Showing all posts written by Lindsay Laddaran

Lindsay Laddaran
Lindsay Laddaran
Lindsay A. Laddaran is an associate in our Orange County Office.
Lindsay earned her J.D. from Georgetown University Law center, where she served as an executive editor of the Food and Drug law Journal. She received her B.S. degree in Biomedical Engineering at Washington University in St. Louis.
Lindsay worked as a summer associate in 2016 and joined the firm in 2017.

FDA Approves Marketing of Self-Fitting Hearing Aid

The U.S. Food and Drug Administration recently announced approval for Bose to market their Bose Hearing Aid.  According to the press release, the Bose Hearing Aid, which was approved through the FDA’s De Novo premarket review pathway, is the first approved hearing aid that can be self-fit and adjusted by a user.

Malvina Eydelman, M.D., the Director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices at the FDA’s Center for Devices and Radiologic Health commented:

“Today’s marketing authorization provides certain patients with access to a new hearing aid that provides them with direct control over the fit and functionality of the device. The FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their health care.”

According to the press release, clinical studies found the self-fitting Bose Hearing Aid to yield comparable outcomes relative to those found using a professional fitting.   The press release also reported that users generally preferred self-adjusted settings over those selected by a professional.

In a statement made to TechCrunch, Joanne Berhiaume, a spokesperson for Bose, stated:

“Now, the De Novo grant by the FDA validates that Bose technologies can be applied to help people with mild to moderate hearing impairment take control of their hearing. We look forward to bringing affordable, accessible and great sounding solutions to the millions of people who could benefit from hearing aids but don’t use them.”

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 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.”

Virtual Reality in Healthcare

Virtual reality is not just a growing trend in the entertainment industry, but is now reaching the healthcare field. As the technology improves and develops, the uses of virtual reality expand for doctors, students, and patients. It could potentially allow doctors to address some of the most challenging medical programs, help patients understand more about their treatment plan and disease, and educate future physicians.

According to a press release, MediSolutions, a medical device company, hopes to use virtual reality to change how patients are educated in their newest virtual reality platform, MediVRx. The product is said to provide virtual reality educational programming of 3D reconstruction of the human body at a molecular level on topics like Type 2 Diabetes and Atrial Fibrillation.

The press release further notes that virtual reality studies “show that the retention of information delivered via VR is much higher than traditional videos” in a way that patients “won’t just see information – they’ll feel it.” MediVRx is set to be launched in March of 2018.

MediSolutions indicates in the press release that they plan to use virtual reality to give patients a better understanding of their diagnoses and treatments as well as a memorable experience to encourage patient adherence to treatment plans. Neil Keene, the president of MediSolutions explained a company press release:

“Imagine a patient diagnosed with cancer, seeing firsthand how their body functions from the inside out, learning the way in which cancer is infiltrating their internal system and organs, and how a proposed medication can directly influence and correct the prognosis.”

MediSolutions’ system is just one example of the ways virtual reality is being used in the healthcare field.

Virtual reality is also being used to educate medical students. Earlier this year, according to an article in the Guardian, surgeon Shafi Ahmed live-streamed his operation using virtual reality. The article notes that students were allowed to access the camera, observe the surgery, and ask questions which Dr. Ahmed answered while he carried out the surgery.

Students can not only observe from the doctor’s perspective, but can also experience the patient’s perspective. According to an article online, one lab has created a program, “We Are Alfred,” to experience a hypothetical patient’s life – specifically, a 74 year old man named Alfred. Participants use a virtual reality headset, headphones, and hand tracking devices and are fully immersed into Alfred’s story. Participants see and hear as Alfred would, including hearing loss and macular degeneration. This program is said to connect patients and doctors in ways they haven’t before, taking “put yourself in someone else’s shoes” to a new level – a virtual reality level.

Platforms can go further than immersive observations of patient and doctor perspectives to allow students to practice operations in a virtual setting. Programs like ImmersiveTouch are said to be able to replicate surgical touch and feel of specific medical devices.

Beyond education, virtual reality technology is being used to directly treat patients. Some programs are being designed to directly treat conditions.