All Forum Challenges, Searches or Forum Topics Tagged 'devices' - MedTech I.Q.2024-03-29T12:52:27Zhttps://medtechiq.ning.com/group/medicaldevicetechnologies/forum/topic/listForTag?tag=devices&feed=yes&xn_auth=noU.S. FDA (Food & Drug Administration) to Alter Rules on Medical Devicestag:medtechiq.ning.com,2010-06-23:2140535:Topic:325812010-06-23T14:34:47.469ZCC-Conrad Clyburn-MedForeSighthttps://medtechiq.ning.com/profile/CCatMedTechIQ
Colleagues,<br></br><br></br>Thank you to <span style="font-weight: bold;">MedTech-IQ</span> members, <a href="http://medtechiq.ning.com/profile/JonathanRosen?xg_source=profiles_memberList">Jonathan Rosen</a>, PhD, Executive Director, Institute for Technology
Entrepreneurship and Commercialization, Boston University, <a href="http://www.bu.edu/itec">www.bu.edu/itec</a>, for the heads-up on this important FDA development ...<br></br><br></br>ENJOY!<br></br><br></br>CC<br></br><hr style="width: 100%; height: 2px;"></hr>... As…
Colleagues,<br/><br/>Thank you to <span style="font-weight: bold;">MedTech-IQ</span> members, <a href="http://medtechiq.ning.com/profile/JonathanRosen?xg_source=profiles_memberList">Jonathan Rosen</a>, PhD, Executive Director, Institute for Technology
Entrepreneurship and Commercialization, Boston University, <a href="http://www.bu.edu/itec">www.bu.edu/itec</a>, for the heads-up on this important FDA development ...<br/><br/>ENJOY!<br/><br/>CC<br/><hr style="width: 100%; height: 2px;"/>... As reported in the Boston Globe ... Fielding complaints about poor communication and delays in reviewing and approving new products, the top US medical device regulator yesterday said his agency will overhaul its procedures to speed innovation while protecting patient safety...<br/><br/><p>... “We have not been clear about our expectations and we need to be,’’ Dr. Jeffrey E. Shuren said during a visit to the Boston area. Shuren, who took over as director of the Food and Drug Administration’s Center for Devices and Radiological Health in January, said regulators are committed to making “midcourse corrections,’’ including seeking more clinical data before devices win clearance.... <br/></p>
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<p>... Hosting a “town meeting’’ for more than 400 medical device executives and other industry professionals at the Hilton Boston/Woburn hotel, Shuren heard plenty of criticism from leaders of start-up companies who said FDA delays, mixed signals, and lack of predictability were causing confusion and threatening their businesses...</p>
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<p>... Shuren, a neurologist who completed his medical internship at Beth Israel Hospital and his residency at Tufts New England Medical Center, didn’t address the complaints of specific<br/> companies. But in an interview after the session, his second of three town meetings scheduled across the country, he said the devices center has been working to improve its standards, training, and decision-making...</p>
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<p>... An initial report on revamping the FDA’s approval process for medical devices, including changes in the development of clinical trials, is expected to be released for public comment in the coming weeks. New procedures could take effect later this year in what is known in the industry as the 510(k) medical device approval process....</p>
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<p>Read on at: <a href="http://www.boston.com/yourtown/woburn/articles/2010/06/23/fda_to_alter_rules_on_devices/">http://www.boston.com/yourtown/woburn/articles/2010/06/23/fda_to_alter_rules_on_devices/</a></p>
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<p>ENJOY!</p>
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<p>CC</p>
<hr style="width: 100%; height: 2px;"/><p style="text-align: left;"><img src="http://storage.ning.com/topology/rest/1.0/file/get/2310105433?profile=original" alt=""/></p>
