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Medical Devices › Technology Sector › Manufacturers

J.S. Held

Beyond Safety & Effectiveness: Business Reasons to Prioritize Human Factors in Medical Device Design

J.S. Held on

To err is human. We have short attention spans and get distracted easily. We have unreliable memories and forget. We have a limited ability to process information, and we overgeneralize rules-of-thumb to the wrong situations....more

Knobbe Martens

Global Market Size and Technological Advancements for Implantable Medical Devices Continue to Grow

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A recent report by Precedence Research estimates the global market size for implantable medical devices will grow from USD 97.62 Billion in 2024 to USD 178.15 Billion by 2034: The rapid increase in the global market size of...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 10, December 2024

Spilman Thomas & Battle, PLLC on

Happy Holidays and welcome to our year-end issue of Decoded. We hope you enjoyed reading our technology law insights e-newsletter this year. We are already planning for 2025. ...more

Sheppard Mullin Richter & Hampton LLP

FDA Maintains Focus on “Intended Use” for Software-Enabled Medical Devices

Sheppard Mullin Richter & Hampton LLP on

On June 21, 2023, the U.S. Food and Drug Administration (“FDA”) issued a warning letter to Zyto Technologies, Inc. (“Zyto”), citing Zyto’s promotion of its Hand Cradle Galvanic Skin Response (“GSR”) device and associated...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - August 2019

Akin Gump Strauss Hauer & Feld LLP on

ANTICORRUPTION DEVELOPMENTS - Telecommunications Company Fined $12 Million for FCPA Violations - On August 29, 2019, The Securities and Exchange Commission (SEC) instituted ceaseand-desist proceedings against...more

Foley & Lardner LLP

OIG Greenlights Digital Health Program Offering Free Smartphones to Patients

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Last week, the federal HHS Office of Inspector General (OIG) gave the greenlight to allow a virtual care company and pharmaceutical manufacturer to loan patients free smartphones, so the patients (which include Medicare...more

Holland & Knight LLP

OIG Approves Pharmaceutical Manufacturer’s Loaning of Smartphones to Support Digital Medicine (DM)

Holland & Knight LLP on

On Jan. 29, 2019, the Office of Inspector General (OIG), in Advisory Opinion 19-2, issued its first opinion on the new "promotes access to care" exception to the beneficiary inducement Civil Monetary Penalties (CMP) law and...more

Akin Gump Strauss Hauer & Feld LLP

OIG Approves Manufacturer Loaning Smartphones as Appropriate Patient Assistance to Support Digital Medicine

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On January 29, the Health and Human Service Office of Inspector General (OIG) released new guidance that sheds further light on the types of patient assistance that may be provided under the “Promotes Access to Care”...more

Hogan Lovells

FDA finalizes 3D printing guidance

Hogan Lovells on

On December 5, 2017, the U.S. Food and Drug Administration (FDA or the Agency) finalized its “leapfrog guidance” entitled, “Technical Considerations for Additive Manufactured Devices”. ...more

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