The development of artificial intelligence is in the ascendant, and the establishment of relevant standards for the approval and supervision of artificial intelligence products at home and abroad is in full swing. Since July 2017, the FDA has released the Digital Health Innovation Action Plan (DHIAP) 9 medical artificial intelligence-related products that have been approved successively since the instructions for safe and effective mobile medical treatment.
1. Kardia App: the first medical device accessory on Apple Watch
On November 30, 2017, the Kardia Band under Alive Cor was approved by the FDA as a standard medical heart rate monitoring device and became the first medical accessory for Apple Watch.
The KardiaBand watchband has a built-in artificial intelligence algorithm, which can accurately detect the user's abnormal heart condition and promptly remind the user. KardiaBand is compatible with the 1, 2, and 3 series of Apple Watch. KardiaBand also adds an extra electrode sensor, and uses the Apple Watch's heart rate sensor to monitor the user's heart rate in real time. The user needs to put his finger or thumb on the metal contact on the strap and wait for 30 seconds before KardiaBand passes. The Bluetooth connection sends the data to the Apple Watch, and the electrocardiogram is displayed on the screen.
2. Embrace: AI artifact for epilepsy monitoring and alerting
In February 2018, the Embrace smart watch was officially approved by the FDA for monitoring a class of extremely dangerous epileptic seizures, and thus became the first smart watch approved by the FDA to be used in the field of neurology.
According to data provided by the Centers for Disease Control and Prevention (CDC), approximately 3.4 million Americans are suffering from epilepsy. Embrace can monitor multiple epilepsy indicators at one time to prevent underreporting caused by the patient's self-report. Its patent-protected "Electrodermal Activity" (EDA) technology can quantitatively detect the physiology related to the activity of the sympathetic nervous system Change, record the time of the seizure.
Empatica’s main product is the Embrace smart watch-a stylish wearable device containing medical-grade sensors and machine learning algorithms designed for epilepsy patients. The device uses electronic activity on the skin to track the wearer's seizures, and last week became the first smart watch to pass the FDA medical device certification. A clinical study compared the effectiveness of smart watches with the effectiveness of three neurologists, and the results showed that within 100% of the time, Embrace detected seizures in 135 patients in 272 days.
3. Wave clinical platform: the first doctor to issue an early warning within 6 hours
The approval of the Wave clinical platform brings good news to the current limited supply of medical resources. Relying on artificial intelligence algorithms, the Wave clinical platform forms the basis of the hospital clinical monitoring system. All physiological data will be automatically collected, analyzed, and risk-stratified. Active monitoring and easy-to-read warning signs are enabled, and hospital workstations are integrated with real-time and historical data including patient medication history, age, physiological status, past medical history, family status, etc., to provide doctors and patients with risk-based clinical decision support.
The Wave clinical platform is developed by Excel Medical. Through this algorithm, it can sense subtle changes in the body and send an alert to the doctor 6 hours before a fatal situation occurs. Since accidental deaths caused by preventable hospital injuries are the third most deadly killer in the United States, the emergence of the Wave clinical platform enables real-time monitoring and early prevention to reduce accidental injuries. In the next step, Excel Medical said it will build an AI wearable device to transfer the monitoring and early warning function from inside the hospital to outside the hospital.
4. Viz.ai: enabling stroke patients to receive precise treatment faster
In February 2018, San Francisco-based health care company Viz.ai announced that it had obtained the FDA's marketing authorization for its stroke care applications. The application provides clinical decision support and uses deep learning algorithms to automatically analyze CT neural images to detect stroke-related indicators.
The Viz.AI application is designed to analyze CT images of the brain and send text notifications to neurovascular experts when suspicious blockages of large blood vessels are found, while first-line providers conduct standard reviews of the images. Under normal circumstances, patients need to wait for the radiologist to check the CT images and notify the neurovascular specialist. Notifications can be sent to mobile devices, such as smartphones or tablets, but experts still need to view the images on the clinical workstation.
The FDA's decision to approve the marketing authorization of Viz.AI also opened a breakthrough for the application of predictive equipment and regulatory classification, enabling subsequent computer-assisted medical software to pass the 510(k) certification process.
5. Cognoa: Use AI to screen for autism
In February 2018, the California company Cognoa issued an announcement stating that one of its products for screening autism with the help of AI was recognized by the FDA as a Class II diagnostic medical device.
