InvisionHeart Receives FDA 510(k) Clearance on Novel ECG System

May 2015

InvisionHeart, a Nashville-based leading developer of a disruptive ECG technology with a secure cloud-based, healthcare IT platform, announced today that the Food and Drug Administration has cleared the InvisionECG technology for sale.

The InvisionHeart ECG System provides a revolutionary, mobile solution for capturing and managing 12-lead ECGs, including the ability to read and visually compare, confirm, report and store diagnostic quality electrocardiograms. This is all done on a browser-based, secure, healthcare IT platform which provides access to ECGs anywhere and anytime an authorized healthcare professional has web access via an appropriate browser. This will potentially lead to earlier cardiac diagnosis, which improves survival when “time is tissue.”

“This is a significant milestone in the development of our technology and, more importantly, a breakthrough in our ability to serve patients where ECGs have been traditionally unavailable. Earlier diagnosis of cardiac issues via improved access will benefit patients, whether in the hospital setting or at home,” stated Josh Nickols, Ph.D., President and CEO.

The company expects its cloud-based ECG solution to be available for clinical use in the early third quarter of 2015. Melanie Varin, Executive Vice President of Sales and Marketing, added, “The InvisionECG system will offer significant advancement in cardiac care for patients and healthcare providers in a wide variety of care settings. Initial interest has been strong from a broad array of potential users, especially those challenged to find a high-quality, low-cost solution that is secure and fully electronic. In addition to hospitals, we’ve detected genuine enthusiasm from the rapidly growing markets for home health and ambulatory care as well as other specialty markets.”

Striking new data (in both the Journal of the American Heart Association and the Journal of the American Medical Association) has identified a delay in cardiac diagnosis within the hospital setting that is associated with increased mortality. “If you have a heart attack while in a hospital, your chances of dying are three-fold greater than those with outpatient-onset heart attacks,” indicated Susan Eagle, Chief Medical Officer based on a JAMA report (Association of Inpatient vs Outpatient Onset of ST-Elevation Myocardial Infarction with Treatment and Clinical Outcomes, JAMA, November 19, 2014 Volume 312, Number 19). InvisionHeart offers a cost-effective technological solution with the potential to increase access and decrease cycle time while filling a critical unmet need of diagnosing cardiac disorders without the need for purchasing expensive IT infrastructure.

About InvisionHeart
InvisionHeart Inc. is developing a cardiac data solution that serves clinicians who care for patients with potential heart conditions. The hardware technology enables physicians, nurses, and care providers to capture, communicate, and utilize patient ECGs in a manner that is both more efficient and cost effective than the current standard of care. At the center of the technology is a cloud-based healthcare IT platform that allows a network of care providers to collaborate, review and annotate patient 12-lead ECG tracings. InvisionHeart has received 510(k) clearance by the FDA as a Class II medical technology.

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InvisionHeart Appoints New Board Member

Jan 2015

Healthcare Veteran Scott MacKenzie Joins InvisionHeart’s Board of Directors

InvisionHeart, a leading developer in disruptive ECG technology and secure cloud platform, today announced the appointment of Scott MacKenzie to the company’s Board of Directors. With his immense experience and extensive background in healthcare and IT management, Mr. MacKenzie will be a valuable asset to InvisionHeart.

“Scott brings a depth of experience in the management of healthcare IT companies that will be invaluable to InvisionHeart as we grow and execute our commercialization plans,” says InvisionHeart CEO Josh Nickols, Ph.D. “Scott has led companies through all phases of development, marketing, sales, and growth, and we intend to utilize his knowledge in these same areas through his participation on the Board of Directors.”

Mr. MacKenzie is currently the CEO of MModal, a market leader in clinical documentation solutions leveraging services and technology to improve productivity and allow physicians to focus on their patients. Prior to MModal, Mr. MacKenzie was the CEO of Passport Health Communications, which was acquired by Experian in November 2013. Mr. MacKenzie has also held executive positions with McKesson and Cerner and has an extensive background in healthcare IT management.