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FREE!</a><p><br/></p> SoloHealth awarded $1.2M N.I.H. grant to advance Eyesite kioskstag:medtechiq.ning.com,2010-06-18:2140535:Topic:323252010-06-18T14:24:53.633ZCC-Conrad Clyburn-MedForeSighthttps://medtechiq.ning.com/profile/CCatMedTechIQ
Colleagues,<br></br><br></br>Thought you might find this post from <span style="font-weight: bold;">TechSouth Journal</span> of interest ... <a href="http://www.solo-health.com/" target="_blank">SoloHealth</a>,
a technology company that develops and deploys interactive health screening kiosks across the US, has been awarded a $1.2M grant by the National Institute of Health (NIH) through its Small Business Innovation Research (SBIR) program ...<br></br><br></br>...The grant is to advance SoloHealth’s initial…
Colleagues,<br/><br/>Thought you might find this post from <span style="font-weight: bold;">TechSouth Journal</span> of interest ... <a href="http://www.solo-health.com/" target="_blank">SoloHealth</a>,
a technology company that develops and deploys interactive health screening kiosks across the US, has been awarded a $1.2M grant by the National Institute of Health (NIH) through its Small Business Innovation Research (SBIR) program ...<br/><br/>...The grant is to advance SoloHealth’s initial product, EyeSite, a
vision screening kiosk, into a more comprehensive self-service health and wellness station. The new product will address highly problematic areas such as hypertension, obesity, eye health and vision, nutrition and diabetes...<br/><br/>...The grant, which is funded by the National Center on Minority Health
and Health Disparities, will aid SoloHealth in bringing free medical screening technology, education and wellness programs to a wider audience, including traditionally underserved communities...<br/><br/>...SoloHealth’s Health and Wellness kiosks represent a new approach in
publicly available, self-service health-screening. The kiosks are data-centric and use a combination of interactive health screening software and self-reported health information to produce individualized<br/>
reports for consumers...<br/><br/>...The customized reports also provide information on prevention,
coupons for relevant products and services as well as doctor referrals to drive consumers to follow-up care and treatment.<br/>
<p>The health kiosk operates in both English and Spanish, and has an analytics engine that is able to communicate to specific demographic and ethnicity...</p>
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<p>... SoloHealth’s EyeSite kiosk, which provides free vision screening, is already deployed in high-traffic retail locations like Kroger and Schnucks in seven markets including Atlanta, Birmingham, Houston, St. Louis, Richmond, Madison, WI and Salt Lake City. Nearly 100 EyeSite<br/>
kiosks are providing vision screening for more than 400,000 people to-date ...</p>
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<p>Read on at: <a href="http://www.techjournalsouth.com/2010/06/solohealth-awarded-1-2m-n-i-h-grant-to-advance-eyesite-kiosks/">http://www.techjournalsouth.com/2010/06/solohealth-awarded-1-2m-n-i-h-grant-to-advance-eyesite-kiosks/</a></p>
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<p>ENJOY!</p>
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<p>CC<br/></p> New GE Healthymagination Fund ... Invests $5 million in CardioDx Inc.tag:medtechiq.ning.com,2010-05-24:2140535:Topic:312222010-05-24T23:57:37.590ZCC-Conrad Clyburn-MedForeSighthttps://medtechiq.ning.com/profile/CCatMedTechIQ
Colleagues,<br></br><br></br>As reported in Silicon Valley Business Journal ...
GE Healthcare is investing $5 million in <a class="story_clink" href="http://profiles.portfolio.com/company/us/ca/palo_alto/cardiodx/205901/"><strong>CardioDx, Inc.</strong></a> as part of a strategic alliance with the Palo Alto, Ca. diagnostic test developer.<br></br><br></br><div id="storycontent"><p>GE Healthymagination Fund, a new equity fund for health care technology companies, made the investment as part of a potential $44.5…</p>
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Colleagues,<br/><br/>As reported in Silicon Valley Business Journal ...
