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Gen-Probe submits PMA to FDA for PROGENSA PCA3 assay

Gen-Probe announced today that the Company has submitted a Premarket Approval Application (PMA) to the US Food and Drug Administration (FDA) for its PROGENSA® PCA3 assay, a new molecular test that may help determine the need for repeat biopsies in men suspected of having prostate cancer.

22 Sep 2010

New, easy-to-use system puts 'Radiology in the palm of your hand'

Physicians now have access to real time radiology services virtually anywhere, anytime. The new Virtual Viewbox- (patent pending) is a portable interface system that delivers images, electronic medical records (EMR), and specialist consultation to physicians using any internet-ready device.

22 Sep 2010

Masimo's noninvasive SpMet provides measurements comparable to invasive methemoglobin testing

Masimo announced today that a new clinical study published in Anesthesia & Analgesia demonstrates that Masimo noninvasive and continuous methemoglobin (SpMet®) measurements provide a high degree of agreement in measurements with corresponding laboratory values of methemoglobin obtained by invasive methemoglobin testing. In addition, the authors concluded that SpMet could facilitate early diagnosis and treatment of methemoglobinemia during high-risk procedures.

22 Sep 2010

Boston Scientific reports positive data from PLATINUM Element Stent quantitative coronary angiography study

Boston Scientific Corporation today announced data from its PLATINUM QCA study, which is designed to evaluate the Company's PROMUS Element™ Everolimus-Eluting Platinum Chromium Coronary Stent. The results provided 30-day and nine-month clinical outcomes and nine-month quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) data supporting the safety and efficacy of the PROMUS Element Stent.

22 Sep 2010

Palomar Medical Technologies to introduce home-use laser device for cosmetic treatments

Palomar Medical Technologies Inc., a leading researcher and developer of light-based systems for cosmetic treatments, today announced that it would move the launch of its patented, home use laser for the treatment of periorbital wrinkles by a few months.

22 Sep 2010

UK researchers launches new house design tool for older people

A new housing design tool, which will help improve the quality of life for older people in the UK, has been launched by researchers at the University of Sheffield this week (21 September 2010).

22 Sep 2010

Study: New percutaneous mitral valve clip offers marked clinical benefit

A percutaneous mitral valve clip designed to stop mitral valve regurgitation demonstrated clinical benefit as measured by the degree of mitral regurgitation, according to a study presented at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

22 Sep 2010

Omega receives CAP accreditation for forensic drug testing of hair

Omega Laboratories, Inc. today announced that it has received accreditation for forensic drug testing of hair from the Commission on Laboratory Accreditation of the College of American Pathologists (CAP). During the CAP accreditation process, inspectors carefully review the laboratory's records and quality control procedures for the preceding two years, as well as the laboratory's equipment, facilities, safety program and record. CAP inspectors also examine laboratory staff qualifications and the overall management of the laboratory.

22 Sep 2010

Mobile Aspects releases next version of RFID enabled iRIScope endoscope tracking system

Mobile Aspects announced today the commercial availability of an enhanced design of its RFID enabled endoscope tracking system, iRIScope. Targeted at increasing care quality and patient safety, iRIScope 2.0 offers additional functional and technical capabilities to help care providers enhance their processes for endoscope storage, use and reprocessing.

22 Sep 2010

FDA grants Phadia 510(k) clearance for CLIA Moderate Complexity, EliA autoimmune antibody assays

Today Phadia announced that it has received FDA 510(k) clearance for two new, CLIA Moderate Complexity, EliA autoimmune antibody assays. The new assays will provide physicians with additional tools needed to aid in the diagnosis of Celiac disease. The newly available assays, EliA GliadinDP IgA and EliA GliadinDP IgG (deamidated peptides), have proven to be essential, sensitive and specific markers to aid in the diagnosis of celiac disease.

22 Sep 2010

A slow, steady move to health IT

Reuters: More physicians are using health IT. "U.S. doctors increasingly are ditching pen and paper and sending prescriptions to pharmacies electronically, lured by up to $27 billion in government funds aimed at speeding the switch to electronic medical records. There are now 200,000 doctors who use e-prescribing, or roughly one in three office-based doctors." E-prescribing is only one piece of the health IT puzzle doctors must solve to get their share of the funds (Steenhuysen, 9/21).

22 Sep 2010

AMA launches new online tool to strengthen the financial health of physician practices

The American Medical Association (AMA) today announced a new online tool designed to help physician practices prepare for billing and payment audits by insurers and federal contractors. The AMA’s Practice Analysis Tools for Healthcare (AMA PATH™) puts self-auditing tools in the hands of physicians, allowing them to develop and evaluate fee schedules and billing safeguards without hiring an expensive consultant.

