News & Analysis as of

Medical Devices

Manufacturing Sector Getting Hit With Cyber-Attacks: Portable Oxygen Device Manufacturer Notifies 30,000 Patients Of Breach

Inogen, which manufactures portable oxygen devices, has alerted the Securities and Exchange Commission in a recent filing that it is notifying 30,000 individuals that their personal information was compromised when a hacker...more

Seeking to reduce premarket burdens, FDA proposes to expand Abbreviated 510(k) Pathway for certain devices

by Hogan Lovells on

Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft guidance seeking to expand use of the historically underutilized...more

Drop in Warning Letters for Medical Devices Raises Interesting Questions About the Industry

In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related to pre-market issues, which include investigational device exemption violations or lack of approval or clearance. Only 33...more

(Don’t) Take the Long Way Home: FDA Issues Draft Guidance on Expansion of the Abbreviated 510(k) Program

by Arnall Golden Gregory LLP on

The Food and Drug Administration channeled, in the other direction, the 1979 Supertramp song, “Take the Long Way Home,” after it issued a draft guidance entitled, “Expansion of the Abbreviated 510(k) Program: Demonstrating...more

FDA Announces Plans to Improve Safety and Advance Innovation of Medical Devices

by Reed Smith on

On April 17, 2018, FDA announced its plan to launch the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health (Action Plan), which aims to support and advance innovation in medical devices while also...more

FDA Announces “Unique” Restriction on Approved Medical Device

by Arnall Golden Gregory LLP on

On April 9, 2018, the Food and Drug Administration announced an additional “unique type of restriction” on the sale and distribution of an approved medical device. FDA issued an order requiring healthcare providers and...more

3D Printing: The Next Frontier

3D printing currently has two basic branches: 3D printing of inorganic mechanical parts and products, and 3D bioprinting of organic biological structures. So what is the next frontier? Answer: a merger of the two processes,...more

FDA Delays Enforcement of the Postmarketing Safety Reporting (PMSR) Final Rule

by Arnall Golden Gregory LLP on

The Food and Drug Administration issued a final rule setting forth postmarketing safety reporting (PMSR) requirements for combination products subject to premarket review by FDA on December 20, 2016. For some of these...more

Top Developments in Hatch-Waxman Litigation for April 2018

by Morrison & Foerster LLP on

This month, we highlight several significant cases including Celgene Corp. v. Hetero Labs Ltd. and Regeneron Pharmaceuticals, Inc. v. Merus N.V. as well as new legislation proposed in both houses of Congress with respect to...more

What device companies need to know ahead of an advisory panel meeting

by Hogan Lovells on

For companies that manufacture new and novel medical devices, advisory panel meetings can be a crucial step toward receiving formal clearance or approval from the FDA. ...more

What device companies need to know ahead of an advisory panel meeting

by Hogan Lovells on

Preparing for advisory panel meetings for companies that manufacture new and novel medical devices, advisory panel meetings can be a crucial step toward receiving formal clearance or approval from the U.S. FDA. To ensure a...more

Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications

by Ropes & Gray LLP on

The rules regarding truthful, non-misleading communications by medical product manufacturers have long been unclear. In recent years, there have been significant developments in the case law, as well as in FDA guidance and...more

FDA Permits Marketing of First AI-based Medical Device; Signals Fast Track Approach to Artificial Intelligence

"The first and only autonomous AI system authorized by the FDA" - On April 11, 2018, the U.S. Food and Drug Administration (FDA) permitted marketing of a medical device that utilizes artificial intelligence to diagnose eye...more

Seventh Circuit Explains the Standard for Certification of a Question of State Law

by Foley & Lardner LLP on

Seventh Circuit Rule 52 allows the U.S. Court of Appeals for the Seventh Circuit, when faced with “questions arising under the laws of [a] state which will control the outcome of a case pending in the federal court” to...more

FDA Approval for Auris' Robotic Endoscopy Platform

by Knobbe Martens on

On March 23, Auris Health, Inc. announced FDA clearance for the Monarch Platform, Auris’ new system for robotic endoscopy. According to Auris Health, the Monarch Platform “integrates the latest advancements in robotics,...more

FDA Limits Sales of Birth Control Device

by Harris Beach PLLC on

The Food and Drug Administration (FDA) has taken the unusual step of limiting and restricting sales of the birth control medical device, Essure®, to healthcare providers who provide adequate risk versus benefit discussions...more

Theranos Charges Provide Perspective for Medical Device Companies, Biotechnology Companies, and Investors

by Knobbe Martens on

On March 14, 2018, the Securities and Exchange Commission (SEC) announced it filed charges against the founder and CEO of Theranos Inc., Elizabeth Holmes, and its former president, Ramesh Balwani....more

FDA grants De Novo Market Clearance of Artificial Intelligence Software

by Knobbe Martens on

According to a U.S. Food and Drug Administration press release, Viz. AI Contact application was granted De Novo premarket review to Viz.AI’s LVO Stroke Platform. According to PR Newswire, Viz.AI’s LVO Stroke Platform is the...more

Hospitals Face Sizable Overpayment Liability for Not Reporting Medical Device Credits

The Office of Inspector General (OIG) continues to unearth widespread noncompliance by hospitals with requirements for reporting the receipt of medical device credits. In a March 2018 report examining payments received by...more

Capitol Hill Healthcare Update

by BakerHostetler on

CONGRESS RECONVENES, WITH A FOCUS ON OPIOIDS - Lawmakers return today to Capitol Hill after a two-week recess, and multiple committees in both the House and Senate are poised to examine the opioid crisis and potential...more

Post-BMS: Jurisdiction over Subsidiary ? Jurisdiction over Parent

by Reed Smith on

The personal injury decisions Daimler AG v. Bauman, 571 U.S. 117 (2014), and Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017), are gifts that keep on giving. The latest development is Wilson v. Nouvag GmbH,...more

First Ever Marijuana-Related Medical Device Approved

by Knobbe Martens on

According to PR Newswire, the Israeli Ministry of Health has grated initial approval to Tel-Aviv-based Kanabo Research for their VapePod vaporizer product as a medical device. PR Newswire notes that with this approval, Israel...more

Brexit at Halfway: Pharma and Medical Devices

by WilmerHale on

The object of this Alert is to highlight some practical implications of Brexit for the supply of pharmaceutical products and medical devices in the European Union (EU) and related action items which companies should be...more

Cyborg-Enhanced Physical Therapy Approved

by Knobbe Martens on

Cyberdyne, Inc. recently announced FDA marketing approval for its Medical HAL [Hybrid Assistive Limb] therapeutic device and services. Cyberdyne describes itself as a Japanese company founded by Professor Yoshiyuki Sankai of...more

When Parallel Claims Are Neither Claims Nor Parallel

by Reed Smith on

This is not new. PMA devices should have broad preemption against product liability claims. Not just from the express preemption provisions of the MDA, but from attempts to get around express preemption by basing claims on...more

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