FDA clears Physiotrace Smart wearable and reusable device for exercise ECG monitoring

NimbleHeart’s Physiotrace^tm Smart got FDA’s class II 510(k) clearance to market. The Physiotrace^tm Smart has a wearable and reusable design that can be wrapped and fastened around the torso. The device uses dry ECG electrodes and embeds an ECG acquisition unit with a Bluetooth Low Energy transmitter. A mobile application controls the data acquisition, displays the status of the device, heart rate and optionally the ECG waveform during a recording session. The mobile App also stores the ECG and the exercise session information and relays it to a cloud server for permanent storage and review by healthcare staff. The Physiotrace^tm Smart is designed to be used without electrolytic gels and without adhesives that necessitate skin preparation.

TiEcon 2016 announces NimbleHeart Inc. as a 2016 TiE50 Winner

NimbleHeart Inc. is excited to announce that it has been selected as a “2016 TiE50 Winner” for the prestigious TiE50 Technology Awards Program. Winners were announced on Friday, May 6th at the organization’s annual entrepreneurial conference, TiEcon. TiEcon is the world’s largest conference for entrepreneurs and intrapreneurs with loyal participation from top technology companies, leading venture capital firms, and global service providers. Each year, about 5000 attendees from across the world converge upon the Silicon Valley to attend TiEcon.

Here is the video link for company CEO Sonal Tambe’s interview at Tiecon: Click to view the video

Steven Keteyian of Henry Ford Hospital joins advisory board

Steven Keteyian, PhD. PhD, FAACVPR the director of Preventive Cardiology at Henry Ford Hospital in Michigan and the board member of American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) has accepted a role on NimbleHeart’s board of advisors.

Delivered second version of Male and Female ECG harnesses to NASA

NimbleHeart delivered second version of Male and Female ECG harnesses to NASA. The following patch was created by NASA AMES research center team to honor our partnership.

Successful completion of pilot clinical study at Henry Ford Hospital

NimbleHeart’s pre-FDA harness was tested on 20 patients at 3 different sites of Henry Ford Hospital Cardiac Rehab program for wearability and patient acceptance.

The study was completed successfully and NimbleHeart received great patient feedback through the same.

“The biggest personal advantage I see is the lack of stickers to deal with. The NimbleHeart harness was faster and quicker to put on and take off. It treated this hairy guy with kid gloves !”

“I liked it so much better. It was not in the way and I didn’t have to contend with the glue from the electrodes that irritate my skin.”

“Can’t wait to replace the old system. (Its more practical and simple and comfortable than old unit by far.)”

Matthew Saval, MS, ACSM-RCEP of Henry Ford Hospital Demonstrates Nimbleheart’s Technology

Matthew Saval, MS, ACSM-RCEP performed a brief live demonstration of NimbleHeart’s innovative, clinical grade one lead dry electrode ECG harness during his presentation on “Integrating Technology into Cardiac Rehabilitation”, during the 62^nd annual meeting of American College of Sports Medicine in San Diego, California.

NimbleHeart’s Technology & Innovative Solution Presented by Dr. Pramod Deshmukh

NimbleHeart Cofounder and Chief Medical Officer, Dr. Pramod Deshmukh presented NimbleHeart’s technology and innovative solution during 2015 Stanford Biodesign New Arrhythmia Technologies Retreat.

Successful Completion of 12 lead ECG harnesses to NASA for Monitoring of Crew Members for Health, Performance & Safety

Successfully completed the design of and delivered 12 lead dry electrode based ECG harnesses to NASA. They were tested on male and female subjects to produce clinical grade ECG during supine position, steady state vertical position and during physical exercises such as treadmill walk and biking. These harnesses will be used in the space flight for monitoring of crew members for health, performance and safety.

NimbleHearts 3 Lead ECG Harness Captures ST Depression during Treadmill Test

Clinical study was performed in India on 50+ treadmill test patients who also had NimbleHeart harness on at the same time. Baseline, noise, ST segment and overall ECG quality for NimbleHeart’s 3 channel harness signals were found comparable with12 lead ECG treadmill traces.

NASA Awards Contract to NimbleHeart for Cardiac Monitoring of Crew Members

NASA acquired 3 custom harness prototypes and 40 custom dry sensors to evaluate for monitoring of astronauts in space flights. 
The requirements include the same electrical and mechanical performance under exacting environmental conditions and during physical exercises by astronauts.

After evaluating all the available technologies worldwide, NASA granted NimbleHeart the prestigious contract to perform R&D and manufacturing of custom designed 12 lead harnesses for ambulatory and resting monitoring of the crew members for the next space flight program.

NimbleHeart Selected as a TieCon Finalist

NimbleHeart was recognized as one of the most enterprising technology startups in medical device space by The Indus Valley Entrepreneurs association (Tie.org) Interview.

NimbleHeart Proves Dry Electrode Harness Technology

Clinical study was performed in India with 25 patients with a goal to validate the dry electrode harness based ambulatory ECG technology. 
12 lead ECG treadmill test was compared against NimbleHeart’s single channel modified CB5 lead proof of concept hardware. NimbleHeart device showed comparable ECG results with ST segment changes in the patients.