Healthcare Medical Devices

News & Analysis as of

Southern Spine Announces 2015 MDEA Honor for StabiLink® MIS Spinal Fixation System

Southern Spine announced recently that StabiLink® MIS Interlaminar Spinal Fixation System has been chosen as the Silver Winner in the Implant and Tissue Replacement category of the 18th Annual Medical Design Excellence Awards...more

VertiFlex Announces FDA Approval of Superion Interspinous Spacer System

VertiFlex, Inc., announced that it has been granted pre-market approval by the FDA for its minimally invasive treatment of lumbar spinal stenosis, the Superion Interspinous Spacer System.  This approval comes after a...more

The Life Sciences Report - Spring 2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more

Washington Healthcare Update

This Week: Leading Up to the SCOTUS King v. Burwell Decision... House Votes to Repeal the Medical Device Tax... CMS Announces It Will Bolster Transitional Reinsurance Payments... MedPAC Releases June Report to Congress....more

DIA 2015 Provides Panels on All Types of FDA-Regulated Products with Many Opportunities for Insight and Interaction – Part Two of...

On the third day, the Center for Biologics Evaluation and Research (CBER) conducted its own Town Hall. CBER Director, Karen Midthun, explained how CBER works proactively to help develop new biological therapies. For example,...more

Blog: Congress Takes Step Towards Scrapping Device Tax

Last week, the House of Representatives voted 280-140 to pass H.R. 160, a bill that eliminates the 2.3 percent medical device tax. The vote was strongly bipartisan with 46 Democrats joining all Republicans voting in favor of...more

Pharmacy Benefit Manager Group Opposes 21st Century Cures Act’s Cost Offset

The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care...more

The Internet of Things

In this Presentation: - Internet of Things - definition - But what is it all about? - But not just that... - The IoT market in figures... - Beecham Research - view of the World - The Connected...more

Health Canada Proposes Changes to the List of Recognized Standards for Medical Devices

Changes affecting the approval of medical devices are coming. On May 6, 2015, Health Canada released a draft List of Recognized Standards for medical devices for stakeholder consultation. The consultation period is open...more

Health Alert (Australia) - June 15, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: New South Wales. O'Sullivan v Medical Council of New South Wales [2015] NSWCATAD 113 The New South Wales Civil and...more

Washington Healthcare Update

This Week: GOP Post-King Contingency Bills Released in Both the House and the Senate... House E&C Committee Draft LDT Bill – Creates FDA In Vitro Center, Sets Agency Review Timeline and Defines Risk Categories... CMS...more

21st Century Cures Act Passes House Committee

The House Energy and Commerce Committee unanimously approved H.R. 6, the “21st Century Cures Act,” on May 21, 2015, after reaching a bipartisan agreement to fund the legislation (Cures bill). Often described as a “landmark...more

Connecticut Passes Legislation Setting Certification Standards for Central Service Technicians

On May 26, 2015, Connecticut Governor Dannel P. Malloy signed into law Public Act 15-11 (PA 15-11), “An Act Concerning Persons Who Decontaminate Reusable Medical Instruments or Devices.” This new legislation requires central...more

Is This The End of RICO?

The short answer is “no.” We are just borrowing a line from one of the original gangster movies, “Little Caesar,” which readers other than McConnell would most likely know from references in “The Sopranos,” if they know it...more

Washington Healthcare Update

This Week: House E&C 21st Century Cures Bill Passes Unanimously Out of Committee... House Votes to Codify Permanent R&D Tax Credit... CMS Released Proposed Rule Concerning Medicaid and CHIP Plans....more

The Continuing Evolution of the French Sunshine Act

Since the general disclosure rule for provider-manufacturer relationships in France was enacted into law on January 1, 2012, its compliance and enforcement have been a common point of discussion for health care professionals,...more

21st Century Cures Markup Underway; Offsets Released

Today the House Energy and Commerce Committee is marking up H.R. 6, the 21st Century Cures Act, a high-profile, bipartisan bill that seeks to accelerate the pace of medical cures in the United States through a variety of...more

Healthcare & Life Sciences Private Equity Deal Tracker: Shockwave Medical Secures $40 Million in Financing

Shockwave Medical, based in Fremont, Calif., develops technology for the treatment of peripheral and coronary vascular disease and aortic stenosis. It is the developer of Lithoplasty balloon catheters....more

Health Alert (Australia) - May 25, 2015

In This Issue: Judgments; Legislation; and Reports & Publications. Excerpt from Reports: Australian Medical Association (AMA) - 19 May 2015 - $19 billion pharmacy deal sign of skewed health...more

Health Care Update - May 2015 #3

In This Issue: - 21st Century Cures Markup; Full Committee to Take Up this Week - Senate Finance Committee Solicits Health Bills for Upcoming Markup - Implementation of the Affordable Care Act - Federal...more

Washington Healthcare Update

This Week: Health Subcommittee Advances 21st Century Cures, Full Committee Action Scheduled…Senate Finance Committee Hearing: Chair Hatch to Launch New Initiative on Improving Chronic Care for Medicare Patients…Hawaii’s...more

FDA Issues Guidance for Mobile Medical Apps

Just so you know, that iPhone or iPad you have with you may be an FDA-regulated medical device. More precisely, the apps on the device may meet the definition of a medical device under the Federal Food, Drug, and Cosmetic Act...more

Connecticut Legislature Reduces Mandatory Reporting of Payments to APRNs

On May 11, 2015, Connecticut Governor Dannel P. Malloy signed into law Public Act 15-4, “An Act Concerning Reporting of Payments by Manufacturers to Independently-Practicing Advanced Practice Registered Nurses” (P.A. 15-4)....more

FDA Initiates Expedited Access Pathway Program for Medical Devices via Final Guidance Document

The U.S. Food and Drug Administration (FDA) initiated an Expedited Access Pathway (EAP) Program, effective April 15, 2015, for certain medical devices that are subject to premarket approval applications (PMAs) or de novo...more

New state law allows access to investigational drugs

In line with a nationwide movement, on April 21, 2015, Governor Fallin signed into law House Bill 1074, the Oklahoma Right to Try Act. The Act allows physicians to prescribe to terminally ill patients investigational drugs,...more

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