Gizmorama - April 18, 2018

Good Morning,

I've been reading up on the unique capabilities and benefits of injectable biosensors. The newest biosensor development could provide continuous, long-term alcohol monitoring. Might be a big step in helping patients in substance abuse treatment programs.

Learn about this and more interesting stories from the scientific community in today's issue.

Until Next Time,
Erin

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*-- Implantable sensor can monitor alcohol use --*
A miniature injectable biosensor -- about 1 cubic millimeter in size -- could provide continuous, long-term alcohol monitoring, according to scientists who developed it.

Engineers at the University of California San Diego are developing an ultra-low-power sensor that is implanted in the body just beneath the surface of the skin through a 16-gauge syringe and is powered by a wireless wearable device, such as a smartwatch or patch.

The work was presented this week at the 2018 IEEE Custom Integrated Circuits Conference on in San Diego. The UCSD engineers also have prepared a paper on the device, though it has not yet been published in a peer-reviewed journal.

"The ultimate goal of this work is to develop a routine, unobtrusive alcohol and drug monitoring device for patients in substance abuse treatment programs," project leader Dr. Drew Hall, an electrical engineering professor at the UC San Diego School of Engineering, said in a press release.

Patients in treatment programs are often monitored by Breathalyzers to estimate blood alcohol levels, but they are clunky devices that require patient initiation and are not that accurate, Hall said. Treatment programs also require blood tests, which need to be performed by train technicians.

Another method for monitoring people are tattoo-based alcohol sensors, but they can be easily removed and are only single-use.

"A tiny injectable sensor -- that can be administered in a clinic without surgery -- could make it easier for patients to follow a prescribed course of monitoring for extended periods of time," Hall said.

The engineers have filed for a provisional patent on the technology and are working to develop it with CARI Therapeutics, a startup based in the Qualcomm Institute Innovation Space at UC San Diego, and Dr. Carla Marienfeld, an addiction psychiatrist at UC San Diego, who specializes in treating substance abuse disorders.

The sensor is coated with alcohol oxidase, which is an enzyme that selectively interacts with alcohol to generate a byproduct to be electrochemically detected. Two additional sensors on the chip measure background signals and pH levels to make the alcohol reading more accurate.

The device uses just 970 nanowatts total, which is roughly one million times less power than a smartphone consumes when making a phone call, the researchers said.

"We don't want the chip to have a significant impact on the battery life of the wearable device," Hall said. "And since we're implanting this, we don't want a lot of heat being locally generated inside the body or a battery that is potentially toxic."

The researchers have tested the device in a mimicked implanted environment using mixtures of ethanol in diluted human serum under layers of pig skin, and are planning to next test it

A test mimicked an implanted environment with mixtures of ethanol in diluted human serum underneath layers of pig skin. They next want to test the chip in live animals.

"This is a proof-of-concept platform technology," Hall said. "We've shown that this chip can work for alcohol, but we envision creating others that can detect different substances of abuse and injecting a customized cocktail of them into a patient to provide long-term, personalized medical monitoring."



*-- FDA approves sale of device that detects diabetic eye disease --*
The Food and Drug Administration on Wednesday approved the first medical device that uses artificial intelligence to detect diabetic eye disease.

The federal agency approved IDx-DR to detect a greater than mild level of diabetic retinopathy -- a vision loss that can affect many of the more than 30 million Americans with diabetes. The condition is the leading cause of vision impairment and blindness among working-age adults, including macular edema.

In diabetic retinopathy, high levels of blood sugar lead to damage in the blood vessels of the retina, the light-sensitive tissue that is in the back of the eye.

"Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy since about 50 percent of them do not see their eye doctor on a yearly basis," Dr. Malvina Eydelman, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health, said in a press release. "Today's decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor's office. The FDA will continue to facilitate the availability of safe and effective digital health devices that may improve patient access to needed health care."

On Feb. 5, Iowa-based IDx LLC submitted the product to the FDA for expedited review, a path for low- to moderate-risk devices.

Laura Shoemaker, director of marketing communications at IDx LLC, told UPI the company was founded in 2010 and has 25 employees, and has worked with retina specialists at the University of Iowa on the device.

The company was founded by Dr. Michael Abramoff, who was working as an ophthalmology resident at a busy clinic in the Netherlands in 1997 when he decided to research ways to automate the process of detecting diabetic retinopathy. He had no training in artificial intelligence.

The device uses an artificial intelligence algorithm to analyze images of the eye taken with a retinal camera called the Topcon NW400. Digital images of the patient's retinas are then uploaded to an IDx-DR server.

The software provides the doctor two possible results -- "more than mild diabetic retinopathy detected: refer to an eye care professional" or "negative for more than mild diabetic retinopathy; rescreen in 12 months."

If a positive result is detected, patients can be referred to an eye care provider for further diagnostic evaluation and possible treatment as soon as possible.

This is the first time the FDA has approved a device that provides a screening decision and does not require a clinician to also interpret the image or results, the agency said.

A clinical study on efficacy of the device included retinal images of 900 patients with diabetes at 10 primary care sites.

In the study, IDx-DR correctly identified the presence of more than mild diabetic retinopathy 87.4 percent of the time, and those who did not have more than mild diabetic retinopathy 89.5 percent of the time.

The FDA said patients with a history of laser treatment, surgery or injections in the eye or certain conditions should not be screened for diabetic retinopathy with IDx-DR.

Among the conditions that disqualify a patient from screening with the device are resistent vision loss, blurred vision, floaters, previously diagnosed macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy or retinal vein occlusion. The device is not recommended for patients with diabetes who are pregnant.

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