MedTech News
Vivos receives FDA 510(k) clearance for oral devices to treat severe sleep apnea
The clearance positions the company to offer an alternative to continuous positive airway pressure devices and neurostimulation implants.
Immune action at a distance
MIT and MGH researchers design a local, gel-based drug-delivery platform that may provoke a system-wide immune response to metastatic tumors.
University of Birmingham develops new diagnostic for traumatic brain injury
Researchers from the University of Birmingham have designed and developed a novel diagnostic device to detect traumatic brain injury (TBI) by shining a safe laser into the eye.
US FDA Grants the BiVACOR Total Artificial Heart IDE Approval for First-in-Human Early Feasibility Study
The EFS will evaluate the safety and feasibility of BTAH as a bridge to a heart transplant in the treatment of subjects with biventricular heart failure.
A new way to deliver drugs more efficiently
Core-shell structures made of hydrogel could enable more efficient uptake in the body.
RTI Surgical Inc. Receives FDA IDE Approval for the Clinical Investigation of Cortiva® Allograft Dermis in Breast Reconstruction
RTI Surgical, a leading global medical device organization, announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for a clinical study designed to confirm the safety and effectiveness of Cortiva® Allograft Dermis in implant-based breast reconstruction.
Smith & Nephew inks $180M CartiHeal buyout, capitalizing on Bioventus turmoil to land knee implant
Bioventus’ protracted buyout bid ultimately fell apart and opened the door to Smith & Nephew.
Another medtech company reports a cybersecurity incident
LivaNova (NASDAQ: LIVN)+
says it’s the latest victim of a cybersecurity incident.