U.S. federal preemption of state liability law for medical devices is firmly established for PMA devices, but this is not the case for devices that are cleared via the FDA‘s 510(k) program. However, some courts have gone a step further in disallowing defendants in product liability litigation from entering evidence of 510(k) clearances from the FDA, a practice that played a role in a $3.3 million verdict against C.R. Bard that the U.S. Court of Appeals for the Seventh Circuit decreed is not eligible for a new trial.
Headpulse shows brain abnormalities days after concussion symptoms subside
A headset developed by the University of San Francisco and licensed by Mindrhythm Inc. detects a digital biometric that can confirm concussion and indicate how long brain changes from concussion persist. Those changes persist nearly two weeks longer than mild traumatic brain injury symptoms, a study published in JAMA Network Open found, suggesting that many athletes cleared to return to play following a concussion based on the current gold standard of symptom-based scoring could remain at elevated risk of longer-term brain damage.
Brain maps uncover individual differences in psychiatric disorders
The study of six types of mental illnesses in a thousand brain regions has demonstrated the differences between individuals within each disorder. Using magnetic resonance images, scientists from Monash University in Australia analyzed the brain changes and built individual maps for each psychiatric disorder. Their results revealed differences between people with the same diagnosis, which could help refine assessments. “Our work highlights and provides an exciting opportunity for more personalized therapy, in order to find targeted [brain] sites that will be relevant for any given individual, as opposed to this one [brain] site that fits all approach that currently exists,” the lead author Ashlea Segal, told BioWorld.
Abiomed, Datascope facing new round of recalls for cardiovascular devices
The markets for ventricular assist devices (VADs) and intraortic balloon pumps (IABPs) are hardly littered with competition, but the few companies that work these two device categories have faced seemingly routine recalls over the past couple of years. The FDA recently reported yet another round of class I recalls for a single model in both Abiomed Inc.’s Impella line of VADs and Datascope Corp.’s Cardiosave line of IABPs, but the agency’s apparent unwillingness to force either manufacturer to withdraw any of these recalled products seems to suggest that product shortages would quickly follow any such move on the FDA’s part.
Fractus expands into health care with new wireless implanted device technology
Fractus SA reported that it has successfully transferred its wireless implantable device technology to improve the way doctors monitor patients remotely, thereby boosting the adoption of implantable health care services by leveraging wireless connectivity. “With the ability to offer real-time data and feedback, our Smart Virtual Antenna technology is expected to dramatically improve patient care, enabling doctors to make timely, informed decisions and promoting personalized consultations,” said Ruben Bonet, co-founder, chairman and CEO of Barcelona-based Fractus. This is a major milestone for Fractus, which aims to meet a health care need that has consistently grown since the start of the COVID-19 pandemic.
Also in the news:
Axonics, Expanse Medical, Treace Medical Concepts, Genedx, Exactech, Nurami.