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<title>Medgadget</title>
<link>http://www.medgadget.com/</link>
<description>Internet journal of emerging medical technologies.</description>
<copyright>Copyright 2010</copyright>
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<item>
<title>Now Available: Stem Cell Therapeutics in US Without FDA Approval</title>
<description><![CDATA[<p><img class="side" src="http://www.medgadget.com/archives/img/1244kjj.jpg" width="196" height="57" />Stem cell therapies are still a long way from receiving FDA approval in the US, but it turns out there is at least one group of doctors that's actually offering it right now.  <strong>Regenerative Sciences</strong> in Broomfield, Colorado makes available the Regenexx procedure, a bone and cartilage regeneration technology, as an alternative to orthopedic surgery or a life time dependence to NSAIDs.  Because Regenerative Sciences operates exclusively within Colorado, the company believes that Federal laws do not apply to it.  This is probably more a study of the commerce clause of the Constitution rather than regenerative medicine, but we're at least glad to see docs taking initiative and testing out the limits of their ability to treat people.</p>

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<p>More from the <em>Singularity Hub</em>: <a href="http://singularityhub.com/2010/03/09/colorado-doctors-skirt-fda-jurisdiction-to-provide-human-stem-cell-therapies-video/">Doctors Skirt FDA To Provide Human Stem Cell Therapy...</a></p>

<p><strong>Link</strong>: <a href="http://www.regenexx.com/">Regenexx...</a></p>]]></description>
<link>http://www.medgadget.com/archives/2010/03/now_available_stem_cell_therapeutics_in_us_without_fda_approval.html</link>
<guid>http://www.medgadget.com/archives/2010/03/now_available_stem_cell_therapeutics_in_us_without_fda_approval.html</guid>
<category>Society</category>
<pubDate>Wed, 10 Mar 2010 09:38:13 -0800</pubDate>
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<item>
<title>da Vinci Robot Hoopla Reaches Pages of NYT</title>
<description><![CDATA[<p><img class="bcntr" src="http://www.medgadget.com/archives/img/5645pot.jpg"><br />
In last week's Sunday <em>New York Times</em>, the newspaper profiled the controversy surrounding the adoption of robotic surgery technology in America's hospitals.  The industry's only real robotic surgical system, the da Vinci from <strong>Intuitive Surgical</strong>, managed to create the buzz necessary to have patients and clinicians egg each other on to buy and use the system as if it were a miracle tool. Even the President decided to literally take a look into the device (see pic above).  In reality, the benefits and disadvantages of robotic surgery are not yet clear, while the costs between the equipment and longer surgical time are exuberant. Still, people seem to believe in wonders of new technologies and demand the da Vinci.</p>

<p>A snippet from NYT:</p>

<blockquote>One large national study, which compared outcomes among Medicare patients, indicated that surgery with a robot might lead to fewer in-hospital complications, but that it might also lead to more impotence  and incontinence. But the study included conventional laparoscopy patients among the ones who had robot-assisted surgery, making it difficult to assess its conclusions.

<p>It is also not known whether robot-assisted prostate surgery gives better, worse or equivalent long-term cancer control than the traditional methods, either with a four-inch incision or with smaller incisions and a laparoscope. And researchers know of no large studies planned or under way.</p>

<p>Meanwhile, marketing has moved into the breach, with hospitals and surgeons advertising their services with claims that make critics raise their eyebrows. For example, surgeons in private practice at the New Jersey Center for Prostate Cancer and Urology advertise on their Web site that robot-assisted surgery provides &ldquo;cancer cure equally as well as traditional prostate surgery&rdquo; and &ldquo;significantly improved urinary control.&rdquo;</blockquote></p>

<p><em>New York Times</em>: <a href="http://www.nytimes.com/2010/02/14/health/14robot.html">Results Unproven, Robotic Surgery Wins Converts...</a></p>

