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 July 17, 2017


Medtronic Announces Five-Year Data for InterStim System

Medtronic announced that the InterStim system, which provides sacral neuromodulation therapy, offers sustained long-term efficacy and quality of life improvements for overactive bladder (OAB) at five years. Results of the InSite study, were published online in the Journal of Urology, found that 82 percent of patients had therapeutic success (defined as a greater than 50 percent improvement in symptoms) at five years and sustained quality of life improvements.


The study also found that forty-five percent of patients with urinary urge incontinence (UI) had complete continence, UI patients had an average reduction of 2 leaks per day (p<0.0001) and urinary frequency (UF) patients had a mean reduction of 5.4 voids per day (p<0.0001) In addition, patients experienced sustained quality of life improvements measured using the ICIQ-OABqol questionnaire (p<0.0001) that were three times greater than what is considered clinically significant.


See more information the InterStim Therapy System on Meddevicetracker.



Sensome Raises Capital to Bring First Product to Clinical Trials

Sensome, a company developing a micro-sensor technology for smart medical devices out of France's Ecole polytechnique, announced that it has completed its €4.7m seed round to bring its first product to clinical trials.


Sensome's novel sensing technology can be integrated with any medical device to reliably identify biological tissues in contact with the device. The technology combines micrometric impedance sensors that communicate wirelessly outside the body and machine learning algorithms for accurate and predictive real-time analysis. Sensome's first product integrates its proprietary technology with a guidewire for the treatment of ischemic stroke.


See more information the Sensome Connected Stroke Guidewire on Meddevicetracker.


July 18, 2017

Voluntis Receives FDA Approval and CE Mark for Insulia with Toujeo

Voluntis announced that Insulia, its digital companion for people with type II diabetes, has received U.S. Food and Drug Administration (FDA) 510(k) clearance and the CE mark to integrate Toujeo insulin glargine U-300 (Sanofi).  Insulia already received FDA clearance and the CE mark for insulins Lantus and Levemir in 2016.  Voluntis launched Insulia in the United States this month and will launch shortly in the European market. 


Insulia is a prescription-only digital companion for people with type II diabetes and their care teams that helps people get to the right dose, every day. Insulia combines a patient mobile app and health care practitioner (HCP) web portal.


See more information the Insulia on Meddevicetracker.



gammaCore Nerve Stimulator for Headaches Launches in the United States

ElectroCore announced the commercial launch of gammaCore (non-invasive vagus nerve stimulator) for the acute treatment of pain associated with episodic cluster headache in adult patients in the United States. The Company claims that GammaCore is the first non-invasive, hand-held medical device applied at the neck and sends patented electrical stimulation through the skin to activate the vagus nerve, resulting in the reduction of pain.


Patients can receive the device by enrolling in gammaCore Patient Registry (GPR), a non-research registry intended to examine the patient experience with gammaCore. As part of the registry, those eligible may receive two months of gammaCore treatment at no cost to the patient, in return for sharing information about their experience with the device along with periodic quality-of-life, self-reported outcomes. 


See more information on the gammaCore on Meddevicetracker.


July 19, 2017

Medovex Announces First Human Cases Using DenerveX Device

Medovex announced the first human cases performed using its recently launched DenerveX System. The first human use cases for the DenerveX System took place in Manchester, England with initial procedural success. The DenerveX System which has recently received CE Mark approval and clearance for commercialization in the European countries in June 2017, is a new and novel device designed for enduring relief of Facet Joint Syndrome related to lower back pain.


See more information on the DenerveX on Meddevicetracker.


AliveCor Announces Collaboration with Mayo Clinic for AI Technology

AliveCor announced a collaboration with Mayo Clinic to develop tools for medical and non-medical personnel to easily screen for long QT syndrome (LQTS) early by combining AliveCor’s AI technology with Mayo’s patented algorithms. LQTS is both a congenital and acquired disorder. 


Through this collaboration, new methods and techniques to detect LQTS will be developed for AliveCor’s portable Kardia Mobile device. The collaboration will combine AliveCor’s patented artificial intelligence technology, algorithms and millions of ECGs, with Mayo Clinic’s data and clinical expertise. The companies envision a tool that would apply machine learning to millions of ECG readings as an enhancement to traditional ECG analysis, and develop a universal screening tool for the early detection of long QT syndrome. 


See more information on the Kardia on Meddevicetracker.


July 20, 2017

Masimo Receives CE Mark for Non-Invasive RPVi Measurement

Masimo announced the CE Marking of RPVi, a noninvasive and continuous measurement of the dynamic changes in perfusion index (Pi) that occur during one or more respiratory cycles. RPVi is designed for use on the Radical-7 Pulse Co-Oximeter, and shows changes that reflect physiologic factors such as vascular tone, circulating blood volume, and intrathoracic pressure excursions.


RPVi is powered by Masimo rainbow technology, and is a multi-wavelength version of the currently available Pleth Variability Index (PVi). RPVi is designed to provide enhanced specificity to changes in fluid volume compared to PVi.


See more information on the Masimo Set Radical 7 Pulse Co-Oximeter on Meddevicetracker.



Cardiac Science Granted Canadian Approval for Powerheart G5 AED

Cardiac Science announced that it has been granted approval by the Canadian regulatory agency, Health Canada, to begin marketing its Powerheart G5 Automated External Defibrillators (AED) in Canada. According to the Company, the Powerheart G5 is the first AED approved by Health Canada to combine automatic shock delivery, dual-language rescue prompting in both French Canadian and English, variable escalating energy, and rapid shock times.


See more information on the Powerheart AED G5 on Meddevicetracker.



Neuro Kinetics Announces Research Collaboration with Department of Defense

Neuro Kinetics (NKI) announced that it signed a Cooperative Research and Development Agreement (CRADA) with the Department of Defense’s (DoD) Walter Reed National Military Medical Center (WRNMMC). The study will evaluate the sensitivity and specificity of oculomotor, vestibular and reaction time for subjects with a history of Traumatic Brain Injury (TBI).


The study is designed as a prospective, non-randomized trial comparing a group of normal controls without a history of TBI to another group of participants who have a confirmed history of TBI. Subjects are to be tested using three devices including NKI’s I-PAS (I-Portal Portable Assessment System). I-PAS is a portable head-mounted system that leverages the company’s commercial I-Portal testing technology running an integrated, multimodal battery of OVRT (oculomotor, vestibular, and reaction time) tests.


See more information on the I-Portal Device on Meddevicetracker.


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