Medical Devices News

ASTM WK21927 to Help Characterize Hydrogels for Medical Purposes  May 30, 2009
ASTM International is developing ASTM WK21927, a standard designed to help characterize hydrogels for people working in regenerative medicine.

ASTM Revises Puncture Resistant Containers for Medical Needles, 'Sharps'  Apr 20, 2009
ASTM International Subcommittee F04.33 on Medical/Surgical Instruments is revising ASTM F2132 - Specification for Puncture Resistance of Materials

Frost: Novel Assays Development Vital for European Immunoassay Diagnostics Market  Jan 6, 2009
The immunoassay diagnostics market is in the late growth stage of the market lifecycle. According to Frost & Sullivan, the market is being challenged by a number of factors, including the commoditization of tests, growing laboratory networks and the heightened popularity of molecular tests in areas like infectious testing.

ASTM Int'l Seeks Participants for Tissue Engineered Medical Products Task Group  Dec 30, 2008
ASTM International seeks participation in a task group that is developing a proposed standard for manufacturers of vascular graft tissue engineered medical products (TEMPs).

Frost: Growing African Demand for Medical Equipment Results in Hospital Revitalization Programs  Dec 15, 2008
The bulk of sub-Saharan Africa's hospital medical equipment is 'third world' in standard, according to Frost & Sullivan, because the equipment was installed many decades ago and does not conform to modern standards.

ASTM Int'l Issues Safety, Performance Requirements Standard for Tracheal Tube Fixation Devices  Dec 16, 2008
ASTM International issued ASTM F2726 - Specification for Fixation Devices for Tracheal Tubes and Other Airway Devices, which covers safety and performance requirements for fixation devices for tracheal tubes.

ASTM Int'l Forms Standard Development Task Group for Antimicrobial Medical Gloves   Dec 16, 2008
ASTM International Committee D11 on Rubber created a task group on antimicrobial medical gloves to help address the growing number and severity of health care association infections.

Frost: Encouraging Prospects for Euro Medical Imaging Equipment Services  Dec 15, 2008
Services form an integral part of most original equipment manufacturer (OEM) revenues.

Frost: Detection Technology Advances Drive Euro Autoimmune Disease Diagnostics Market  Dec 5, 2008
The European autoimmune disease diagnostics market demonstrated sustained growth due to advances in detection technology and automation, according to Frost & Sullivan.

ISO 2007 Certification Survey Shows Management Systems Standards Implemented in 175 Countries   Nov 21, 2008
The International Organization for Standardization (ISO) Survey of Certifications - 2007 indicates certification activity around one or more ISO management system standards in 175 countries, up from 170 in 2006.

IECEE MEE Task Force Issues Revised Risk Management Requirements Guidance for IEC 60601  Nov 10, 2008
The International Electrotechnical Commission (IEC) System of Conformity Assessment Schemes for Electrotechnical Equipment and Components (IECEE) Certification Management Committee (CMC) approved a report and guidance document on risk management requirements for the 3rd edition of IEC 60601-1 - medical electrical equipment.

Frost: Health Care Sector Offers Vast Potential for Taiwan's Medical Imaging Markets   Oct 28, 2008
Taiwan's aging population is one of the primary drivers for its medical imaging markets, according to Frost & Sullivan, including the growing digital radiography (DR) and computer aided diagnosis (CAD) markets.

AIM Global to Develop Health Care Test Protocols  Oct 21, 2008
AIM Global's radio frequency identification (RFID) Experts Group (REG) will develop a set of test protocols for testing of RF emitters to ensure a benign effect in a health care setting.

IEEE Approves Seven Health Informatics Standards  Oct 14, 2008
The Institute of Electrical and Electronics Engineers (IEEE) approved seven standards for health informatics.

DIN Updates Standard on Medical Device Labeling  Aug 29, 2008
The Deutsches Institut für Normung e. V. (DIN) published a revised edition of standard DIN EN 980, Symbols for use in the labeling of medical devices.

