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Medical Devices Personalized Medicine

American Conference Institute (ACI)

[Event] 21st Annual Life Sciences IP Summit - September 27th - 28th, Munich, Germany

Hosted by C5 Group, the 21st Annual Life Sciences IP Summit returns for another exciting year with curated programming with speakers from the pharma, biotech and medical device industries that will provide practical insights...more

Foley & Lardner LLP

The Health AI Frontier: New Opportunities for Innovation Across the Health Care Sector

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With the health care industry under pressure to improve patient outcomes while controlling costs, artificial intelligence (AI) and machine learning (ML) are quickly becoming indispensable tools. These technologies show...more

Rivkin Radler LLP

FDA Announces Digital Health Center of Excellence

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On September 22, the U.S. Food and Drug Administration (FDA) announced the launch of its Digital Health Center of Excellence within the Center for Devices and Radiological Health. The FDA called this an important step toward...more

Hogan Lovells

Updates on the newest regulatory legislation (Royal Decree 717/2019) in Spain

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On 5 December 2019, the Official State Gazette of Spain published a new regulation passed by the Spanish government which has introduced many significant developments in the Spanish legal framework on medicinal products for...more

Knobbe Martens

European Commission Proposes Stronger Cooperation for Health Technology Assessment

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On January 31, 2018, the European Commission adopted a legislative proposal with the aim of strengthening EU cooperation among Member States when conducting a Health Technology Assessment (HTA) of new medicines and certain...more

Foley & Lardner LLP

Dueling Records: Are Statements in Your 510(k) Putting Your Patents at Risk?

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Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more

Foley & Lardner LLP

FDA Oversight of Diagnostic Medicine – A Trap for the Unwary

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Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more

Foley & Lardner LLP

AmerisourceBergen Guest Post: Solutions to Overcome Reimbursement Challenges in Personalized Medicine

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The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more

Wilson Sonsini Goodrich & Rosati

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

Foley & Lardner LLP

Considering Sex-Specific Variation for Personalized Medicine

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Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a...more

Latham & Watkins LLP

Preparing for a "New Era of Medical Product Development"

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FDA report demonstrates support for personalized medicine and more efficient regulatory pathways. In a new report issued by the Food and Drug Administration (FDA) on October 28, 2013, Commissioner of Food and Drugs...more

Patrick Malone & Associates P.C. | DC Injury...

Getting the Best Medical Care: a Newsletter from Patrick Malone - January 2013

In This Issue: - Six Things to Think About as Technology Advances - For More Information - Recent Health Care News You Should Know About - Check Out Our Previous Tips - Deep Thoughts for the New Year: Ethical...more

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