RSSCategory: Government

Dark Daily Webinar: Tougher Lab Regulations and New Legal Issues in 2018: More Frequent Payer Audits, Problems with Contract Sales Reps, Increased Liability for CLIA Lab Directors, Proficiency Testing Violations, and More

| November 6, 2017 | 0 Comments

Join the webinar, Wednesday Nov. 8th – Register Now Attention clinical laboratory and pathology group execs: learn the steps you and your management team need to take NOW to mitigate risk and keep your lab organization financially strong! Looking forward into 2018, Medicare Part B clinical laboratory price cuts are not the only big story. […]

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XIFIN Highlights Flaws in CMS 2018 Draft PAMA Pricing

| September 25, 2017 | 0 Comments

Rate Setting Not Market-based and Circumvents Legislative Intent SAN DIEGO, Calif., Sept. 25, 2017 /PRNewswire/ — XIFIN, Inc., the healthcare information technology company revolutionizing the business of healthcare diagnostics, has conducted an initial review of the draft laboratory rates published on Sept. 22 by the Centers for Medicare and Medicaid Services for 2018 clinical laboratory tests under the Protecting Access […]

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WSI Device Clearances After the Philips De Novo Classification: An Outlook on the Regulatory Road Ahead

| September 22, 2017 | 0 Comments

By Christopher Ivicevich, Director of Regulatory Affairs & Quality Compliance, OptraSCAN With the recent shift in the industry as the result of this decision, a common question is “What lies in store for digital pathology system manufacturers in the wake of the FDA granting Philips’ de novo classification request for its IntelliSite device?” First, What […]

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Promega Intends to Seek FDA Approval for Microsatellite Instability Assay to Assist in Strategic Cancer Decisions

| July 9, 2017 | 0 Comments

Promega Corporation intends to seek FDA approval and CE-IVD marking for a commercially available Microsatellite Instability (MSI) assay to assist oncologists and pathologists in determining colorectal cancer decisions. The current Promega Research Use Only MSI Assay has been available and used in the market as part of Lab-Developed Tests since 2004 and is considered the […]

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Q&A with Philips Digital Pathology

| June 23, 2017 | 0 Comments

I recently had an opportunity to speak with Esther Abels, Director of Regulatory, Clinical and Medical Affairs for Philips Digital Pathology Solutions about Philips’ recent approval to market their Philips Intellisite Pathology System (PIPS) for primary diagnosis of biopsies and excisions in the United States. My thanks to Esther and Philips’ marketing team for their […]

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Tomorrow’s Webinar from Philips: Unlocking the Full Potential of Digital Pathology

| June 12, 2017 | 0 Comments

Tuesday, June 13th, Philips Digital Pathology Solutions will host two webinars for: North America: 10:00 AM – 11:00 AM EDT Register Asia & Europe: 3:00 PM – 4:00 PM SGT Register Philips IntelliSite Pathology Solution is now available for primary diagnostic use in the USA; but what does this news mean for the field of pathology? In […]

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FDA Approval of Immunotherapy For MSI-High or Mismatch Repair Deficient Tumors

| June 5, 2017 | 0 Comments

Last month the FDA approved pembrolizumab (KEYTRUDA) for adult and pediatric patients with with metastatic or unresectable, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment. KEYTRUDA has also been approved fro MSI-H or dMMR colorectal cancers that have progressed following treatment with conventional chemotherapies. The immunooncology/immunotherapy story is fascinating. […]

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What is Wrong with the Veterans Administrations Hospitals?

| May 29, 2017 | 0 Comments

This past Memorial Day weekend I gave a lot of thought to those who have passed defending our freedoms and way of life as well as those who have served and survived to be cared for by our society. About 3 years ago stories began to break about a scandal involving a Veterans Administration (VA) […]

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What does FDA Approval Mean for the Digital Pathology Market? Part 1

| May 15, 2017 | 0 Comments

Much is being said, written and discussed about the recent FDA clearance for Philips digital pathology solution for primary surgical pathology diagnosis. Of course, this means an advantage for Philips right now in the market as the only FDA approved whole slide imaging system for primary diagnosis. For groups and hospitals that appreciate the two main […]

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Webinar: Philips IntelliSite Pathology Solution Now Available for Primary Diagnostic Use in the U.S.

| April 30, 2017 | 0 Comments

Thu, May 4th, 2017 11:00 AM EST (1 hour) As a leader in the field, Philips is a driver of the adoption of digital pathology. Our solution was developed with the aim to increase efficiency and collaboration in your clinical lab. We are very proud to announce the Philips Intellisite Pathology Solution is the first, […]

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162 Days of Change

| April 17, 2017 | 1 Comment

As of last Thursday, April 12, 2017 and going back to a rainy night in Cleveland on November 2, 2016, the past 162 days have seen at least 3 things most Americans, and perhaps many across the world thought they would never see happen in their lifetimes. That rainy night in Cleveland started the clock […]

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FDA Allows Marketing of First Whole Slide Imaging System for Digital Pathology

| April 13, 2017 | 1 Comment

Welcome news anticipated from FDA for some time with recent Philips submission for approval. Philips Intellisite Pathology Solution (PIPS) first WSI system approved with special controls on the system to insure patient safety. More to follow on FDA approval of WSI for clinical use! The U.S. Food and Drug Administration today permitted marketing of the […]

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DPA Companion Meeting to Take Place at 2017 Pathology Informatics Summit

| April 1, 2017 | 0 Comments

SAVE THE DATE! DPA COMPANION MEETING To take place at the 2017 Pathology Informatics Summit Monday, May 22, 2017 | 5:00-7:00 PM Wyndham Grand Pittsburgh Hotel | King’s Garden 2/3 Pittsburgh, PA Presentations Include: Quantitative Image Analysis for HER2 Immunohistochemistry for Breast Cancer: Guideline Update and – Review of Draft Recommendations by Dr. Marilyn Bui Primary Diagnosis […]

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The Restaurateur Who Thought Like a Pathologist

| March 21, 2017 | 0 Comments

Again, the talk of not healthcare reform but rather healthcare payment reform and the interests of lawmakers, physicians, patients, payers and industry at stake with potential significant cost/reimbursement and research budget cuts proposed has led me to thinking, without politicizing, how bizarre it all really can be. My first year of medical school a friend and I […]

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