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FDA should collect information needed to develop new framework for 510(k) clearance process

The U.S. Food and Drug Administration should gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices, says a new report from the Institute of Medicine.

30 Jul 2011

Class I recall for Vital Signs HCH/Anesthesia Breathing Circuit

In April 2011, Vital Signs Devices, a GE Healthcare Company, initiated a voluntary worldwide field correction of the Vital Signs Hygroscopic Condenser Humidifier (HCH)/Anesthesia Breathing Circuit.

30 Jul 2011

Former Specialty Hospital patient credits Left Ventricular Assist Device surgery

What do former Vice President Dick Cheney, Izzie's boyfriend, Denny, on "Grey's Anatomy" and Anthony Freeman from East Baltimore all have in common? Each is associated with a Left Ventricular Assist Device.

30 Jul 2011

FDLI conference to discuss IOM study on 510(k) Clearance Process

On the heels of the release of the highly anticipated Institute of Medicine (IOM) report, Public Health Effectiveness of the FDA 510(k) Clearance Process, The Food and Drug Law Institute (FDLI) is holding a "Dialogue" on the report August 4 in Washington, D.C.

30 Jul 2011

FDA to open docket to seek public comments on IOM's report on 510(k) program

The FDA today announced that it will open a public docket to begin receiving public comments on the Institute of Medicine's report on the 510(k) program, the most common pathway to market for lower-risk medical devices.

30 Jul 2011

New website can facilitate collaboration of doctors in Health Industry

A new website has been created using file-sharing technology that was originally developed to facilitate doctor to doctor collaboration in Health Industry.

30 Jul 2011

POSI first in the U.S. to provide Genium Bionic Prosthetic System for patients

Prosthetic Orthotic Solutions International (POSI), a Physiotherapy Associates company with locations in Marlton, NJ and Horsham, PA, announces it is one of the first clinics in the U.S. to fit patients with Otto Bock Healthcare's Genium Bionic Prosthetic System, and the first facility in the NJ/PA metro area to fit patients with this system.

30 Jul 2011

LA Times: Robots and pharmacies

At Molina Medical Group clinics in Southern California, a vending machine rather than a pharmacist dispenses prescription drugs. Molina officials say the machines make life simpler for patients, but their use has drawn objections from some pharmacists.

30 Jul 2011

New software tools for fast, accurate reconstruction of neural networks

The human brain is the most complex of all organs, containing billions of neurons with their corresponding projections, all woven together in a highly complex, three-dimensional web. To date, mapping this vast network posed a practically insurmountable challenge to scientists.

30 Jul 2011

New fluorescent tool can track mysterious workings of cellular RNAs

The ability to tag proteins with a green fluorescent light to watch how they behave inside cells so revolutionized the understanding of protein biology that it earned the scientific teams who developed the technique Nobel Prizes in 2008.

30 Jul 2011

First cardiac ablation procedure using Thermocool SmartTOUCH catheter performed at Mount Sinai

The Mount Sinai Medical Center has become the first hospital on the east coast to perform a cardiac ablation procedure using the Thermocool Smarttouch Contact Force-Sensing Catheter for the treatment of symptomatic, paroxysmal atrial fibrillation (AF), or periodic rapid and irregular heartbeats.

30 Jul 2011

Motorcycle helmets may contribute to hearing loss

Motorcycle helmets, while protecting bikers' brains, may also be contributing to hearing loss. Scientists mapped the airflow and noise patterns to find out why.

30 Jul 2011

Pharmalucence selects Bosch to provide isolated filling line for Billerica production facility

Pharmalucence, Inc. has selected Robert Bosch Packaging Technology, Inc. to provide a state-of-the-art isolated pharmaceutical filling line for the new Pharmalucence production facility being constructed in Billerica, MA.

30 Jul 2011

Varian Medical Systems signs agreement with CIVCO to offer Body Pro-Lok to its customers

CIVCO is pleased to announce the signing of a reseller agreement that would allow Varian Medical Systems to offer CIVCO's Body Pro-Lok to its customers.

30 Jul 2011

New methods to detect illegal clouding agents in sports drinks

The European Commission's Joint Research Centre has developed three new methods to detect an illegal clouding agent which can be found in sports drinks imported from Taiwan.

29 Jul 2011

Human kinome RNAi screening performed using Roche’s xCELLigence MP Instrument

RNA interference studies are a powerful technology for high-throughput screening. However, endpoint analyses only provide a snapshot of the analyzed cellular phenotype, as it is not possible to measure developmental changes over time.

29 Jul 2011

NanoString introduces new assay for leukemia fusion gene analysis

NanoString Technologies, Inc., a privately held provider of life science tools for translational research and developer of molecular diagnostics, today announced the availability of a comprehensive multiplexed assay for the simple and cost-effective analysis of fusion genes linked to leukemia.

From NanoString Technologies 29 Jul 2011

Kansas Health IT officials get first big test; Utah faces digital incompatibility

The state hospital association has asked the Kansas Information Exchange to probe pricing structures of electronic health record vendors, the Kansas Health Institute News reports.

29 Jul 2011

Time Temp Trac system can aid in successful conservation of stored blood

Human blood is a precious resource. Because stored blood has a very limited shelf life, keeping every available unit of it suitable for medical use is a crucial function at hospitals and other health care facilities - especially during supply shortages such as those currently being experienced in the Triad, other parts of North Carolina and numerous sections of the country.

29 Jul 2011

Conference to discuss latest advances in brain tumours by non-surgical means, space science

The latest advances in the treatment of brain tumours by non-surgical means, space science and non-fossil fuel energy generation, are among the topics being discussed by over 500 international scientists at Queen's University this week.

29 Jul 2011

Device / Technology News

FDA should collect information needed to develop new framework for 510(k) clearance process

Class I recall for Vital Signs HCH/Anesthesia Breathing Circuit

Former Specialty Hospital patient credits Left Ventricular Assist Device surgery

FDLI conference to discuss IOM study on 510(k) Clearance Process

FDA to open docket to seek public comments on IOM's report on 510(k) program

New website can facilitate collaboration of doctors in Health Industry

POSI first in the U.S. to provide Genium Bionic Prosthetic System for patients

LA Times: Robots and pharmacies

New software tools for fast, accurate reconstruction of neural networks

New fluorescent tool can track mysterious workings of cellular RNAs

First cardiac ablation procedure using Thermocool SmartTOUCH catheter performed at Mount Sinai

Motorcycle helmets may contribute to hearing loss

Pharmalucence selects Bosch to provide isolated filling line for Billerica production facility

Varian Medical Systems signs agreement with CIVCO to offer Body Pro-Lok to its customers

New methods to detect illegal clouding agents in sports drinks

Human kinome RNAi screening performed using Roche’s xCELLigence MP Instrument

NanoString introduces new assay for leukemia fusion gene analysis

Kansas Health IT officials get first big test; Utah faces digital incompatibility

Time Temp Trac system can aid in successful conservation of stored blood

Conference to discuss latest advances in brain tumours by non-surgical means, space science

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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