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The Gray Sheet
   Full-text available via subscription Subscription journal
     ISSN (Print) 1530-1214
     Published by Informa plc Homepage  [13 journals]
  • FDA Questions Cross-Study Comparisons In Lead Up To EDAP’s
           Ablatherm HIFU Panel
    • Abstract: FDA’s Gastroenterology and Urology Devices Panel July 30 will assess EDAP TMS’ PMA in support of the Ablatherm high intensity focused ultrasound device to treat localized prostate cancer. FDA is questioning the clinical meaningfulness of comparing HIFU metastasis outcomes against data from a distinct radical prostatectomy trial.
      PubDate: Tue, 29 Jul 2014 18:20:01 -040
  • FDA Warning Letters: July 23 And 29
    • Abstract: The agency issued a total of two device-focused warning letters in the past two weeks, including one to CareFusion with citations for quality systems and adverse event reporting violations, and for marketing certain devices without proper approval or clearance.
      PubDate: Tue, 29 Jul 2014 15:40:01 -040
  • Software Risk Should Drive Regulation, AAMI, AdvaMed Say
    • Abstract: Most industry groups weighing in on FDA’s April FDASIA Health IT Report support the agency’s basic ‘hands off’ approach to regulating health management software, but the voluntary standards group AAMI warns that administrative health IT software with incorrect records can lead to poor diagnosis or treatment.
      PubDate: Tue, 29 Jul 2014 15:30:03 -040
  • Most FDA Device User Fee Rates Will Drop In Fiscal 2015
    • Abstract: FDA user-fee rates will decline beginning Oct. 1 for all pre-market device submissions, including standard PMAs and 510(k)s, and PMA annual reports. Meanwhile, the annual FDA registration fee for all device companies will increase by about $300.
      PubDate: Tue, 29 Jul 2014 15:20:01 -040
  • Diagnostics News: Qiagen Companion Dx; Ortho-Clinical Agreement; BD
    • Abstract: Qiagen will co-develop and commercialize a companion diagnostic for AstraZeneca’s Iressa lung-cancer drug under an agreement between the firms. Ortho-Clinical Diagnostics will sell a test system for acute kidney injury.
      PubDate: Mon, 28 Jul 2014 17:30:00 -040
  • New Product Briefs: Devices From Covidien Sorin Cynosure And Phillips
    • Abstract: Covidien is gearing-up to sell its new Emprint ablation system for soft tissue. Sorin announced the CE mark for its Crown PRT valve with proprietary anti-calcification treatment.
      PubDate: Mon, 28 Jul 2014 17:05:01 -040
  • Adding UDIs To Claims Is Crucial for Device Surveillance, Pew Tells
    • Abstract: Incorporating unique device identifiers into insurance claims forms is necessary to leverage FDA’s Sentinel postmarket surveillance initiative to devices, Josh Rising of The Pew Charitable Trusts emphasized to House lawmakers last week.
      PubDate: Mon, 28 Jul 2014 16:00:00 -040
  • Regulatory Harmony Needed To Fulfill Personalized Medicine Promise
    • Abstract: Barriers to reaching the full potential of personalized medicine diagnostics include low reimbursements, best methods to validate tests and physician education needs, as well as discordance between regulations for lab-developed tests and diagnostic test kits, witnesses told a House panel July 23.
      PubDate: Mon, 28 Jul 2014 00:03:01 -040
  • Allergan Pitches Cost-Cutting Plan In Continued Defense Of Valeant Bid
    • Abstract: Allergan continued to fend off Valeant during its second quarter earnings call by announcing a plan to save $475 million over the next five years, which includes 1,500 job cuts. Valeant bit back by complaining to the SEC.
      PubDate: Mon, 28 Jul 2014 00:01:06 -040
  • Paradigm Persists: FDA Finalizes 510(k) Guidance Without Special 510(k)
    • Abstract: FDA has finalized an important guidance on 510(k) substantial equivalence, but decided to hold off on including sections that would overwrite the popular 1998 “The New 510(k) Paradigm” guidance that describe the abridged special and abbreviated 510(k) routes. Industry strongly objected to FDA’s proposed changes to the special 510(k) program in the 2011 draft 510(k) guidance.
      PubDate: Fri, 25 Jul 2014 17:35:01 -040
  • More Cohesive Coverage-With-Evidence Authority Needed, Lawmakers Told
    • Abstract: Former CMS coverage chief Louis Jacques told House lawmakers that the agency’s authorities to implement coverage-with-evidence-development policies are fragmented, hindering application of the program.
      PubDate: Fri, 25 Jul 2014 15:05:03 -040
  • Clinical Registries Need Streamlining To Reap Benefits, Mussallem Tells
    • Abstract: Clinical registries can yield useful information on patient outcomes that can support approval, reimbursement and care decisions but the benefits of registries need to be balanced against their costs, Edwards Lifesciences CEO Michael Mussalem told a House Energy and Commerce subcommittee July 22.
