Category Archives: Technology

FDA Update: Ophthalmic Device Panel Meeting To Review Implantable Eye Telescope

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The FDA Ophthalmic Devices Panel will meet Apr 24, 08 8:30 AM – 5:00 PM & Apr 25, 08 8:30 AM – 5:00 PM in the Gaithersburg Holiday Inn, Ballroom – 2 Montgomery Village Ave. Gaithersburg , MD

On April 24, 2008, the committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by VisionCare Technologies, Inc., for an implantable miniature telescope (IMT™). The IMT™, a visual prosthetic device, is indicated for monocular implant in patients with stable, moderate to profound central vision impairment due to bilateral central scotomas associated with end-stage macular degeneration with geographic atrophy or disciform scar, foveal involvement and cataract.

Since these diseases lead to central dysfunction of the retina the implantable telescope spreads the visual image over a larger area of normal retina.

The prosthetic telescope, together with the cornea, acts as a telephoto system to enlarge images 3X or 2.2X, depending on the device model used. The telephoto effect allows images in the central visual field (‘straight ahead vision’) to not be focused directly on the damaged macula, but over other healthy areas of the central and peripheral retina. This generally helps reduce the ‘blind spot’ impairing vision in patients with AMD

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Pills That Monitor If You Took Them

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Compliance with taking medications is a huge problem in medicine. Studies show more than half of all prescriptions are either not filled or not taken. Everyone is familiar with how easy it is to forget to take medications. This problem becomes overwhelming in complex diseases such as cancer or HIV where patients are on rigorous schedules throughout the day. Even worse is the situation where the
patient may have compromised cognitive abilities.

A new development is a chip containing networked pill that reports back on medication taking and the dissolution of the pill as reported by MIT technology review.

The company behind the technology, Proteus Biomedical, of Redwood City, CA, calls its technology the Raisin system.

In the Raisin system, each pill contains an “ingestible event marker” (IEM). The IEM consists of a sand-grain-size microchip with a thin-film battery that is activated on ingestion, as it is exposed to water. The battery, Proteus says, is nontoxic because it is made from materials similar to those in a vitamin pill. Once swallowed, the IEM sends through the body’s tissues a high-frequency electrical current that’s modulated in such a way that it provides a unique marker of the pill. It’s not an RFID technology: it uses the conductive tissues of the body to conduct the signal, rather than a radio, and the signal is confined within the body.

I previously wrote about about the development of swallowable RFID chips- a technology I like better.

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New FDA 510(k) Approvals for March 2008-(pt.1) New Video Monitor Screens

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The FDA has published its 510(k) approval letters for March 2008. In terms of surgery, endoscopy, and imaging a few items caught my eye. The first is a pair of high resolution monitors from Eizo.

Eizo is upgrading both monchrome and color workstations to 5-megapixel units. This will be useful for radiologic workstations.

Here is the text from the FDA

DEVICE: 5 MEGAPIXEL MONOCHROME LCD MONITOR, MODEL RADIFORCE GS520 EIZO NANAO CORPORATION 510(k) NO: K080422(SPECIAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 81 76 2742468 153 SHIMOKASHIWANO-CHO SE DECISION MADE: 10-MAR-08 HAKUSAN, ISHIKAWA-KEN, JAPAN 924-8510(k)

DEVICE: COLOR LCD MONITOR, MODEL RADIFORCE RX211 EIZO NANAO CORPORATION 510(k) NO: K080457(SPECIAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 817 627 42468 153 SHIMOKASHIWANO-CHO SE DECISION MADE: 20-MAR-08 HAKUSAN, ISHIKAWA-KEN, JAPAN 924-8510(k)

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New Technique Sees Inside Blood Vessels in a Microsecond

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Technology Review is reporting on a new technology to look inside the tiniest spaces such as blood vessels in a microsecond. Up until now endoscopic surgery has been limited as engineers tried to shrink telescopes to ever smaller diameters shifting from glass lenses to fiberoptic scopes to newer technologies. You can read my brief history and overview of microendoscopy here.

The new scope is based on optical coherence tomography but now uses new mathematical image analysis. Read the full article if you are interested in the heavy technical foundations of the system.

Suffice it to say, the system is a sort of “ultrahigh resolution optical ultrasound” and the new modification allows it to process the signal so fast that it could be used inside blood vessels without needing to interrupt blood flow and flush out the blood. The players in this development are two compnaies – LightLab and CardioSpectra of Austin, TX. The latter company was recently purchased by Volcano, one of the leading manufacturers of IVUS products for $25M.

Example of an OCT image of a fingertip (standard old OCT system)

Basic Explanation of How the Foundation Technology of OCT Works from wiki

“OCT is a technique for obtaining sub-surface images of materials at a resolution equivalent to a low-power microscope. It is effectively ‘optical ultrasound’, imaging reflections from within tissue to provide cross-sectional images. It is attracting a great deal of interest in the medical community, because of its potential to provide images at a far higher resolution (better than 10 µm) than is possible with other imaging modalities such as MRI or ultrasound.”

