Vertebral compression fractures are one of the more obvious signs of osteoporosis but can be difficult to diagnose, one of several reasons the U.K. National Institute for Health and Care Excellence has given the nod to five AI products that can improve rapid detection of these fractures.
Medtronic plc received a CE mark for its Vitalflow extracorporeal membrane oxygenation (ECMO) system, which provides temporary support for the heart and lungs in critically ill patients in intensive care units (ICU). The company said the Vitalflow ECMO system represents a ‘new paradigm’ in ECMO therapy as it is designed to simplify ICU operations and brings performance, ease of use and adaptability to the forefront of patient care.
Researchers from UCLA’s Department of Cardiac Surgery filed for protection of a smart multistage peripherally inserted cannula with active fixation for temporary cardiopulmonary support which simultaneously drains both sides of the heart.
The neonatology unit at Bonn University Hospital (UKB) in Germany conducted the world’s first study of portable magnetic resonance imaging at the bedside on children undergoing extracorporeal membrane oxygenation (ECMO) therapy. This procedure involves oxygenating the blood outside the body. The 10-strong neonatology team demonstrated that it is safe and feasible to perform portable MRI at the bedside in this patient population.
Eurosets Srl reported the first patient treatments using Colibri, which the company asserts is the world’s lightest extracorporeal life support (ECLS) system. This first clinical procedure was performed using an ECLS device weighing less than 9 kg in the ICU department at the Arnaud de Villeneuve University Hospital in Montpellier, France.
Chinabridge (Shenzhen) Medical Technology Co. Ltd.’s extracorporeal membrane oxygenation (ECMO) machine Lifemotion gained NMPA approval, making it the first domestically developed ECMO unit given a greenlight in China. The approval includes the ECMO machine and the disposable consumables used in combination to treat acute respiratory failure or acute cardiopulmonary failure in seriously ill COVID-19 patients.
Johnson & Johnson (J&J) agreed to acquire circulatory support device maker Abiomed Inc. for $380 per share in cash, corresponding to an enterprise value of $16.6 billion and a more than 50% premium on the share price as of the market close on Oct. 31. Abiomed shareholders will also receive a non-tradeable contingent value right that entitles them to $35 per share in cash, if certain milestones are met. That would bring the premium to 60%.
Patients and investors in Alung Technologies Inc. can breathe a little easier now that the company’s Hemolung respiratory assist system has won a de novo approval from the FDA. The FDA approval comes more than eight years after Hemolung received CE mark and Health Canada approval. Hemolung gained FDA emergency use authorization for patients with COVID-19 in April 2020.
Abiomed Inc. has won the U.S. FDA’s nod for its Breethe Oxy-1 device, an all-in-one, compact cardiopulmonary bypass system designed for easy mobility. The company plans a controlled release at U.S. hospitals between now and March of 2021, with widespread availability later that year.