“I am excited to join the Board of InvisionHeart and be part of the successful growth of InvisionHeart’s disruptive innovations to improve access to healthcare technology at the right place and the right cost for healthcare providers and their patients,” says MacKenzie. “I look forward to working with Josh, the other members of the board and the InvisionHeart team to support this unique solution that will improve the quality and cost of care.”

InvisionHeart named winner at Next Awards

Nov 2014

The Nashville Area Chamber of Commerce and Nashville Entrepreneur Center recognized a number of local businesses and CEOs at its annual Next Awards. InvisionHeart was the honored recipient of Startup healthcare category.

Read full article from Nashville Business Journal, click here.

Nashville Area Chamber of Commerce Next Award Winner

Nov 2014

The NEXT Awards, hosted by the Nashville Area Chamber of Commerce and the Nashville Entrepreneur Center, honor Nashville’s fast-growing, innovative companies and leading entrepreneurs. More than 50 companies and 10 individuals were named as finalists in five sectors.

InivisionHeart was awarded Startup of the year in the healthcare category.

Read full article from The Tennessean, click here.

InvisionHeart Raises $1.9M

Jun 2014

Cardiac data company also names COO, chairman.

Nashville-based InvisionHeart, a cardiac data technology company, has raised $1.9 million in Series A financing led by The Martin Companies.

InvisionHeart is based on wireless electrocardiogram technology developed at Vanderbilt University and aims to capture and analyze cardiac data through mobile hardware and cloud-based transmission. Its growth capital, which also came from TriStar Technology Ventures, Mountain Group Capital and NueCura Partners, will help complete its technology buildout, seek clearance from the U.S. Food and Drug Administration and begin pilot sales. The electrocardiogram is part of a larger communication system that includes smartphones, tablets and a HIPAA-compliant platform.

“We are very pleased to have brought together such a seasoned group of investors,” Dr. Josh Nickols, CEO of InvisionHeart, said in a release. “Their collective experience will be invaluable as we move InvisionHeart forward.”

Additionally, David Landman has been named COO and Christopher Rand will serve as chairman of the board of directors. Landman is a former president of tech transfer company Vertex Clinical Innovations while Rand is a co-founder and partner at TriStar Technology Ventures.

“A critical component of the ACA is making sure patients receive appropriate care in the appropriate setting,” said Charlie Martin, founder of The Martin Companies. “The technology under development at InvisionHeart does just that by allowing clinicians to remotely analyze critical patient data. This gives patients access to top-notch expertise in lower cost settings, like ambulatory care facilities, while reducing cost.”

Emily Kubis, Nashville Post

InvisionHeart lands $100K from AOL founder Steve Case

Apr 2014

Executives of InvisionHeart, a Nashville startup, pitched their business to Silicon Valley investors at Google today and walked away with a $100,000 equity investment from AOL founder Steve Case.

As part of Google for Entrepreneur’s demo day, 10 companies from Google’s tech hub network, which includes Nashville’s Entrepreneur Center, were invited to present their companies to venture capital firms at the company’s Mountain View, Calif., headquarters. At the culmination, Case, acting as a demo day judge, awarded each company with $100,000.

For InvisionHeart, founded by Vanderbilt University cardiac anesthesiologist Susan Eagle and led by CEO Josh Nickols, that investment means the company is close to completing a $1.25 million Series A funding round that will allow it to finish its technology phase, seek clearance from the U.S. Food and Drug Administration and begin sales.

“We thought we’d come out here and just have an opportunity to present to Google, develop some relationships, network a bit,” Nickols said. “100K from Steve Case is certainly a big piece of our Series A.”

InvisionHeart was created by Eagle and biomedical engineering professor Franz Baudenbacher, also at Vanderbilt. The device uses smartphones or tablets to transmit electrocardiogram (EKG) information to physicians and cardiologists and allows them to make decisions concerning a patient’s health more quickly.

During the event, Eagle and Nickols pitched to about 40 venture funds, the majority from the Silicon Valley area, and Nickols said he plans to follow up with a handful of firms that expressed interest. He is spending the rest of the week meeting with venture firms located in the area and potential partners.

“It was an amazing experience,” Eagle said. “We have many more collaborative opportunities in Silicon Valley and Palo Alto. It’s going to lead to some great things for us in the very near future.”