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Interactive Objects and Gesture Control-Microsoft Vision of Medical Future

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Microsoft produced this video as a demo of their vision of the future of healthcare.  I was delighted to see that they share so much with my vision of technologies that will be key transformers in the future of medicine.

Key technologies I predict will change health care that I see in the video include:

  1. implantable glucose monitor sensors
  2. display surface
  3. wireless charger
  4. gesture control
  5. interactive smartwalls that become displays
  6. RFID taggged medicine bottles
  7. Digital examination tols interfacing with EMR’s
  8. LCD opaque windows
  9. Digital wallets
  10. Biometrics

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Bizarre Russian Interactive Art is Surgery Control Concept!

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I have written many times on the concept of what I call “gesture control”. This is the idea of waving your arm or hand in a movement that is picked up by sensors (optical or other tracking) and which is then translated into the movement of a robotic surgical device, OR room or equipment control, or energy delivery system. You can see all these posts by clicking gesture control on the category drop down on the sidebar. Some faves are here here and here.

Lily Chaos has reviewed a bizzare interactive Russian art display that employs gesture control concepts.

She writes

A new video art installation by Russian media artist Sergey Kotsun invites the viewer to become the author and main character of an interactive audio-visual performance.

The viewer’s image is captured via a webcam and thrown up onto a projection screen. On the screen, two lines of transparent square boxes are also displayed, with the lines approaching each other at the top and veering away at the bottom, almost forming two sides of a triangle. Inside the boxes are different geometrical shapes.

As the viewer waves or makes other motions that can be picked up by the webcam, a computer program analyzes those movements. Any time a movement is perceived to intersect with one of the transparent squares, the corresponding geometrical shape displays onscreen and the sound of a musical instrument is played.

The viewer, in effect, becomes the artist as well as an integral part of the performance, creating movements that translate into sounds and abstract compositions of circles, squares, lines and half-moons. Kind of like playing an air banjo from inside a colorful kaleidoscope.

Here is a video of it in play- too Yoko Ono for my musical taste but pay attention to how the participant’s gestures are picked up by the camera and converted into actions- the same principle I advocate in the OR.

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If you have a webcam you can try a home demo!

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Glimpse the Future of Medicine at a Cell-Phone Convention: What is 4G?

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The annual cell-phone (I should say wireless) convention of the year just wound up over at CTIA in Vegas. Usually these meeting spark some idea in me due to a new device or new wireless technology such as a universal wireless device charger, or an image recognition and analysis system that can lead to a future medical device. No such individual device or software at this meeting- but much bigger I am amazed at the awesome potential of the next generation wireless system in general: 4G wireless. This always on technology promises a wireless future where multiple devices that are always on will pull and deliver all sorts of data from your patients or surgical devices. A 4G system will be able to provide a comprehensive solution where voice, data and streamed multimedia can be given to users on an “Anytime, Anywhere” basis, and at higher data rates.

My analysis of the awards given out at CTIA was struck by the focus on developing 4G technologies.

First some background definitions – What is 4G: The History of Wireless Cell-phone Technologies: Briefly the first generation systems were analog based (1G). 2G second generation systems were the first that were all digital. Reported advantages of digital 2G systems are voice data can be compressed more effectively than allowing more calls to be packed into the same amount of radio bandwidth and they required less radio power.

3G systems promised: (such as Verizon’s EV-DO)

  1. Enhanced multimedia (voice, data, video, and remote control).

  2. Usability on all popular modes (cellular telephone, e-mail, paging, fax, videoconferencing, and Web browsing).

  3. Broad bandwidth and high speed (upwards of 2 Mbps).

  4. Roaming capability throughout Europe, Japan, and North America

Why 4G Will Transform Medicine & Surgery: Let me be the first to ring the bell for the promise of 4G in medicine. It has been written that it is expected that end-to-end intenet lanuage (IP) based system and high-quality streaming video will be among 4G’s distinguishing features. Fourth generation networks are likely to use a combination of WiMAX and WiFi- like your high speed wireless internet at home. The explosive potential is:

When fully implemented, 4G is expected to enable pervasive computing, in which simultaneous connections to multiple high-speed networks provide seamless handoffs throughout a geographical area. Network operators may employ technologies such as cognitive radio and wireless mesh networks to ensure connectivity and efficiently distribute both network traffic and spectrum.

4G networks, when coupled with cellular phones equipped with higher quality digital cameras and even HD capabilities, will enable vlogs to go mobile, as has already occurred with text-based moblogs. New models for collaborative citizen journalism are likely to emerge as well in areas with 4G connectivity.

In medicine this means you can have surgical devices, electronic medicial records, imaging devices, and your cell-phone like handheld all communicating and sharing info at broadband speeds in HD.

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Can Vision Testing Improve Surgical & Athletic Performance?

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visual testing Gizmodo is reporting today about how White Sox catcher A.J. Pierzynski said he improved his performance though the daily use of a Nintendo video game. This reminded me of research I did while at Yale on similar visual testing on surgeons. We found back then that for both athletes, and surgeons (especially endoscopic surgeons) visual acuity correlated with performance and both could be improved with exercises.

