Portuguese researchers are developing and testing a smart, portable system to manage Parkinson's disease in real time. The so-called Rempark system has been tested on more than 50 volunteers from Spain, Italy, Ireland and Israel, reports Medical Xpress. Unlike previous studies, these outpatients lived at home and used the device in real-world conditions.
The Brookings Institution has just laid out its vision of a comprehensive medical device postmarket surveillance system in a report to various device industry stakeholders. The report's ideas were further detailed and debated during a series of moderated discussions at the think tank featuring the CEOs of Medtronic and Edwards Lifesciences, and the head of FDA's device arm, or CDRH.
HeartWare has issued a voluntary recall of some of its Ventricular Assist System Controllers due to their higher susceptibility to electrostatic discharge than some newer, commercial controllers. An electrostatic discharge can cause a pump to stop, which could result in serious injury or death.
Medtronic has published detailed results for the first time of a 5-year trial for deep brain stimulation therapy in treatment-resistant epilepsy. The device giant has said that it will make another run at an FDA approval for its DBS device in that indication.
Several companies are experimenting with long-term wearable insulin delivery systems that work via continuous subcutaneous infusion to help ease the administration of the medication, thereby making it easier for patients to remain compliant. One such system from startup CeQur recently reported data from a small pilot study.
Startup Beta-O2 Technologies already has a bioartificial pancreas in a tiny three-person clinical trial. Now, it has preclinical data for its next device that uses the same implantable bioreactor technology with a new cell type--the βAir Bio-artificial Adrenal system.
Biotronik announced that the second clinical trial of its Dreams drug-eluting bioresorbable stent met another milestone as it races to become the third player in the emerging space. The Biosolve-II trial has completed enrollment, the company said. Its primary outcome measure is late lumen loss at 6 months, according to ClinicalTrials.gov.
Artificial, mechanical hearts are effective in getting almost three-quarters of patients to a donor heart transplant, recent data on the SynCardia Total Artificial Heart suggest. But that feat doesn't contain SynCardia's ambitions--it recently started a trial for permanent use of its artificial heart that's ultimately designed for FDA submission.
Study finds Medtronic MiniMed's insulin suspension feature cuts incidence of low blood sugar in diabetics
Medtronic touted data from a retrospective study of 20,973 diabetes patients finding that the Threshold Suspend feature of its MiniMed 530G system is helpful in reducing episodes of hypoglycemia, or low blood sugar.
In a presentation at the American Stroke Association's International Stroke Conference, Dr. Vishnumurthy Hedna said that conducting an optic ultrasound can help in the identification of stroke patients who are at imminent risk of dying.