FDA publishes Unmet Medical Device Needs for Rare Diseases

From late 2015 to 2016, FDA and NCATS/ORDR at NIH conducted a needs assessment to better understand unmet medical device needs for rare diseases; generate meaningful data to inform patients, practitioners, policymakers, and device developers on the needs, barriers, and incentives related to medical device development for rare diseases; and increase public awareness of these needs. The assessment included a subfocus on pediatric rare disease patients. This report describes the results of that assessment, which offers key findings about device needs in adult and pediatric rare disease populations.

May this motivate us all to explore, push limits, innovate, and invent.  Onward software warriors!

Where New Software is Needed

The report encourages the development of intelligent software for:

  1. Control of rehabilitation devices, and prediction of physiological signals and human behavior with use of devices.
  2. Interpretation of MRI or PET images for diagnosing aortitis.
  3. Aiding in the lab automation and workflow management for diagnosing multiple myeloma.
  4. Detecting primary ciliary dyskinesia via exhaled nitrous oxide.

Read the report here:  Unmet Medical Device Needs_Full Report plus Appendices

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.