Medical Devices News and Research

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FDA approves Velomedix’s IDE to expand design of VELOCITY trial for heart attack

Velomedix, Inc., a venture-backed medical device company advancing the field of therapeutic hypothermia, announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to expand the design of its VELOCITY pilot clinical trial.

29 Nov 2012

Democrats resist significant changes to Medicare, other entitlement programs

Efforts to avert the looming "fiscal cliff" have revived talk of raising Medicare's eligibility age. Some Republicans also suggest that spending to carry out the health law should be viewed as a source for savings. Meanwhile, an important meeting is scheduled for Wednesday.

28 Nov 2012

New coverage decisions by private payers and Medicare for OAB and urge incontinence

Uroplasty, Inc., a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, today announced significant new coverage decisions by private payers and Medicare.

27 Nov 2012

TriReme raises new financing round

TriReme Medical, Inc. and its affiliates announced today a new round of financing that brings a total of US$18 million into the group.

27 Nov 2012

Samsung Medison highlights medical devices at RNSA 2012 meeting

Samsung Medison, a leading global medical devices company, announced that it participated the "RSNA (Radiological Society of North America) 2012", held in McCormick Place, Chicago from November 25th to 30th, in the biggest scale thus far.

27 Nov 2012

First U.S. breathing lung transplant performed in Ronald Reagan UCLA Medical Center

First there was the "heart in a box," a revolutionary experimental technology that allows donor hearts to be delivered to transplant recipients warm and beating rather than frozen in an ice cooler. Now that same technology is being used to deliver "breathing lungs."

27 Nov 2012

UPC teams conduct research in biomedical engineering to improve people's health

Systems to improve patient rehabilitation, methods that help detect diseases, and smart biomaterials for optimising treatments—scientific advances in the field of biomedical engineering are unstoppable. A number of leading UPC teams are carrying out research aimed at harnessing technology to improve people's health.

23 Nov 2012

CHKD surgeons use vacuum bell device to treat pectus excavatum

Surgeons at Children's Hospital of The King's Daughters (CHKD) have fitted a patient with a device that might eliminate the need for surgery in some patients with one of the world's most common chest deformities, pectus excavatum, often called sunken chest syndrome.

22 Nov 2012

Portable bed rails actually increase risk of injury and death

Portable bed rails marketed to "make any bed safer" actually increase the risk of injury and death, according to an article in the November 15 issue of Biomedical Safety & Standards (BS&S).

21 Nov 2012

Enhancements to Mindray DC-8 ultrasound system to be showcased at RSNA annual meeting

Mindray Medical International Limited, a leading developer, manufacturer and marketer of medical devices worldwide, today announced that it will showcase the latest enhancements to the DC-8 ultrasound system at the 98th Annual Meeting of the Radiological Society of North America to be held during November 25-30, 2012 in Chicago.

From Mindray 21 Nov 2012

St. Jude Medical’s Portico transcatheter heart valve receives European CE Mark approval

St. Jude Medical, Inc., a global medical device company, today announced it has received European CE Mark approval for its 23 mm Portico Transcatheter Aortic Heart Valve and Transfemoral Delivery System.

20 Nov 2012

Dune Medical Devices gets FDA PMA Approvable Letter for MarginProbe System

Dune Medical Devices, Inc., announced today that it has received an Approvable Letter for its Premarket Approval Application (PMA) from the Food and Drug Administration. The Approvable Letter states that the MarginProbe System PMA is approvable subject to final agreement with FDA on the design of the required Post Approval Study.

20 Nov 2012

Viewpoints: Obama must tell allies that entitlements can't be excluded from fiscal deal; Medical device tax will thwart innovation

As bipartisan negotiations over avoiding the "fiscal cliff" draw nearer, many of President Obama's core Democratic supporters are urging him to fix the debt through defense cuts and tax increases rather than by tackling Social Security, Medicare and other federal entitlement programs. It's a reprise of progressive resistance to the entitlement trims Mr. Obama contemplated during the abortive debt-reduction negotiations with House Speaker John A. Boehner (R-Ohio) last year.