<p><a href="http://www.google.com/search?hl=en&safe=off&client=firefox-a&rls=org.mozilla%3Aen-US%3Aofficial&hs=ktx&q=%22da+vinci%22+site%3Amedgadget.com&aq=f&aqi=&oq=">Medgadget da Vinci archives...</a></p>]]></description>
<link>http://www.medgadget.com/archives/2010/02/da_vinci_robot_hoopla_reaches_pages_of_nyt.html</link>
<guid>http://www.medgadget.com/archives/2010/02/da_vinci_robot_hoopla_reaches_pages_of_nyt.html</guid>
<category>Society</category>
<pubDate>Tue, 16 Feb 2010 12:57:47 -0800</pubDate>
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<item>
<title>Masimo Invests in Anesthesia Awareness Technology. Good Move? We Don&apos;t Think So.</title>
<description><![CDATA[<p><img class="bside" src="http://www.medgadget.com/archives/img/oioiiwenn.jpg" width="241" height="216" /><strong>Masimo </strong>is one of the coolest companies out there. Any time it announces a new device, we get excited to profile the company's new technologies. But when Masimo recently <a href="http://www.masimo.com/news/index.cfm#2929">announced</a> an investment of $3.5 million in <strong>SEDLine</strong> brain function monitoring business, we raised our eyebrows. </p>

<p>SEDLine, Inc's electroencephalogram (EEG) brain function monitors are eerily similar to <strong>Aspect Medical</strong>'s <a href="http://www.aspectmedical.com/HealthcareProfessionals.aspx">BIS technology</a>. Available for many years now, BIS has been promoted by the company as a useful gadget for intraop use to monitor the depth of anesthesia, either for MAC or general anesthetic cases. Truth be told, after millions of dollars and years of promotion, BIS did not get far. It's still rarely used, because most anesthesiologists would rather adjust the depth of anesthesia based on heart rate, BP, and other indirect parameters, rather than on a number derived by a proprietary algorithm that no one has seen. Furthermore, the American Society of Anesthesiologists <a href="http://medgadget.com/archives/2005/10/anesthesiology.html" title="not to recommend widespread use of "brain function monitoring devices"">does not recommend the widespread use of brain function monitoring devices</a>, such as BIS. The other problem, of course, is the <a href="http://content.nejm.org/cgi/content/full/358/11/1097">devastating study</a> published in the March, 2008 issue of the <em>New England Journal of Medicine</em>, from which Aspect's stock has never recovered.</p>

<p>So to our eyes, the EEG-based depth of anesthesia monitoring technology has hit the wall. We don't know everything, and the future might be bright, but somehow paint us skeptical on this Masimo move.</p>

<p>Aspect Medical Systems's stock chart is below.</p>

<p><img alt="" class="bcntr" src="http://www.medgadget.com/archives/img/4232drta.jpg" width="468" height="225" /></p>

<p><strong>Press releases:</strong> <a href="http://www.masimo.com/news/index.cfm#2929" title="Masimo Announces Investment in SEDLine Brain Function Monitoring Business">Masimo Announces Investment in SEDLine Brain Function Monitoring Business...</a>; <a href="http://www.businesswire.com/portal/site/pecom/?ndmViewId=news_view&newsId=20100112005983&newsLang=en" title="SEDLine™ Announces Acquisition of Hospira Brain Function Monitoring Business">SEDLine&trade; Announces Acquisition of Hospira Brain Function Monitoring Business</a></p>

<p><strong>Product page:</strong> <a href="http://hospira.se/Products/SEDline.aspx" title="SEDLine™ Brain-Function Monitoring System">SEDLine&trade; Brain-Function Monitoring System...</a></p>

