Standardized approach to assess cybersecurity and progress in exoskeleton reimbursement

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Regulatory News

FDA-tasked Mitre Forges Ahead with Cyber Vulnerability Scoring System Tailored to Devices

A new medical device development tool (MDDT) intends to ensure consistency in scoring cybersecurity risks. MDDT qualification will enable a standardized approach for manufacturers to assess potential cybersecurity risk in the product development phase consistent with the idea of security by design.
(RAPS 1/31/19)

Combo Product Reviews: FDA Drafts Guidance

New draft guidance explains what combination products are, how their various FDA center assignments are determined, and considerations for making approval pathway determinations.
(RAPS 2/5/19)

CDRH Drafts Method to Provide Feedback on FDA Form 483 Citations

Guidance provides a way for medical device establishments to hear nonbinding feedback, upon request, regarding proposed corrective and preventive actions on 483 observations, following an FDA manufacturing site inspection. Required nonbinding feedback is only given when the request from either the owner, operator or agent in charge of a facility describes how one or more inspectional citations “involve a public health priority,” “implicate systemic or major actions” or “relate to emerging safety issues (as determined by [FDA]).”
(RAPS 2/15/19)

IEEE publishes safety standards draft for medtech interoperability

IEEE Approved Draft Standard for Service-Oriented Medical Device Exchange Architecture & Protocol Binding defines an architecture for service-oriented, distributed point of care medical devices and medical IT systems.
(MassDevice 2/15/19)

UK Marking to replace CE Marking for medical devices

The British government has published a design for UK marking (UKCA), replacing CE Marking in the UK after Brexit. For the near future CE Marking will still be recognized in the UK. Devices certified by UK-based Notified Bodies will require UKCA marking.
(Emergo 2/5/2019)

FDA to spur new advancements in novel brain implants that can help patients with paralysis or amputation gain mobility

Draft guidance on implanted BCI devices provides proposed recommendations for developers on what non-clinical testing and clinical study design could be used to develop BCI devices for patients with paralysis or amputation. Proper design of clinical trials is essential to provide reasonable assurance of safety and effectiveness to support a regulatory submission to the FDA.
(FDA 2/22/19)

Payment News

Cigna to Review Submissions for Use of Exoskeleton Devices

ReWalk Robotics announced that health insurer Cigna will now review submissions for the use of exoskeleton devices for individuals with spinal cord injuries after a chance to its coverage policies that will take effect in or around Q3 of 2019.
(MassDevice 2/13/2019)

CMS Launches Podcast to Reach Stakeholders via Modern Platform

The new CMS podcast was created as a method to explain the agency’s policies and programs. The inaugural episode focuses on Evaluation and Management Coding.
(CMS 2/19/2019)


NCC-PDI Announces $250K Pediatric Pitch Competition for Orthopedic Medical Device Innovators

The competition is focused on pediatric devices developed for use in the orthopedic and spine sector, an area of critical need which lacks innovation. Winning companies receive awards up to $50,000 and are invited to participate in the newly created NCC-PDI “Pediatric Device Innovator Accelerator Program” led by MedTech Innovator.
(Biospace 2/26/2019)

The Simbex Regulatory and Reimbursement Recap is a monthly briefing for news in the regulatory and healthcare reimbursement space relevant to Simbex areas of expertise. The briefing is curated by Amaris Ajamil, PhD, Simbex Research Engineer and Cassie Brugger, MA, Simbex Centers Senior Program Administrator.  A story’s inclusion does not imply endorsement by Simbex, LLC.

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