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Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualific

2013-02-15 22:57:00 (читать в оригинале)

The FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. (Source: Food and Drug Adminstration (FDA): CDRHNew)







Pediatrician schedule: Jasmine Estates 24,099
Pediatrician schedule: Jensen Beach 12,121
Pediatrician schedule: Jupiter 50,606
Pediatrician schedule: Kendale Lakes 61,808
Pediatrician schedule: Kendale Lakes-Lindgren Acres, FL 341,815
Pediatrician schedule: Kendall West 47,202
Pediatrician schedule: Kendall, FL 81,713
Pediatrician schedule: Kendall-Perrine, FL 169,007
Pediatrician schedule: Key Biscayne 10,142
Pediatrician schedule: Key Largo 10,979
Pediatrician schedule: Key West 22,463
Pediatrician schedule: Keystone, FL 17,056
Pediatrician schedule: Kings Point, FL 13,597
Pediatrician schedule: Kissimmee 62,632
Pediatrician schedule: La Belle, FL 19,514
Pediatrician schedule: Lady Lake 15,148
Pediatrician schedule: Lake Butter 8,339
Pediatrician schedule: Lake City, FL 12,614
Pediatrician schedule: Lake Lorraine 7,519
Pediatrician schedule: Lake Lucerne 9,919
Pediatrician schedule: Lake Magdalene 33,531
Pediatrician schedule: Lake Mary 15,230
Pediatrician schedule: Lake Park, FL 8,732
Pediatrician schedule: Lake Wales 14,245
Pediatrician schedule: Lake Worth Corridor 20,788
Pediatrician schedule: Lake Worth, FL 35,975
Pediatrician schedule: Lakeland Highlands 14,836
Pediatrician schedule: Lakeland, FL 93,738
Pediatrician schedule: Lakes by the Bay 9,835
Pediatrician schedule: Lakeside, FL 39,830
Pediatrician schedule: Lakewood Park 14,081
Pediatrician schedule: Land O' Lakes 27,748
Pediatrician schedule: Lantana, FL 10,157
Pediatrician schedule: Largo, FL 73,215
Pediatrician schedule: Lauderdale Lakes 32,082
Pediatrician schedule: Lauderhill 61,652
Pediatrician schedule: Laurel, FL 9,465
Pediatrician schedule: Lecanto 6,083
Pediatrician schedule: Leesburg, FL 22,286
Pediatrician schedule: Lehigh Acres 44,074
Pediatrician schedule: Leisure City 24,062
Pediatrician schedule: Lighthouse Point 11,201
Pediatrician schedule: Live Oak, FL 7,169
Pediatrician schedule: Lockhart, FL 15,286
Pediatrician schedule: Longboat Key 7,263
Pediatrician schedule: Longwood, FL 13,491
Pediatrician schedule: Lower Keys 10,859
Pediatrician schedule: Lutz 19,918
Pediatrician schedule: Lynn Haven 15,368
Pediatrician schedule: Macclenny 6,069


Teleflex Signs New Agreement with Novation for Weck Vista(TM) Access Line
Obamacare excise tax showing up on receipts for sporting goods
Colder Products Company Expands FitQuik Product Line With Additional Material Options
ZOLL Receives Shonin Approval from Japanese Ministry of Health, Labour and Welfare to Market Intravascular Temperature Management Technology
Final Sunshine Regs: Physicians Win Some, Lose SomeFinal Sunshine Regs: Physicians Win Some, Lose Some
Colibri Heart Valve Announces Issuance of a Patent for a Pre-mounted, Pre-packaged, Sterilized Dry Heart Valve on a Delivery System
TYRX Receives Approval For New AIGISRx R Fully Resorbable Antibacterial Envelope From Health Canada
Diffusion of Novel Healthcare Technologies to Resource Poor Settings.
Imaging Technologies Transformed By New Modeling Approach
A Call to Keep Untested, High-Risk Medical Devices Off the Market

