Archives: 3/2011

7eckfr5e Merits ASAP Aspiration Catheter System Green Lighted in U.S.
Merit Medical (South Jordan, Utah) has received FDA OK for its ASAP aspiration catheter kit for peripheral vascular applications. The dual lumen device is wire braided for kink resistance and designed to get to the emboli or thrombus rapidly and safely.
hest47c4 Merits ASAP Aspiration Catheter System Green Lighted in U.S.Features from the product page:

  • Large Aspiration Lumen to Facilitate Quick Aspiration

  • Single Extrusion 100% Wire Braided Kink Resistant 140cm Catheter
  • Depth Positioning (non radiopaque markers 90cm, 100cm, 110cm)
  • Tapered Tip for Smooth Catheter Transition
  • Hydrophilic Coating Distal 20cm of Catheter
  • 2cm Rapid Exchange Length
  • 6F Guide Catheter Compatibility (0.070″ min. ID)
  • 0.014″ Guide Wire Compatibility

  • Product page: ASAP Aspiration Catheter…
    Press release: Merit Medical Announces 510(k) Clearance for the ASAP(TM) Thrombus Aspiration Catheter …

    qkr542x7 A Look at UCSFs Robotic PharmacistsAt the University of California, San Francisco, pharmacists are welcoming its newest employees – a team of robots designed to streamline and simplify the process of filling prescriptions for the medical center.
    The new robotic pharmacy handles just about the entire process: receiving electronic orders, locating the medicine in a secured, sterile environment, dispensing the correct dosage, and packaging the medication so it is ready to be delivered to a patient. The robots can even assemble all of a patient’s medication for a 12-hour period into one set.
    Some of the robots are ForHealth TechnologiesIntelliFill, which can fill IV medication, and Swisslog‘s PillPick pharmacy automation system. The pharmacy also features three Robotic IV Automation (RIVA) Systems from Intelligent Hospital Systems, designed to prepare hazardous chemotherapy drugs.
    xmmnstl8 A Look at UCSFs Robotic Pharmacists
    So far, the robots have managed to dispense over 350,000 doses of medication without a single error, a feat difficult for even the best UCSF pharmacists. But will the new robots put their human druggist counterparts out of a job? According to UCSF:

    By using robots instead of people for previous manual tasks, pharmacists and nurses will have more time to work with physicians to determine the best drug therapy for a patient, and to monitor patients for clinical response and adverse drug reactions.

    Mary Anne Koda-Kimble, Dean of the UCSF School of Pharmacy, adds this: “The beauty of this robotic pharmacy system is that the pharmacist is taken out of that mechanical aspect of pharmacy practice, and they can use their intellect to be sure that the patients at the bedside are getting absolutely the right medicine.”
    Take a look at the new robotic pharmacy at UCSF below:


    Full story from UCSF: New UCSF Robotic Pharmacy Aims to Improve Patient Safety…
    (hat tip: CNet)

    h2389s Spaulding IQ One Button Handheld ECG Device Receives FDA Approval
    Spaulding Clinical Research has received FDA 510(k) approval of their Spaulding IQ foolproof ECG device. It is primarily purposed for centralized ECG collection in clinical trials, the core business of Spaulding Clinical Research. The IQ is a handheld device with a single-button design and a high level of automation. It captures the subject’s voiceprint as a means of biometric identification together with five minutes of ECG recording. Directly after recording, the ECG data, demographic and visit information are sent to the Spaulding Clinical ECG Information System. The high level of automation should reduce errors and allow for data capture in less time and at a lower cost.
    Press release: Spaulding Clinical Receives 510k Approval for Proprietary ECG Device…

    6fgg7iyo Repurposed NASA Light System Shown Effective for Pain Therapy Post Chemo/Radiation
    A device originally developed for NASA to perform plant growth experiments in space has been found in a two year clinical trial to be effective in reducing pain associated with oral mucositis, a side effect of chemotherapy and radiation treatment, in bone marrow and stem cell transplant patients. Quantum Devices, of Barneveld, Wisconsin developed the WARP 75 device that uses 288 LED’s, each supposedly generating the light energy equivalent of being illuminated by 12 suns.
    xyrtfy8i Repurposed NASA Light System Shown Effective for Pain Therapy Post Chemo/Radiation

    The WARP 75 device was used for light therapy treatment on cancer patients during a two-year clinical trial funded by NASA’s Innovative Partnerships Program at the Marshall Space Flight Center in Huntsville, Ala.
    The clinical trial found that 670 nanometers of light technology, used for plant growth experiments on the International Space Station, improved the painful side effects of chemotherapy and radiation in cancer patients undergoing bone marrow or stem cell transplants. The trial included 20 cancer patients from Children’s Hospital of Wisconsin, and 60 cancer patients from the University of Alabama at Birmingham Hospital and the Children’s Hospital of Alabama, also in Birmingham.
    The device uses High Emissivity Aluminiferous Luminescent Substrate, or HEALS, which is a type of LED technology that provides intense light energy.


