Iris International (Chatsworth, California) said it intends to resubmit its 510(k) for its NADiA prostate specific antigen (PSA) ultra-sensitive diagnostic test with a prognostic claim.
Following FDA advice, Iris said it has already submitted a request for a Pre-Investigational Device Exemption meeting, an optional process through which the applicant consults with the FDA for the purpose of improving the quality of submissions and to shorten review times. Iris said it will submit a new 510(k) seeking clearance of a prognostic claim for identifying post-prostatectomy patients with low-risk of prostate cancer recurrence. The company estimates market introduction to be in the first half of 2009.
"We are particularly pleased with our discussions with the FDA," said C sar Garc a, president/CEO and chairman of Iris. "This investigational diagnostic test, we believe, represents a potential major contribution to medicine that will result in improved patient care and comfort at significant healthcare savings."
Garc a said Iris is planning a clinical study which, when concluded, will be used to support the filing of a new 510(k) submission.
"The new 510(k) submission will seek clearance for a prognostic claim for the NADiA PSA as an in-vitro diagnostic assay intended to be used in conjunction with clinical evaluation as an aid in predicting risk for recurrence of prostate cancer after radical prostatectomy. We have maintained continuous communication with the FDA over the last several months, and the pre-IDE meeting should formalize the collaborative review process via written feedback on the protocol and intended use claims from the FDA prior to initiating the study, significantly reducing interpretation risks by either party. We have been notified by the FDA that the Pre-IDE review meeting will be held in August 2008," Garc a said.
Iris is an in vitro diagnostics company focused on products that analyze particles and living cell forms and structures, or morphology of a variety of body fluids.
Greenway included in MHCC vendor list
Greenway Medical Technologies (Carrollton, Georgia), with its Certification Commission for Health Information Technology (CCHIT) certified electronic health record (EHR), PrimeSuite 2007 R2, has been included in the Maryland Health Care Commission's (MHCC) Select 2007 CCHIT EHR Vendor list. The inclusion distinguishes Greenway as one of 23 EHR solutions — out of 44 CCHIT Certified vendors — available to physicians and physician practices within the state of Maryland.
PrimeSuite was selected after meeting a set list of advanced technical requirements for functionality, interoperability, and security determined by the CCHIT, and an extensive process set forth by the MHCC that focused on the product, pricing, and policies.
CCHIT is the recognized certification body (RCB) for EHRs whose mission is to accelerate adoption of health information technology (HIT) by creating efficient, credible and sustainable certification programs.
The MHCC is an independent state regulatory agency whose mission is to plan for health system needs, promote informed decision-making, increase accountability and improve access in a rapidly changing health care environment by providing timely and accurate information on availability, cost and quality of services to policy makers, purchasers, providers and the public.
Greenway's PrimeSuite is a fully-integrated, single-database EHR, practice management and interoperability solution that helps to streamline a practice's clinical, financial and administrative processes. PrimeSuite 2007 R2 was the first EHR to be certified by CCHIT based on 2007 Ambulatory Certification requirements.
Aurora Health converts to Masimo oximetry
Masimo (Irvine, California) said that Aurora Health Care (Milwaukee) has completed a system-wide conversion to Masimo SET pulse oximetry technology. The integrated health care provider with 13 hospitals and more than 100 clinics performed an independent evaluation of pulse oximetry technologies and chose Masimo over all other available technologies to unify patient monitoring capabilities across their entire network.
"The decision to convert all of our hospital and surgery facilities to Masimo SET pulse oximetry originally grew out of clinical preference in the Post Anesthesia Care Unit (PACU) and Neonatal Intensive Care Unit (NICU) because of Masimo's superior performance during the most challenging of patient conditions," said Alan Gresch, corporate manager of clinical engineering, Aurora Health Care. "Performance preference soon gave way to clinical efficiencies and cost savings created by standardization to the Masimo SET technology platform. Now, in addition to better technology across the board, our staff no longer has to change sensors or monitors when patients are transferred between departments."
Masimo is the inventor of pulse CO-Oximetry and measure-through-motion-and-low-perfusion-pulse oximetry.