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01.31.13 -- LoProfile Multi-Sinus Dilation Tool With Light Fiber Introduced

2013-02-15 22:57:00 (читать в оригинале)

01/31/13Medical Design Online Newsletter (Source: Medical Design Online News)







Pediatrician schedule: Jasmine Estates 24,099
Pediatrician schedule: Jensen Beach 12,121
Pediatrician schedule: Jupiter 50,606
Pediatrician schedule: Kendale Lakes 61,808
Pediatrician schedule: Kendale Lakes-Lindgren Acres, FL 341,815
Pediatrician schedule: Kendall West 47,202
Pediatrician schedule: Kendall, FL 81,713
Pediatrician schedule: Kendall-Perrine, FL 169,007
Pediatrician schedule: Key Biscayne 10,142
Pediatrician schedule: Key Largo 10,979
Pediatrician schedule: Key West 22,463
Pediatrician schedule: Keystone, FL 17,056
Pediatrician schedule: Kings Point, FL 13,597
Pediatrician schedule: Kissimmee 62,632
Pediatrician schedule: La Belle, FL 19,514
Pediatrician schedule: Lady Lake 15,148
Pediatrician schedule: Lake Butter 8,339
Pediatrician schedule: Lake City, FL 12,614
Pediatrician schedule: Lake Lorraine 7,519
Pediatrician schedule: Lake Lucerne 9,919
Pediatrician schedule: Lake Magdalene 33,531
Pediatrician schedule: Lake Mary 15,230
Pediatrician schedule: Lake Park, FL 8,732
Pediatrician schedule: Lake Wales 14,245
Pediatrician schedule: Lake Worth Corridor 20,788
Pediatrician schedule: Lake Worth, FL 35,975
Pediatrician schedule: Lakeland Highlands 14,836
Pediatrician schedule: Lakeland, FL 93,738
Pediatrician schedule: Lakes by the Bay 9,835
Pediatrician schedule: Lakeside, FL 39,830
Pediatrician schedule: Lakewood Park 14,081
Pediatrician schedule: Land O' Lakes 27,748
Pediatrician schedule: Lantana, FL 10,157
Pediatrician schedule: Largo, FL 73,215
Pediatrician schedule: Lauderdale Lakes 32,082
Pediatrician schedule: Lauderhill 61,652
Pediatrician schedule: Laurel, FL 9,465
Pediatrician schedule: Lecanto 6,083
Pediatrician schedule: Leesburg, FL 22,286
Pediatrician schedule: Lehigh Acres 44,074
Pediatrician schedule: Leisure City 24,062
Pediatrician schedule: Lighthouse Point 11,201
Pediatrician schedule: Live Oak, FL 7,169
Pediatrician schedule: Lockhart, FL 15,286
Pediatrician schedule: Longboat Key 7,263
Pediatrician schedule: Longwood, FL 13,491
Pediatrician schedule: Lower Keys 10,859
Pediatrician schedule: Lutz 19,918
Pediatrician schedule: Lynn Haven 15,368
Pediatrician schedule: Macclenny 6,069


Class I Medical Device Recall: GE Healthcare, LLC, Giraffe and Panda T-Piece Resuscitation Systems, and the Giraffe and Panda Bag and Mask Resuscitation Systems
Hospira gets FDA notice over medical device problems
People's experiences of being mechanically ventilated in an ICU: A qualitative study
Colder Products Company Expands FitQuik Product Line With Additional Material Options
Mobile, Fast, Low-Cost Device Uses The Cloud To Speed Up Diagnostic Testing For HIV And More
ZOLL Receives Shonin Approval from Japanese Ministry of Health, Labour and Welfare to Market Intravascular Temperature Management Technology
Final Sunshine Regs: Physicians Win Some, Lose SomeFinal Sunshine Regs: Physicians Win Some, Lose Some
Teleflex Signs New Agreement with Novation for Weck Vista(TM) Access Line
WetAlert Wireless Wetness Detector From Fresenius Medical Care
New Technology Helps Physicians Diagnose Quickly & Accurately

