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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]
  • Home-Use E-Labeling Pilot Round 2: CDRH Seeks Volunteers
    • Abstract: FDA’s device center issued a request to participate for a pilot asking companies to electronically submit labeling for home-use devices to help develop a label database. This is the agency’s second go at such a pilot but the submissions process appears to be simplified this time around.
      PubDate: Fri, 17 Apr 2015 15:00:01 -040
  • People Briefs: CryoLife, VisionCare, Nihon Kohden, Nephros
    • Abstract: CryoLife Executive Chairman retires. VisionCare Ophthalmic Technologies and Nihon Kohden, appoint new CEOs; Nephros appoints new leadership.
      PubDate: Fri, 17 Apr 2015 13:35:00 -040
  • Visual Podcast: Expert Tips For Staving Off De Novo Troubles
    • Abstract: King & Spalding's Quynh Hoang offers device manufacturers a handful of tips for pursuing de novo classification submissions – including urging firms to determine whether clinical studies are needed for a potential de novo submission – in this "Gray Sheet" podcast.
      PubDate: Fri, 17 Apr 2015 11:30:01 -040
  • FDA, CMS Task Force Seeks Sweet Spot For Lab Quality Oversight
    • Abstract: The agencies established a joint team to address concern and confusion in the lab community about the intersection between the Quality System Regulation and CMS’s CLIA oversight process.
      PubDate: Thu, 16 Apr 2015 22:00:02 -040
  • Warning Letter Roundup & Recap – April 14, 2015
    • Abstract: Employees weren't trained in GMP, quality, CAPA and manufacturing equipment procedures at Visionary Contact Lens; maker of air filters and spirometers cited for quality system reg violations; and more. Three warning letters were listed by FDA this week.
      PubDate: Thu, 16 Apr 2015 21:50:01 -040
  • FDA Asks Experts For Advice On Aneurysm Flow Diverter Clinical Trials
    • Abstract: With the explosion of new interventional aneurysm devices under development, especially flow diverters, the agency asks its Neurological Devices Panel to discuss appropriate trial designs, patient follow-up and other study details for this device category during an April 17 meeting.
      PubDate: Thu, 16 Apr 2015 18:10:01 -040
  • Trade Promotion Authority Bill Prioritizes Reimbursement Transparency
    • Abstract: Trade promotion authority legislation introduced April 16 in the Senate and House includes provisions that would prioritize transparency for foreign reimbursement schemes and eliminating price controls in ongoing and future international trade negotiations.
      PubDate: Thu, 16 Apr 2015 17:55:03 -040
  • Boston Scientific Deepens China Endoscopy Roots
    • Abstract: A strategic alliance with Suzhou, China, surgical device firm Frankenman Medical Equipment Company could give Boston Scientific an advantage in the local endoscopy market. Boston points out that more than a million bile duct stone removals are performed with open surgery in China when they could be done with less invasive endoscopy.
      PubDate: Thu, 16 Apr 2015 15:00:01 -040
  • J&J-Google Robot Surgery Device A Few Years Away
    • Abstract: J&J executives said a robotic surgery device the firm will develop with Internet giant Google should be ready in several years and will “dramatically revolutionize surgery.”
      PubDate: Thu, 16 Apr 2015 14:20:00 -040
  • Should Government Or Industry Develop Wireless Test Bed Standards'
    • Abstract: During a joint FCC/FDA meeting, stakeholders disagreed on who should be tasked with developing standards for the environments in which wireless medical devices are tested. Some said it's time for the government to step in, while others warned federal regulations could stifle innovation.
      PubDate: Wed, 15 Apr 2015 18:05:01 -040
  • Permanent Doc Pay Bill Heads To President’s Desk, Promotes Remote
    • Abstract: The Senate passed a House Medicare physician pay bill, setting a new permanent payment system for the program’s providers that will ultimately encourage value-based payments. The legislation also includes provisions on remote monitoring, gainsharing and durable medical equipment.
      PubDate: Wed, 15 Apr 2015 18:00:00 -040
  • Medicaid Chiefs Cite Need To Keep Costs Low For ‘Cures’
           Devices, Drugs
    • Abstract: State Medicaid directors are saying initiatives in the House 21st Century Cures draft bill to accelerate delivery of innovative devices and drugs will make them too costly for payers, and may inappropriately “lower the evidentiary standard” for device approvals.
      PubDate: Wed, 15 Apr 2015 16:00:05 -040
  • Startup InPress Reports First Clinical Data For Postpartum Hemorrhage
    • Abstract: Data from 10 patients supports quick action to stop hemorrhages, the leading cause of perinatal maternal death. InPress Technologies hopes to launch an FDA trial later this year.
