Archives: 6/2011

2smartheart iPhone App Reco Smartheart Lightweight Personal 12 Lead ECG Announced
SHL Telemedicine recently announced the Smartheart, a lightweight personal ECG. The device, about the size of the average smartphone, is strapped around the chest and records a full 12-lead ECG. The strap seems to include many of the ecg electrodes that are normally attached separately to the chest. One separate lead is still needed that connects to the lower left part of the belly. The device is to be used in conjunction with a mobile app, available on iPhone, Android, and BlackBerry, which connects to the ECG wirelessly and captures the ECG within about 30 seconds. The results can be emailed to the cardiologist or hospital, and the device will sport some form of automatic assessment.

A few questions about the device still remain unanswered. While we can see how this device will be able to measure the V1-V6 leads, it is still a mystery how it will produce accurate results for each of the limb leads. Also it will be interesting to see if the company can limit the amount of false positives that often plague automatic ECG interpretations. The device is planned to be released coming fall, and still has to achieve regulatory approval. The device itself will cost 500 dollars, while a subscription based analysis and medical advice service will cost under 20 dollars a month. The announcement of the Smartheart was recently made at Disrupt NYC, an event organized by Techcrunch.

Source: Techcrunch: Smartheart Turns Your Mobile Phone Into A Heart Monitor…

Product page: Smartheart…

(hat tip: iMedicalapps)

hfh3o GEs AngioViz Vascular Flow Analysis Software FDA OKd

GE Healthcare received FDA approval for AngioViz software that uses Digital Subtraction Angiography (DSA) to produce an image of vascular flow within the brain or other parts of the body. Previously, DSA images provided an anatomical view of the vasculature and a radiologist had to flip through a series of them to visualize blood flow.  AngioViz provides a one shot representation that encompasses the dynamic nature of the region’s vascular flow.

AngioViz provides a new visualization of the vascular flow seen in DSA imaging utilizing a technique called parametric imaging. AngioViz looks at each pixel in the image series and determines two things—the peak value of opacification caused by the contrast, and the time it takes for that pixel to reach peak opacification. These two parameters can be displayed as separate images or combined into a single color-coded image that represents parameters of vascular flow. This enables doctors to perceive parameters of flow quickly to support decision-making. In addition, AngioViz allows easy comparison of parametric images from different DSA acquisitions, such as pre- and post-treatment images. This can help physicians understand the impact on flow dynamics of various interventional treatments.AngioViz bold flow visualization has the potential to be applied to a variety of clinical situations

  • Help see where a blocked artery diminishes blood flow in the brain or other tissue
  • Identify the timing and amount of blood flow in abnormal vessel anatomy
  • Observe flow in abnormal tissue before and after treatment to support interventional oncology treatment
  • Visualize peripheral artery blood flow before and after balloon angioplasty and stenting

 

Press release: GE Healthcare’s AngioViz Vascular Vision Software Receives FDA Clearance …

Flashback: GE’s New Vascular Visualization Applications for Interventional Radiology

234gfsld Watermark Medical Brings Sleep Apnea Testing to the HomeSleep apnea testing generally requires an overnight stay in a sleep clinic, tens of wires attached to your head and body (glued), and tubes inserted into your nose and in front of your mouth. This setup makes for a difficult sleep on top of existing abnormalities, and, because the clinics need to be staffed all night, is relatively expensive.

Watermark Medical, out of Boca Raton, Florida, provides at home diagnostic solutions for sleep disorders such as apnea by giving patients a headset, of sorts, to wear at home during sleep. Their device, the ARES Unicoder, collects O2 saturation, nasal airflow, pulse rate, snoring, head movement, and REM/NREM via an EEG. This data is combined with clinical indicators to provide an apnea index and respiratory disturbance index that allows physicians to diagnose sleep apnea.

The product, named by the Cleveland Clinic as a top 10 medical innovation of 2010, is being marketed as a reimbursable, less expensive alternative to in-lab sleep apnea testing.

Link: Watermark Medical…

38gfj3ud Covidiens Parietex Optimized Composite Mesh for Hernia Repair Approved on Both Sides of The AtlanticCovidien received U.S. and E.U. approvals to bring to market its Parietex Optimized Composite (PCOx) mesh. The device is an improvement on the company’s Parietex Composite (PCO) mesh used in open and laparoscopic ventral hernia repair procedures. According to Covidien, “the new product design incorporates a more resistant barrier and a proprietary textile design with better visibility and increased strength.”