Cognoa's AI algorithm has been trained and iterated through massive research data: there are research data from Denis Wall, a professor of pediatrics and psychiatry at Stanford, which contains an existing behavioral observation data set of approximately 10,000 children. By analyzing children’s natural behavior information and videos provided by parents, the company’s app uses machine learning to assess whether the child is growing at a normal rate and assess their behavioral health. In addition to being a diagnostic tool, the app also provides parents with personalized recommendations for intervention or treatment at home.
6. Guardian Connect: The accuracy rate of blood glucose AI prediction reaches 98.5%
On March 12, 2018, medical technology company Medtronic announced that Guardian Connect, an independent intelligent CGM system, has been reviewed and approved by the FDA.
The Guardian Connect system is suitable for diabetic patients aged 14-75. It can continuously measure the patient's glucose level and send the information to the smartphone every 5 minutes. Medtronic confirmed in a clinical study that the Guardian Connect system has an accuracy rate of 98.5% in predicting hypoglycemia symptoms.
The system consists of a small sensor that, after the user inserts it into the abdomen, can measure the glucose content of the liquid under the skin, and attach it to a slim Bluetooth® transmitter to send the reading to an app on a smartphone. Users can continuously view glucose readings in the app and set customizable alarms.
7. IDx-DR, the first artificial intelligence medical device
On April 11, 2018, the Food and Drug Administration (FDA), the US health regulatory agency, has approved the world's first artificial intelligence medical device IDx-DR, which can diagnose diseases without the help of a doctor.
IDx-DR will be used to detect diabetic retinopathy, high blood sugar can cause retinal blood vessel damage and vision loss. Its built-in camera is used to take a picture of the patient’s eyes, and then the algorithm is used to evaluate the picture to determine whether the patient has signs of diabetic retinopathy.
In a clinical trial, IDx-DR has an accurate recognition rate of 87.4% for mild diabetic retinopathy and 89.5% for mild diabetic retinopathy.
The FDA announced the approval of IDx-DR on Wednesday, making IDx-DR the first artificial intelligence device approved by the FDA for independent testing without the need for doctors to interpret the results. This means that any doctor can use it, including primary care doctors who often deal with diabetic patients, and patients do not need to seek the help of an ophthalmologist on their own.
8. OsteoDetect, wrist fracture detection software
In May 2018, the U.S. Food and Drug Administration (FDA) recently approved a new artificial intelligence tool called OsteoDetect that can help doctors diagnose hand bone fractures. The tool is a computer-aided detection and diagnosis software application that uses AI algorithms to help doctors determine wrist fractures faster than traditional diagnostic techniques.
The FDA said the software can identify fractures (if they exist) and automatically mark them on the image, helping doctors quickly find and diagnose problems. The software is suitable for adult wrists and can identify distal radius fractures. Emergency rooms, primary care offices, and emergency care facilities can all benefit from this technology. It is important to note that this software will not replace healthcare professionals; instead, it is classified as an accessory tool.
OsteoDetect research and development company demonstrated the usefulness of this AI software to diagnose carpal fractures through a study involving 1,000 X-ray images, and another study involving 24 providers who examined 200 cases. According to the FDA, these two studies show that OsteoDetect improves the detection and diagnosis of carpal fractures.
9.DreaMed Advisor Pro uses AI to achieve precise control of insulin dose
In June 2018, DreamMed Diabetes, a developer of personalized diabetes management solutions, announced that the U.S. Food and Drug Administration (FDA) has approved the De Novo application for its company's product DreamMed Advisor Pro, an AI-based diabetes treatment Decision support software.
DreaMed Diabetes was founded in 2014 and is headquartered in Petah Tikva, Israel. It is a medical company dedicated to the development of intelligent treatment solutions for type I and type II diabetes. DreaMed's mission is to simplify treatment, improve patient experience, and provide patients and healthcare providers with personalized diabetes solutions. We have developed the only diabetes solution technology approved by the regulatory authorities, through continuous glucose monitoring data, intelligent adjustment Insulin treatment process.
DreaMed's diabetes medical team has developed a solution that introduces artificial intelligence into this process based on years of experience: the MD-Logic artificial pancreas algorithm program.