Joe Kiani’s reign at Masimo Corp. abruptly ended following a vote at the annual shareholders meeting on Sept. 19 that saw Kiani, Masimo’s founder and CEO, ousted from the board as part of a hard-fought battle with activist investor Politan Capital Management. Michelle Brennan, a Politan nominee and former Johnson & Johnson senior executive who won her board seat last year, was named interim CEO.
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 U.S. FDA approved Apple Inc.’s Airpods Pro 2 as an over-the-counter assistive hearing device for adults with mild-to-moderate hearing loss, making the ubiquitous devices the first assistive hearing technology to receive this designation.
Qure.ai Technologies Private Ltd.’s Qxr artificial intelligence-powered chest X-ray interpretation system identified high-risk pulmonary nodules an average of 32 months before physicians diagnosed lung cancer, a study presented September 8 at the International Association for the Study of Lung Cancer 2024 World Conference on Lung Cancer in San Diego found.
The U.S. FDA caught up with four makers of CPAP cleaning machines in the form of warning letters advising the manufacturers that the claims made for their systems fall under the definition of a regulated medical device. In two of these warning letters, the FDA said it had been in touch with the manufacturer for at least two years, indicating that the agency has been steadily working on enforcement activities in this space for some time.
Noze Inc. breathes a little easier with a new $5 million equity investment from the Bill & Melinda Gates Foundation to support the development of Diagnoze, a breath-based, hand-held diagnostic device. The foundation provided two earlier grants focused on diagnosing tuberculosis in low- and middle-income countries. “We're thrilled to see our partnership with the Bill & Melinda Gates Foundation continue to grow,” Noze CEO Karim Aly told BioWorld.
Owens & Minor Inc. plans to acquire Rotech Healthcare Holdings Inc. in a $1.36 billion cash transaction expected to close by year end. The deal shows serious commitment to a strategy outlined in December to build out its home health business.
The U.S. FTC’s campaign against the Orange Book listing of patents claiming device components gained momentum when a federal judge in New Jersey ordered Teva Pharmaceuticals USA Inc. to delist five device patents pertaining to its Proair HFA (albuterol sulfate) inhaler.
London, Ontario-based Deep Breathe Inc. filed for protection of a wearable ultrasound sensor that is used to obtain ultrasound data, and digital ultrasound images are processed using a machine learning model to predict the probability of lung sliding and detection of pneumothorax (collapsed lung) if lung sliding is absent or deem it likely if lung sliding is present.
Researchers from the University of Chicago and Northwestern University have filed for protection of an mobile application to track individualized patient needs, engagement in continuous positive airway pressure machine use, and the correlation of risk behaviors to determine sleep apnea treatment progress.