GE Healthcare is investing $5 million in <a class="story_clink" href="http://profiles.portfolio.com/company/us/ca/palo_alto/cardiodx/205901/"><strong>CardioDx, Inc.</strong></a> as part of a strategic alliance with the Palo Alto, Ca. diagnostic test developer.<br/><br/><div id="storycontent"><p>GE Healthymagination Fund, a new equity fund for health care technology companies, made the investment as part of a potential $44.5 million Series D financing round undertaken by CardioDx...</p>
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<a class="story_clink" href="http://profiles.portfolio.com/company/us/ct/fairfield/general_electric_company/1177020/"></a>... GE says it plans to invest $3 billion over five years in health care technologies and<br/>
biotech.<br/>
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<p>CardioDX, founded in early 2005 and led by President and CEO David Levison, a year ago started marketing its Corus CAD test. That is shoebox-size kit that uses a two-teaspoon draw of blood to test for obstructive coronary disease...</p>
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<p>... CardioDx’s lab runs the blood across 23 genes in its algorithm and reports back with a score — from zero to 40 — that translates into the likelihood of a patient having heart disease.</p>
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<div style="overflow: hidden; color: rgb(0, 0, 0); background-color: transparent; text-align: left; text-decoration: none; border: medium none;" id="TixyyLink"><br/>Read at : <a href="http://sanjose.bizjournals.com/sanjose/stories/2010/05/24/daily24.html?ed=2010-05-24&ana=e_du_pub">http://sanjose.bizjournals.com/sanjose/stories/2010/05/24/daily24.html?ed=2010-05-24&ana=e_du_pub</a><br/><br/>ENJOY!<br/><br/>CC<br/><hr style="width: 100%; height: 2px;"/><br/><p style="text-align: left;"><img width="721" src="http://storage.ning.com/topology/rest/1.0/file/get/2310104460?profile=RESIZE_1024x1024" alt=""/></p>
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<br/></div> Devices Must Show Best Clinical Outcomes Under CMS Accountable Care Organization (ACO) & Medical Home Pilotstag:medtechiq.ning.com,2010-05-22:2140535:Topic:311572010-05-22T23:18:58.504ZCC-Conrad Clyburn-MedForeSighthttps://medtechiq.ning.com/profile/CCatMedTechIQ
Colleagues,<br></br><br></br><span style="font-weight: bold;">The times ... They are a Changing ...</span><br></br><br></br>Device makers will be under increased pressure to prove that their products provide the best clinical outcomes among alternatives as the Center for Medicare and Medicaid Services (CMS), the organization that determines reimbursement, tests out new business models in accordnace with the new health care reform law ...<br></br><br></br>... As President Obama recently joked at the annual White House…
Colleagues,<br/><br/><span style="font-weight: bold;">The times ... They are a Changing ...</span><br/><br/>Device makers will be under increased pressure to prove that their products provide the best clinical outcomes among alternatives as the Center for Medicare and Medicaid Services (CMS), the organization that determines reimbursement, tests out new business models in accordnace with the new health care reform law ...<br/><br/>... As President Obama recently joked at the annual White House Correspondents' Association<br/>dinner, <span style="font-weight: bold;">The Patient Protection and Affordable Care</span> <span style="font-weight: bold;">Act</span> has literally has hundreds of provisions we don't know about yet ...<br/><br/>One provision that will be of interest to many <span style="font-weight: bold;">MedTech-IQ</span> medical device CEOs, investors and business development executives, calls for CMS to operate several new pilot programs ... Accountable Care Organizations (ACO), Medical Homes and increased bundling payment practices...<br/><br/>... These pilots will deliver care within the framework of scrutinizing the results of the stimulus funded Comparative Effectiveness Research (CER) data to compare clinical performance of different devices to each other, or to other treatment options...<br/><br/>... Eventually, this means that CMS will reimburse, and that providers will choose the products that empirically demonstrate the best clinical outcomes, or, if faced with several equally effective products, will choose those available at the most reasonable costs ...<br/><br/>... CMS said recently that it has three medical home demonstrations in development, and expects to implement its Multi-payer Advanced Primary Care Practice Demonstration soon...<br/><br/>... Similarly, ACOs (Accountable Care Organizations) will be making purchasing decisions for hospitals and hospital systems by seeking out treatments and therapies that provide the best clinical outcome, or if the treatments are equal, those at the most reasonable cost ...<br/><br/>... This will be a very different business model than traditional fee for service ... <br/><br/>... As Bob Dylan said many years ago ... "The Times ... They are a Changing"... Start collecting data now...<br/><br/>ENJOY!<br/><br/>CC<br/> AdvaMed establishes new division to support in vitro diagnostics companiestag:medtechiq.ning.com,2009-12-21:2140535:Topic:281292009-12-21T18:38:49.473ZCC-Conrad Clyburn-MedForeSighthttps://medtechiq.ning.com/profile/CCatMedTechIQ