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NHS trust deploys Stanley asset tracking and management technology

2013-02-15 22:57:00 (читать в оригинале)

Dorset County Hospital NHS Foundation Trust (DCHFT) in the UK has deployed Stanley Healthcare's asset tracking and management technology for the management of crucial medical equipment throughout the hospital. (Source: Hospital Management)







Pediatrician schedule: Jasmine Estates 24,099
Pediatrician schedule: Jensen Beach 12,121
Pediatrician schedule: Jupiter 50,606
Pediatrician schedule: Kendale Lakes 61,808
Pediatrician schedule: Kendale Lakes-Lindgren Acres, FL 341,815
Pediatrician schedule: Kendall West 47,202
Pediatrician schedule: Kendall, FL 81,713
Pediatrician schedule: Kendall-Perrine, FL 169,007
Pediatrician schedule: Key Biscayne 10,142
Pediatrician schedule: Key Largo 10,979
Pediatrician schedule: Key West 22,463
Pediatrician schedule: Keystone, FL 17,056
Pediatrician schedule: Kings Point, FL 13,597
Pediatrician schedule: Kissimmee 62,632
Pediatrician schedule: La Belle, FL 19,514
Pediatrician schedule: Lady Lake 15,148
Pediatrician schedule: Lake Butter 8,339
Pediatrician schedule: Lake City, FL 12,614
Pediatrician schedule: Lake Lorraine 7,519
Pediatrician schedule: Lake Lucerne 9,919
Pediatrician schedule: Lake Magdalene 33,531
Pediatrician schedule: Lake Mary 15,230
Pediatrician schedule: Lake Park, FL 8,732
Pediatrician schedule: Lake Wales 14,245
Pediatrician schedule: Lake Worth Corridor 20,788
Pediatrician schedule: Lake Worth, FL 35,975
Pediatrician schedule: Lakeland Highlands 14,836
Pediatrician schedule: Lakeland, FL 93,738
Pediatrician schedule: Lakes by the Bay 9,835
Pediatrician schedule: Lakeside, FL 39,830
Pediatrician schedule: Lakewood Park 14,081
Pediatrician schedule: Land O' Lakes 27,748
Pediatrician schedule: Lantana, FL 10,157
Pediatrician schedule: Largo, FL 73,215
Pediatrician schedule: Lauderdale Lakes 32,082
Pediatrician schedule: Lauderhill 61,652
Pediatrician schedule: Laurel, FL 9,465
Pediatrician schedule: Lecanto 6,083
Pediatrician schedule: Leesburg, FL 22,286
Pediatrician schedule: Lehigh Acres 44,074
Pediatrician schedule: Leisure City 24,062
Pediatrician schedule: Lighthouse Point 11,201
Pediatrician schedule: Live Oak, FL 7,169
Pediatrician schedule: Lockhart, FL 15,286
Pediatrician schedule: Longboat Key 7,263
Pediatrician schedule: Longwood, FL 13,491
Pediatrician schedule: Lower Keys 10,859
Pediatrician schedule: Lutz 19,918
Pediatrician schedule: Lynn Haven 15,368
Pediatrician schedule: Macclenny 6,069


Better Science Makes Better Products
Imaging Technologies Transformed By New Modeling Approach
Bill introduced to repeal medical device tax
ZOLL Receives Shonin Approval from Japanese Ministry of Health, Labour and Welfare to Market Intravascular Temperature Management Technology
New Medical Device Shown To Be Highly Effective In Cluster Headache
TYRX Receives Approval For New AIGISRx R Fully Resorbable Antibacterial Envelope From Health Canada
NorthShore University HealthSystem Goes ‘Live' With Nuvon's Medical Device Connectivity System
Hospira gets FDA notice over medical device problems
Neusoft to buy out Philips share of joint venture
New Technology Helps Physicians Diagnose Quickly & Accurately

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Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff

2013-02-15 22:57:00 (читать в оригинале)

