Intellirod Spine (Akron, Ohio), a medical device company making wireless sensing technologies for use in spinal care, has entered into licensing and distribution agreements with X-spine Systems (Miamisburg, Ohio), to use X-spine Fortex implants in conjunction with Intellirod's forthcoming Loadpro disposable microelectronic sensor. The Loadpro system is used during corrective spinal surgeries, and clamps onto a spinal rod at the time of implantation. The Loadpro system enables surgeons to monitor rod strain levels as corrections are being made. This new data can help the surgeon balance left/right rod loads during corrective surgeries as well as indicate the level of strain in each rod.
Ric Navarro, CEO of Intellirod, expects this new data to lead to correlations between intra-operative rod loading and the incidences of screw loosening, implant breakage, and even fusion outcomes. "For the first time, surgeons will have guiding information to balance loads and bring consistency to their procedure which can lead to improved outcomes, fewer complications and lower post-operative care costs," said Navarro.
Intellirod Spine is an emerging technology company dedicated to developing and commercializing sensor technologies to optimize operative and post-operative spine care.
X-spine is a medical device manufacturer which provides class-leading products for the treatment of spinal disease.
In other agreements/contracts news:
• The Center for Devices and Radiological Health (CDRH), a group within the FDA, has signed a three-year research collaboration agreement with MED Institute (West Lafayette, Indiana), a Cook Group company that supports developers of medical products through the key phases of obtaining market approval.
CDRH and MED Institute will collaborate on a research project to assess the radio frequency (RF) induced heating of passive metallic medical devices during magnetic resonance imaging (MRI). Typical metallic devices including vascular and orthopedic implants will be used to understand RF-induced heating's dependency on geometrical, material and electrical device characteristics. The information learned will guide engineers in designing appropriate MR safety testing strategies and understanding thresholds for heating.
The results of the study will be shared with the medical device community via peer-review manuscripts and written communications.
MED Institute has for over 30 years supported development of medical products assisting manufacturers to make them available to clinicians and patients.
• Qualcomm Life (San Diego), a subsidiary of Qualcomm, and AMC Health, a privately held provider of 'real-time' patient management solutions, reported what it calls a collaborative effort to accelerate the transformation of chronic care and population health management by significantly enhancing connectivity and care coordination for at-risk patients, specifically those with heart failure, hypertension, diabetes, asthma or COPD, in a cost-effective manner. The companies will integrate Qualcomm Life's 2net Connectivity Platform with AMC Health's CareConsole care coordination platform.
The innovative 2net Platform, 2net Hub and 2net Mobile solutions enable seamless capture, transmission and aggregation of biometric data from a wide array of FDA-listed medical devices in near real time. 2net offers increased interoperability and flexibility to capture device data from patients while they are in their homes or on the go, and securely transmit to AMC Health's CareConsole platform. The CareConsole platform has a sophisticated analytics system that collects, verifies and analyzes patient data, presenting clinically actionable, daily patient information in an easy-to-use format to clinicians via a secure web portal.
AMC Health's expertise in customizing and implementing chronic care programs has contributed to significant improvements in health outcomes and reductions in costs of care, which have been validated in peer-reviewed publications. AMC Health solutions have been proven to reduce all-cause hospital readmissions by 20%, reduce costs of care for patients with heart failure by 11%, improve HbA1c levels for patients with diabetes by 1.8 points, and improve blood pressure levels for patients with hypertension by 11/6 mmHg.
AMC Health is a provider of customized, scalable, cost-effective "real-time" patient management solutions, the company assists organizations serving at-risk populations and those conducting clinical trials. Qualcomm makes 3G, 4G and next-generation wireless technologies.