      PubDate: Thu, 24 Jul 2014 18:15:00 -040
  • Hypertension Experts Push For New Trial Of Renal Denervation To Show
    • Abstract: Since Medtronic’s sham-controlled SYMPLICITY HTN-3 trial of its Symplicity renal denervation device failed to meet its primary efficacy endpoint, manufacturers developing renal denervation systems have been working with researchers and FDA to map the next steps in researching and developing this hypertension therapy.
      PubDate: Thu, 24 Jul 2014 17:15:00 -040
  • FDA’s Expedited PMA Pathway Proposal: To Expand Or Contain'
    • Abstract: Companies want FDA to expand the bounds of its accelerated device development program, while others urge FDA to be cautious.
      PubDate: Thu, 24 Jul 2014 17:00:01 -040
  • Boston Scientific Launches Three Interventional Cardiology Devices
    • Abstract: A bare-metal stent approved in the U.S., a coronary-focused drug-coated balloon launched in Europe, and a global launch of a new intravascular imaging system were announced this week by Boston Scientific.
      PubDate: Wed, 23 Jul 2014 18:15:02 -040
  • People Briefs: Appointments At Covidien, Stryker, DaVita, InspireMD, JDRF
    • Abstract: Covidien expands group president Bryan Hanson’s portfolio to include all business units. Stryker adds board chairmen role for CEO Kevin Lobo.
      PubDate: Wed, 23 Jul 2014 18:00:01 -040
  • FDA Recalls List – July 16, 2014
    • Abstract: The agency’s July 16 enforcement report includes recalls from Hospira, Covidien and Terumo.
      PubDate: Wed, 23 Jul 2014 16:05:01 -040
  • PMA Data: High Approval Volume, Reduced Supplement Review Time For May
    • Abstract: FDA achieved highs in the volume of original PMAs and supplements approved in May, and lows in PMA supplement review times for approvals that month, according to analysis by “The Gray Sheet” of the agency’s most recent official monthly PMA listing. Exclusive graphical elements included.
      PubDate: Tue, 22 Jul 2014 14:00:02 -040
  • Stryker Bucks Trend With Strong Recon Sales
    • Abstract: Stryker’s second-quarter sales figures paint the U.S. joint reconstruction market in a more positive light than some feared earlier in the month.
      PubDate: Mon, 21 Jul 2014 17:00:00 -040
  • Medtech Provides $23 Billion In Net Economic Benefits, Milken Report Finds
    • Abstract: The broad economic benefits provided by advanced diagnostics and devices outweigh the costs of using medical technology by about $23 billion annually, suggests a recent industry-sponsored report.
      PubDate: Mon, 21 Jul 2014 16:20:00 -040
  • GOP Tries To Codify FDA’s Guidance Policy On Low-Risk Mobile Devices
    • Abstract: Republican Rep. Marsha Blackburn, Tenn., said at a July 17 House Energy and Commerce subpanel meeting on digital health she intends to codify FDA’s ‘hands off’ position for most low risk mobile medical apps and digital software, as in the mobile device guidance.
      PubDate: Mon, 21 Jul 2014 00:01:16 -040
  • New Products: Titan Spine Earns 510(k) For Lateral Fusion Device; Data On
           Misonix’ Ultrasonic BoneScalpel Published;
           Boston Scientific Earns CE Mark For Midsized TAVR
    • Abstract: Titan boasts its Endoskeleton TL is the first lateral spine fusion device to feature surface technology. New trial data shows surgical correction of adolescent idiopathic scoliosis with the ultrasonic BoneScalpel reduces blood-loss.
      PubDate: Fri, 18 Jul 2014 15:00:03 -040
  • Senators Push OMB For Lab-Developed Test Guidance, Academic Labs Resist
    • Abstract: Several Democratic Senators want the Office of Management and Budget to release the FDA draft guidance on lab-developed tests that has been stuck at OMB for years. Academic clinical labs send their own letter to the budget office, pleading that the guidance not be released.
      PubDate: Thu, 17 Jul 2014 14:00:02 -040
  • FDA Recalls List – July 9, 2014
    • Abstract: Medtronic Neurosurgery recalls Duet external drainage and monitoring systems due to unexpected disconnection risk. Siemens recalls Mobilett XP digital mobile X-ray system after discovering the batteries present a fire hazard.
      PubDate: Thu, 17 Jul 2014 12:00:03 -040
  • FDA Panel Advises Patient Consent With Power Morcellators To Warn Of
           Cancer Risk
    • Abstract: FDA’s Obstetrics and Gynecology Devices Advisory panel recommended a mandatory patient consent form, signed by both patient and physician, for use of laparascopic power morcellators during minimally invasive hysterectomy, and advised the morcellators not be used in individuals with suspected malignant sarcomas.
      PubDate: Wed, 16 Jul 2014 17:00:08 -040
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