Rcadia Medical Imaging Ltd. (Haifa, IL)
What is a Software Medical Device for Method and system for automatically analyze blood vessel structures in order to detect calcium or soft plaque pathologies
Chest pain is a typical complaint in a hospital or clinic emergency room (ER). It can be difficult to identify and determine the cause of chest pain. The ER doctor must be able to diagnose and rule out the three most serious causes of chest pain: aneurysm, pulmonary embolism (PE) and myocardial injury (coronary artery stenosis). This type of triage is known in the industry as “triple rule out.” In the past in the past, the ER utilized three different diagnostic techniques to determine all possible causes. Today, 64-slice multi-detector, computed tomography systems provide visualization of all three vascular beds–the heart, the lungs, and the thoraco-abdominalaorta. The process of computed tomography (CT) is a method that combines the utilization of x-rays along with computer-aided analysis of the pictures. Beams of x-rays are passed from a rotating device through an area of interest in a patient’s body from several different angles to createcross-sectional images, which are assembled by computer into a three-dimensional (3-D) picture of the area being studied. 64-slice CT comprises 64 rows of detectors that permit simultaneous scanning of large areas. Therefore, 64-slice CTprovides an entire set of images for evaluating the three main causes of chest pain.
Methods for the analysis of CT images are semi-automatic, and requires a radiologist to carry out an array of procedures in a step-by-step manner. The radiologist examines blood vessels one by one by looking at their lumens and looking for pathologies. It can be tedious, time-consuming and error-prone. What is required is a method and system for automatically identifying and finding blood vessel pathologies. A method and system that can automatically quantify the level of blood vessel obstruction is also needed.
An exemplary embodiment provides an approach and system for the automatic computerized analysis imaging data. The marking of branches of the coronary tree could be done to identify the coronary artery tree. The blood vessel that is being studied can be traversed todetermine a position and/or the size of any pathologies. Another illustration could offer an approach and system for displaying the coronary artery, pulmonary tree trees, or the aorta as well as pathologies that are detected by analysis of image data. The automated computerized analysis of imaging studies can comprise any of the features described in this document. Additionally, the automatic computerized analysis of images could contain any combination of characteristics described in this document.
A system is described that can identify a calcium or soft plaque inside a blood vessel using images. The system comprises however, it is not limited to an imaging device configured togenerate imaging data and a processor which is connected to the imaging device to receive the resulting imaging data. The processor is able to apply a initial level of threshold to slices of three-dimensional imaging data from a blood vessel. This will allow the processor to determine the highest intensity of the blood vessel using defined voxels over the first threshold. To determine the distance between the center of the blood vessel and the maximum intensity, the processor will evaluate the calculated distance against the distance threshold. If the threshold for distance is higher than the calculated distance and the processor can identify a calcium deposit. The processor could also be set up to apply an additional threshold to the slice to identify voxels below the second threshold, and if a calcium deposit is identified it will be able to determine if there is a soft plaque in the defined voxels below the second threshold. In the event that a calcium deposit is not identified, to examine if the voxels that are below the second threshold exhibit an oblong shape, and if the voxels that are below the second threshold display a half-moon shape, to detect the soft plaque.
In an example embodiment the invention relates to a device that can detect an underlying calcium or soft plaque that has formed in a blood vessel using imaging data of the blood vessel is offered. The device includes however, it is not limited to, a memory the memory capable ofstoring imaging data defined in three dimensions, and a processor that can be connected with the memory to receive the image data. The processor can be set to apply a threshold to an image slice that contains three-dimensional information of the blood vessel, to define those voxels which are higher than the first threshold; to identify a maximum intensity of the blood vessel from the voxels that are defined above the threshold first; to determine a distance from the maximum intensity identified to the central point of the blood vessel; to compare thecalculated distance with the distance threshold and, when the distance calculated exceeds the threshold for distance it will identify a calcium deposit. A second threshold can be added to the slice to delineate those voxels that are below the second threshold. If a calcium deposit has been detected the processor calculates a distance from the identified highest intensity to the central point of the blood vessel. To determine if the calculated distance is greater than a distance threshold and, in the event that it is, to detect plaques that are soft.
Another example provides a method for identifying soft and calcium plaque deposits in blood vessels using imaging data. To detect voxels above the threshold of the first, a slice of three-dimensional image data from a blood vessel is used as an initial threshold. A maximum intensity of the blood vessel can be identified by analyzing the Voxels. A distance from the identified maximum intensity to a central point of the blood vessel is calculated and then compared to a distance threshold. If the distance calculated exceeds the distance threshold then a calcium deposit has been discovered. To define voxels below the threshold, a second threshold is added to the slice. If a calcium deposit is identified or if the voxels that are defined below the threshold are of the shape of a half moon, then the presence of a soft plaque is discovered.
In a further exemplary example computer-readable instructions are given that, upon execution by a processor, cause the processor to implement the steps of identifying a calcium and/or a soft plaque deposit within a blood vessel using imaging data of the blood vessel.