15 Nov 2012

As health law's fate becomes more clear, insurers, medical device makers try to stem new taxes

Insurers and medical device makers are planning ad campaigns and intense lobbying to try to stop taxes in the health law from cutting at their bottom lines.

15 Nov 2012

Antibody-coated stents carry increased risk of myocardial infarction and re-operation

If narrowed or blocked coronary vessels have to be widened or opened, a vascular support (stent) is usually inserted. Drug-coated stents are preferred for patients at high risk of renewed narrowing of vessels (restenosis). However, the use of antibody-coated stents has been increasing in recent years. Current studies provide indications that these new antibody-coated stents more frequently lead to myocardial infarction and make re-operation necessary.

15 Nov 2012

Hydrus stent may significantly reduce eye pressure in glaucoma patients

A tiny medical device no larger than an eyelash may significantly reduce eye pressure in glaucoma patients and allow some to stop using eye-drop medications, according to year-one clinical trial results for the device.

14 Nov 2012

Mindray initiates voluntary recall for A3/A5 Anesthesia Delivery System

Mindray Medical International Limited, a leading developer, manufacturer and marketer of medical devices worldwide, has initiated a voluntary recall affecting the A3/A5 Anesthesia Delivery System. Mindray has initiated this recall due to the possibility of a system leak resulting from improper seating of the CO2 absorbent canister gasket.

From Mindray 14 Nov 2012

Health law preparations go full throttle

The re-election of President Barack Obama all but ensured the survival of the law, news outlets report. Now, a slew of regulations must be issued and political and financial and organizational obstacles overcome.

9 Nov 2012

Semprus BioSciences to develop surface-modified endotracheal tube

Teleflex Incorporated, a leading global provider of medical devices for critical care and surgery, has announced that Semprus BioSciences, a wholly owned subsidiary of Teleflex Incorporated, has been awarded the initial phase of a $2.3 million research grant from the U.S. Army's Telemedicine and Advanced Technology Research Center (TATRC), located at Fort Detrick, MD.

9 Nov 2012

Avinger receives FDA clearance for Ocelot System

Avinger, Inc., a medical device manufacturer of innovative, multi-functional catheters for crossing chronic total occlusions (CTOs) in patients with Peripheral Artery Disease (PAD), announces its Ocelot System has been cleared for sale in the U.S. by the Food and Drug Administration (FDA).

9 Nov 2012

Medical Devices News and Research

FDA approves Velomedix’s IDE to expand design of VELOCITY trial for heart attack

Democrats resist significant changes to Medicare, other entitlement programs

New coverage decisions by private payers and Medicare for OAB and urge incontinence

TriReme raises new financing round

Samsung Medison highlights medical devices at RNSA 2012 meeting

First U.S. breathing lung transplant performed in Ronald Reagan UCLA Medical Center

UPC teams conduct research in biomedical engineering to improve people's health

CHKD surgeons use vacuum bell device to treat pectus excavatum

Portable bed rails actually increase risk of injury and death

Enhancements to Mindray DC-8 ultrasound system to be showcased at RSNA annual meeting

St. Jude Medical’s Portico transcatheter heart valve receives European CE Mark approval

Dune Medical Devices gets FDA PMA Approvable Letter for MarginProbe System

Viewpoints: Obama must tell allies that entitlements can't be excluded from fiscal deal; Medical device tax will thwart innovation

As health law's fate becomes more clear, insurers, medical device makers try to stem new taxes

Antibody-coated stents carry increased risk of myocardial infarction and re-operation

Hydrus stent may significantly reduce eye pressure in glaucoma patients

Mindray initiates voluntary recall for A3/A5 Anesthesia Delivery System

Health law preparations go full throttle

Semprus BioSciences to develop surface-modified endotracheal tube

Avinger receives FDA clearance for Ocelot System

Industry Focus eBook - Medical Devices (3rd Edition) eBook

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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