Vassol Inc. (River Forest, IL)

A method and system are described for presenting anatomical information and blood flow data included in a magnetic imaging (MRI) dataset. The system creates three-dimensional (3D), representation of blood flow that changes in time. It is also known as an asymmetrical (4D) presentation or display. The system permits the visualization of the dynamics of blood flow, as well as the visualization of anatomical data by fusion of various types of MRI data sets.

A variety of methods for measuring blood flow in the human body are used today, including ultrasound and phase contrast magnetic resonance (PCMR), and the results from these tests are often presented in a variety of ways. However, current medical software to display blood flow information typically presents the data in an abstract format. The physician would be able to see the flow of blood within an anatomical context in a more clinically-useful way. The display can be used to help visualize and plan the best course of action for stroke patients.

This invention relates to a method for presenting anatomical and blood flow information within a magnetic resonance imaging dataset (MRI). A three-dimensional (3D) representation of blood flow is presented and its evolution in time, described in this disclosure as a four-dimensional (4D) presentation or display. Such a system may allow not only the visualization of the dynamics of both arterial and venous flow at the same time, but also the visualization of anatomicalinformation via the fusion of different types of MRI data sets.

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What is a software medical device?

The FDA refers to functions in software that can include ” Software as a Medical Device” (SaMD), and “Software in Medical Device (SiMD) ), which is software that is part of (embedded within) a medical device.

Section 201(h) of the?Federal Food, Drug, and Cosmetic Act 21 U.S.C. 321(h)(1), defines an medical device as an apparatus, instrument, instrument, machine, contrivance, implant, in vitro reagent, or other similar or related device, including an accessory or component that is . . . (b) intended for use in the diagnosis of disease or other conditions, or in the cure or treatment or prevention of disease for animals or humans, or (c) intended to affect the structure or function of the human body or other animals.? Therefore, in order to be considered a medical device and subject to FDA regulation, your software must meet two requirements:

  • It should be designed for use to diagnose or treat patients; or
  • It must not be designed to alter the structure or the function of the body.

If your software is designed to be utilized by healthcare professionals to diagnose, treat or manage patient data in hospitals and other medical facilities, the FDA will likely consider such software as medical devices and subject to review under the regulations.

Is Your Software a Medical Device?

According to FDA’s current oversight strategy that looks at the capabilities of the software higher than its platform, FDA will apply its regulatory oversight only to devices for medical use that possess functions that pose a danger to patient safety. Some examples of Device Software and Mobile Medical Apps FDA is focused on

  • Software functions to help those suffering from psychiatric disorders diagnosed (e.g., post-traumatic stress disorder (PTSD) or anxiety, depression, obsessive compulsive disorder) keep their behavioral strategies for coping by providing the “Skill of the Day” behavior technique or audio messages that users can access when experiencing increased anxiety;
  • Software functions that provide regular reminders, motivational guidance and information on education to those recovering from addiction, or who are looking to quit;
  • Software functions that utilize GPS location data to warn asthmatics that they are in areas of high risk (substance users) or warn them of possible environmental conditions that could cause symptoms.
  • Software functions that use video and games in order to motivate patients to do their physical therapy exercises at home;
  • Software functions that ask a user to enter which drug and herb they’d like to use simultaneously and give information on the likelihood of interactions being reported in the literature and a summary of what type of interaction was described;
  • Software functions that consider the characteristics of patients, like gender age, gender, and other risk factors, to provide patient-specific counseling, screening, and prevention recommendations from established and respected experts.
  • Software functions that utilize an inventory of typical symptoms and signs to give guidance on when it is appropriate to visit an ophthalmologist and what next.
  • Software functions that help users to navigate through a questionnaire about symptoms and to give a recommendation for the most appropriate medical facility to treat them.
  • Mobile apps that are intended to enable users to make a pre-determined nurse phone or emergency call using broadband or cellular phone technology.
  • Mobile applications that permit a patient or caregiver to design and send an alarm or general emergency message to emergency responders.
  • Software that monitors medications and provides user-configured reminders to increase the adherence to medication.
  • Software functions that offer patients a portal into their personal health records for example, access to data gathered at a previous visit to the doctor or historical trending and comparison of vital sign (e.g. body temperature, heart rate, blood pressure, or respiration rate);
  • Software functions that show trends in personal healthcare incidents (e.g. hospitalization rates or alert notification rate)
  • Software features permit users to electronically or manually input blood pressure data, to share it with e-mail, track it and trend it, and then upload it into an electronic or personal health record.
  • Mobile apps that allow to track and remind users about oral health or tools for tracking patients suffering from gum disease.
  • Mobile apps give patients suffering from prediabetes advice or tools to help them improve their eating habits, or to increase physical exercise;
  • Mobile apps that show when appropriate pictures or other messages for a substance abuser who wants to stop addictive behavior;
  • Software functions that report drug-drug interactions and relevant safety information (side effects and interactions with drugs active ingredient) as a report , based on demographic information (age and gender) and medical information (current diagnosis), and current medications; and
  • Software functions provide the surgeon with the list of suggested intraocular lens powers and recommended the axis of implantation, based on the inputs of the surgeon (e.g. an anticipated surgically induced astigmatism, the length of the patient’s axial axis and corneal astigmatism prior to surgery, etc.)
  • Software, usually mobile apps, converts a mobile platform into a medical device that can be regulated.
  • Software that is connected to the mobile platform through a sensor or lead to display and measure electrical signals generated by the heart (electrocardiograph; ECG).
  • Software that attaches sensors or other tools to mobile platforms in order to observe, record and analyze eye movement to detect balance problems
  • Software that inquires about their donor history and their records and then sends those answers to the blood collection facility. This software is used to determine whether a donor is eligible for blood collection or other components.
  • Software that is connected to an existing device to control its operation, function, or energy source.
  • Software that modifies or blocks the functions of an infusion pumps
  • Software that controls the inflation or deflation of a blood pressure Cuff
  • Software that is used to calibrate hearing devices and assess the electroacoustic frequencies, the characteristics of sound intensity, and emanating from hearing aids master hearing aids hearing aids for groups or auditory trainers for groups.

