Sensus Healthcare Receives MDSAP Certification for Full SRT Product Portfolio, Enhancing International Sales Efforts

Sensus Healthcare's entire portfolio of superficial radiation therapy (SRT) systems has received Medical Device Single Audit Program (MDSAP) certification, which should streamline international regulatory efforts and accelerate commercial expansion into key global markets. The certification allows a single regulatory audit to satisfy QMS requirements in multiple countries, including the US, Canada, Brazil, Japan, and Australia. This should enable Sensus to more efficiently support its growing base of distribution partners and deliver its non-invasive SRT solutions more quickly and reliably to physicians and healthcare institutions outside the US.

Sensus Healthcare, Inc. (Nasdaq: SRTS) has received Medical Device Single Audit Program (MDSAP) certification for its entire portfolio of superficial radiation therapy (SRT) systems, including the SRT-100®, SRT-100+™, and SRT-100 Vision™. This certification is expected to streamline the company's international regulatory efforts and accelerate commercial expansion into key global markets [1].

The MDSAP certification allows a single regulatory audit to satisfy the Quality Management System (QMS) requirements of the U.S. Food and Drug Administration (FDA), Health Canada, Brazil’s ANVISA, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and Australia’s Therapeutic Goods Administration (TGA). This certification underscores Sensus Healthcare's commitment to maintaining robust quality standards and ensuring consistent product performance across global markets [1].

With MDSAP certification, Sensus can more efficiently support its growing base of distribution partners through global regulatory alignment, eliminating duplicative audit requirements and expediting the product registration process in participating countries. This will enable Sensus to deliver its non-invasive SRT solutions more quickly and reliably to physicians and healthcare institutions outside the U.S. [1].

Michael Sardano, President and General Counsel of Sensus Healthcare, stated, "Receipt of MDSAP certification marks a meaningful milestone as we look to expand our international commercial footprint. This certification enables us to satisfy QMS requirements and accelerate commercial deployments in several key geographies with large addressable markets. Additionally, upon receipt of FDA clearance, our TransDermal Infusion (TDI) product is also expected to be granted MDSAP certification, enhancing its commercial prospects outside the U.S." [1].

Benson Suen, Sensus Healthcare’s Vice President of International Sales, added, "This certification provides a compelling advantage in markets where regulatory pathways can be a burdensome barrier to entry. We believe MDSAP will significantly enhance our efforts to scale SRT system adoption across international markets while deepening our engagement with distributors and prospective customers who prioritize validated manufacturing and quality systems." [1]

Sensus Healthcare's first-quarter 2025 financial results showed revenues of $8.3 million, a net loss of $2.6 million, or $(0.16) per share, and shipped 21 SRT systems, including 15 to a large customer and one internationally [2]. The company showcased its SRT systems and several pre-commercial products at key dermatology conferences, including the 2025 Winter Clinical Dermatology Conference and the 2025 American Academy of Dermatology (AAD) Annual Meeting.

Joe Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, commented, "During the first quarter, we invested in several important initiatives that we expect will benefit our business for the rest of the year and beyond, including in sales and marketing and in research and development. Three of the year’s most important dermatology medical conferences took place during the quarter, and we were delighted by the extremely strong response to our event at the AAD for customers and prospects that featured Olympic swimmer Katie Ledecky. Due to the event’s success, we placed orders for additional units to be manufactured to meet expected demand." [2]

References:
[1] https://www.stocktitan.net/news/SRTS/receipt-of-mdsap-certification-for-sensus-healthcare-s-full-srt-mkuvhmxlj2dw.html
[2] https://www.businesswire.com/news/home/20250515467478/en/Sensus-Healthcare-Reports-First-Quarter-2025-Financial-Results