Hexoskin Receives FDA 510(k) Clearance : A Major Milestone for Remote Cardio-Respiratory Monitoring

Laurent Van Lerberghe
4 hours ago
2 min read

We are proud to highlight a major regulatory and strategic milestone achieved by Hexoskin, one of ballas invest’s portfolio companies.The Hexoskin Medical System (HMS) has officially received FDA 510(k) clearance for long-term ECG and respiratory monitoring a key step toward large-scale deployment of continuous remote care solutions in the United States.

This clearance marks an important validation of Hexoskin’s technology and reinforces its position as a leading player in clinically-grade wearable health monitoring.

A regulatory breakthrough with strong clinical significance

The FDA 510(k) clearance confirms that the Hexoskin Medical System is substantially equivalent to existing, legally marketed medical devices, authorizing its use in clinical and care settings across the U.S.

Unlike many consumer wearables, HMS is now officially recognized as a medical-grade solution, capable of delivering reliable, clinically actionable data over extended periods of time.

This approval is particularly significant in a healthcare environment increasingly shaped by:

Remote patient monitoring
Home-based care
Telemedicine
Decentralized clinical trials

From episodic to continuous monitoring : Hexoskin receives FDA 510(k) clearance

Traditional cardio-respiratory monitoring tools such as Holter monitors, are typically limited in duration, uncomfortable for patients, and poorly suited for capturing intermittent or rare events.

Hexoskin fundamentally changes this model.

The Hexoskin smart garment enables:

Long-term, continuous ECG (3-lead) monitoring
Respiratory monitoring
Activity and physiological context tracking
Comfortable, non-intrusive daily use in real-life conditions

This allows clinicians and researchers to capture high-quality longitudinal data outside hospital walls, providing a far more comprehensive understanding of patient health over time.

A scalable solution for modern Healthcare Systems

Beyond clinical practice, the FDA clearance opens the door to broader adoption across multiple use cases:

Remote monitoring of chronic patients, particularly in cardiology and pulmonology
Telehealth and home-care programs, reducing hospital burden while improving patient comfort
Clinical research and decentralized trials, where continuous, real-world physiological data is becoming a critical asset
Digital biomarkers development, enabling earlier detection, stratification, and personalized care

Hexoskin’s platform combines hardware, software, and secure data infrastructure a combination increasingly essential in data-driven healthcare models.

Why ballasinvest supports Hexoskin

We invest in health technologies that sit at the intersection of clinical value, data intelligence, and real-world impact.

Hexoskin exemplifies this vision:

A clinically validated, regulated product
A strong scientific and technological foundation
A clear answer to structural healthcare challenges: aging populations, care accessibility, system efficiency

Hexoskin receives FDA 510(k) clearance is not only a regulatory achievement it is a signal of maturity, scalability, and long-term relevance in global healthcare markets.

Looking ahead : toward global remote care adoption

With FDA clearance secured, Hexoskin is now positioned to accelerate its expansion in the U.S. while strengthening its role internationally.

We believe this milestone represents more than the success of a single company. It reflects a broader shift toward:

Continuous care instead of episodic care
Data-driven clinical decisions
More human-centered, patient-friendly monitoring solutions

At ballasinvest, we remain committed to supporting companies like Hexoskin that are shaping the future of healthcare through innovation, regulation-ready technology, and measurable clinical impact.