      PubDate: Wed, 15 Apr 2015 16:00:01 -040
  • Perseon Cancer Ablation Therapy Expanded To Treat Liver Tumors
    • Abstract: The newly renamed company says FDA has cleared its MicroThermX microwave ablation system to treat complicated non-resectable liver tumors.
      PubDate: Tue, 14 Apr 2015 17:40:01 -040
  • Samsung To Work With Mass General System On mHealth Development
    • Abstract: The Massachusetts-based Partners Healthcare system is partnering with Samsung Electronics to launch new software development and clinical research efforts toward technologies for monitoring chronic disease.
      PubDate: Tue, 14 Apr 2015 16:10:00 -040
  • IBM Makes Big Health Care Splash With J&J, Medtronic, Apple
    • Abstract: IBM is partnering with some major medical technology players to use its Watson Health Cloud to aggregate medical data and use cognitive computing to provide physicians and researchers with more treatment options.
      PubDate: Tue, 14 Apr 2015 16:05:01 -040
  • Medtronic Enters Leadless Pacemaker Competition With
           Micra CE Mark
    • Abstract: The firm’s ultra-small leadless pacing system has been cleared to launch in Europe, where it will face off with St. Jude’s Nanostim, which is slowly recovering from a pause in implants in 2014.
      PubDate: Tue, 14 Apr 2015 14:00:01 -040
  • CardiAQ Uses Early-Feasibility IDE Paradigm To Bring Trans-Mitral Valve
           Device To U.S. Clinicians
    • Abstract: The California startup was able to leverage a new FDA process for early-feasibility device trials to launch a small U.S. study of its transfemoral and transapical transcatheter mitral valve implantation systems.
      PubDate: Mon, 13 Apr 2015 17:10:04 -040
  • Standardized Device Labeling' CDRH Studies Practitioner Perceptions
    • Abstract: The format of device labeling is controlled by the individual manufacturer, but CDRH is exploring whether health care practitioners can more easily find information from a more standardized device label template that includes a short-summary section. Industry advocates are skeptical that broad-scale standardization is feasible due to the diversity of devices and device users, but companies are assisting in the center’s plans to perform a cognitive study of clinicians this summer.
      PubDate: Mon, 13 Apr 2015 17:00:01 -040
  • First Firm Audited Under MDSAP Urges Companies To Pay Closer Attention To
           International Regs
    • Abstract: Orthopedic device manufacturer Arthrex was the inaugural auditee of IMDRF's Medical Device Single Audit Program. During the inspection it was dinged by auditors when the company wasn't wholly familiar with Australian regulatory requirements.
      PubDate: Fri, 10 Apr 2015 15:20:02 -040
  • Hamburg To Advise Institute of Medicine On International Issues
    • Abstract: Having shepherded FDA through hurdles resulting from globalization, the now-former FDA Commissioner Hamburg will advise IOM on international issues that affect the U.S. healthcare system as IOM's newly appointed foreign secretary.
      PubDate: Thu, 09 Apr 2015 18:00:03 -040
  • Medtronic Launches Registry Of Phased RF Ablation For AFib
    • Abstract: The European registry is the first observational “real world” study of Medtronic’s PVAC Gold multi-electrode ablation catheter.
      PubDate: Thu, 09 Apr 2015 18:00:01 -040
  • FDA Asks For More Industry Help To Train Staff
    • Abstract: CDRH is asking for another round of volunteers to allow officials to visit manufacturing and clinical facilities to get first-hand perspective of how they operate as part of the center's Experimental Learning Program.
      PubDate: Thu, 09 Apr 2015 15:50:03 -040
  • Experts Call For More Clinical Trials Of Percutaneous Circulatory Devices
    • Abstract: A new multi-society clinical expert consensus statement on percutaneous mechanical circulatory support is intended to help physicians select devices for the patients who are most likely to benefit, but the authors identify several questions about the devices that need to be addressed in future clinical studies.
      PubDate: Thu, 09 Apr 2015 14:00:04 -040
  • CDRH Expedited Access Program Set For April 15 Launch, Extended To De
    • Abstract: The agency finalized guidance on its Expedited Access Program for devices intended to treat or diagnosis life-threatening or irreversibly debilitating conditions that address an unmet need. The program is primarily targeted at PMA devices, but those that use the de novo classification route are also eligible for a watered-down version for the program. 510(k)s are not eligible for the program.
      PubDate: Wed, 08 Apr 2015 18:50:02 -040
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