First the report on the catcher and the video game. Gizmodo writes:

We were just about to stuff Nintendo’s Flash Focus vision game into the snake oil file when White Sox catcher A.J. Pierzynski revealed he actually improved his hitting through daily use of the software. Like many of the White Sox batters last year, Pierzynski stunk, and to come around he played Flash Focus in the off season. Now, one week into the 2008 schedule, the hapless catcher has two home runs, a .529 average and a team-leading seven RBIs.

What is Flash Focus?: Flash Focus is a video game for the Nintendo DS. Basically it is a series of hand eye coordination exercises designed to improve overall visual acuity through vision “exercises”. A review of the game and screen shots are here.

The Concept of Optomeric Testing for Athletes and Surgeons: The idea behind optomic testing is two fold. First, there are innate differences in visual performance between people second, elite athletes perform significantly better on objective tests of visual performance and hand-eye coordination, and third, specific testing and exercises can identify areas of optical performance weakness and improve them- and performance.

A review of optometric testing in general for athletes can be read here:

The basic tests they mention are:

  1. Visual acuity – right and left eye separately without an occluder
  2. Stereopsis at distance – contour and random dot
  3. Ocular dominance – independent of handedness
  4. Letter contrast
  5. Contrast sensitivity – at spatial frequencies known to be related to sport performance
  6. Contrast sensitivity with glare
  7. Reaction time
  8. Reaction time with varying targets

Our experiments with surgeons- Some years ago whenI was at Yale My Partner David Olive and I conducted a lerge study of novice and expert endoscopic surgeons using the validated athletic optometric testing tools. We testing a very large group of trainees as well as experts at an international AAGL conference. We found similar patterns as with the athletes. Namely significant differerences existed between visual ability and eye hand coordination skills and these were related to measures of performance and skill. We also found that with exercise performance could improve.

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New Monitoring System Approved by FDA- Potential for Future Robotic Diagnostics

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freestyle glucose sensor

The FDA has just approved the FreeStyle Navigator Glucose Monitoring System – a glucose sensor that reports glucose values continuously for up to 120 hours.  Here is a copy of the FDA PMA letter.  This device is interesting to me since it works with a sensor inserted in either the abdomen or the back of the upper arm.   The device then continuous provides glucose readings and updated glucose trend information for viewing and contains a built-in alarm that can be programmed to alert the user when results fall below pre-set values.  Other similar devices have been approved that monitor for 7 days. 

Potential for Future Robotic Diagnostics  I have written before that I predict a whole new field of chip based biologic disease screening and monitoring in the future.  This is another step to that result.  Here a sensor is placed under the skin that measure blood sugar.  In the future minitaturized chips could be placed in any body cavity or organ to sense any imaginable molecule.

Options for Future Diagnostics: 

  1. DNA based sensors screen for cancer metastasis or recurrances such as an intrabdomnal ovarian cancer detector.
  2. Sensore that measure drug levels in target tissues – chemotherapy of course comes to mind
  3. protein sensors that look for the earliest stages of disease development.

As personalized genetics becomes more widespread, we will identify individuals at particular risk for particular diseases before they occur.  Since the genetic basis of these diseases will be known markers will likely exist.  Implanted chip sensors could then be placed to sniff for these markers and wireless transmit the alarm- or even deliver a predetermined treatment agent- all before there is any external sign of the disease.  First generation implantable devices such as this for blood sugar monitoring are lisated here (none yet available):

Here are links to some of the technology that will be involved for these future diagnostics including tiny sensors that transmit with RFID, smartdust sensors the size of a speck of dust or less, smart pills that travel through the body transmitting data and the concept of personalized genetic information based diagnostics and personalized genetics in general.

All approved continuouis blood sugar monitoring devices are here and a comparison from a patient site here:  

As an aside – in terms of glucose monitoring the use of thse devices may come into question.  An ongoing diabetes study called ACCORD was cut short in one treatment arm when it was shown that ultra tight strict blood sugar control in diabetics with heart disease actually WORSENED outcomes!

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Fertility Treatment is the Likely Cause of the Identical Triplets

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Many are reporting today that a woman on Long Island gave birth to rare identical triplets.  She actually gave birth at one of my main hospitals and I know her Ob.  The story goes on to say she had IVF but only one embryo was replaced.  I was not her treating fertility doctor.  However, this event raises and important fact.  More and more fertility specialists are turning to a technique called blastocyst transfer.  Here we let the embryo grow and additional 2 days in the dish in the lab.  Instead of transferring it on day 3 we let it grow until day 5 (occasionally 6).  By letting them grow more each embryo that survives has a greater chance of implanting.  Therefore we can transfer less of them, reduce the risk of multiples (usually!) and keep pregnancy rates high.  The risk is if the embryos are not very strong then none may survive.

Why this may be the cause:   It has been know for some time that when we use this technique the rate of identical twins (ie a single embryo splits into two) is significantly great – up to 5% or so.  Therefore it makes perfect sense that the rate of identical triplets could rise as well.  Since a single embryo was transferred they say- this is usually done in blastocyst cases.

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