<p><strong> American Society of Anesthesiologists' </strong> <a href="http://www.asahq.org/patientEducation.htm" title="Patient Awareness">patient awareness info...</a></p>]]></description>
<link>http://www.medgadget.com/archives/2010/01/masimo_invests_in_anesthesia_awareness_technology_good_move_we_dont_think_so.html</link>
<guid>http://www.medgadget.com/archives/2010/01/masimo_invests_in_anesthesia_awareness_technology_good_move_we_dont_think_so.html</guid>
<category>Society</category>
<pubDate>Wed, 13 Jan 2010 11:26:47 -0800</pubDate>
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<title>Study Looks Into Potential Side Effects of Terahertz Full Body Scanner Technology</title>
<description><![CDATA[<p><img class="bcntr" src="http://www.medgadget.com/archives/img/38483.jpg" width="468" height="152" /><br />
As new government directives are now mandating full body (terahertz) scanning (or pat down searches) of our private parts on all US inbound flights, a recent research article in <em>arXiv</em> points to potential negative health effects from the new technology.  Terahertz waves penetrate non-conducting material like clothing, but then they deposit energy in the skin.  Now researchers at the Center for Nonlinear Studies at Los Alamos National Laboratory have shown that terahertz radiation may be able to do some serious damage to the DNA it encounters when bouncing off your body</p>

<p><em>Physics arXiv Blog</em> explains:</p>

<p><img class="bside" src="http://www.medgadget.com/archives/img/t32n3.jpg" width="150" height="257" /><blockquote>Alexandrov <em>[Boian Alexandrov at the Center for Nonlinear Studies at Los Alamos National Laboratory in New Mexico --ed.]</em> and co have created a model to investigate how THz fields interact with double-stranded DNA and what they've found is remarkable. They say that although the forces generated are tiny, resonant effects allow THz waves to unzip double-stranded DNA, creating bubbles in the double strand that could significantly interfere with processes such as gene expression and DNA replication. That's a jaw dropping conclusion.</p>

<p>And it also explains why the evidence has been so hard to garner. Ordinary resonant effects are not powerful enough to do do this kind of damage but nonlinear resonances can. These nonlinear instabilities are much less likely to form which explains why the character of THz genotoxic effects are probabilistic rather than deterministic, say the team.</blockquote></p>

<p><a href="http://www.technologyreview.com/blog/arxiv/24331/">More</a> at <em>Physics arXiv Blog</em>... </p>

<p>Full article in <em>arXiv Biological Physics</em>: <a href="http://arxiv.org/abs/0910.5294">DNA Breathing Dynamics in the Presence of a Terahertz Field</a></p>]]></description>
<link>http://www.medgadget.com/archives/2010/01/study_looks_into_potential_side_effects_of_terahertz_full_body_scanner_technology.html</link>
<guid>http://www.medgadget.com/archives/2010/01/study_looks_into_potential_side_effects_of_terahertz_full_body_scanner_technology.html</guid>
<category>Society</category>
<pubDate>Mon, 04 Jan 2010 00:00:02 -0800</pubDate>
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<item>
<title>Legal Social Networking Tips for MDs</title>
<description><![CDATA[<p><img class="bside" src="http://www.medgadget.com/archives/img/xxxzzxz.jpg" width="222" height="281" />The <em>Massachusetts Medical Law Report</em> recently ran an article discussing the legal issues surrounding doctors' use of social networking sites like Facebook and Twitter.  The consensus seems to steer towards paranoia and to thinking twice before discussing actual patient cases.</p>

<p>A snippet:</p>

<blockquote>&ldquo;If you can&rsquo;t do something at a cocktail party without people staring and looking at you strangely, you shouldn&rsquo;t be able to do the same thing online,&rdquo; says Jim Tobin, president of Ignite Social Media, a Cary, N.C., social-media agency that is developing a social-networking program for the Massachusetts Medical Society and its members.</blockquote>

<p>Article in <em>Massachusetts Medical Law Report</em>: <a href="http://mamedicallaw.com/blog/2009/10/19/social-networking-101-for-physicians/">Social networking 101 for physicians...</a></p>

<p>Image credit: <a href="http://www.flickr.com/photos/rosefirerising/1175879764/">rosefirerising</a></p>

