Medical Devices

News & Analysis as of

IEEE Releases Med Device Cybersecurity Guidelines

Amid myriad media reports about potential vulnerabilities in medical device cybersecurity and the FDA’s efforts to strengthen medical device cybersecurity, the IEEE Cybersecurity Initiative released a report entitled...more

Unfortunately Disappointing 3D Printing Law Review Article

We’ve blogged before about the interesting product liability issues created by 3D printing/additive manufacturing, in particular the novel separation that these techniques create (at least potentially) between “manufacturing”...more

Acelity Reported to Plan $1 Billion IPO

San Antonio, Texas based medical device company Acelity LP Inc. is reported to be considering an initial public offering that could raise up to $1 billion, according to the Wall Street Journal. Acelity has reportedly...more

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it...more

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

FDA Approves St. Jude Medical’s Upgradeable, MRI-Compatable Spinal Cord Stimulation System

St. Jude Medical, Inc., a global medical device manufacturer, announced that it has received FDA approval of the company’s Protégé MRI™ spinal cord stimulation (SCS) system, along with approval for related percutaneous leads,...more

FDA Reports Results of Annual Crack Down on Illegal Internet Pharmacies

Last week, FDA announced that more than 1,050 websites had illegal drugs and devices seized or received warning letters as part of the Eighth Annual International Internet Week of Action (IIWA). IIWA is an international...more

Molex Acquires ProTek Medical

On May 19, 2015, Molex Incorporated announced that Molex Ireland Holdings B.V. has acquired ProTek Medical Ltd. According to the press release, ProTek Medical, based in Sligo, Ireland, specializes in cleanroom injection...more

No Prescription For Consumer Protection

Allowing plaintiffs to pursue claims under consumer protection statutes in prescription medical product liability litigation is trying to pound a square peg into a ham sandwich. It doesn’t fit, and the combination isn’t very...more

CMS Proposes HCPCS Changes for Miscellaneous DME

CMS is proposing to revise the coding used to describe miscellaneous durable medical equipment (DME). The agency notes that HCPCS code E1399, “durable medical equipment, miscellaneous,” is currently used to bill for...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

OIG Approves Subsidies to Medicare Beneficiaries Provided by a Clinical Research Study

On May 28, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued an advisory opinion approving a medical device manufacturer’s proposed arrangement to provide subsidies to certain...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

Medical Device Update: FDA Issues Draft Guidance on Benefit-Risk Determinations for IDEs

The US Food and Drug Administration (FDA or the Agency) issued draft guidance on June 18 about assessing the benefits and risks for Investigational Device Exemption (IDE) applications. The draft guidance provides a...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

MDL Court Agrees – Tincher Doesn’t Change Pennsylvania Drug/Device Law

Several months ago we responded with some disdain to recent plaintiff-side arguments we had seen claiming that the strict liability decision in Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014), somehow altered...more

Q&A Series: Locke Lord’s Jim Tyrrell on the Keys to a Winning Products Liability Defense

What is the key to succeeding for a client in a complex products liability or toxic tort matter? JT: It’s all in the ‘C’s.’ Command of the facts, command of the law, command of the science, command of the courtroom and...more

OIG Advisory Opinion Approves Patient Subsidies For Clinical Study

On June 4, 2015, OIG published an advisory opinion (No. 15-07) stating that it will not impose administrative sanctions on a medical device manufacturer that planned to pay for copayments and certain other costs for Medicare...more

IP/Unfair Comp. Case Applies Buckman

The very name “intellectual property law” suggests it’s not for us. There are episodes of The Simpsons that seem too complicated for our pretty little heads. Anything deemed “intellectual” scares us away. We usually race...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

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