Features from the product page:

  • Parietexâ„¢ Composite dual-sided mesh provides optimal tissue in-growth and fewer visceral attachments
  • The skirt on parietal side provides accessible, secure fixation points
  • Increased rigidity during implantation allows superior handling
  • The polyester material softens and conforms to the anatomy once implanted
  • Protects viscera from fixation points
  • Available in three sizes to meet a wide range of clinical needs

Product page: Parietexâ„¢ Composite: Polyester Mesh Resorbable Film …

Press release: Covidien Announces U.S. 510(k) Clearance and European CE Mark Approval of Parietexâ„¢ Optimized Composite Mesh …

8438sj Lasers Visualize Arterial Plaques in 3D
Purdue researchers have developed a new method of imaging the 3D structure of plaques within arteries using a nanosecond pulsed near-infrared laser. Currently tested in a laboratory environment, the researchers are now working on miniaturizing this technology for 3D visualization of arteries in clinical settings. The research is scheduled to be published next week in Physical Review Letters.

The imaging reveals the presence of carbon-hydrogen bonds making up lipid molecules in arterial plaques that cause heart disease. The method also might be used to detect fat molecules in muscles to diagnose diabetes and for other lipid-related disorders, including neurological conditions and brain trauma. The technique also reveals nitrogen-hydrogen bonds making up proteins, meaning the imaging tool also might be useful for diagnosing other diseases and to study collagen’s role in scar formation.

The laser generates molecular “overtone” vibrations, or wavelengths that are not absorbed by the blood. The pulsed laser causes tissue to heat and expand locally, generating pressure waves at the ultrasound frequency that can be picked up with a device called a transducer.

The Purdue researchers are the first to show that a strong photoacoustic signal can arise from the absorption of light by the chemical bonds in molecules. The near-infrared laser causes enough heating to generate ultrasound but not enough to damage tissue.

The approach represents a major improvement over another imaging technique, called coherent anti-Stokes Raman scattering, or CARS, which has been used by the Purdue-based lab to study three-dimensional plaque formation in arteries.

Full story: New imaging tech promising for diagnosing cardiovascular disease, diabetes …

pwfjjfd PatientsLikeMe Unveils Clinical Trial Matching Tool

PatientsLikeMe, the social network for people with medical conditions, has unveiled a new online tool for discovering clinical trials that may be relevant to an individual’s unique situation. Using data updated daily from ClinicalTrial.gov, the tool matches patients to appropriate trials being conducted in their area.

More from the announcement:

PatientsLikeMe is also improving its clinical trial awareness service for companies, nonprofits, and academia. Trial investigators can now find their trial listed on PatientsLikeMe, see and search for eligible patients that match their criteria, as well as purchase enhanced listings that include the ability to message eligible patients anonymously through targeted email.

Link: PatientsLikeMe Clinical Trials …

Press release: PATIENTSLIKEME LAUNCHES NEW FEATURE FOR PATIENTS TO ACCELERATE CLINICAL TRIAL ENROLLMENT …

kjvrj Bluetooth 4.0 Adds Special Support for Medical DevicesAn estimated 40 million medical devices currently include Bluetooth, the wireless technology that allows many of our mobile devices to communicate with each other. The newest upcoming standard, Bluetooth 4.0, features lower power and higher speed transmission while supporting older Bluetooth services. In a press release from the Bluetooth Special Interest Group (SIG), it was announced that medical devices would be the first to use the new Bluetooth 4.0 technology.

Specifically, the Bluetooth SIG approved a Health Thermometer Profile and a Heart Rate Profile as the first mobile health profiles built on Bluetooth v4.0. Utilizing Bluetooth 4.0 could pave the way for smarter, more advanced medical devices. As an example, the press release describes using the Health Thermometer Profile in a low power consuming patch that can send temperature measurements to a mobile phone every half hour.

The press release also made mention of a Blood Pressure Profile and Service that is expected to be approved in late July.

