Harsha Rajasimha, Ph.D.
Harsha Rajasimha, Ph.D.

AI and the Lack of Diversity in Data: Implications and the Path Forward for Rare Disease Research

By MedTech Intelligence Staff
No Comments

Genomics data scientist Harsha Rajasimha, Ph.D., Founder and Executive Chairman of IndoUSrare, highlights the risks of developing AI/ML algorithms based on biased data, as well as efforts underway to improve global collaboration on the collection and sharing of health data that may help us realize the potential of AI in diagnoses and treatment of rare diseases.

Continue reading

Cybersecurity
Cybersecurity

Preparing for the PATCH Act and RTA

By MedTech Intelligence Staff
No Comments

The FDA announced that on October 1, 2023, it would begin to Refuse to Accept (RTA) medical device premarket submissions that do not comply with PATCH Act requirements. Erez Kaminski, former head of AI with Amgen and founder of  Ketryx, and Paul Jones, former FDA official and Executive Vice President of Ketryx, provide an overview of challenges companies face as they work to comply with the new cybersecurity regulations and standards.

Continue reading

Renée Bailey
Renée Bailey

Instructional Materials: The Basis for Safety Between Users and Medical Devices

By Renée Bailey
No Comments

Instructional materials help users grasp how to use a device safely. Renée Bailey, Certified Instructional Technologist (CIT), explains how effective instructional materials are vital for the medtech design process, and shares necessary considerations to produce instructions that are coherent, easy to understand and aligned with the human factors engineering process.

Continue reading

FDA Logo
FDA Logo

FDA Issues Three New Draft Guidances on the 510(k) Program

By MedTech Intelligence Staff
No Comments

The FDA has issued three new draft guidances related to the 510(k) submissions program, including Best Practices for Selecting a Predicate Device, Use of Clinical Data in Premarket Notification and Evidentiary Expectations for Implant Devices. The agency is accepting comments and will host a webinar for stakeholders on October 26, 2023, to provide more information on the guidances.

Continue reading

Patient on ventilator
Patient on ventilator
MEDdesign

MD PnP Presents Remote Control Care Testing and Verification Method

By MedTech Intelligence Staff
No Comments

For “Systematic Testing of a Ventilator Remote Control System Towards Safe Use in Tele-Critical Care and Prolonged Care,” researchers developed a prototype system for network-based far remote-control of the NKV-550 critical care ventilator, with the goals of identifying and implementing foundational remote-control capabilities, and exploring essential performance, interoperability, and cybersecurity requirements.

Continue reading