Frost: U.S. Medical Devices Industry Poised for Healthy Growth   Jun 26, 2008
The U.S. medical devices industry continues to witness solid growth, due largely to an aging baby boomer population.

Frost: Demand for Better Therapies Maintains Growth of Medical Device Manufacturing   Apr 26, 2008
Greater awareness of the availability of improved therapies is prompting patients to demand treatments that enable them to lead productive lives post-surgery.

IEEE Launches Standard for Point-of-Care Medical Device Communication - IEEE P11073-10202  Apr 3, 2008
The Institute of Electrical and Electronics Engineers (IEEE) began work on IEEE P11073-10202 - Standard for Health Informatics - Point-of-Care Medical Device Communication - Domain Information Model (DIM) - XML Schema Format.

Frost: 3-D Medical Imaging Solutions Becoming Affordable in Europe   Mar 11, 2008
According to Frost & Sullivan, 3-D imaging has become one of the highest growth segments in the field of medical imaging, and the European 3-D imaging market is expanding as applications become increasingly affordable.

Frost: Lower Acuity Segment Ensures Growth in N. American Multiparameter Monitoring Equipment Markets  Mar 11, 2008
Low-acuity settings remain at a peak position of the North American multiparameter monitoring equipment market, according to Frost & Sullivan, spurring unit growth by adding new monitors to this highly replacement-driven market.

ASTM Int'l Publishes Fatigue, Fracture of Medical Metallic Materials, Devices - ASTM STP 1481   Jan 15, 2008
ASTM International published special technical publication ASTM (STP) 1481 - Fatigue and Fracture of Medical Metallic Materials and Devices.

U.S. FDA Modifies List of Recognized Medical Device Standards  Jan 14, 2008
The U.S. Food and Drug Administration (FDA) updated the list of consensus standards for use in evaluating medical devices before they are approved by the agency for market entry.

U.S. FDA Modifies List of Recognized Medical Device Standards  Jan 14, 2008
The U.S. Food and Drug Administration (FDA) updated the list of consensus standards for use in evaluating medical devices before they are approved by the agency for market entry.

AAMI Publishes Biological Evaluation, Implantable Devices Standards - AAMI 10993-6, AAMI PC69  Jan 13, 2008,
The Association for the Advancement of Medical Instrumentation (AAMI) published standards addressing biological evaluation and implantable devices.

ASTM Int'l Releases 'Standards on Sterilization of Health Care Products'   Jan 13, 2008
ASTM International released ASTM Standards on Sterilization of Health Care Products.

Frost: Increased Funding, Expansion Initiatives Drive Africa's Demand for Medical Devices   Dec 19, 2007
An improving legal framework and increased funding for the health care industry drive the medical devices market in sub-Saharan Africa, according to Frost & Sullivan.

Pharmaceutical Products Committee Approves ASTM Int'l Standard - ASTM E 2500  Dec 16, 2007
ASTM International Committee E55 on Manufacture of Pharmaceutical Products developed a standard that covers the life cycle of pharmaceutical and biopharmaceutical manufacturing systems.

ISO 2006 Survey Reveals 16% Rise in ISO 9001, ISO 14001 Certifications  Dec 5, 2007
Certification to ISO 9001 for quality management and to ISO 14001 for environmental management increased during 2006 by 16%, according to an International Organization for Standardization (ISO) survey.

AAMI Updates Quality System Compendium  Nov 27, 2007
The Association for the Advancement of Medical Instrumentation (AAMI) updated The Quality System Compendium.

Proposed ASTM Int'l Rubber Products Standard Will Provide Allergen Tests - ASTM WK16334  Nov 23, 2007
Testing for potent allergens in rubber is the purpose of ASTM WK16334 - Test Method for the Immunological Measurement of Four Principal Allergenic Protein (Hev b 1, 3, 5 and 6.02) in Natural Rubber and Its Products.