    Press release: NASA’S LIGHT TECHNOLOGY SUCCESSFULLY REDUCES CANCER PATIENTS’ PAINFUL SIDE EFFECTS FROM RADIATION AND CHEMOTHERAPY
    More from NASA: NASA Light Technology Successfully Reduces Cancer Patients’ Painful Side Effects from Radiation and Chemotherapy
    Product page: WARP 75…
    (hat tip: Qmed)

    ENT

    348923nn SoundBite Dental Hearing Aid Wins European ApprovalSonitus Medical (San Mateo, CA), having received FDA clearance in January for its SoundBite hearing aid, is now following up with European approval. The dental insert works similar to a cochlear implant, receiving an audio signal from a transmitter in the ear and in turn resonating the cochlea, but via the teeth.

    To take advantage of the natural acoustic benefits provided by the patient’s own ear, sound in the environment is picked up by a tiny microphone placed within an open fit dome worn in the canal of the impaired ear and connected to the BTE by a small translucent tube. The BTE uses a digital signal processor to process the sound, a second microphone for noise cancellation, and a wireless chip to transmit the signals to the ITM hearing device, which in turn sends imperceptible vibrations via the teeth near-simultaneously to both cochleae. SoundBite hearing system is intended to deliver sound across a broad frequency range of 250 to more than 12,000 Hz.
    SoundBite Oral DeviceThe ITM device is custom made to fit around either the upper left or right back teeth, does not require any alteration of the teeth, and is easily inserted and removed by the wearer. It contains electronics, a sealed, flat, rechargeable battery, wireless capability that picks up sound transmissions from the BTE, and a small actuator that converts those signals into vibratory energy. All of these miniaturized components are hermetically sealed inside a dental grade acrylic that has been safely used for making dentures for many years.

    Press release: Sonitus Medical Receives European CE Mark for SoundBite™ Hearing System…
    Product page: SoundBite Hearing System…
    Flashbacks: SoundBite Cochlear-Dental Hearing Aid Gets FDA Clearance; Dental Hearing Aid Technology from Sonitus Medical; SoundBite, a Cochlear Hearing Aid Without The Implant

    Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine, returned to TED2011 a couple weeks ago to give updates on his breakthroughs in regenerative medicine. In addition to explaining the process of growing bioengineered organs, valves, and tissues, he also demonstrates how he is using printing technology to fabricate body parts and even print skin tissue directly onto a patient’s wound. Other highlights of the talk include a live demo of a kidney-shaped mold being printed on the TED stage, and a reunion with a young patient who was one of the first recipients of a bioengineered bladder from Atala’s lab.


    Be sure to also check out Dr. Atala’s talk from TEDMED 2009…
    Additional comments from the Institute for Regenerative Medicine at Wake Forest…
    More from TED…

    fh29dnh Elana Device for Intracranial Artery Bypass Gets FDA Nod
    Performing an artery bypass in the brain typically requires shutting off blood flow, potentially leading to a stroke in some patients. voeowoax Elana Device for Intracranial Artery Bypass Gets FDA NodBased on a technology developed at UMC Utrecht, Elana, also out of Utrecht, The Netherlands, just received FDA Humanitarian Use Device approval for its commercialized product called ELANA (Excimer Laser Assisted Non-Occlusive Anastamosis) Surgical Kit, a tool that allows neurosurgeons to reroute blood flow around an aneurysm or a tumor without stopping the flow of blood.

    To create the bypass, a surgeon sutures the ring and a section of replacement blood vessel onto the surface of the affected artery. Once attached, the surgeon tunnels the tip of the laser handpiece down the open end of the replacement blood vessel until the tip of the laser touches the ring.
    The laser then cuts a circular hole in the affected artery, and suction removes the cut tissue. The process is repeated with a second replacement blood vessel. Once both replacement blood vessels are in place, the open ends of the two replacement blood vessels are sutured together to complete the path around the aneurysm or tumor.

    Press release: FDA approves device to maintain blood flow during artery bypass brain surgery
    Product page: Elana Surgical Kit
    Elana Surgical Kit product brochure…

    bvifl7uvb NVIDIAs New Quadro 2000D Professional Video Card for Medical ApplicationsNVIDIA today released its new Quadro 2000D graphics card aimed at diagnostic medical workstations. It supports both 10 and 12 bit grayscale for up to 10 megapixels, packs a 1Gb frame buffer, 3D support, and DICOM monitor calibration functions, and will drive two monitors via DVI at a combined 2560×1600 resolution.
    Putting all this together, this editor concludes that a radiologist can have a great time on break with his favorite first person shooter between analyzing patient images.
    Product page: NVIDIA Quadro 2000D…

    3xeatoh2 iPrescribe Electronic Prescription App Review
    The fellows over at iMedicalApps have a review of iPrescribe, an electronic prescription app for the iPhone. As far as we know, it is still the only prescription app available for any smartphone, using the U.S. SureScripts national e-prescribing network to process the electronic prescriptions.
    They conclude that “iPrescribe is leading the path for iPhones and other portable devices to more completely become tools of the doctor’s trade” and: “For physicians with iPhones, who do not have ready access to e-prescribing through their EHR, iPrescribe is a highly attractive option”. Head over to the link below for the full review.
    iMedicalApps: iPrescribe turns your iPhone into a prescription pad…
    Flashback: You Prescribe with iPrescribe on iPhone…