Medical Devices

News & Analysis as of

Medical Device Update

In This Presentation: • Medical device patent statistics • Non-practicing entity (NPE) litigation • Inter partes reexam (IPR) update • Important litigation – Edwards v. Medtronic – Masimo v. Philips –...more

Vascular Solutions Inc. and its CEO Face Criminal Charges for Selling Unapproved Medical Devices

Last week, the Civil Division of the U.S. Department of Justice (DOJ) filed an indictment charging Vascular Solutions Inc. (VSI) and its CEO Howard Root with (1) selling medical devices without the approval of the U.S. Food...more

CMS Updates Manual Instructions to Implement CY 2014 MPFS Changes for Reimbursement of Investigational Devices and Related...

On November 6, 2014, CMS announced changes to its Medicare Benefit Policy Manual and Medicare Claims Processing Manual related to coverage of items and services in Category A and B Investigational Device Exemption (IDE)...more

Student Health & Safety and Discipline Related Legislative Changes

This update of student health & safety and discipline related legislative changes is issued by Kronick as part of a series of Legal Alerts about new education related laws from this latest 2014 legislative session. All laws...more

New FDA Cybersecurity Guidance for Medical Device Manufacturers

Last month, the U.S. Food and Drug Administration issued its final guidance, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” Those guidelines make non-binding recommendations on the...more

EP Committee Study on Legislative Areas of the TTIP Addresses Nanomaterials

The European Parliament (EP) Committee on Environment, Public Health, and Food Safety (ENVI) has posted a study entitled ENVI Relevant Legislative Areas of the EU-US Trade and Investment Partnership Negotiations (TTIP). The...more

Vascular Solutions Indicted

The Star Tribune reports that a federal grand jury indicted Howard Root, CEO of Vascular Solutions, Inc. (VSI), on one felony count of conspiracy and eight misdemeanor charges of selling unapproved and adulterated medical...more

The Game Plan for Health Care Enforcement: Office of Inspector General Releases 2015 Work Plan

The Office of Inspector General (“OIG”) within the federal Department of Health and Human Services (“HHS”) is charged with protecting the integrity of HHS programs by combating fraud, abuse and waste. On Halloween of 2014,...more

Nokia Sensing XCHALLENGE Announces its Competition #2 Winners

The Nokia Sensing XCHALLENGE has announced its Q3 2014 Winners. According to XPRIZE, a non-profit organization that manages public competitions to advance technological development, the Nokia Sensing XCHALLENGE was offered...more

Real Property, Financial Services & Title Insurance Update: Weeks Ending October 24, 31 & November 7, 2014

REAL PROPERTY UPDATE - - Commercial Landlord Duty: commercial landlord has no common law duty to provide automatic external defibrillator in its stores for use in medical emergency – Verdugo v. Target Corp., No....more

Recent Developments in Patent Law for Medical Device Companies

In This Presentation: - Recent Patent Cases From The Supreme Court - Medical Device Patent Statistics and Cases - USPTO Post-Grant Proceedings: Lessons Learned After Two Years - Excerpt from Recent Cases...more

The Medical Device Tax in the Wake of 2014 Midterm Elections

Repeal of the medical device tax has seen frequent news coverage since the tax’s enactment in 2010 as part of the Affordable Care Act. The tax, which went into effect in January, 2013, imposes a 2.3% sales tax on a range of...more

FDA Regulatory and Compliance Monthly Recap - October 2014

In This Issue: - FDA issues final guidance on discerning device recalls from market withdrawals related to medical device enhancements in apparent bid to appease industry concern over draft being overly broad, lacking...more

Florida High Court to Decide Duties Owed by Public School Regarding Automated External Defibrillator

On October 6, 2014, the Florida Supreme Court heard oral argument in a case involving whether a public school owes a duty to maintain, make available, and use an automated external defibrillator (AED) on a student athlete who...more

Butterfly Network Launches With Over $100M in Financing to Make Handheld Medical-Imaging Device

Butterfly Network, Inc. announced on November 3rd that it has raised over $100 million to commercialize a medical device designed to reduce the cost of real-time, three-dimensional imaging and treatment. Butterfly states that...more

Reliance on the Same Prior Art Dooms Medtronic's Attempt to Correct its Previously Rejected IPR Petition

In IPR proceeding involving Medtronic, Inc. v. NuVasive. Inc., the petitioner, Medtronic, file a petition seeking review of U.S. Patent No. 8,361,156 relating to a spinal implant and methods of spinal fusion using the...more

$1B Settlement Reached in Stryker Hip Implant Mass Tort

Thousands of plaintiffs in New Jersey and around the country who had surgery to remove failed hip implants settled their claims November 3 in a deal that is expected to pay out more than $1 billion. It was reached after four...more

School Districts: Recent Health Related Legislation Affecting Schools (11/14)

Governor Cuomo recently signed two health related bills affecting schools into law. The first, codified under Education Law § 305(52) and signed on October 21, 2014, went into effect immediately. The law directs the...more

D.C. Circuit Rejects FDA’s Claim of Inherent Authority to Reclassify a Device by Rescinding a 510(k) Substantial Equivalence Order

On September 26, 2014, the D.C. Circuit issued an opinion holding that the Food and Drug Administration (“FDA”) failed to follow the appropriate statutory procedure for reclassifying a device when the Agency relied on its...more

Stryker Enters Settlement and will Pay $1.43B to Settle Hip Implant Cases

Howmedica Osteonics Corp. (“Stryker Orthopaedics”), a subsidiary of Stryker Corporation, and Court-appointed committees of attorneys representing Rejuvenate Modular-Neck and ABG II Modular-Neck plaintiffs in New Jersey...more

Blog: FDA Cybersecurity Workshop for Healthcare

On October 21-22 the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Departments of Health and Human Services and Homeland Security, conducted a public workshop entitled “Collaborative Approaches for...more

CME Payments Largely Remain Excluded From Sunshine Act Reporting

The Centers for Medicare & Medicaid Services (“CMS”) has finalized changes to a number of reporting requirements under the regulations implementing the Physician Payments Sunshine Act (“Final Rule”). When CMS proposed...more

Blog: HHS OIG Hands Out 2015 Work Plan For Halloween

On Friday October 31, 2014, the U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) released its annual “Work Plan” for fiscal year 2015. The Work Plan is a compilation of the OIG’s plans for...more

Private Equity Summary Report 2014

In This Issue: 1. Key Findings 2. Disruptive Forces 3. Health Care Private Equity Overview 4. Transaction Value 5. Subsector Activity 6. Venture Capital 7. Accountable Care Organizations 8....more

Medical Device Update: Distinguishing Medical Device Recalls from Medical Device Enhancements

On October 15, the U.S. Food and Drug Administration (FDA) issued the final guidance “Distinguishing Medical Device Recalls from Medical Device Enhancements.” This guidance revises and finalizes the draft version that...more

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