AAMI Releases 4 Revised Dialysis Standards  Nov 2, 2007
The Association for the Advancement of Medical Instrumentation (AAMI) updated its dialysis standards on CD to include four standards released in 2007.

AAMI Releases Guidance Document on Water Quality for Reprocessed Devices  Nov 2, 2007
The Association for the Advancement of Medical Instrumentation (AAMI) developed a guidance document addressing water quality for the reprocessing of medical devices.

Frost: Advancements in Glucose Monitoring Focus on Affordable, Accurate Testing  Oct 31, 2007
Given the rising diabetic population, there is a tremendous awareness drive that aims to communicate the importance of proper and regular glucose control.

Frost: Advancements in Related Markets Drive Growth of N. American Medical Device Packaging  Oct 23, 2007
An increased demand for surgical and implant devices is driving the medical device packaging market.

Frost: Economic Growth, Foreign Donations to Drive Growth in Sub-Saharan African Health Care Industry  Oct 22, 2007
The African health care industries on the African continent have been poorly understood and investigated, according to Frost & Sullivan, and, as a result, the African pharmaceutical and medical devices sectors are essentially untapped.

ISO: Technical Report Ensures Patient Safety via Health Software - ISO TR 27809  Sep 5, 2007
The International Organization for Standardization (ISO) released a technical report, ISO TR 27809:2007 - Health informatics - Measures for ensuring patient safety of health software, which considers the control measures required to ensure patient safety in respect to health software products and the standards needed to underpin them.

Frost: Replacements, New Clinical Applications Boost Growth of MRI Systems   Aug 21, 2007
Magnetic resonance imaging (MRI) is one of the most powerful and widely employed diagnostic tools by physicians today, despite increasing pricing pressures, regulatory issues and competition from computed tomography (CT) that need to be overcome in the European MRI systems market.

FDA, DOD Share Medical Data to Address Medical Product Safety  Aug 20, 2007
The U.S. Food and Drug Administration (FDA) and the U.S. Department of Defense (DOD) are partnering to share data and expertise related to the review and use of FDA-regulated drugs, biologics and medical devices.

Bluetooth SIG Adopts Core Specification Version 2.1  Aug 10, 2007
The board of directors of the Bluetooth Special Interest Group (SIG) adopted Core Specification Version 2.1 + Enhanced Data Rate (EDR).

FDA Nanotechnology Report Outlines Scientific, Regulatory Challenges  Aug 1, 2007
The U.S. Food and Drug Administration (FDA) Nanotechnology Task Force released a report that recommends the agency consider developing guidance and taking other steps to address the benefits and risks of drugs and medical devices using nanotechnology.

ASTM Int'l Proposes Standard Test Method for Vascular Stent Radial Stiffness, Strength - ASTM WK15227  Aug 1, 207
ASTM International Committee F04 on Medical and Surgical Materials and Devices is developing a proposed standard that will help the medical device industry with the measurement and reporting of vascular stent radial stiffness and strength.

Frost: Awareness, Standardization Initiatives to Drive Surgical Infection Control Market  Jun 12, 2007
Growing awareness of nosocomial infections and their multi-level effects will drive the European surgical infection control market.

EBV Elektronik Presents Reference Platform for ARM7 Controllers - ChameleonARM  May 24, 2007
EBV Elektronik presented ChameleonARM, a reference platform for the LPC23xx product line from NXP. ChameleonARM combines a board and software in one package.

UL Extends Two-Week Turnaround Guarantee on FDA 510(k) Third-Party Submissions  May 23, 2007
Underwriters Laboratories (UL) announced the extension of its two-week guaranteed turnaround for UL reviews under the U.S. Food and Drug Administration (FDA) Third Party 510(k) review program. UL was the top FDA 510(k) Third Party reviewer in 2006.

Dassault Systèmes Delivers PLM SOA Enterprise Middleware with ENOVIA MatrixOne 10.7.1  May 18, 2007
Dassault Systèmes (DS) announced availability of ENOVIA MatrixOne 10.7.1, which is targeted at the semiconductor, apparel, aerospace and defense and medical device industries.

