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  The Gray Sheet
   Full-text available via subscription Subscription journal
   ISSN (Print) 1530-1214
   Published by Informa plc Homepage  [14 journals]
  • Updated SOFTWARE Act: Still Too Ambiguous For Industry'
    • Abstract: While some industry experts say the updated version of the SOFTWARE Act strikes a tenable balance between industry's need for certainty and FDA's need to ensure patient safety, others argue it does not go far enough to explicitly state what kinds of health IT software the agency will not regulate.
      PubDate: Tue, 26 May 2015 18:30:02 -040
  • EuroPCR In Brief
    • Abstract: Device trial data at the EuroPCR 2015 conference, held in Paris May 19-22, featured presentations on TAVR, stents and drug-coated balloons.
      PubDate: Tue, 26 May 2015 18:00:01 -040
  • HRS In Brief
    • Abstract: Data highlighted earlier this month at the Heart Rhythm Society annual conference in Boston include results for new ablation systems, quadripolar leads and antibacterial cardiac implant wraps.
      PubDate: Tue, 26 May 2015 17:40:01 -040
  • To Panel or Not To Panel' FDA May Address Criteria In Upcoming
    • Abstract: Industry advocates anticipate FDA will be issuing guidance on the criteria it uses to determine if a premarket submission warrants advisory panel review. The time burden of panel meetings was demonstrated by FY 2013-received PMAs, which were subject to a greater than normal proportion of panel meetings and a spike in decision times.
      PubDate: Tue, 26 May 2015 17:20:02 -040
  • TAVR May Be A Good Choice For Even Low-Risk Patients, NOTION Trial Shows
    • Abstract: So far, transcatheter aortic valves are only indicated for patients for whom surgery presents high or even intolerable risks. Two-year data from a trial in Scandinavia suggests TAVR could eventually supplant surgical valve replacement in patients at low risk during surgery, but this approach will require more study.
      PubDate: Mon, 25 May 2015 11:00:02 -040
  • Novel Devices Penetrate Migraine Headache Market
    • Abstract: Several new device-based therapies are emerging d to fill the treatment gap for migraine sufferers who do not respond to traditional migraine therapies. The novel treatments include a headband-like device designed to stimulate the trigeminal nerve and an image-guided intranasal interventional treatment.
      PubDate: Mon, 25 May 2015 10:00:01 -040
  • Danaher Buys Filtration Firm Pall, Will Split Into Two
    • Abstract: The major acquisition will be followed by a company split – the Danaher name will stay with the business that includes diagnostics and dental segments, and a second, more industrial-focused company will be formed by the end of 2016.
      PubDate: Mon, 25 May 2015 00:00:01 -040
  • $550 Million FDA Fund Approved In Cures Bill, Paid For With Oil Reserves
    • Abstract: A House panel agreed 51-0 to approve 21st Century Cures legislation, including a $550 million, five-year fund to cover some of the FDA mandates in the bill, but not the device reforms. Reform spending would be offset by the sale of eight million barrels of oil from the Strategic Petroleum Reserve.
      PubDate: Thu, 21 May 2015 18:30:03 -040
  • National Medicare Analysis Opened For Watchman Device
    • Abstract: CMS will consider a national policy for the left atrial appendage closure device in response to a request from Boston Scientific.
      PubDate: Thu, 21 May 2015 18:15:01 -040
  • Ilumien Trials Support Optimal Coherence Tomography During PCI
    • Abstract: St. Jude is touting data from two trials supporting optical coherence tomography as an important decision-making tool during percutaneous coronary intervention.
      PubDate: Thu, 21 May 2015 17:00:06 -040
  • Direct Flow Reports Second-To-None Two-Year TAVR Survival Data
    • Abstract: Results from the CE mark trial of the company's transcatheter aortic valve as well as early data from the post-market registry so far support the company's claim that its device virtually eliminates aortic regurgitation.
      PubDate: Thu, 21 May 2015 17:00:01 -040
  • TAVR Leaflet Thickening Side-Effect Should Not Change Practice –
    • Abstract: New data presented at the EuroPCR conference in Paris suggest the valve leaflet thickening seen with St Jude Medical’s Portico transcatheter aortic valve is not a danger to patients.
      PubDate: Thu, 21 May 2015 16:30:02 -040
  • Quality System Certification Would Supplant Some 510(k)s In Updated House
    • Abstract: Committee-approved 21st Century Cures legislation includes a revised third-party quality system assessment provision that would allow certain types of modifications to 510(k) devices without a new submission if the firm's quality system has been specially certified by a third-party auditor.