What does it mean if your software/SaaS is classified as a medical device?

SaaS founders need to be aware of the compliance risks that medical devices pose. Data breaches are one of the biggest risks. Medical devices often contain sensitive patient data, which is why they are subject to strict regulations. This data could lead to devastating consequences if it were to become unprotected. SaaS companies who develop medical devices need to take extra precautions to ensure their products are safe.

So who needs to apply for FDA clearance? The FDA defines a ?mobile medical app manufacturer? is any person or entity who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components. This term does not include persons who exclusively distribute mobile medical apps without engaging in manufacturing functions; examples of such distributors may include the app stores.

Software As Medical Device Patenting Considerations

The good news is that investors like medical device companies which have double exclusivity obtained through FDA and US Patent and Trademark Office (USPTO) approvals. As such, the exit point for many medical device companies is an acquisition by cash rich medical public companies. This approach enables medical devices to skip the large and risky go-to-market (GTM) spend and work required to put products in the hands of consumers.

Now that we have discussed the FDA review process, we will discuss IP issues for software medical device companies. Typically, IP includes Patents, Trademarks, Copyrights, and Trade secrets. All of these topics matter and should be considered carefully. However, we will concentrate on patents to demonstrate how careless drafting and lack of planning can lead to problems, namely unplanned disclosures of your design that can then be used as prior art against your patent application.

In general, you should file patent application(s) as soon as practicable to get the earliest priority dates. This will help you when you talk to investors, FDA consultants, prototyping firms, and government agencies, among others. Compliance or other documents filed with any government agency may be considered disclosure to third parties and could make the document public. In general, disclosures to third parties or public availability of an invention trigger a one year statutory bar during which you must file your patent application. Failure to file your application within the required time frame could result in you losing your right to protect your invention.

The information from your FDA application may find its way into FDA databases, including DeNovo, PMA and 510k databases and FDA summaries of orders, decisions, and other documents on products and devices currently being evaluated by the FDA. Your detailed information may be gleaned from Freedom of Information Act requests on your application. This risk mandates that you patent your invention quickly.

When you patent your medical device invention, have a global picture of FDA regulatory framework when you draft your patent application. Be mindful of whether your software/SaaS application discusses the diagnosing and treating patients or affecting the structure or function of the body and add language to indicate that such description in the patent application relates to only one embodiment and not to other embodiments. That way you have flexibility in subsequent discussions with the FDA if you want to avoid classification of your software/SaaS/software as a medical device. In this way, if you wish to avoid FDA registration and oversight, you have the flexibility to do so.

An experienced attorney can assist you in navigating the regulatory landscape and ensure that you comply with all applicable laws. This area of law is complex and constantly changing. It is important that you seek legal advice if you have any questions about whether or not your software should be registered with FDA.

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