Samsung spinoff Wellysis wins FDA nod for wearable ECG

The S-Patch Ex wearable ECG system. [Image courtesy of Wellysis]Competition in the wearable ECG space continues to heat up, with Samsung spinoff Wellysis as the latest U.S. market entrant.

Seoul, South Korea–based Wellysis announced today that it has secured FDA clearance for its S-Patch Ex. The device already has a CE Mark, with Wellysis marketing the S-Patch Ex in 14 countries. Its markets include the U.K., Spain, Italy, Greece, Poland, Australia, Thailand, India, and Korea.

Wellysis plans a U.S. launch this month by establishing partnerships with service and platform providers.

The company sees uses for the ECG and heart rate recording device in both home and clinical settings. Samsung Electronics’ next-generation bio-processor, embedded in the S-Patch Ex, ensures accurate ECG waveforms, according to Wellysis.

“We are excited to introduce its outstanding features to the U.S. market base with the FDA clearance in the U.S.,” Wellys…

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Researchers in Finland develop biodegradable ECG patch

The biodegradable ECG patch in parts. [Image courtesy of VTT Technical Research Centre of Finland]

Researchers at the VTT Technical Research Centre of Finland developed a new sustainable electrocardiogram (ECG) patch made of biomaterials.

The fully-recyclable, modular patch features easily removable electronic components, capable for later reuse. VTT made the patch from its new material cellulose e-skin, which replaces traditional plastic in wearable skin applications. It printed the nanocellulose material with carbon conductors and sensing electrodes.

“The healthcare industry has one of the heaviest environmental footprints, and manufacturers are increasingly faced with regulations to make more sustainable products. Bio-based substrates like cellulose e-skin are promising alternatives to fossil-based ones,” said Mohammad H. Behfar, senior scientist at VTT. “The tricky part is the fact that t…

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HeartBeam picks Triple Ring to co-develop portable heart attack detector

HeartBeam (Nasdaq: BEAT) said today that it has signed a professional services agreement with Triple Ring Technologies to help develop and design its personal, portable heart attack detector.

Santa Clara, California-based HeartBeam said it plans to submit what it calls a “telehealth complete solution 3D vector electrocardiogram (ECG) collection device” for FDA 510(k) clearance in the fourth quarter of 2022.

The company said patients will be able to use the credit-card-sized device at home to help their doctors determine whether chest pain is due to a myocardial infarction (the medical term for a heart attack) using cloud-based software for real-time data transmission.

The project includes device builds for design verification and validation, device packaging and a manufacturing technology transfer. HeartBeam said it is talking with several contract manufacturers.

“The joint effort will be a five-phase expedited device development proje…

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Philips launches at-home, 12-lead ECG for clinical trials

Philips’ new 12-lead, at-home ECG. [Image courtesy of Philips]Royal Philips (NYSE: PHG, AEX: PHIA) announced today that it is expanding its remote cardiac monitoring portfolio with a patch-based, clinical-grade ECG.

The new at-home electrocardiogram monitors could reduce the need for site visits during clinical trials, according to the Dutch medtech giant. At-home ECG is a hot space: iRhythm Technologies CEO Quentin Blackford recently spoke with Medical Design & Outsourcing about iRhythm’s plans to roll out asymptomatic atrial fibrillation (AFib) screening pilots with payors in 2022.

Get the full story on our sister site Medical Design & Outsourcing. 

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