Avnet Electronics Marketing Distributes ADS Embedded Computer Systems  May 3, 2007
Applied Data Systems (ADS) and Avnet Electronics Marketing Americas have inked a distribution agreement for the ADS line of application-ready embedded single board computers.

Frost: Minimally-Invasive Surgeries Drive Innovation, Growth in Medical Lasers Markets  Apr 23, 2007
Innovative product development has driven the rapid growth of the European medical lasers markets over the past few years.

Sandia Handheld Instrument Assesses Dental Disease  Apr 23, 2007
According to a paper in the March 27 issue of the Proceedings of the National Academy of Sciences, a pilot study conducted with the University of Michigan shows that a Sandia National Laboratories handheld device determined in minutes - from a tiny sample of saliva alone - not only if a patient has gum disease but quantitatively how advanced the disease is.

IHF, GS1 to Improve Patient Safety through Global Supply Chain Standards  Apr 16, 2007
The International Hospital Federation (IHF) and GS1 are teaming to promote the development and adoption of global supply chain standards in hospitals for pharmaceuticals and medical devices.

IEC Releases Safety Requirements for Electromedical Equipment - IEC 60601-1-2  Apr 10, 2007
The International Electrotechnical Commission (IEC) released the latest edition of IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests.

AAMI Revises Hemodialysis Water Treatment Standard - AAMI RDRD62   Apr 4, 2007
The Association for the Advancement of Medical Instrumentation (AAMI) Renal Disease and Detoxification Committee (RDDC) revised its standard for water treatment equipment, adding alternative and supplementary methods of removing toxic chloramines from water.

AAMI Publishes Standard for Sterilization Containment Devices - AAMI ST77   Apr 4, 2007
The Association for the Advancement of Medical Instrumentation (AAMI) released the first-ever standard that specifies requirements for container systems and containment devices that hold sterilized surgical instruments building on a record number of new and revised sterilization standards and guidance documents that have been released or published over the last year.

EC Calls for Improved Safety of Medical Devices   Mar 29, 2007
The European Parliament is expected to adopt a new proposal by the European Commission (EC) that would significantly improve the safety of medical devices, such as surgical equipment or implants.

ASTM Int'l 3rd Edition Standards on Emergency Medical Services Available on CD-ROM   Feb 24, 2007
The CD-ROM version of ASTM Standards on Emergency Medical Services, 3rd Edition, is available from ASTM International.

Biomedical Engineers Advance 'Smart Bladder Pacemaker' Research   Feb 19, 2007
Duke University biomedical engineering researchers announced research advances into a "smart bladder pacemaker" that might one day restore bladder control in patients with spinal cord injury or neurological disease.

Frost: Mature U.S. Artificial Heart Valve Industry Seeks New Opportunities   Feb 19, 2007
Improved manufacturing techniques and materials have enhanced the durability of tissue-based heart valves - extending them 20 years longer, far exceeding the performance of previous generations.

NIST Uses Nanomagnets to Enhance Medical Imaging   Feb 19, 2007
Nanoscale magnets in the form of iron-containing molecules might be used to improve the contrast between healthy and diseased tissue in magnetic resonance imaging (MRI) - as long as the concentration of nanomagnets is carefully managed.

Frost: Fast Results Boost Euro Penetration Rates of Blood Gas Analyzers, Monitors   Feb 15, 2007
After overcoming restraining factors such as price, the hospital use of blood gas analyzers and monitors is increasing across Europe.

Frost: Silicone Becoming Ideal Choice for Varied Medical Device Applications   Feb 6, 2007
With its long history of successful use in the medical industry and unique combination of properties, silicone is well-positioned to meet the ever-demanding material requirements of medical device fabricators.