This guidance provides FDA?s recommendations on clinical trial designs for surgical ablation devices intended for the treatment of atrial fibrillation (AF). The recommendations in this guidance address clinical studies for new surgical ablation devices i (Source: Food and Drug Adminstration (FDA): CDRHNew)







Pediatrician schedule: Jasmine Estates 24,099
Pediatrician schedule: Jensen Beach 12,121
Pediatrician schedule: Jupiter 50,606
Pediatrician schedule: Kendale Lakes 61,808
Pediatrician schedule: Kendale Lakes-Lindgren Acres, FL 341,815
Pediatrician schedule: Kendall West 47,202
Pediatrician schedule: Kendall, FL 81,713
Pediatrician schedule: Kendall-Perrine, FL 169,007
Pediatrician schedule: Key Biscayne 10,142
Pediatrician schedule: Key Largo 10,979
Pediatrician schedule: Key West 22,463
Pediatrician schedule: Keystone, FL 17,056
Pediatrician schedule: Kings Point, FL 13,597
Pediatrician schedule: Kissimmee 62,632
Pediatrician schedule: La Belle, FL 19,514
Pediatrician schedule: Lady Lake 15,148
Pediatrician schedule: Lake Butter 8,339
Pediatrician schedule: Lake City, FL 12,614
Pediatrician schedule: Lake Lorraine 7,519
Pediatrician schedule: Lake Lucerne 9,919
Pediatrician schedule: Lake Magdalene 33,531
Pediatrician schedule: Lake Mary 15,230
Pediatrician schedule: Lake Park, FL 8,732
Pediatrician schedule: Lake Wales 14,245
Pediatrician schedule: Lake Worth Corridor 20,788
Pediatrician schedule: Lake Worth, FL 35,975
Pediatrician schedule: Lakeland Highlands 14,836
Pediatrician schedule: Lakeland, FL 93,738
Pediatrician schedule: Lakes by the Bay 9,835
Pediatrician schedule: Lakeside, FL 39,830
Pediatrician schedule: Lakewood Park 14,081
Pediatrician schedule: Land O' Lakes 27,748
Pediatrician schedule: Lantana, FL 10,157
Pediatrician schedule: Largo, FL 73,215
Pediatrician schedule: Lauderdale Lakes 32,082
Pediatrician schedule: Lauderhill 61,652
Pediatrician schedule: Laurel, FL 9,465
Pediatrician schedule: Lecanto 6,083
Pediatrician schedule: Leesburg, FL 22,286
Pediatrician schedule: Lehigh Acres 44,074
Pediatrician schedule: Leisure City 24,062
Pediatrician schedule: Lighthouse Point 11,201
Pediatrician schedule: Live Oak, FL 7,169
Pediatrician schedule: Lockhart, FL 15,286
Pediatrician schedule: Longboat Key 7,263
Pediatrician schedule: Longwood, FL 13,491
Pediatrician schedule: Lower Keys 10,859
Pediatrician schedule: Lutz 19,918
Pediatrician schedule: Lynn Haven 15,368
Pediatrician schedule: Macclenny 6,069


Class I Medical Device Recall: GE Healthcare, LLC, Giraffe and Panda T-Piece Resuscitation Systems, and the Giraffe and Panda Bag and Mask Resuscitation Systems
TYRX Receives Approval For New AIGISRx R Fully Resorbable Antibacterial Envelope From Health Canada
Boston Scientific to Cut More Jobs
Colibri Heart Valve Announces Issuance of a Patent for a Pre-mounted, Pre-packaged, Sterilized Dry Heart Valve on a Delivery System
NHS trust deploys Stanley asset tracking and management technology
Bill introduced to repeal medical device tax
Final Sunshine Regs: Physicians Win Some, Lose SomeFinal Sunshine Regs: Physicians Win Some, Lose Some
Smiths Medical Receives FDA Clearance for CADD-Solis VIP Ambulatory Infusion System
The Effects of Polymer End-group Chemistry and Order of Deposition on Controlled Protein Delivery from Layer-by-layer Assembly.
Diffusion of Novel Healthcare Technologies to Resource Poor Settings.

