless connection to allow clinicians to remotely monitor patients’ data near-real-time from where they are— whether at home or in any part of the hospital. Launched in the fourth quarter of 2023, the SESHAT project is expected to continue for at least three years. It aims to integrate up to…