Nashville was named a Google tech hub in September, connecting it to Google representatives and to other Google tech hubs, including 1871 in Chicago, CoCo in Minneapolis; The American Underground in Durham, N.C.; Galvanize in Denver; Communitech in Waterloo, Ontario; and Grand Circus in Detroit.

Jamie McGee, The Tennessean

InvisionHeart to pitch at Google Demo Day

Mar 2014

InvisionHeart, LLC, a startup based on a wireless electrocardiogram (ECG) system developed at Vanderbilt, has been selected as one of 10 startups nationwide to participate in Google’s inaugural Demo Day April 2, 2014.

CEO Josh Nickols will pitch the company to a roomful of investors at the spring Silicon Valley event.

“We’re thrilled to be selected by the Nashville EC and Google Ventures to present our technology to Silicon Valley investors and companies,” said Nickols. “It is a fantastic opportunity to access new capital and develop partnerships that will grow a valuable technology beyond the Vanderbilt and Nashville healthcare community.”

Demo Day will be held at Google Headquarters in Mountain View, Calif. The startups will have five minutes to pitch their products followed by a brief Q&A with the judges panel: Steve Case, chairman and CEO of Revolution, founder of American Online, and chairman of UP Global and The Case Foundation; Stephanie Palmeri, principal with SoftTech VC; and MG Siegler, general partner at Google Ventures. After all pitches have been heard, the judges will select a winner.

InvisionHeart is a smart health care platform and digital ECG that allows health care providers, first responders and patients to record and send current tracings of the heart’s electrical activity via a smartphone or tablet directly to physicians for interpretation.

The smart health care platform can be expanded to monitor activity, posture, blood pressure, fluid status and cardiac stroke volume.

It was developed by Franz Baudenbacher, associate professor of biomedical engineering; André Diedrich, physician and research professor of medicine and biomedical engineering; Susan Eagle, physician and associate professor of clinical anesthesiology; Rene Harder, Ph.D. candidate in electrical engineering, and Jonathan Whitfield, M.Eng., biomedical engineer.

InvisionHeart won first place last year in Vanderbilt University’s TechVenture Challenge, an initiative that teaches students how to turn patented ideas developed by Vanderbilt faculty members into marketable products. In November 2013 InvisionHeart was finalist in the Global Food and Health Innovation Challenge, part of Global South Summit, a forum in Nashville that brings together executives and experts from around the world to concentrate on food and health issues.

Watch inventors Franz Baudenbacher and Susan Eagle talk about the power of collaboration and the invention that will soon be pitched at Google Demo Day.

InvisionHeart is building a small, smart 12-lead EKG device to get scans in the cloud

Jan 2014

A Nashville medical device company is working on a new approach to EKGs that is easier, more convenient and more portable than current 12-lead systems.

Invision Heart is developing both the hardware component that takes the EKG and the software that turns the scan into a digital file.

“We will take patient data and then upload it to the cloud to give the doctor access to make quick decisions,” said InvisionHeart CEO Joshua Nickols.

EKGs are an example of another healthcare communication process that desperately needs updating. The current solution involves – you guessed it – paper and faxing.

“EKGs, as they exist in the hospital, are 20- or 30-year-old devices that print paper, and they’ve gone overlooked as a problem over time,” he said. “We are updating a critical diagnostic tool that is still wedded to an old way of data transmission.”

The file would be available to all providers in an institution.
“If the doctor has a nurse practitioner supporting her work, she could double her workload,” Nichols said. “This system also could work in nursing homes or minute clinics.”

Invision Heart has also updated the form factor of the device. The prototype is the size of a deck of cards.

“By having a very small form factor, the device could be brought to the patient much more easily,” he said. “Also with the back-end piece, a doctor could look at the EKG at home.”

The system would also allow an archive of patient EKGs. Nickols said that there is potential for Medicare fraud if EKG reports are unsigned. His solution would take care of that problem as well.

Nickols came to Nashville 15 years ago to get a doctorate in molecular neuroscience from Vanderbilt University. He also has an MBA and was the CTO for a molecular diagnostic company.