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02.14.13 -- Single-Procedure Surgical Instruments With Wick Away Technology

2013-02-15 22:57:00 (читать в оригинале)

02/14/13Medical Design Online Newsletter (Source: Medical Design Online News)







Pediatrician schedule: Jasmine Estates 24,099
Pediatrician schedule: Jensen Beach 12,121
Pediatrician schedule: Jupiter 50,606
Pediatrician schedule: Kendale Lakes 61,808
Pediatrician schedule: Kendale Lakes-Lindgren Acres, FL 341,815
Pediatrician schedule: Kendall West 47,202
Pediatrician schedule: Kendall, FL 81,713
Pediatrician schedule: Kendall-Perrine, FL 169,007
Pediatrician schedule: Key Biscayne 10,142
Pediatrician schedule: Key Largo 10,979
Pediatrician schedule: Key West 22,463
Pediatrician schedule: Keystone, FL 17,056
Pediatrician schedule: Kings Point, FL 13,597
Pediatrician schedule: Kissimmee 62,632
Pediatrician schedule: La Belle, FL 19,514
Pediatrician schedule: Lady Lake 15,148
Pediatrician schedule: Lake Butter 8,339
Pediatrician schedule: Lake City, FL 12,614
Pediatrician schedule: Lake Lorraine 7,519
Pediatrician schedule: Lake Lucerne 9,919
Pediatrician schedule: Lake Magdalene 33,531
Pediatrician schedule: Lake Mary 15,230
Pediatrician schedule: Lake Park, FL 8,732
Pediatrician schedule: Lake Wales 14,245
Pediatrician schedule: Lake Worth Corridor 20,788
Pediatrician schedule: Lake Worth, FL 35,975
Pediatrician schedule: Lakeland Highlands 14,836
Pediatrician schedule: Lakeland, FL 93,738
Pediatrician schedule: Lakes by the Bay 9,835
Pediatrician schedule: Lakeside, FL 39,830
Pediatrician schedule: Lakewood Park 14,081
Pediatrician schedule: Land O' Lakes 27,748
Pediatrician schedule: Lantana, FL 10,157
Pediatrician schedule: Largo, FL 73,215
Pediatrician schedule: Lauderdale Lakes 32,082
Pediatrician schedule: Lauderhill 61,652
Pediatrician schedule: Laurel, FL 9,465
Pediatrician schedule: Lecanto 6,083
Pediatrician schedule: Leesburg, FL 22,286
Pediatrician schedule: Lehigh Acres 44,074
Pediatrician schedule: Leisure City 24,062
Pediatrician schedule: Lighthouse Point 11,201
Pediatrician schedule: Live Oak, FL 7,169
Pediatrician schedule: Lockhart, FL 15,286
Pediatrician schedule: Longboat Key 7,263
Pediatrician schedule: Longwood, FL 13,491
Pediatrician schedule: Lower Keys 10,859
Pediatrician schedule: Lutz 19,918
Pediatrician schedule: Lynn Haven 15,368
Pediatrician schedule: Macclenny 6,069


Hospira gets FDA notice over medical device problems
New Technology Helps Physicians Diagnose Quickly & Accurately
Colder Products Company Expands FitQuik Product Line With Additional Material Options
New Medical Device Shown To Be Highly Effective In Cluster Headache
Obamacare excise tax showing up on receipts for sporting goods
SpectraScience, Inc.: SpectraScience and PENTAX Showcase WaveSTAT4 Optical Biopsy System at Arab Health 2013
Mobile, Fast, Low-Cost Device Uses The Cloud To Speed Up Diagnostic Testing For HIV And More
Teleflex Signs New Agreement with Novation for Weck Vista(TM) Access Line
A Call to Keep Untested, High-Risk Medical Devices Off the Market
Bill introduced to repeal medical device tax