ASTM Int'l Guide Designed to Improve Sterilizable Pouch Specifications - ASTM F 2559   Jan 12, 2007
In order to minimize confusion about how sterilized medical pouches should be specified by users and manufacturers, ASTM International Committee F02 on Flexible Barrier Packaging developed ASTM F 2559 - Guide for Writing a Specification for Sterilizable Peel Pouches.

ASTM Int'l Approves Complement Activation Standard - ASTM F 2567   Dec 4, 2006
Understanding how blood within a human body will interact with any substance with which it comes in contact is a crucial part of any medical process.

Frost: Aging Population Drives Growth of Euro Orthopedic Implant Market   Nov 30, 2006
Changing demographics are driving Europe's orthopedic implant market, according to Frost & Sullivan. As Europe's population ages rapidly, a number of age-related conditions, including orthopedic problems, will underpin an increase in the number of implant surgeries.

NIST Finds Robot Wheelchair Gives Patients More Independence   Oct 25, 2006
Engineers at the National Institute of Standards and Technology (NIST) are developing a robotic system that may offer wheelchair-dependent people independent, powered mobility and the ability, depending on patient status, to move to and from beds, chairs and toilets without assistance.

Frost: Digitization, Price Erosion, Multi-modality Deals Drive Consolidation in Euro Medical Imaging Market   Oct 25, 2006
Amidst challenges such as price erosion, reduced hospital beds, lack of radiologists and a trend toward multi-modality deals, novel picture archiving and communication systems (PACS) and digitization initiatives are spurring growth in the European medical imaging market.

Frost: Proteomic Revolution, Customized Drugs Market Drives U.S. Mass Spectrometer Demand   Oct 2, 2006
With the incorporation of technological advances in hardware design and computational power, dramatic improvements have been made in the reliability and design of today's mass spectrometers.

Cambridge Consultants Introduce NFC Medical Device for Management of Diabetes   Sep 22, 2006
Cambridge Consultants created a medical device for managing diabetes that uses near field communication (NFC) to integrate glucometers and insulin pumps.

NHS Connecting for Health to Pilot IT Specification for Blood Safety   Sep 22, 2006
NHS Connecting for Health, supported by the National Patient Safety Agency (NPSA), is looking to work with one or more acute trusts in England to pilot a national information technology (IT) specification for blood tracking.

Frost: Magnetic Resonance Imaging Has Greater Functionality Than Ever Before   Sep 19, 2006
he range of clinical applications performed on magnetic resonance imaging (MRI) scanners is nothing short of astounding, according to Frost & Sullivan.

NIST Workshop Addresses Biomedical Imaging Technology, Standards   Sep 13, 2006
Medical and pharmaceutical researchers are increasingly looking to biomedical imaging as a tool to track disease progress, speed drug discovery and improve patient outcomes.

Frost: Aging Baby Boomers Enlarge Potential Customer Base for Cardiac Device Markets   Aug 15, 2006
Increasing demand for minimally invasive surgeries amongst a rapidly aging population is expected to spark further growth in the cardiovascular devices market.

FDA Seeks Comments on Use of Identifier System for Medical Devices   Aug 14, 2006
The U.S. Food and Drug Administration (FDA) is seeking information on how the use of a unique identifier system for medical devices may reduce medical errors, facilitate device recalls and improve medical device adverse event reporting.

Frost: Convenience, Minimal Invasiveness Drive Diagnostic, Surgical Endoscopy   Aug 10, 2006
The endoscopes market, although young, has reached maturity in a short timespan. The key challenges include facility and surgeon consolidation and price erosion.

NEMA Test Standards Measure Performance Parameters for MRI Systems   Aug 9, 2006
The National Electrical Manufacturers Association (NEMA) published four standards that are part of a series of test standards developed by the medical diagnostic imaging industry for measuring performance parameters (e.g., noise levels, energy deposition and electric field strength) that govern image quality of magnetic resonance imaging (MRI) systems.

AAMI Highlights Medical Electrical Equipment Standard   Jul 31, 2006
The Association for the Advancement of Medical Instrumentation (AAMI) announced ANSI/AAMI ES60601-1:2005 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance standard is generating interest.

