FDA grants De Novo Market Clearance of Artificial Intelligence Software
According to a U.S. Food and Drug Administration press release, Viz. AI Contact application was granted De Novo premarket review to Viz.AI’s LVO Stroke Platform. According to PR Newswire, Viz.AI’s LVO Stroke Platform is the “first artificial intelligence triage software” and its approval begins “a new era of intelligent stroke care begins as regulatory approval.” The Viz.AI LVO Stroke Platform, according to the U.S. Food and Drug Administration press release, is a clinical support software designed to analyze Computerized Tomography (CT) scans, identify suspected large vessel blockage, and send a notification to specialist of a potential stroke in patients sooner.
According to the Centers for Disease Control and Prevention, strokes are the fifth leading cause of death in America. A stroke occurs when the blood vessels in the brain are damaged, compromising the necessary blood flow to the brain. There are many types of strokes and can often lead to brain damage, long term disability, and death. A CT scan can show the location and extent of the damage to the brain to diagnose the stroke as well as the type of stroke that has occurred.
Viz.AI is a healthcare company based in San Francisco and Tel Aviv, dedicated to “expand Direct-to Intervention care” which “advances information about treatable patients straight to the interventionalist.” Neurosurgeon and CEO of Viz.Al, Dr. Chris Mansi stated in a press release:
“The Viz.ai LVO Stroke Platform is the first example of applied artificial intelligence software that seeks to augment the diagnostic and treatment pathway of critically unwell stroke patients.”
According to the FDA press release, Viz. AI Contact application was granted De Novo premarket review, which is a “regulatory pathway for new types of medical devices that are low to moderate risk and have no legally marketed predicate device to base a determination of substantial equivalence.” This is a new regulatory classification, “which means that subsequent computer-aided triage software devices with the same medical imaging intended use may go through the FDA’s premarket notification (510 (k)) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.”
The Viz.AI Contact application is one example of what the FDA calls “clinical decision support software (CDS). CDS includes technology that aids in diagnosing and identifying treatment plans. CDS includes “technology has the potential to enable providers and patients to fully leverage digital tools to improve decision making.” The FDA is currently creating a regulatory framework for CDS to provide guidance and encourage developers in this field.
According to Robert Ochs, acting deputy director for radiological health, Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, “(This) software device could benefit patients by notifying a specialist earlier thereby decreasing the time to treatment. Faster treatment may lessen the extent or progression of a stroke.”
Nestlé Continues Medical Industry Expansion
Nestlé Health Science S.A. recently announced that it will acquire Manchester, England-based Phagenesis Ltd. in a staged acquisition.
Nestlé Health Science S.A., a subsidiary of Nestlé S.A., is the owner of more than a dozen nutritional supplement brands. It has previously invested in several businesses that develop solutions for nutrition- and digestion-related disorders and diseases.
Phagenesis is the developer of the Phagenyx®, a device designed for the treatment of dysphagia, the inability to safely swallow. Phagenesis explains that the device aims to restore neurological control of swallowing lost due to stroke by delivering Pharyngeal Electrical Stimulation (PES). According to Phagenesis, electrical stimulation of the pharynx induces a new part of the brain to assume control of such lost swallowing function.
The Phagenyx® product includes a treatment catheter and a base station. The catheter carries two electrodes, which deliver the PES, and is designed to be introduced through the nose. The catheter can optionally accommodate a feeding tube. The catheter is connected to the base station, which controls the amount of stimulation delivered and stores the patient’s treatment information. Phagenyx® is currently undergoing clinical evaluation. While the device received its CE mark in 2012, it has yet to be approved for use in the US by the FDA.
According to its press release, Nestlé Health Science’s acquisition of Phagenesis will start with an upfront payment followed by milestone-based payments contingent upon successful completion of Phagenyx’s® European and US development programs.
The acquisition was announced on the same day former Fresenius Medical Care CEO Ulf Mark Schneider joined Nestlé S.A. In June 2016, Nestlé announced Mr. Schneider’s appointment to the position of CEO, which will become effective on January 1, 2017.
St. Jude Medical Announces First Patient Implant in Clinical Trial of Cardiac Plug
St. Jude Medical, Inc. issued a press release today announcing the first patient implant in a clinical trial of the company’s AMPLATZER™ Cardiac Plug (ACP), a device designed to prevent stroke in patients with non-valvular atrial fibrillation. According to the press release, the ACP is
[a] self-expanding occlusion device constructed from nitinol mesh, and delivered via catheter [and] is designed to completely seal the [left atrial appendage (LAA)] (a tubular-shaped, muscular appendage connected to the left atrium of the heart) at its opening, and minimize blood clots from forming in the LAA and migrating into the bloodstream.
The press release states that the trial will compare the safety and efficacy of the device to the traditional treatment option of using long-term, blood-thinning medication.
Share