<p>(hat tip: <a href="http://www.kevinmd.com/blog/2009/12/avoid-social-networking-pitfalls-physicians.html">Kevin MD</a>)</p>]]></description>
<link>http://www.medgadget.com/archives/2009/12/legal_social_networking_tips_for_doctors.html</link>
<guid>http://www.medgadget.com/archives/2009/12/legal_social_networking_tips_for_doctors.html</guid>
<category>Society</category>
<pubDate>Fri, 18 Dec 2009 00:00:35 -0800</pubDate>
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<title>Track Driven Wheelchair for Off-Road Adventure</title>
<description><![CDATA[<p><img class="bcntr" src="http://www.medgadget.com/archives/img/2nn2nnk.jpg" width="468" height="296" /><br />
We've covered all-terrain motorized wheelchairs before (<a href="http://medgadget.com/archives/2006/04/tankchair_1.html">1</a>,<a href="http://medgadget.com/archives/2008/01/tank_chair.html">2</a>) and you know what? These "tank-chairs" are awesome and so we're talking about it again. </p>

<p>The latest company to enter the fray is <strong>Action Manufacturing</strong> of Marshall, MN, makers of the Action Trackchair. If you're paralyzed below the waist but have a hankering to explore a little off the beaten path, you've got a mini tank under you to help out.</p>

<p>Here's a report from <em>KARE</em> news:</p>

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<p>Prices on Action's website run for $6000 for most models, though "Orange with Blue Metallic Splash" seems to be on sale for $5500. </p>

<p></p>

<p><strong>Product page</strong>: <a href="http://www.actiontrackchair.com" title="all-terrain wheelchair">Action Trackchair - off road wheelchair</a></p>]]></description>
<link>http://www.medgadget.com/archives/2009/12/track_driven_wheelchair_for_offroad_adventure.html</link>
<guid>http://www.medgadget.com/archives/2009/12/track_driven_wheelchair_for_offroad_adventure.html</guid>
<category>Rehab</category>
<pubDate>Thu, 10 Dec 2009 13:33:01 -0800</pubDate>
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<item>
<title>The Regulatory Future of Mobile Medical Apps</title>
<description><![CDATA[<p><img src="http://www.medgadget.com/archives/img/5534dkkd.jpg" class="side">Medical and health applications for iPhones, Blackberry devices, Android phones and other mobile gadgets already number in the thousands.  The problem is that only one app, <a href="http://medgadget.com/archives/2009/04/intrapartum_live_waveforms_on_the_go.html">AirStrip OB</a>, actually earned FDA's explicit blessings to be marketed as a medical device.  So the big question is whether the FDA is going to "put its foot down" and require that it provide clearance before new apps go to market.  <em>MobiHealthNews</em> has been following this dilemma and provides some thoughts on the direction that regulation of this industry may take.</p>

<blockquote>&ldquo;At a high-level, we look for two things: (1) a device with (2) a medical intended use. The first prong of the test &mdash; that there must be an actual product &mdash; means FDA doesn&rsquo;t regulate, for example, medical procedures. The thing in question must be a thing, and not information or something else intangible. Software can be a medical device if it&rsquo;s written on computer media, as opposed to printed on paper. The media with the code written on it is enough of a &lsquo;thing&rsquo; for FDA to regulate,&rdquo; Thomspon [Bradley Merrill Thompson, Partner at Epstein Becker &amp; Green] writes. &ldquo;In the area of mobile health technology, it&rsquo;s important to understand that an accessory or a component of a medical device is itself a regulated medical device. Further, the difference between an accessory and a component is who buys it. End-users buy accessories, while manufacturers buy components. Thus the exact same piece of equipment could be either an accessory or a component depending on the target purchaser.&rdquo;</blockquote>

<p><strong>Link</strong>: <a href="http://mobihealthnews.com/5530/when-will-the-fda-drop-the-gavel/">When will the FDA drop the gavel?</a></p>]]></description>
<link>http://www.medgadget.com/archives/2009/11/the_regulatory_future_of_mobile_medical_apps.html</link>
<guid>http://www.medgadget.com/archives/2009/11/the_regulatory_future_of_mobile_medical_apps.html</guid>
<category>Society</category>
<pubDate>Tue, 24 Nov 2009 10:36:40 -0800</pubDate>
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<title>Public About Ready for a Brave New World</title>
<description><![CDATA[<p><img class="bside" alt="cyborgmadonna.jpg" src="http://www.medgadget.com/archives/img/cyborgmadonna.jpg" width="222" height="258" /><strong>Zogby International </strong>recently conducted a poll of American adults asking how likely they are to be interested in having assistive microchips implanted in their brains.  Would people be interested in having the Internet wired straight to their brains, or perhaps a chip that programs the immune system to ward off all disease?  Turns out that up to a quarter of the population seems willing to do it, given enough practical benefit from the implantation.</p>