Frost: Growing Acceptance of Prosthetic Devices Drives Biomechatronics   Jul 25, 2006
Biomechatronic innovations are realizing a successful phase, while contributing to a tremendous improvement in quality of life for many end-users. Research in this area is focusing on finding solutions for the complete restoration of normal functions of organs through prosthetic devices.

Frost: Electrical Discharge Machines Surpass Traditional Machining Processes   Jul 14, 2006
Electrical discharge machines (EDMs) are benefiting from the growing needs of various end-user industries - including medical devices, electronics, automotive, parts manufacturing and metal working - for highly accurate machining of increasingly complex and intricate designs.

CLSI Publishes New Guideline for Analysis of Body Fluids   Jul 12, 2006
Clinical and Laboratory Standards Institute (CLSI) published a new document, Analysis of Body Fluids in Clinical Chemistry; Proposed Guideline (C49-P).

ASTM Int'l Approves Enteral Feeding Device Standard   Jul 3, 2006
A new standard, developed by ASTM International Committee F04 on Medical and Surgical Materials and Devices, establishes performance requirements for single-use, enteral feeding devices with retention balloons.

Frost: Medicare Reductions Reshape Oxygen Therapy Devices Market   Jun 1, 2006
Decreasing reimbursement rates have forced health care providers and manufacturers to cut costs and increase the lifetime of oxygen therapy devices. These market changes have slowed demand for several devices, thereby lowering unit shipments for manufacturers.

Frost: Infection Prevention Measures Will Drive Euro Thermometer Sales   May 23, 2006
Non-contact thermometers are finding increasing uptake in the European market, largely due to growing public awareness about the need for enhanced infection control. According to Frost & Sullivan, the European temperature monitoring devices market generated revenues of $150.0M in 2005, with estimates to reach $240.0M by 2012.

Frost: Medical Devices Ensure Growth for Antimicrobial Coatings Market   May 23, 2006
An overwhelming need to arrest the hospital-acquired infection rates in the U.S. is a serious concern in the health care industry. According to Frost & Sullivan, the ability of antimicrobial coatings to address this issue expects to offer good growth opportunities.

Frost: New Technology to Spur Euro Nuclear Medical Imaging Markets   May 23, 2006
The introduction of new technologies is set to revitalize the increasingly mature European nuclear medical imaging markets. According to Frost & Sullivan, innovative and enhanced imaging techniques, such as single photon emission computed tomography (SPECT), will energize the saturated gamma camera segment.

Frost: Demographic Shift Drives Blood Pressure Monitoring Markets   May 12, 2006
As the U.S. population diagnosed with high blood pressure and hypertension increases, the awareness and trial of blood pressure self-monitoring will continue to grow. According to Frost & Sullivan, this will lead to increased preventative care as people try to avoid the serious effects of hypertension.

Frost: Orthopedic Medical Device Technologies Expected to Succeed   Apr 26, 2006
Those who use medical device technologies for orthopedic applications want systems that offer maximum comfort with minimum physical supervision.

FDA Issues List of Recognized Consensus Standards for Medical Devices   Apr 26, 2006
The U.S. Food and Drug Administration (FDA) updated the list of consensus standards recognized by the agency for use in evaluating medical devices before they are approved for market entry.

Frost: Full-Service Agreements, Remote Service Delivery Grow Euro Medical Imaging Equipment Services Market   Apr 24, 2006
An expanding installed base of higher-end medical imaging equipment modalities, such as computed tomography (CT) and magnetic resonance imaging (MRI), is pushing the uptake of related vendor-based services, according to Frost & Sullivan.

Frost: Integration of Patient Monitoring, Healthcare IT to Change Europe's Medical Delivery Process   Apr 24, 2006
Healthcare information technology (IT) vendors in Europe are expanding their product portfolios through mergers and strategic alliances with IT service providers, as well as clinical information system vendors.