InvisionHeart has been around for about year and went through the Jumpstart Foundry program in Nashville. InvisionHeart has raised some angel capital so far and is looking to raise a Series A round of $750,000 to $1 million.

Nickols estimates that he needs a year to get to market with the new system. He said the prototype has demonstrated proof of concept and now he is working with a manufacturer to commercialize the device.

“We need a robust software architecture to capture the data and make it available from the point of acquisition to a doctor’s smartphone or tablet,” he said.

Jumpstart Foundry Investor Day 2013: InvisionHeart Pitch from Jumpstart Foundry on Vimeo.

During the summer of 2013, eight technology start-ups graduated from an intense, 14-week, business accelerator program called Jumpstart Foundry (JSF). JSF is the leading start-up business accelerator in the Southeast. The summer accelerator program ends on Investor Day when each company pitches to a room filled with hundreds of investors, mentors and media.

Sit back and learn about JSF alum, InvisionHeart, a mobile hardware and cloud system that allows for the capture and review of cardiac data, serving hospitals, clinics and ambulatory care.

The secure cloud platform at the center of our technology enables a network of physicians, nurses, technicians, and billing specialists to securely access and annotate patient ECG tracings. From credentialed mobile devices, a recipient can instantly access captured ECG tracings, as well as select alerts and push notifications to aid the rapid turnaround of completed reports by busy practices and hospital departments.

As patients are increasingly treated in ambulatory surgery centers, rural hospitals and care clinics, there is a need for technology to provide connectivity among geographically distant clinicians. Further, as technology travels within hospitals and to patients, conventional ECG devices are physically challenging to transport. The InvisionHeart ECG is small enough to be carried in a lab coat pocket, powerful enough to operate for several days, and transmit data via a HIPAA-compliant, 256-bit encryption system.

Veronica Combs, MedCity News

Meet the Jumpstart Foundry teams that will pitch to investors this month

Aug 2013

On Aug. 22, eight Jumpstart Foundry startup teams will present their companies to investors after 14 intense weeks of developing business models, cultivating customers and gathering feedback from mentors to refine their business models.

Jumpstart, created in 2010 by a group of investors and entrepreneurs, is a business accelerator that has worked with 21 companies in past years and boasts about a 65 percent success rate, based on the companies’ ability to raise capital or generate sustainable revenue, according to co-founder Vic Gatto.

Jumpstart companies receive $15,000 in seed funding that helps entrepreneurs get by during the 14-week period, free legal services, access to investors and to more than 100 mentors who can put them in touch with others in their field.
The teams will pitch to more than 500 people at Northstar Studios, getting the word out about their companies to investors and media.

Meet the companies:
dVisit: dVisit enables patients to be treated for routine care by their family doctor through a mobile and Web application, saving time for both patients and their doctors, and allowing patients to more easily access a doctor they have an established relationship with. connects companies seeking top software development talent with developers looking for freelance work. charges companies to post job descriptions and scout for talent and allows developers to share code they have written for public use and demonstrate their experience.

InvisionHeart: InvisionHeart is a mobile hardware and cloud system that allow hospitals and clinics to capture and review cardiac data.

UtilizeHealth: UtilizeHealth is an online service that matches patients with neurological disabilities to specialized therapies and facilities, allowing them to maximize their potential for recovery. Patients create a profile and an algorithm connects them to potential facilities, allowing them to make appointments.

NewsBreak: NewsBreak is an advertising and promotion service for gas stations and convenience stores that uses video at the pump to encourage consumers to make purchases inside, rather than just fueling up. NewsBreak can target customer needs, such as promoting umbrellas on a rainy day or breakfast items in the morning.

Poliana: Poliana provides data on politicians’ ties to lobbying and special interest groups to bring more transparency to the political process.

Rocket Raise: Rocket Raise is a text-messaging application that allows people to raise money for causes they care about each time they text, while at the same time bringing brand awareness for corporations. Companies commit to donating to a particular cause if a certain metric of texting is reached and will be able to display mobile ads to those participating, tapping into younger generations’ texting habits and interest in social responsibility.

Zingfin: Zingfin helps stock investors identify trends and patterns using social sentiments datamined from Twitter that will help them make smarter investment decisions.

Jamie McGee, Nashville Business Journal