The FDA’s new program for communicating the hazards of devices is in play and resulted in the posting of a notice of a problem seen with the Ivenix line of large volume infusion pumps by Fresenius Kabi USA, which will require some repair work by the manufacturer.

Europlaz Technologies Ltd. has developed a new neonatal flow sensor that could help improve neonatal care and save the lives of babies born prematurely. The company created an integrated ‘sidestream’ carbon dioxide (CO2) sampling port, which when added to the side of its existing neonatal flow sensor will enable clinicians to monitor CO2 being exhaled from the baby’s lungs to better inform care.

Positrigo AG is raising $10 million for production and commercialization of its Neurolf brain positron emission tomography system in the U.S. The system hepls to diagnose Alzheimer’s disease. With drugs such as Leqembi and Kisunla gaining U.S. FDA approval to treat the devastating neurological condition, the company is seeing increasing demand for its system, Neurolf CEO and co-founder Jannis Fischer, told BioWorld.

Third-party patent litigation funding has been a concern for device makers for some time, but a recent report by the U.S. Government Accountability Office indicates that the Department of Justice is looking into the practice for evidence that foreign entities are involved in patent litigation funding.

At its investor day conference, Edwards Lifesciences Corp. prognosticated that an expanded indication in transcatheter aortic valve replacement and rapid growth in its newer mitral and tricuspid heart valve technologies will accelerate total company sales in 2026 and beyond.

The COVID-19 pandemic reset expectations of Medicare telehealth coverage, prompting a letter from dozens of members of Congress to Capitol Hill leadership asking for legislation that will memorialize telehealth benefits. But concerns over spending, fraud and abuse still hang over the discussion.