Frost: Wireless Technologies on the Rise in European Health Care   Apr 13, 2006
Heightened awareness about the benefits of remote monitoring, combined with the growing popularity of home care, will likely boost the uptake of wearable wireless patient monitoring systems in Europe over the next four to five years, according to Frost & Sullivan.

Frost: Growth Creates Opportunities in Euro Medical Devices Markets   Mar 27, 2006
The accession of several Eastern European countries to the European Union (EU) has brought in standardized regulations, while also opening up new markets for medical device manufacturers in the region.

Frost: Cost-control Tactics Curb Progress in Euro Medical Device Market   Mar 23, 2006
As the result of increasing cost pressures and diminishing healthcare budgets, today's European medical devices industry is focusing on cost-containment and the rationalization of medical resources, according to Frost & Sullivan.

Frost: Wireless Patient Monitoring Reduces Hospital Operating Costs   Mar 21, 2006
Cost reduction pressures and the need for shortened in-patient stays are promoting the use of wireless patient monitoring systems in hospitals.

Frost: After-Service Critical in Uptake of Disposable Electrosurgical Devices   Mar 17, 2006
Heightened awareness among both electrosurgical device companies and consumers about the potential spread of communicable diseases during surgery is encouraging the use of disposable electrosurgical devices.

FDA Issues Guide on Hospital Bed Design to Reduce Patient Entrapment   Mar 15, 2006
The U.S. Food and Drug Administration (FDA) published final guidance designed to reduce the occurrence of hospital bed entrapments, which can cause injury and death.

Competition, Standardization Drive Respiratory Equipment Markets   Mar 14, 2006
The demand for respiratory protective equipment in Western Europe has increased significantly, while new opportunities continue to contribute to impressive market growth, according to Frost & Sullivan.

EC Proposes Ban on Mercury in Fever Thermometers   Feb 23, 2006
The European Commission (EC) has recently proposed to ban the marketing of mercury in new fever and room thermometers, barometers, blood pressure gauges and manometers and sphygmomanometers.

Euro Medical Device Companies Face Asian Competition   Feb 21, 2006
As Asia continues to emerge as a prime low-cost medical devices manufacturing site, European medical device companies run the risk of losing valuable market share.

AAMI Approves New and Revised Standards   Jan 25, 2006
The Association for the Advancement of Medical Instrumentation (AAMI) approved one new standard and several revised standards.

Euro Commission Revises Medical Device Directives   Dec 28, 2005
The European Commission proposed amendments to the legislative framework for medical devices and the health care industry.

IEC Releases New Edition of Basic Standard for Electromedical Equipment   Dec 19, 2005
The International Electrotechnical Commission (IEC) released IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, the latest edition of the basic standard covering electrical equipment used in medicine.

IEEE Developing 2 Health Informatics Standards for Point-of-Care Medical Devices   Nov 14, 2005
The Institute of Electrical and Electronics Engineers Inc. (IEEE) started work on two health informatics standards for point-of-care medical device communications.

EU 'Harmonised Standards' Program Addresses Protective & Telecom Equip., Medical Devices, EMC, Rail   Oct 31, 2005
The European Union (EU) listed several categories of "harmonised standards" falling under its New Approach program, including personal protective equipment, electromagnetic compatibility, radio & telecom terminal equipment, in vitro diagnostic medical devices, medical devices and high-speed rail.

ISO/IEC/ITU-T Team to Promote, Harmonize Medical Technology Standards   Oct 20, 2005
A trio of key standards development organizations - the International Electrotechnical Commission (IEC), the International Organization for Standardization (ISO) and the International Telecommunications Union (ITU) - recently formed the ISO/IEC/ITU-T Healthcare Technology Task Force (HTTF) to address medical technology standardization issues.

IEEE Developing Point-of-Care Medical Device Standards   Jun 29, 2005
The Institute of Electrical and Electronics Engineers Inc. (IEEE) is developing two new point-of-care medical device standards.