LivaNova’s Seizure Fighting Vagus Nerve Stimulators Approved for MRI

LivaNova’s Seizure Fighting Vagus Nerve Stimulators Approved for MRI

LivaNova, a company with offices in Texas and Belgium that makes vagus nerve stimulation (VNS) systems that help to prevent the onset of epileptic seizures, received FDA approval for patients with the implants to be free to undergo MRI scans. While some precautions are still necessary, the previous MRI related approval required special equipment to be used during scans that is rarely available. The new approval essentially means that patients should be able to safely receive MRI scans at any imaging facility, greatly expanding the diagnostic options for people that have a high chance of requiring imaging in the future. “The FDA’s approval to expand our MRI labeling changes the landscape for device-based epilepsy therapies,” in a statement said Jason Richey, LivaNova’s President of North America & General Manager of the Neuromodulation franchise. “This further differentiates our technology from other epilepsy treatment options and adds a new dimension in our ability to support patients’ long-term treatment plans.” Flashback: AspireHC Vagus Nerve Stimulator Cleared in U.S. Market… Link: LivaNova VNS Therapy info page… Via:...
EaseCentral Raises $6.5M and Launches Two Offerings for Health Insurance: Interview with CEO David Reid

EaseCentral Raises $6.5M and Launches Two Offerings for Health Insurance: Interview with CEO David Reid

EaseCentral, a cloud-based benefits enrollment software platform built for small and medium insurance brokers and employers, has announced a $6.5 million Series A round of funding led by Propel Ventures and involving current investors Freestyle Capital, Compound, Upside Partnership, and Transmedia Capital. Along with the raise is the announcement of EaseCentral’s two new health insurance broker offerings. The first is a free, employee-facing iOS mobile application that facilitates access to insurance cards, health plan information, and paid time off days along with paperwork documentation like W9 forms. The second is an integration with ADP to allow easy payroll setup, syncing between benefits and payroll systems, and automatic updates to deductions based on an employee’s open enrollment decisions. Commenting on the announcement, David Reid, EaseCentral’s CEO stated, “Our mission is disseminating the very best technology to brokers via the most user-friendly platform.” Medgadget had a chance to ask David a few follow-up questions regarding EaseCentral’s latest health insurance offerings.   Medgadget, Mike Batista: What was EaseCentral’s motivation behind offering a mobile app? David Reid: Over one third of the workforce is made up of millennials and mobile devices are their preferred method for accessing the internet.  This is a quickly growing segment of the population and will soon represent the majority.   Medgadget: Both of EaseCentral’s new offerings (ADP integration + mobile app) are specifically identified for health insurance brokers. How do these offerings specifically benefit the health insurers and their customers? Reid: While our primary customer is the insurance broker, we provide solutions that enable them to better serve their customers. For employers:  Our ADP integration will primarily benefit Group Administrators by streamlining Benefits Administration...
The Digital Health Update by Paul Sonnier ⋅ Jun 16, 2017 ⋅ #279

The Digital Health Update by Paul Sonnier ⋅ Jun 16, 2017 ⋅ #279

I made this announcement to 56,516 members of the Digital Health group on LinkedIn. If you’re on LinkedIn, please do join the group, which allows you to opt in to receiving these announcements in addition to connecting with thousands of other global stakeholders in digital health. Note that I will continue to update this announcement up until sending out the final version via LinkedIn. I’m also now using Constant Contact to send an html and image-rich version of my announcements. You can subscribe to that version here. The Digital Health Update by Paul Sonnier ⋅ Jun 16, 2017 ⋅ #279 Dear Group, Philips has launched their 2nd annual Future Health Index, which is the result of surveys and interviews with over 33,000 stakeholders globally (including yours truly). The study evaluates how health systems can use digital technology to prepare for the future by looking at where connectivity has the most benefit, and where it needs further investment to ease the burden on healthcare systems. Creating a system fit for the 21st century is a complicated process, but this report aims to increase understanding about where society is, and point to sustainable solutions that will ultimately yield better health for all. You can download the report here. In my previous newsletter, I focused on how digital health can help to ameliorate healthcare disparities. While conducting background research on the Philips Future Health Index report, I came across a story about a ‘hospital on wheels’ being deployed by Philips India. Note that the above is sponsored content. The support from Philips and other companies is vital to sustaining my social entrepreneurship work, so...
BIOTRONIK’s Pacemakers Get 3 Tesla MR-Conditional Approval in Europe

