Alydia Health Inc., of Menlo Park, Calif., has completed enrollment in the pivotal PEARLE investigational device exemption (IDE) study, which is assessing the safety and effectiveness of the Jada system to rapidly control and treat abnormal postpartum uterine bleeding and postpartum hemorrhage. Read More
BEIJING – Researchers from The Hong Kong Polytechnic University (PolyU) have developed a diagnostic system that they claim is the world’s most comprehensive as it can identify 30 to 40 pathogens in one single test within an hour. Read More
The response from industry regarding the Environmental Protection Agency’s (EPA) draft rule for ethylene oxide (EtO) varied considerably, but the Advanced Medical Technology Association (Advamed) argued a fundamental methodological point in its comments to the docket. Advamed’s Ruey Dempsey said the EPA approach to determining safe levels of EtO relies on “a single epidemiological study,” an approach Dempsey said has drawn fire from the National Academies of Science. Read More
LONDON – Surgeons in the Netherlands have carried out what is claimed as the first human supermicrosurgery, connecting vessels of a diameter as low as 0.3 mm using a purpose-designed robotic system. Read More
PERTH, Australia – Brisbane, Australia-based Field Orthopaedics was formed when a group of orthopedic surgeons were exasperated by ongoing shortcomings in surgical practice and decided to do something about it. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Prolung, Yourgene. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Brainsway, National Government Services, Wisconsin Physician Services. Read More
Keeping you up to date on recent developments in neurology, including: PTSD linked to a dysfunction of the brain networks that control memory; Molecule offers hope for halting Parkinson's; Brain abnormalities associated with schizophrenia in individuals with 22q revealed. Read More