Colleagues,<br />
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The Advanced Medical Technology Association (AdvaMed) announced that it has established a new division - AdvaMed Dx - to focus solely on issues facing companies that manufacture in vitro diagnostic technologies. The division will function as an association within an association, while still having access to, and support from, the broader resources offered by AdvaMed.<br />
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"In vitro diagnostics exemplify the promise of better patient care in this exciting era of the life sciences.…
Colleagues,<br />
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The Advanced Medical Technology Association (AdvaMed) announced that it has established a new division - AdvaMed Dx - to focus solely on issues facing companies that manufacture in vitro diagnostic technologies. The division will function as an association within an association, while still having access to, and support from, the broader resources offered by AdvaMed.<br />
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"In vitro diagnostics exemplify the promise of better patient care in this exciting era of the life sciences. Having an advocacy organization that solely focuses on the unique regulatory, reimbursement and other policy interests of in vitro diagnostics companies will help this vitally important sector continue to grow and thrive, helping patients better detect and fight disease," said Stephen J. Ubl, president and CEO of AdvaMed.<br />
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AdvaMed Dx will be governed by an 18-member Board of Directors and an 8-member Executive Committee, comprised of CEOs from in vitro diagnostics companies. The Board of Directors will be chaired by Scott Garrett, Beckman Coulter's chairman, president and chief executive officer...<br />
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... Some of the issues of particular importance that AdvaMed Dx will focus on include establishment of a modernized risk-based approach to the regulation of in vitro diagnostics to support timely patient access to safe and effective tests. It will also focus on reforming the antiquated Medicare payment system for clinical laboratory diagnostic tests to fully recognize the value of new tests, especially the new generation of molecular diagnostic tests...<br />
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Read on at: <a href="http://www.news-medical.net/news/20091217/AdvaMed-establishes-new-division-to-support-in-vitro-diagnostics-companies.aspx" target="_blank">http://www.news-medical.net/news/20091217/AdvaMed-establishes-new-division-to-support-in-vitro-diagnostics-companies.aspx</a> Top 10 Medical Technology Hazards for 2010tag:medtechiq.ning.com,2009-12-05:2140535:Topic:275002009-12-05T19:09:20.950ZCC-Conrad Clyburn-MedForeSighthttps://medtechiq.ning.com/profile/CCatMedTechIQ
Colleagues,<br />
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ECRI, the pioneering not for profit healthcare research Institute, has published the 10 most important medical technology hazards for 2010. ECRI is among a handful of organizations designated as both a Collaborating Center of the World Health Organization and an Evidence-Based Practice Center by the U.S. Agency for Healthcare Research and Quality...<br />
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The 10 most important medical technology hazards for 2010, are:<br />
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<b>1. Cross-Contamination from Flexible Endoscopes:</b> Incidents of…
Colleagues,<br />
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ECRI, the pioneering not for profit healthcare research Institute, has published the 10 most important medical technology hazards for 2010. ECRI is among a handful of organizations designated as both a Collaborating Center of the World Health Organization and an Evidence-Based Practice Center by the U.S. Agency for Healthcare Research and Quality...<br />
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The 10 most important medical technology hazards for 2010, are:<br />
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<b>1. Cross-Contamination from Flexible Endoscopes:</b> Incidents of pathogen transmission related to flexible endoscopy continue to be reported ... Often in these cases, large numbers of patients must be notified of exposure to potentially contaminated endoscopic equipment.<br />
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<b>2. Alarm Hazards:</b> Clinical alarms, which warn caregivers of hazards, can be instrumental in preventing patient injury or death—as long as caregivers get the message. But, if alarm conditions aren’t effectively communicated, or alarm limits aren’t set appropriately, then patients are at risk.<br />
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<b>3. Surgical Fires:</b> Surgical fires don’t happen often, but when they do, patients can be seriously injured, disfigured, or killed. Our latest estimates are that 550 to 650 surgical fires occur in the United States each year, making them roughly as frequent as other surgical mishaps like wrong-site surgery.<br />