<p>John Zogby analyzes the findings at <em>Forbes.com</em>:</p>

<blockquote>A quick analysis reveals a hierarchy of needs. One in four would be open to allowing an artificial intelligence into his or her body to ward off disease (and possibly mortality itself). Slightly fewer are so sure knowledge is power that they too would want the chip implant. But only 6% would want a computer chip just to be entertained. Being wired to the Internet can satisfy a lot of needs, both practical and prurient. So the fact that we found 13% who might want to turn themselves into Me.com makes some sense in this needs hierarchy.

<p>We don't know how many would-be cyberheads might actually go through with this when the hypothetical physician enters the room with surgical lasers and nano-sized computer chips in hand. But we can certainly draw conclusions from our polls about which demographic groups are most open to being hooked up to the Internet and computer technology. This is especially true in the survey of 41,175, where sub-group sizes are in the thousands.</p>

<p>If your first guess is that younger people are the most likely, you are correct, but only to a degree. On being wired to the Internet, the First Global generation of 18- to 29-year-olds is the leader at 24%. The percentages decline with age to only 8% of people 65 and older. First Globals are also more likely than the other age groups to want the entertainment chip, but that number is still only 10%. First Globals are about 5% more likely to want the knowledge chip. However, there is no age difference on the immunity chip question. </blockquote></p>

<p><a href="http://www.forbes.com/2009/08/05/neural-implant-artificial-intelligence-opinions-columnists-john-zogby.html?partner=links">Read on</a> at <em>Forbes.com</em>...</p>

<p>Image credit: <a href="http://www.flickr.com/photos/13521837@N00/2577665727/">Walraven</a></p>]]></description>
<link>http://www.medgadget.com/archives/2009/08/public_about_ready_for_a_brave_new_world.html</link>
<guid>http://www.medgadget.com/archives/2009/08/public_about_ready_for_a_brave_new_world.html</guid>
<category>Society</category>
<pubDate>Tue, 11 Aug 2009 00:24:11 -0800</pubDate>
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<title>POTUS Tries Out Da Vinci Surgical Robot</title>
<description><![CDATA[<p><img alt="" class="bcntr" src="http://www.medgadget.com/archives/img/5645pot.jpg" width="468" height="312" /><br />
During Barack Obama's healthcare reform tour, while touting cheaper clinical and technological approaches for medicine, the President got a hands-on experience with the Da Vinci robotic surgical system from <strong>Intuitive Surgical</strong>.  The Cleveland Clinic, perhaps having an odd sense of humor, touted to the President one of the most expensive pieces of equipment used in the OR. We are all for new technology, but opinions about costs and benefits of robotic surgical systems are far from uniform.</p>

<p>Here's what Paul Levy, President and CEO of Beth Israel Deaconess Medical Center in Boston, <a href="http://runningahospital.blogspot.com/2008/11/uncle.html">wrote</a> on his blog:</p>

<blockquote><a href="http://runningahospital.blogspot.com/2007/02/da-vinci-uncoded-or-surgical-robots.html">Many months ago</a>, I wrote about the da Vinci Robot Surgical System and expressed doubts about whether there was evidence to support the clinical efficacy of this equipment, as opposed to the marketing efficacy of the company selling it. Well, the time has come to graciously say, "Uncle!"

