Despite being treatable with early screening, colorectal cancer remains the second biggest killer among all types of cancer. Check-Cap are trying to help alter that fact, and earlier this year GE healthcare partnered with them to assist with validating and developing high-volume manufacturing for their x-ray source production and ingestible capsule for colorectal cancer screening.
The system works in the following way:
1. The patient takes a capsule with some contrasting agent (this is a substance which is used to help improve the clarity of images of bodily fluid or structures).
2. The patent continues to drink small amounts of contrasting agent with their meals during the 3-4 day screening process (while the capsule is passing through the body).
3. The capsule moves through the intestines taking x-ray images of the intestinal wall as it progresses. These 3D images are then sent to a data receiver worn on the lower back where the data is stored.
4. When the capsule has been excreted the data receiver will alert the patient. The patient then gives the data to a doctor who looks for any abnormalities.
As this device uses x-rays rather than optics, its image is not obstructed by intestinal content – hence there is no need for the patient to fast before or during scanning. The process also removes other invasive and off-putting aspects of having a colon scan such as the insertion of a camera into the colon, and stool sampling.
Wearable devices are becoming increasingly intimate and unobtrusive. Here are two tattoo-style devices currently being tested.
Duoskin is at prototyping level. Duoskin is a joint project of MIT Media Lab and Microsoft Research. Based on the idea of temporary tattoos Duoskin is a temporary transfer of gold leaf based capacitive circuits placed directly onto the skin. Different patterns perform different functions. Golden chevrons enable a swipe function when the tattoo is connected via NFC to a device. A grid of interlaced silver and gold bands can act as a 2D control pad. There are also button designs and discrete slider designs, and a tattoo which changes colour based on heat. This could have potential medical applications; for instance alerting the tattooed patient when they are experiencing abnormal body temperature.
Engineers at University of Illinois at Urbana-Champaign and Northwestern University have devised a wearable electronic health device which is thin, soft and sticks to skin, much like a band-aid or transfer tattoo. Owing to some cleverly engineered wires –twisted and folded like origami – and raised electronics, it is able to flex with the body. This device is wirelessly powered and can send real-time body monitoring data to a computer or smartphone. The team see potential to use the technology to create an EKG/EEG monitoring machine which could be worn 24/7 without any need to alter the user’s lifestyle to get data – even allowing for more natural sleep data and use on fragile skin e.g. baby skin. In side-by-side comparisons with traditional EEG and EKG monitors they found that the wearable device performed as well as traditional monitoring devices.
In August 2016, the International Medical Device Regulators Forum (IMDRF), released a draft document entitled ‘Software as a Medical Device (SaMD)’, which was intended for the US Food and Drug Administration (FDA). It is believed that the FDA will approve the content of the draft guidance document.
SaMDs are defined as software programs which are intended to be used for one or more medical purposes, and that perform their purposes without being part of a hardware medical device - for example, an app which connects with a glucose monitor.
The document suggests that the SaMD should be tested against different validity criteria:
• Scientific validity – establishes how well the output of SaMD correlates to the intended clinical use, by comparison with existing verified methods.
• Clinical performance – the suitability of SaMD to provide clinically meaningful data.
• Analytical validity – measures the ability of the SaMD to correctly and repeatedly return reliable, identical output from identical input.
The SaMD would also be measured against the significance of its information for patient health: SaMD output that would be used to treat and diagnose would be the most significant (most strictly regulated); output which would inform clinical management would be least significant (lightly regulated).
Gold is almost ideal for use in the construction of wearable circuits as it meets the needs of something which is going to be in contact with organic material: it doesn’t corrode and it is non-toxic. Both good.
But it cracks easily: bad. Which means after a few squat-jumps it’s going to break. Not good for yoga lovers. Therefore, gold has traditionally been used in conjunction with rigid plastic surfaces.
Rayes-Hernandez, a microfluidics researcher at the US National Institute of Standards and Technology (NIST), has discovered something which could open gold’s potential to wearables. He made a porous polyester membrane studded with gold electrodes to see if the tiny holes in the polyester material would separate fluid components. He twisted the material a few times and discovered that, although it had some cracks, the gold could still conduct electricity. The holes in the polyester material were apparently supporting the integrity of the gold.
Unexpectedly the porous membrane’s electrodes showed higher levels of conductivity than those on a traditional rigid surface.
Modern technology and particularly wearables are promising to alleviate some of the danger and suffering associated with epilepsy. One such device is Empatica’s Embrace watch, which links via Bluetooth to the user’s smartphone. It monitors galvanic skin response (a measure of the electrical activity of the skin) which is caused by reflexive systems within the body. When the watch detects any unusual events like seizures it will send an alert to caregivers, as an automated call and text message, using the smartphone’s data or Wi-Fi connection.
Microsoft has also been using its Microsoft Band to help doctors monitor epileptic patients. A collaboration in the UK of Poole Hospital, Kent University and software companies Graphnet and Shearwater will be trialling a system of epilepsy monitoring and care. Using the band, software on smartphones and Microsoft’s deep learning Azure cloud platform, the participants’ data will be logged and analysed to spot trends and crisis points. That data will then be sent to the primary care provider and doctor so changes can be made to the patient’s care.
Founded in 2014, Ava released a fertility tracking bracelet in July 2016. Ava say that this is the first fertility-tracking device that can identify the fertile days in a woman’s cycle in real-time. Ava monitors the wearer as she sleeps and builds a database so as to be able to accurately predict at least five fertile days per cycle and display the results on a smartphone; all of which means that there is no need to go to the hassle of using ovulation sticks and BBT thermometers.
During sleep Ava monitors and collects over 3 million data points including heart rate and variability, breathing rate, sleep quality, temperature and so on which are related to an increase in fertility hormones, enabling prediction of the user’s most fertile times.
Rich Lee is a biohacker. Lee has implanted tubes on his shins, to see whether they would protect them from bone impact, and magnets in his fingers. He also has magnets implanted in the tragus of his ear. The magnets can act as earphones allowing Rich to hear audio signals without an earphone. An audio signal is sent from a smartphone or MP3 player to a coil which is like a necklace. Due to amplification of the voltage the coil generates a large magnetic field causing the magnet to vibrate and a sound to be heard.
There is the possibility this tech could be modified to act as a hearing aid.
Mindfulness is everywhere at the moment. Mindfulness is being aware of the moment. It’s about destressing, decluttering and ordering your mind to get, and keep, it on track and focused. Below are some of the recent wearable products riding the wave of mindfulness.
Muse: Muse is a headband which although not wearable in a 24/7 sense can be worn during meditation. It works by monitoring the wearers brain activity and provides real-time audio feedback via Bluetooth to help calm and focus the mind. Its software records progress, and provides users with rewards and milestones to keep them motivated.
Spire: Spire can help the wearer improve posture and breathing. Spire is a small clip-on device which looks like a pebble; when breathing becomes tense Spire vibrates to remind the wearer to breathe deeply. The associated app can show the amount of calm, focused and tense minutes the user has had throughout the day, provide guided meditation and of course monitor and log progress.
Prana: Prana is another posture and breathing wearable that clips onto a belt. It buzzes to alert the user of bad posture, and can also send an alert to a phone. It has games to help with breathing exercises.
Pip: By reading a user’s galvanic skin response when they hold it between finger and thumb Pip monitors stress levels throughout the day. Pip then uses the reading to project the user’s stress levels onto a tablet computer or smartphone in the form of pictures and audio, which change (becoming prettier or uglier) based on stress level. The device has all the usual user data history and progress features.