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<b>4. CT Radiation Dose:</b> Computed tomography (CT) is fast, reliable, and convenient—so much so that only recently has its comparatively high x-ray dose begun to garner significant attention. That dose can pose a significant cancer risk: In the United States alone, CT is thought to be responsible for about 6,000 additional cancers a year, roughly<br />
half of them fatal.<br />
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<b>5. Retained Devices and Unretrieved Fragments:</b> ECRI Institute and the U.S. Food and Drug Administration (FDA) frequently receive reports of foreign bodies left inside patients following treatment. Reports typically describe one of two adverse events:<br />
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- Retained devices, in which an entire device is unknowingly left behind.<br />
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- Unretrieved device fragments, in which a portion of a device (e.g., catheter tip, forceps jaw) breaks away and remains inside the patient.<br />
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<b>6. Needlesticks and Other Sharps Injuries:</b> Accidental needlesticks and other sharps related injuries keep happening, despite the common use of needles, intravenous administration sets, and other devices that include mechanisms to protect against such injuries. It’s not only clinicians who are at risk: Patients, laboratory personnel, pharmacy staff, housekeeping personnel, and waste handlers can also be injured by an exposed needle or other sharp. Consequences can include serious cuts and exposure to bloodborne pathogens such as HIV or the hepatitis B or C virus.<br />
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<b>7. Problems with Computerized Equipment and Systems:</b> Computers have become an increasingly integral and critical component of many medical devices—they read, analyze, display, disperse, and record patient data, and they facilitate the exchange and communication of medical information to and from different clinical and data systems. This convergence of medical technology and information technology (IT) is evident in many areas, including medication management systems, the routing of medical alarms to clinician-worn devices (e.g., cell phones and pagers), and the incorporation of medical data from devices such<br />
as physiologic monitors and ventilators into electronic medical records. Convergence presents many benefits, but also many risks. If systems and interfaces are poorly planned, implemented, or managed, they can threaten patient safety and can lead to inefficiencies, significant interruptions in operations, and uncaptured or lost revenue.<br />
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8. Surgical Stapler Hazards:</b> Surgical staplers expedite surgical procedures by replacing tedious manual suturing. But like any medical device, staplers occasionally fail to perform as expected. Although not all failures harm the patient, ECRI Institute is aware of numerous instances that have resulted in prolongation of surgery, serious tissue injury, and even death.<br />
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<b>9. Ferromagnetic Objects in the MR Environment:</b> The clinical literature and problem<br />
reporting databases continue to include numerous reports of injuries and equipment damage in magnetic resonance (MR) centers attributed to the presence of ferromagnetic devices and equipment, including implants, in the MR environment.<br />
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<b>10. Fiberoptic Light-Source Burns:</b> Fiberoptic light sources are designed to illuminate treatment sites through a number of devices, among them endoscopes, retractors, and headlamps. Frequently referred to as “cold” light sources, these devices are anything but. In fact, each year, ECRI Institute receives reports of burns to staff and patients resulting from use of these devices. The two burn hazards most commonly reported are:<br />
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- Burns from the light itself. This hazard is frequently presented when a clinician places the endoscope or the distal end of the fiberoptic cable (after disconnecting it from the instrument)<br />
on the patient without shutting off or otherwise suspending the light source. The light that is continually emitted can generate enough heat to burn objects in very close proximity, sometimes even resulting in fires.<br />
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- Burns from heated cable connections. This hazard can occur when the diameter of the light cable is too large for the light post on the connected device. Some of the light emitted from the cable can contact the metal portion of the light post (rather than the fibers within, which transmit light to the treatment site), heating the connection. If the connection contacts skin, a burn may result.<br />
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Read the full ECRI report at: <a href="https://www.ecri.org/Forms/Documents/Top_Ten_Technology_Hazards_201">https://www.ecri.org/Forms/Documents/Top_Ten_Technology_Hazards_201</a>...<br />
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Tags: devices, hazards, medical, safety, technology