• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Sensus Healthcare wins FDA nod for next-gen SRT-100+ radiation therapy system

Sensus Healthcare wins FDA nod for next-gen SRT-100+ radiation therapy system

August 2, 2018 By Fink Densford

Sensus Healthcare

Superficial radiation therapy device developer Sensus Healthcare (NSDQ:SRTSU) said today it won FDA 510(k) clearance for its SRT-100+ next-gen superficial radiation therapy system.

The newly cleared device includes all the features of the Boca Raton, Fla.-based company’s SRT-100 as well as an expanded energy range, remote diagnostics and operation tracking, a new X-ray tube for extended functionality and an advacned console and system mobility.

“We have integrated both clinical and patient feedback to bring to life exciting new elements with the SRT-100+—from live lesion and patient cameras for monitoring during treatment to best-in-class system enhancements for better patient setup and comfort. The sophisticated operation of the SRT-100+ also offers significant benefits to doctors specifically, as it will be integrated with practices’ information technology and management / electronic medical records, as well as provide vital data backup and logging. This represents the technology of the future when it comes to treating NMSC and keloids safely and effectively,” CTO Kal Fishman said in a prepared statement.

“The SRT-100+ is truly the next step forward for Sensus’ transformative products that have treated more than 400,000 skin cancer and keloids patients all around the world. This new offering is the culmination of all of our clinical experience and best practices that we have learned from our broad global user base of physicians and patients. Most importantly, this 510(k) market clearance uniquely positions Sensus to fuel continued innovation in the clinical dermatology space,” CEO Joe Sardano said in a press release.

In April, Sensus Healthcare released plans for a global expansion, including new distribution agreements in China, Germany, Mexico, Cuba and Costa Rica.

Filed Under: Oncology, Regulatory/Compliance Tagged With: Sensus Healthcare LLC

More recent news

  • Medtronic escapes $106.5M payment in Colibri TAVR patent suit after court overturns jury verdict
  • RadNet closes iCAD acquisition, expands AI breast‑imaging portfolio
  • Hyperfine reports first commercial sales of next-gen AI-powered Swoop
  • Stereotaxis announces $12.5M offering
  • Nuwellis ends clinical trial of its ultrafiltration tech for heart failure

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy