FDA


Cloud-based platform enables use of AI on medical images

#artificialintelligence

The Food and Drug Administration has approved Arterys' web-based imaging analytics platform, which marries cloud-based supercomputing and artificial intelligence, for clinical use. The FDA approval allows the Arterys product, called MICA, to supply clinical guidance to clinicians treating cardiac patients. The company is awaiting FDA clearance that would allow the platform to be used by oncology teams treating patients with lung and liver conditions. MICA is web-based and runs on a scalable distributed graphics processing architecture, enabling the product to apply various AI algorithms to image studies of specific cases. This addresses one of the major challenges of applying a variety of algorithms that use artificial intelligence to imaging studies--intelligently calling upon the right algorithm to provide guidance to clinicians while they are investigating a case or making treatment decisions.


fda-issues-new-guidance-for-clinical-and-patient-decision-support-software

#artificialintelligence

This morning, the Food and Drug Administration released highly anticipated guidance on clinical and patient decision support that has been in the works at the agency for several years, advising the digital health community about how it plans to regulate software that offers recommendations or feedback to its users--both healthcare professionals, and patients and caregivers. It also provides guidance on FDA's interpretation of new software provisions in Section 3060 of the 21st Century Cures Act. Given the explosion of these innovative digital health tools and their strong potential to transform healthcare, this guidance is a significant development for tech companies and investors focusing on this space. Comments will be accepted for 60 days. Industry has been innovating and evolving rapidly.


This new FDA-approved Apple Watch band measures the electricity in your heart

Mashable

The Federal Drug Administration just cleared a new band for the Apple Watch that monitors the electrical rhythms in your heart. After a two-year process to satisfy the FDA's stringent requirements, AliveCor announced today that the Kardia Band is now available for purchase for $199. It's a mobile electrocardiogram (EKG), which measures a heart's electrical activity and has traditionally been used by doctors to identify abnormal cardiac rhythms. "It's a regulated measure of physiology by the FDA. Doctors can recognize over 100 conditions when they see an EKG," AliveCor CEO Vic Gundotra told Mashable.


EKG-Reading Kardia Band Is First Apple Watch Accessory To Get FDA Clearance

#artificialintelligence

Kardia Band attaches to the Apple Watch like any other replaceable watch band. The user rests a finger on the sensor pad embedded in the band, allowing an EKG reading to be taken. The Kardia Band transmits its EKG reading to the Apple Watch (via a high-pitch audio signal) where it's displayed in real time as a moving waveform. When the 30-second EKG is finished, the user can view it on their phone or easily send the results as a PDF to their physician. Doctors can diagnose hundreds of diseases using EKG data, but AliveCor is cleared by the FDA only to record the EKG and to advise a user that the reading is normal, or possibly indicative of atrial fibrillation.


FDA-approved robot assistant gives surgeons force feedback

Engadget

Surgeons are trained to accurately operate on you when you need it, but robotic assistants could help them get to hard-to-reach areas and boost their accuracy even more. Senhance, the robotic surgical assistant that has just earned the FDA's approval, was designed to accomplish both of those. According to TransEnterix, the company that developed the machine, it's the first surgical assistant for the abdominal area to get the FDA's approval since 2000. As you can see above, surgeons sit behind a console with a 3D view of the site of operation to control three surgical arms.


Autonomous Robots Coming To U.S. Hospitals

#artificialintelligence

The FDA approved the country's first human-interacting autonomous robot for hospitals on Thursday. The RP-VITA, made by iRobot (best known to consumers as the makers of the Roomba) and InTouch Health, is a human-sized telepresence robot which allows doctors to remotely interact with hospital patients. The robot can navigate hospital corridors autonomously, while medical professionals talk and interact with patients through a special iPad app. The Food and Drug Administration has given the RP-VITA full 510(k) clearance for hospital use.


Healthcare Industry Will Stagnate Without AI – Know Why! - HIE Answers

#artificialintelligence

In healthcare, the opportunity for AI is not just limited to making doctors and medical providers more competent in their work; in fact, it's about saving lives and making the lives of the patients better. It enhances the digital healthcare experiences of patients by offering them conversational and personalized engagement. Moreover, doctor's efforts will be greatly supported, especially when conducting differential diagnosis and evidence-based treatment and precision medicine practice using artificial intelligence with IBM's Watson. Whether it is a voice-based medical intelligence system for remotely monitoring a patient, or diagnosing disease symptoms, or sending alerts for medical appointments and medications and more.


AI diagnostics are coming

#artificialintelligence

Earlier this year, artificial intelligence scientist Sebastian Thrun and colleagues at Stanford University demonstrated that a "deep learning" algorithm was capable of diagnosing potentially cancerous skin lesions as accurately as a board-certified dermatologist. Unlike more-traditional vision software, where a programmer defines rules--for example, a stop sign has eight sides--in deep learning the algorithm finds the rules itself, but often without leaving an audit trail to explain its decisions. The FDA required Arterys to do extensive testing to make sure the results from its algorithm were on par with those generated by physicians. These covered 2,032 different diseases and included 1,942 images of confirmed skin cancers.


First FDA Approval For Clinical Cloud-Based Deep Learning In Healthcare

#artificialintelligence

The first FDA approval for a machine learning application to be used in a clinical setting is a big step forward for AI and machine learning in healthcare and industry as a whole. Arterys's medical imaging platform has been approved to be put into use to help doctors diagnose heart problems. It uses a self-teaching artificial neural network which has learned from 1,000 cases so far, and will continue to improve its knowledge and understanding of how the heart works with each new case it examines. In order to be approved by the US Food and Drug Administration (FDA), it had to pass tests to show it can produce results at least as accurately as humans are currently able to. The key difference though is that Arterys takes an average of 15 seconds to produce a result for one case, which a professional human analyst would expect to spend between 30 minutes to an hour working on.


Flipboard on Flipboard

#artificialintelligence

The first FDA approval for a machine learning application to be used in a clinical setting is a big step forward for AI and machine learning in healthcare and industry as a whole. Arterys's medical imaging platform has been approved to be put into use to help doctors diagnose heart problems. It uses a self-teaching artificial neural network which has learned from 1,000 cases so far, and will continue to improve its knowledge and understanding of how the heart works with each new case it examines. In order to be approved by the US Food and Drug Administration (FDA), it had to pass tests to show it can produce results at least as accurately as humans are currently able to. The key difference though is that Arterys takes an average of 15 seconds to produce a result for one case, which a professional human analyst would expect to spend between 30 minutes to an hour working on.