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 U.S. 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 Murray Hill, N.J.-based C.R. Bard Inc. that the U.S. Court of Appeals for the Seventh Circuit decreed is not eligible for a new trial. Read More
Recruitment underway for Toronto-based Vielight Inc. has commenced recruitment for a clinical trial in the U.S. to study how brain stimulation photobiomodulation (PBM) might mitigate long-term cognitive impairment from long Covid. The study intervention comes on the heels of Canadian approval of a device to treat the acute version of Covid, involving light emitting diodes (LEDs) placed inside the nasal cavity and on the chest to deliver near infrared (NIR) light to the body. Read More
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. Read More
The markets for ventricular assist devices (VADs) and intraortic balloon pumps (IABPs) are hardly littered with competition, but the few companies that work in these two device categories have faced seemingly routine recalls over the past couple of years. The U.S. 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. Read More
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 (MRI), 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. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Auris Health, Intuitive Surgical, J&J, Titan Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Exactech, Nurami Medical, Magassist. Read More
