Medical Devices

News & Analysis as of

Certain Medical Devices Exempted from 510(k) Requirements

The Food and Drug Administration (FDA) recently identified a list of Class II Medical Devices that, when finalized, will be exempt from premarket notification (510(k)) requirements. This publication was made by the FDA...more

FDA Approval for Medtronic’s Reveal LINQ ICM with TruRhythm Detection

On March 13, 2017, Medtronic announced FDA 510(k) clearance for its Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection. Previously, Medtronic received Ministry of Health, Labor and Welfare approval for the...more

Ingestible e-Pill Approved For Use in Hospitals

BodyCap, a France-based company said to be dedicated to the development of miniature wireless electronic sensors, recently announced that its e-Celsius® device has earned CE mark approval and is now commercially available for...more

Regulation A+ Issuer Aims for NYSE MKT Listing

Myomo, Inc. has had an offering statement qualified by the SEC in which it discloses an intent to apply to list its common stock on the NYSE MKT LLC. The offering seeks to raise $15 million on a “best efforts” basis without...more

AGG Food and Drug Newsletter - March 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Cures Act Developments: FDA Proposes Class II Device Exemptions

Since the 21st Century Cures Act became law on December 13, 2016, we have been blogging on regulatory and clinical areas affected by its provisions. On March 14, 2017, FDA made further progress on its Cures Act obligations by...more

Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such...more

Congressional Hypocrisy — Taking away your rights

As a part of the recent speed racing bills through Congress, they have put up HR 1215. Quite erroneously, they have titled it: “Protecting Access to Care Act of 2017”. A read of the act’s text quickly tells any objective...more

FDA to Exempt Over 1,000 Types of Medical Devices from Premarket Notification Requirements

On March 13, 2017, the U.S. Food and Drug Administration (FDA or the Agency) identified a list of 1,003 types of Class II medical devices that, when finalized, will be exempt from the Agency’s premarket notification (i.e.,...more

Obamacare Replacement Would Repeal Medical Device Tax

Republican lawmakers recently proposed a replacement of Obamacare known as the American Health Care Act (AHCA). One provision of the proposed legislation would permanently repeal Obamacare’s 2.3% medical device excise tax. ...more

"Trends in Corporate Integrity Agreements Reflect New HHS OIG Guidance on Use of Exclusion Authority"

2016 was a year of change for the Department of Health and Human Service's Office of Inspector General's (OIG) approach to corporate integrity agreements (CIA). The OIG began to use its new model CIA format and applied its...more

Pro Te: Solutio - Vol.9 No.3 – Fall 2016

The Fall 2016 issue of Pro Te is about all things regulatory, including a peek at the newly developing issue of crowdfunding for medical devices. In EMA Guidance on Clinical Data Publication, we discuss recent guidance...more

Hip Implant MDL Denies Summary Judgment on Claims of Plaintiffs Who Failed to Preserve Explanted Devices

Regular readers of this blog know that we have a pretty jaded view of many MDLs. Obviously consolidation makes sense, at least on paper, in terms of efficiency and the best use of scarce court resources. But, in practice,...more

Section 337 Actions at the ITC: another forum for pharma and biosimilars litigation?

With the growing volume of biosimilar and pharma litigation in district courts and before the PTAB, the U.S. International Trade Commission may emerge as another forum for patent holders against imported biosimilars. Section...more

Voxello Receives FDA 510(k) Clearance for the Noddle Communication Device

Voxello recently announced FDA 510(k) clearance of its noddle™ device, following submission of its application in October 2016. According to the press release, the noddle gives patients who are unable to speak a way to...more

Medical Device Malware Medjack.3 Poses Threat to Hospitals

Medjack is a form of malware that was specifically developed to attack medical devices, such as heart monitors, CT and MRI machines, insulin pumps and PAC systems....more

Washington: Product Manufacturers Must Warn Hospitals; May Be Strictly Liable for Failure to Warn

In Washington, manufacturers of medical devices now have a duty to warn hospitals that purchase their devices. Additionally, product manufacturers of “unavoidably unsafe products” face strict liability for failure to warn...more

[Webinar] Willful Patent Infringement in Today’s World of Medical Devices: Opinions of Counsel and Operating in a State of Flux -...

As courts apply the Supreme Court’s direction on willful infringement, U.S. companies have guideposts to look to on the bounds in which they can operate. For in-house counsel with a budget, obtaining an opinion letter for...more

Outsourcing of Services in the Medical Device Industry

As the medical device market continues to grow, the medical device industry has strived to reduce costs through outsourcing. An industry report has found that the global medical device outsourcing market was valued at $33.2...more

Top Ten International Anti-Corruption Developments for January 2017

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

What The Intuitive Ruling Means For Medical Device Makers

Last month, in Taylor v. Intuitive Surgical Inc., the Washington Supreme Court saddled medical device manufacturers with a new duty to warn under Washington law — the duty to warn hospitals about potential risks their...more

EU Finalizes Medical Device Regulations

The European Council has released the final versions of its Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR). According to JDSupra, the Council of the European Union will vote on March 7, 2017...more

Southern District of Indiana Excludes Plaintiffs’ Experts in Hernia Mesh Case

We loved La La Land. We were enchanted by the colors and the music and the dancing. We were transported by the dreams-come-true and saddened by the could-have-beens. We disappeared into the characters’ world for two hours...more

FDA Enforcement Activities Update for FY 2016: CDRH Warning Letters Fall to 8-Year Low

The Food and Drug Administration (FDA) recently released statitistics regarding its enforcement actvities for FY 2016. Of note, the number of warning letters issued by the Center for Devices and Radiological Health (CDRH),...more

Summary of California Appellate Decisions - February 2016

INSURANCE; BAD FAITH; GENUINE DISPUTE DOCTRINE - Paslay v. State Farm General Insurance Co. (2016) 248 Cal.App.4th 639 203 Cal.Rptr.3d 785 - FACTS: State Farm issued a homeowners policy to Paslay, the...more

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