BIOTRONIK’s Pacemakers Get 3 Tesla MR-Conditional Approval in Europe

BIOTRONIK won European regulatory approval allowing its Edora, Evity, and Enitra series of pacemakers to be safe for 3 Tesla full body scans, as long as certain precautionary measures are taken. This approval will allow more patients to take advantage of the high quality imaging that the more powerful MRI scanners offer, as previously these implants had MR-conditional approval up to only 1.5 Tesla. Full body scanning, on the other hand, opens up scanning of the chest, heart, and other organs close to the pacemaker and its leads. Since these are existing pacemakers and it’s getting a bit confusing which are cleared for which scanner strengths, BIOTRONIK has setup a website (ProMRIcheck.com) to help cardiologists and radiologists quickly get the official word. “As 3 T MRI becomes increasingly prevalent in the management of a variety of diseases, it is vital that pacemaker patients also have access to this invaluable mode of imaging,” in a published statement said Dr. Matthias Schmitt, University Hospital of South Manchester NHS Foundation Trust, UK. “Thoracic imaging at higher field strengths has improved significantly in recent years, allowing 3 T MRI to take on a significant role in cardiac imaging for events such as cardiac perfusion, cardiac toxicity and myocardial infarction, where visualization is key in guiding clinical decision-making. With more options for cardiac imaging, we can strive to improve care for patients with pacemakers.” Via:...
OrbusNeich Is Bringing Its Sapphire PTCA Balloon Catheters to U.S.

OrbusNeich Is Bringing Its Sapphire PTCA Balloon Catheters to U.S.

OrbusNeich, a company based in Hong Kong, is releasing in the U.S., following FDA clearance, its Sapphire II PRO and the Sapphire NC Plus PTCA balloon dilation catheters. Both devices are indicated for dilation of coronary artery or bypass graft stenoses in cases of ischemia, and for opening up coronary artery occlusions following an infarct. The Sapphire NC Plus can also be used according to labeling for treating in-stent restenosis and to stretch open stents within the coronary artery. Both devices were developed for navigating through particularly challenging blockages, while the Sapphire II Pro is particularly good at traveling through curvy vasculature. The Sapphire NC Plus sports a non-compliant balloon that’s tightly folded into the stent for easier passage through the lesions. The company’s Hydro-X coating is another characteristic helping the catheter of the Sapphire NC Plus to slide through. “The Sapphire II Pro and Sapphire NC Plus are tried and proven technology in both the interventional coronary and interventional radiology markets outside the US. Entering the US market with our proven coronary dilatation catheters is a long overdue and logical step for our company,” said Scott Addonizio, Chief Operating Officer, OrbusNeich, in a released statement. Flashbacks: OrbusNeich’s New Sapphire II NC Coronary Balloon Catheter…; Sapphire II Coronary Dilation Catheter Gets Clearance in Europe… Product page: Sapphire II PRO… (there isn’t one for Sapphire NC Plus yet) Via:...
Siemens Biograph Horizon Flow Edition PET/CT with FlowMotion Cleared by FDA

Siemens Biograph Horizon Flow Edition PET/CT with FlowMotion Cleared by FDA

Siemens won FDA clearance for its Biograph Horizon Flow edition, a budget friendly positron emission tomography/computed tomography (PET/CT) scanner that includes some advanced features of its more expensive cousin. The main selling point is that the new device includes FlowMotion continuous bed motion scanning technology, an offering that was previously introduced on Siemens Biograph mCT Flow PET/CT. Another advantage is HD•Chest, a feature that prodcues motion-frozen chest scans much faster than traditional techniques. According to Siemens, FlowMotion “differs from conventional step-and-shoot PET/CT scanning in that it enables personalized exam protocols based on patient anatomy.” Four different regions can be setup based on a patient’s anatomy, each resulting in a different bed speed, helping the radiology team standardize scans and perform common imaging exams quickly and reliably. “With the addition of Biograph Horizon Flow edition to the Siemens Healthineers PET/CT portfolio, customers tasked with reaching a certain price point no longer need to make compromises in the PET/CT technology they offer patients,” said Doug Darrow, Vice President of Molecular Imaging at Siemens Healthineers North America, in a statement. ‘The Biograph Horizon Flow edition is the ideal PET/CT system not only for progressive community hospitals but also for satellite campuses of large healthcare networks that are looking to provide the same premium continuous bed motion technology as their flagship facilities.”...