First HoloLens application gets FDA approval for pre-operative planning | MSPoweruser

Image: Novarad

The OpenSight Augmented Reality System is the first AR medical solution for Microsoft HoloLens cleared by the FDA receiving 510(k) clearance for use in pre-operative surgical planning.

OpenSight is intended to enable users to display, manipulate, and evaluate 2D, 3D, and 4D digital images acquired from CR, DX, CT, MR, and PT sources. It is intended to visualize 3D imaging holograms of the patient, on the patient, for pre-operative localization and pre-operative planning of surgical options. OpenSight is designed for use only with performance-tested hardware specified in the user documentation.

OpenSight is intended to enable users to segment previously acquired 3D datasets, overlay, and register these 3D segmented datasets with the same anatomy of the patient in order to support pre-operative analysis.

OpenSight is intended for use by trained healthcare professionals, including surgeons, radiologists, chiropractors, physicians, cardiologists, technologists, and medical educators. The device assists doctors to better understand the anatomy and pathology of the patient.

The OpenSight Augmented Reality system uses the Microsoft HoloLens hardware and the Microsoft 10 Operating System as the platform on which this system runs. The OpenSight technology is written specifically for this hardware.

(“Novarad OpenSight 510(k) Submission | 2018,” 2018, p. 5)

via First HoloLens application gets FDA approval for pre-operative planning

FDA clears HoloLens for medical use in “pre-operative surgical planning” | On MSFT

OnMSFT credited story photo

I tried to wrap my head around 4D imaging; all it did was make my mind hurt at this hour.

The FDA cleared the Microsoft HoloLens for 510(k) clearance to the OpenSight Augmented Reality System. OpenSight is the first AR (augmented reality) application for use in “pre-operative surgical planning.” As outlined in a press release by Novarad, OpenSight uses 2D, 3D, and 4D images overlayed onto patients’ bodies to provide a visual guide on what doctors may encounter internally during surgery.

via FDA clears HoloLens for medical use in “pre-operative surgical planning” | On MSFT

FDA Announces New Steps to Empower Consumers and Advance Digital Healthcare

I wondered out-loud in a draft version of this blog post the following:

I cannot tell if this is the career politician FDA speaking or what, and frankly, this shouldn’t be an issue with any administration, but it sure is with this one.

Upon further review, this is the type of announcement was expected and favored; and consistent with the history of the FDA Commissioner, a political appointee of POTUS45. I fully understand the temptation to speed the process up of software when it comes to medical capabilities. This process has been thought carefully, but two things stand out for me.

1. HIPAA is the law of the land when it comes to digital medical records. This is a complicated system; that is where we are. How does this idea of a pre certification tie into these requirements? Blog posts on this subject here, here, here, and here.
2. All of this is moot if the majority of citizens can’t access it due to not being covered under Medicare and Medicaid; the very constituency that can be best served by digital medical options in software including telehealth initiatives.

As for point #2, the rules for current Medicare reimbursement are found here (PDF) and are in my opinion, lacking. A change of mindset when it comes to payment overshadows any other aspect of our current system. In my ideal health care system, there would be Medicare for all with the private insurance market to fill gaps similar to Medicare Supplement policies of today and to “jump the line” in services for a fee. Digital medical options, such as Telehealth and Software based Medical Case Management would be included in the base Medicare and Medicaid plans.

FDA Announces New Steps to Empower Consumers and Advance Digital Healthcare [Official]