<p>Without making any representations about the relative clinical value of this robotic system versus manual laparoscopic surgery, I am writing to let you know we have decided to buy one for our hospital. Why? Well, in simple terms, because virtually all the academic medical centers and many community hospitals in the Boston area have bought one. Patients who are otherwise loyal to our hospital and our doctors are transferring their surgical treatments to other places. Prospective residents who are trying to decide where to have their surgical training look upon our lack of the robot as a deficit in our education program. Prospective physician recruits feel likewise. And, these factors are now spreading beyond urology into the field of gynecological surgery. So as a matter of good business planning, concern for the quality of our training program, and to continue to attract and retain the best possible doctors, the decision was made for us.</blockquote></p>

<p>So there you have it. As the company's latest device, the da Vinci Si HD Surgical System, comes with a $1.75 million price tag, it is not clear whether the healthcare reform plan would consider alternative, more traditional laparoscopic devices, as a saving option to the modern, advanced technology found in the Da Vinci.</p>

<p><strong>Link</strong>: <a href="http://www.whitehouse.gov/blog/A-Health-Reform-Town-Hall-in-Ohio/">White House Blog...</a>...</p>

<p><strong>Medgadget archives</strong>: <a href="http://www.bing.com/search?q=da+Vinci+Surgical+System+site%3Amedgadget.com&go=&form=QBRE&qs=n">da Vinci Surgical System...</a></p>]]></description>
<link>http://www.medgadget.com/archives/2009/07/potus_tries_out_da_vinci_surgical_robot.html</link>
<guid>http://www.medgadget.com/archives/2009/07/potus_tries_out_da_vinci_surgical_robot.html</guid>
<category>Society</category>
<pubDate>Tue, 28 Jul 2009 00:07:38 -0800</pubDate>
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<title>Where Are Medicare Stories at BarackObama.com?</title>
<description><![CDATA[<p><img alt="" class="bside" src="http://www.medgadget.com/archives/img/43534ggt.jpg" width="300" height="230" />We rarely delve into politics. But if we must, Independence Day is probably a good occasion. </p>

<p>So over coffee and a brioche, we were reading <a href="http://stories.barackobama.com/healthcare" title="Health Care Stories for America  BarackObama.com">Health Care Stories for America @ BarackObama.com</a>. There we noticed an interesting pattern: scolding of health insurance companies is on at full steam, but no one wants to talk about the elephant in the room: Medicare. And that's where the real health care dollars are being sucked in, like into a giant black hole. </p>

<p>Don't believe our independent Medgadget team of doctors? Ask practically any other physician, and he or she will tell you about real horrors. How about stories where hundreds of thousands of dollars are spend on each patient that has practically hit the wall? How about pacemakers and AICDs on 90 year olds with Alzheimer's, Parkinson's or stroke?  How about interventional radiology procedures, where a terminal elderly patient becomes a cushion pad for physicians? How about CAT scans, MRIs, leg bypasses, peripheral catheters, exploratory laparotomies, and hundreds of lab tests that are done every day, that often prolong more suffering than life?</p>

<p>We understand that there are many problems in healthcare when it comes to younger patients. We know that people lose jobs, have prior conditions, and as a result they end up losing their insurance coverage. We also understand there are abuses in the health insurance industry. But the real bulk of the societal problems is not with the people under 60, but <a href="http://content.nejm.org/cgi/content/full/342/19/1409">with older patients</a>. In other words, with Medicare. And when families, who don't have to co-pay for any medical services, are being asked to estimate the risk/benefits ratios of going ahead with a treatment, the hope itself forces them to go "all in." And that is how the tax payer's money are being spent nowadays. For all the talk over at the <em>Health Care Stories for America</em>, there is indeed little substance but lots of fear. And that is from the administration that has promised us hope.</p>

<p>And, finally, the real question. Why does the President and his team use the wrong symbol of <a href="http://en.wikipedia.org/wiki/Caduceus">Caduceus</a> for his health care initiative? As <a href="http://medgadget.com/archives/2005/06/the_staff_of_as.html">we noted</a> before, the Staff of Asclepius should be a single serpent encircling a staff, and no wings and no snake families, please. We hope you have a nice Independence Day!</p>]]></description>
<link>http://www.medgadget.com/archives/2009/07/where_are_medicare_stories_at_barackobamacom.html</link>
<guid>http://www.medgadget.com/archives/2009/07/where_are_medicare_stories_at_barackobamacom.html</guid>
<category>Society</category>
<pubDate>Thu, 02 Jul 2009 13:02:47 -0800</pubDate>
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