Regulatory en Device tax repeal still possible, Senator Daschle tells Cleveland Clinic audience <div class="node-body blog-body"><div></div>Washington came to Cleveland last night in the form of Senator Tom Daschle (D-SD), who told an audience of healthcare executives, investors, and analysts, that while repeal of the medical device tax may be “off the table” for now, that could change. Addressing a dinner audience at The Cleveland Clinic’s Innovation Summit on “Obesity, Diabetes and the Metabolic Crisis” on Day 14 of the government shutdown and about 48 hours before the country reaches the debt ceiling, the former US Senate Majority Leader said, “With so much bipartisan support in Washington, this issue could continue to reappear and resurface as we consider long-term issues and options moving forward.”</div> <p><a href="" target="_blank">read more</a></p> Regulatory DoubleTake Tue, 15 Oct 2013 16:22:00 +0000 10191 at AdvaMed commends APEC focus on health initiatives <div class="node-body article-body"><div></div>This month’s APEC CEO Summit in Bali, Indonesia, drew praise from AdvaMed for APEC’s continued commitment to creating ethical business environments that support sustainable economic medtech and health care growth. “For more than three years the medical device and diagnostics industry has been proud to work with the APEC forum to advance our shared goal of improving business ethics through establishment and promotion of the Kuala Lumpur Principles for ethical interactions between medical technology firms and health care providers,” said <a href="" title=""></a> AdvaMed CEO Stephen J. Ubl in a prepared statement. “As of this year, more than two-thirds of APEC members have adopted codes that conform to these principles."</div> <p><a href="" target="_blank">read more</a></p> Regulatory Tue, 15 Oct 2013 12:23:00 +0000 10131 at Speak your mind to FDA leaders <div class="node-body blog-body"><div></div>Perhaps you’ve been surprised by the FDA review process and you have some questions about how it works and what is being done to improve communications between the agency and device makers. Or maybe you want to know more about FDA recommendations for cybersecurity practices and policies pertaining to medical device in order to prevent unauthorized access or modification to devices. Whatever FDA-related medtech issues are on your mind, a special Town Hall Meeting at next month’s AdvaMed 2013 conference in Washington will provide you the opportunity to pose your questions to five FDA leaders, face-to-face. The interactive panel session will be held September 25, 2:15-3:30 pm, and will include . . . </div> <p><a href="" target="_blank">read more</a></p> Regulatory DoubleTake Tue, 20 Aug 2013 12:55:00 +0000 9401 at House legislation would make user fees exempt from sequestration <div class="node-body blog-body"><div></div>Legislation that would exempt FDA user fees from cuts under sequestration was introduced this week in the House. Medical Design joins AdvaMed in praising Reps. Leonard Lance (R-NJ), Anna Eshoo (D-CA), Doris Matsui (D-CA), Mike Rogers (R-MI) and the other co-sponsors of this legislation, which will let FDA to have full access to the user fees paid by medical technology companies and other FDA-regulated industries. </div> <p><a href="" target="_blank">read more</a></p> Regulatory DoubleTake Fri, 19 Jul 2013 12:38:00 +0000 9031 at FDA and CMS leaders to address AdvaMed 2013 <div class="node-body article-body"><div></div>FDA Commissioner Margaret Hamburg and CMS Administrator Marilyn Tavenner will speak on US policy and regulatory issues affecting medical technology at AdvaMed 2013 in Washington, Sept. 23-25.</div> <p><a href="" target="_blank">read more</a></p> Regulatory Wed, 26 Jun 2013 16:30:00 +0000 8861 at <p> The announcement of the guests at this year&#39;s 2013 AdvaMed conference. The FDA&#39;s Margaret Hamburg and CMS Administrator Marilyn Tavenner&nbsp;will be on-hand&nbsp;at the&nbsp;MedTech&nbsp;gathering in Washington, D.C.&nbsp;&nbsp;</p> UL announces RoHS II services for medical and lab equipment <div class="node-body article-body"><div></div>Underwriters Laboratories (UL) announced a new program that supports medical device and laboratory equipment manufacturers in their RoHS II Directive (2011/65/EU) compliance efforts. Manufacturers of medical and laboratory equipment, previously excluded from the scope of the original RoHS Directive, are now finding that their devices are within scope of the recast RoHS II Directive. Manufacturers placing these devices in Europe must be in compliance with the new Directive by July 22, 2014. Due diligence on the part of these manufacturers is required to ensure that their Declaration of Conformity and Technical File meets the applicable requirements.</div> <p><a href="" target="_blank">read more</a></p> Regulatory Mon, 06 May 2013 20:03:00 +0000 8271 at Medtech funding shifts to new sources; unstable regulatory environment shares the blame <div class="node-body article-body"><div></div>Christopher J.P. Velis, chairman & CEO of MedCap Advisors has spent more than 20 years as an investment banker, consultant, and venture investor in medical technology. Having represented more than 150 medical device mergers and venture investments, he has brokered a wide array of transactions including licensing agreements, joint venture partnerships and mergers and acquisitions, and exit strategies. In this Q&A, he talks with Medical Design about the investment challenges facing the medical device industry and examines what he says are the three key factors affecting the prosperity of US medtech entrepreneurs. </div> <p><a href="" target="_blank">read more</a></p> Regulatory Mon, 08 Apr 2013 19:03:00 +0000 7821 at <p> Christopher J.P. Velis</p> FDA issues AED PMA proposal <div class="node-body article-body"><div></div>FDA has received approximately 45,000 adverse event reports between 2005 and 2012 associated with the failure of AEDs. Manufacturers have also conducted dozens of recalls. The most common issues involve the design and manufacture of the devices and inadequate control of components purchased from other suppliers, according to an FDA news release. The release goes on to state that the FDA will make sure that automated external defibrillators remain available so that they can continue to save lives.</div> <p><a href="" target="_blank">read more</a></p> Regulatory Tue, 26 Mar 2013 14:12:00 +0000 7741 at User fee access safe for now; sequester still needs to be addressed <div class="node-body blog-body"><div></div>The Senate approved this week a continuing resolution (CR) that preserves House-passed language correcting an anomaly in the current CR that would have barred FDA from spending $40 million of the fees it is collecting from device and diagnostics companies.</div> <p><a href="" target="_blank">read more</a></p> Regulatory DoubleTake Fri, 22 Mar 2013 14:33:00 +0000 7651 at FDA approves new silicone gel-filled breast implant, but requires post-approval safety studies <div class="node-body article-body"><div></div>FDA has approved Allergan’s Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.</div> <p><a href="" target="_blank">read more</a></p> Regulatory Silicone Mon, 25 Feb 2013 19:10:00 +0000 7421 at