Press release: Mobile Health Device Manufacturers Ramp Up New Products Using Bluetooth Technology Version 4.0 …

More information about Bluetooth technology in healthcare from Bluetooth SIG…

biographnmr Siemens Biograph mMR MR/PET Scanner Gets EU Green Light
Siemens has received EU’s CE Mark for its Biograph mMR, the world’s first integrated MR/PET scanner. One pass through the machine can provide physicians with both anatomic and functional imaging of the patient, or it can be used selectively as a 3T MRI or just as a traditional PET scanner.

j4r2odj Siemens Biograph mMR MR/PET Scanner Gets EU Green Light
More about the device from Siemens:

Biograph mMR is the world’s only fully integrated whole-body molecular MR with simultaneous MR and PET data acquisition technology.

Biograph mMR comprises a 3-Tesla magnetic resonance (MR) scanner and an integrated positron emission tomography (PET) detection system with an architecture that performs as one and was designed for uncompromised MR and PET image quality. While MR provides exquisite morphological and functional details in human tissue, PET goes further to investigate at the same time the human body at the level of cellular activity and metabolism. With its simultaneous data acquisition, the innovative system is expected to prove to be particularly valuable in the identification of neurological, oncological and cardiac conditions of disease and in supporting therapy planning. The Biograph mMR also opens new opportunities for research, such as the development of new biomarkers or new therapeutic approaches. Siemens has already installed a number of Biograph mMR systems at customer sites for clinical research, including university hospital Klinikum rechts der Isar of the Munich Technical University, the university hospital of the Eberhard Karls University Tuebingen in Germany, and Massachusetts General Hospital in Boston, USA.

Press release: Siemens Receives CE Mark For Whole-Body Molecular MR System …

Product page: Biograph mMR …

Flashback: Siemens Brings Together Magnetic Resonance and Positron Emission Tomography Into One Machine

03ugf3 St. Judes Portico Transcatheter Aortic Valve Implanted in Human (Exclusive Pics)
St. Jude Medical has just announced the first successful human implantation of the company’s Portico transcatheter aortic heart valve in a patient with aortic stenosis. The procedure was performed by Dr. John Webb, director of cardiac catheterization and interventional cardiology at St. Paul’s Hospital in Vancouver, British Columbia. We hear that St.Jude is working hard to make sure the device is safe and secure, so things like perivalvular leaks and valve displacements do not happen during or after implantation. 38djjjlj St. Judes Portico Transcatheter Aortic Valve Implanted in Human (Exclusive Pics)Furthermore, the company is looking into ways to develop both transapical and transfemoral deliveries for the valve. And, in addition, the device, when it is finally approved, might feature the company’s proprietary Linx anticalcification technology that might actually prolong the life of the device and/or prevent calcium buildup and things like embolizations.

Check our exclusive images of the device, and here’s more info about it from the announcement:

The valve, which is made of bovine pericardial tissue, is designed to increase physicians’ control and placement accuracy during valve deployment. The Portico transcatheter heart valve can be completely resheathed (the process of bringing the valve back into the delivery catheter) and retrieved before it is released from the delivery system, allowing physicians to reposition the valve at the implant site. No transcatheter valve currently on the market has the ability to be re-sheathed, repositioned, or retrieved.

The St. Jude Medical transcatheter heart valve was designed for the estimated 400,000 patients with severe aortic stenosis who are considered to be high risk or inoperable for conventional open-heart valve replacement therapy. Two delivery methods will be available for the Portico valve, transfemoral (delivered via the femoral artery) and transapical (delivered via a small incision in the apex of the left ventricle).

Commenting on the first implant, Dr. Gregory Fontana, professor and vice chairman, Department of Surgery at the Cedars-Sinai Heart Institute in Los Angeles, Calif., said, “Many of the shortcomings of first generation devices have been addressed with the next generation St. Jude Medical Portico transcatheter valve.”

In February 2010, St. Jude Medical announced that Dr. Fontana, and Dr. Raj Makkar, director of the Interventional Cardiology and Cardiac Catheterization Laboratory at the Cedars-Sinai Heart Institute, will be the principal investigators in the company’s transcatheter aortic valve implantation (TAVI) clinical trial. The study will evaluate the safety and efficacy of the St. Jude Medical transcatheter aortic valve for patients who experience severe aortic stenosis and who may be at an elevated risk for open-heart surgery.

Press release: St. Jude Medical Announces First Implant of Portico Transcatheter Heart Valve …