Other principal features and advantages of this invention will become apparent to those who are skilled in the art after review of the following sketches, the full description and the attached claims.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA may refer to software functions that include ” Software As a Medical Device” and “Software in a Medical Device(SiMD)” as they are software functions that are integral to (embedded in a) medical device.
Section 201(h),?21 U.S.C. 321(h),(1) defines a medical device to be?an apparatus, device, machine, contrivances, implant an in vitro regulator or other similar or related articles and a component or accessory. . . (b) is designed to diagnose disease or other conditions or treat, mitigate, or avoid them. (c) has the potential to alter the structure or function of the body or animals. To be considered a medical device and thus subject to FDA regulations the software must satisfy the minimum of these conditions:
- It is essential to use it in diagnosing and treating patients.
- It must not be designed to alter the structure or function of the body.
If your program is intended to be utilized by healthcare professionals to diagnose treat, or manage patient information in hospitals, the FDA will likely consider such software as medical devices that are subject to review by the regulatory authorities.
Is Your Software a Medical Device?
In accordance with FDA’s current approach to oversight, which considers the functionality of the software, rather than the device’s platform, FDA will apply its regulation only to medical devices with functions that pose a danger to patient safety. Examples of Device Software and Mobile Medical Apps that FDA is looking at include
- Software functions to help patients suffering from diagnosed psychiatric illnesses (e.g. post-traumatic stress disorder (PTSD) anxiety, depression, obsessive compulsive disorder) retain their strategies for coping by offering the “Skill of the Day” behavioral technique or audio messages that the user can access when experiencing increased anxiety;
- Software functions provide regular educational information, reminders, or motivational guidance for smokers who are trying to quit, recovering from addiction, or pregnancies women;
- Software functions that utilize GPS location information to notify asthmatics to be in high-risk areas (substance users), or to alert them of potential environment-related conditions that could trigger symptoms.
- Software that makes use of games and video to help people to do their take part in exercise at home.
- Software functions which allow users to select which herb or drug they wish to take at the same time. They also provide information on interactions and provide an overview of the type of interaction reported.
- Software functions that are able to take into consideration patient characteristics, such as gender, age, and risk factors, to provide individual counseling, screening and preventive advice from established and respected authorities.
- Software functions that use a checklist of common symptoms and signs to provide a list of possible health conditions and advise on when it is appropriate to speak with a health care provider;
- Software functions that guide the user through a checklist of signs and symptoms to give a recommendation on the kind of health care facility most appropriate to their requirements;
- These mobile applications allow users to make nurse calls, or emergency calls using the internet or cell phone technology.
- Mobile apps that allow the patient or caregiver to create and transmit an alarm or general emergency alert to emergency personnel;
- Software functions keep track of medications and provide user-configured reminders to ensure better medication adherence;
- Software functions that offer patients with access to their personal health records for example, access to the information gathered during a prior visit to a doctor or historical trends, and comparison of vital signs (e.g. body temperature or heart rate, blood pressure, or respiration rate);
- Software functions that reveal trends in personal health events (e.g. rate of hospitalization or alert notification rates)
- Software functions let users electronically or manually input blood pressure data, and to share it via e-mail, track it and trend it, and then upload it into an electronic health record.
- Mobile applications that give reminders about oral health or tools to track users suffering from gum disease.
- Apps that give mobile users access to information and tools for prediabetes patients;
- Mobile apps that display when appropriate images or other messages for those who abuse substances and want to stop addictive behavior;
- Software functions that provide drug-drug interactions and relevant safety information (side effects and drug interactions, active ingredient) in a report based on demographic data (age gender, age) as well as clinical information (current diagnosis) and the current medication; and
- Software functions allow the surgeon to determine the best intraocular lens powers for the patient, as well as the axis of implantation. The data is based on the surgeon’s inputs (e.g. the expected surgically induced astigmatism and the length of the patient’s axial axis, preoperative cornea astigmatism, etc.).
- Software, mostly mobile apps, converts a mobile platform into a medical device that is regulated.
- Software that connects with an mobile platform using a sensor or lead to display and measure electrical signals coming from the heart (electrocardiograph; ECG).
- Software that attaches a camera to the mobile platform or other tools in the platform, in order to monitor, record, and analyze eye movements to detect balance disorders
- Software that inquires about their history as donors and records and/or transmits those answers to an institution for blood collection. This program determines the eligibility of a potential donor to collect blood or any other component.
- Software that is connected to the device’s type in order to control its operation, function or energy source.
- Software that alters or deactivates the functions of an infusion pump
- Software that regulates the inflation and deflation a blood pressure cuff
- Software used to calibrate hearing aids and to evaluate the electroacoustic frequency, the characteristics of sound intensity, and coming from hearing aids, master hearing aids, group hearing aids or group auditory trainers.
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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