The Warsaw, IN-based company has received clearance for the ROSA Knee System to be used in robotically-assisted total knee replacement procedures.
The suspension follows the Irvine, CA-based company’s voluntary recall of the device earlier this month.
FDA has about two or three months of device user fees as the backlog of unreviewed devices continues to grow.
Day Zero Diagnostics has raised $8.6 million to further develop a sequencing-based rapid diagnostic that identifies, within hours, both the species and the antibiotic resistance profile of a bacterial pathogen.
MD+DI takes a look at five deals that transformed companies for the better and five deals that resulted in controversy for the parties involved.
The Mountain View, CA-based company received a nod from FDA for the MUTYH-Associated Polyposis Genetic Health Risk report.
The Dublin-based company is launching a post-market study that will evaluate the use of the SynchroMed II intrathecal drug delivery system as an alternative to oral opioids.
The test, developed by Researchers at the Institute for Global Food Security at Queen’s University Belfast, can detect proteases, enzyme markers that are responsible for the progression of many diseases.
The collaboration will use the Apple Watch to measure the outcomes of J&J’s heart health engagement program.
The acquisition comes hot on the heels of Boston Scientific making a significant acquisition into the mitral valve space.
The Irvine, CA-based company is slated to pay out $180 million to Boston Scientific in a move that would end both firms’ outstanding TAVR lawsuits and injunctions.
The Palo Alto, CA-based company will collaborate with Magic Leap, a specialist in augmented reality and spatial computer technology to bring its technology to an AR platform.
ARGONet is an AI solution developed by researchers from the Computational Health Informatics Program at Boston Children’s Hospital, and results evaluating the method's effectiveness were published in Nature Communications.
FDA has granted AWAK Technologies a breakthrough device designation for a wearable and ultra-portable peritoneal dialysis device.