21 Sep 2010

Bioconnect's Optiflow Vascular Anastomotic System granted CE mark approval

Bioconnect Systems, Inc. today announced CE mark approval for the Optiflow™ Vascular Anastomotic System. The Optiflow™ enhances a surgeon's ability to create precise vascular connections. The initial indication is the creation of an arteriovenous fistula needed for vascular access in hemodialysis patients.

21 Sep 2010

Echo commences development of new transdermal biosensor for continuous lactate monitoring

Echo Therapeutics, Inc., a company developing its needle-free Symphony™ tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system and its Prelude™ SkinPrep System for transdermal drug delivery, today announced that it is beginning a development program designed to create a new transdermal biosensor for continuous lactate monitoring to be used in critical care and sports medicine.

21 Sep 2010

Biodegradable polymers represent future of stent design

Three-year data demonstrated that satisfactory clinical and safety outcomes of sirolimus eluting stents with a biodegradable polymer were sustained in a real world setting. The results were presented at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

21 Sep 2010

Greenway announces advanced allergy module in integrated EHR solution

Greenway Medical Technologies, Inc. today announced the most advanced allergy module available in an integrated electronic health record (EHR) solution for ear, nose and throat (ENT) and allergy physician practices. Developed in conjunction with a leading ENT and allergy testing and treatment practice, the Greenway® Allergy Module for PrimeSuite® provides unmatched allergy testing, serum creation, allergy shot record, lot maintenance and reporting functionality for today's ENT and allergy practice groups.

21 Sep 2010

PROMUS Element Stent receives expanded indications approval for high-risk diabetic and AMI patient groups

Boston Scientific Corporation today announced that its PROMUS® Element™ Everolimus-Eluting Coronary Stent System has received CE Mark approval for use in patients with diabetes and those experiencing an acute myocardial infarction (AMI), or heart attack.

21 Sep 2010

Aethlon Medical reestablishes efforts to advance Aethlon Hemopurifier

Aethlon Medical, Inc., the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, disclosed today that it has reestablished efforts to advance the Aethlon Hemopurifier within U.S. Government programs that support the development and purchase of treatment countermeasures against bioterror threats.

21 Sep 2010

Lehigh Valley Health Network automates IRB processes with Click Commerce eResearch Portal software

Click Commerce, the pioneer in customer-configurable solutions for the business of research, announced today that Lehigh Valley Health Network (LVHN) will use the company's eResearch Portal software to automate its Institutional Review Board (IRB) processes, which monitor the safe and ethical conduct of research involving human subjects.

21 Sep 2010

Richmond Hill Children's Clinic patients to have real-time access to PHRs at mypatientaccess.ca

Canadian Patient Access Inc. and Nightingale Informatix Corporation, an application service provider (ASP) of electronic medical records (EMR) software and related services today announce that mypatientaccess.ca, Canada's first secure, interactive patient portal will soon be made available to parents of more than 10,000 pediatric patients treated at the Richmond Hill Children's Clinic (Richmond Hill, ON).

21 Sep 2010

Device / Technology News

Gen-Probe submits PMA to FDA for PROGENSA PCA3 assay

New, easy-to-use system puts 'Radiology in the palm of your hand'

Masimo's noninvasive SpMet provides measurements comparable to invasive methemoglobin testing

Boston Scientific reports positive data from PLATINUM Element Stent quantitative coronary angiography study

Palomar Medical Technologies to introduce home-use laser device for cosmetic treatments

UK researchers launches new house design tool for older people

Study: New percutaneous mitral valve clip offers marked clinical benefit

Omega receives CAP accreditation for forensic drug testing of hair

Mobile Aspects releases next version of RFID enabled iRIScope endoscope tracking system

FDA grants Phadia 510(k) clearance for CLIA Moderate Complexity, EliA autoimmune antibody assays

A slow, steady move to health IT

AMA launches new online tool to strengthen the financial health of physician practices

Bioconnect's Optiflow Vascular Anastomotic System granted CE mark approval

Echo commences development of new transdermal biosensor for continuous lactate monitoring

Biodegradable polymers represent future of stent design

Greenway announces advanced allergy module in integrated EHR solution

PROMUS Element Stent receives expanded indications approval for high-risk diabetic and AMI patient groups

Aethlon Medical reestablishes efforts to advance Aethlon Hemopurifier

Lehigh Valley Health Network automates IRB processes with Click Commerce eResearch Portal software

Richmond Hill Children's Clinic patients to have real-time access to PHRs at mypatientaccess.ca

Scaling organ‑chip technology for human‑relevant drug discovery

Unlocking drug amorphization: Continuous, solvent-free twin screw granulation

How can super-resolution technology help study neurotransmission?

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