      PubDate: Thu, 21 May 2015 14:10:04 -040
  • CDRH Staff Credits Advocacy Groups For Patient Preference Guidance
    • Abstract: Top CDRH officials say while they have been working to incorporate patient preference into their regulatory process, it was the push from patients to get more involved in the agency's decision making process that led the agency to develop a new draft guidance on the topic.
      PubDate: Thu, 21 May 2015 13:15:01 -040
  • Cures Bill Would Mandate Flurry Of Device Guidance Documents
    • Abstract: A long list of device-related draft guidances, most due within 12 months of passage, would result from the 21st Century Cures bill that is set for a full House Committee vote May 21.
      PubDate: Wed, 20 May 2015 18:00:02 -040
  • Eli Lilly Invests In Digital-Friendly Insulin Pen Firm
    • Abstract: The drug firm led the latest funding round for San Diego start-up Companion Medical, which is developing a Bluetooth-enabled insulin pen and associated smartphone app.
      PubDate: Wed, 20 May 2015 16:20:03 -040
  • New Product Briefs
    • Abstract: Product news from Silk Road Medical, St. Jude, Tandem Diabetes and Abbott.
      PubDate: Tue, 19 May 2015 17:35:04 -040
  • Edwards Undeterred By Latest Speed Bump In Transcatheter Mitral Valve
    • Abstract: Edwards has temporarily paused the FORTIS clinical program evaluating a new transcatheter mitral valve to resolve valve thrombosis issues that emerged in the first 20 patients.
      PubDate: Tue, 19 May 2015 17:25:01 -040
  • Veracyte's Lung Cancer Test Shows Promise
    • Abstract: As more people become eligible for routine annual lung cancer screenings, Veracyte says its Percepta bronchial genomic classifier lung cancer test provides a less invasive test than biopsies and more reliability than bronchoscopy alone, according to newly published data.
      PubDate: Tue, 19 May 2015 15:30:00 -040
  • Warning Letter Roundup & Recap – May 19, 2015
    • Abstract: After evaluating information gathered during an FDA inspection and reviewing ZYTO Technologies' website, the agency discovered that the firm promoted its device for functions outside its cleared intended use; MicroAire had no internal systems for determining whether an event was MDR-reportable; and more. Two warning letters were listed by FDA this week.
      PubDate: Tue, 19 May 2015 14:40:02 -040
  • FDA Advisors Call For New Cleaning Methods, Sterilization For
    • Abstract: Current reprocessing methods for duodenoscopes provide no reasonable assurance of safety and effectiveness, and manual cleaning steps need improvement, an FDA panel said. Most panelists called for upgrading manual cleaning, followed by lengthy sterilization of the products until they can be redesigned.
      PubDate: Mon, 18 May 2015 18:30:02 -040
  • Modifying Clinical Studies Midstream Can Be Done, With Caution, FDA Says
    • Abstract: Adaptive device clinical trials, where study is designed in anticipation of midstream changes, are the focus on a new FDA draft guidance. Adaptive trials can reduce the duration and cost of a study without undermining its integrity, but the practice should be applied with caution, FDA says.
      PubDate: Mon, 18 May 2015 17:15:02 -040
  • FDA Funding In Cures Bill Complicated By Metrics, Appropriators
    • Abstract: The wide-ranging reforms in the House 21st Century Cures bill have attracted a good measure of bipartisan support, but the lack of extra funding for FDA continues to be a source of tension.
      PubDate: Mon, 18 May 2015 00:01:51 -040
  • Burgess Still Wants to Limit FDA LDT Oversight
    • Abstract: Despite failing to move on a bill to restrict FDA oversight of lab developed tests (LDT) or reintroducing the bill in recent sessions, Rep. Michael Burgess, R-Texas, says he still supports the idea and is still working on trying to limit the agency's authority.
      PubDate: Fri, 15 May 2015 16:30:04 -040
  • MDIC Catalog Outlines Patient Preference Methods
    • Abstract: Sponsors who think patient preference could be a key factor to the approval of their device can look to the appendix section of the new MDIC report for study methods that can help support claims with information showing that patients may be willing to take on more risks to get their hands on the treatment.
      PubDate: Fri, 15 May 2015 13:00:00 -040
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