News & Analysis as of

Diagnostic Tests Life Sciences Health Care Providers

Hogan Lovells

Key takeaways – UK MHRA’s response to consultation on ‘Medical Devices Regulations: Routes to market and in vitro diagnostic...

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more

American Conference Institute (ACI)

[Event] 2nd Annual Life Sciences AI Summit - February 20th - 21st, New York, NY

Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...more

McDermott Will & Schulte

What the New CLIA Rules Mean for Labs and At-Home Testing

New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became effective on July 11, 2024,...more

Paul Hastings LLP

Considerations in View of the Lived Experience of Affected Individuals: Compliance in the Rare Disease Space

Paul Hastings LLP on

Over 10,000 rare diseases are currently affecting more than 30 million Americans. This article, written in partnership with members of the Rare Disease Compliance Consortium, focuses on the role of Patient Advocacy...more

Womble Bond Dickinson

Artificial Intelligence - The Promise of Early Disease Diagnosis and Improved Treatment and the Potential of Liability

Womble Bond Dickinson on

If there is one thing that everyone can agree on, it is that health is an important factor in life. In 2021, over 3 million people died in the United States with heart disease and cancer topping the list....more

McDermott Will & Schulte

[Webinar] 2021 +Dx Diagnostics Forum - April 6th, 12:00 pm - 3:30 pm EST

Celebrating its sixth program, McDermott+Consulting’s +Dx Diagnostics Forum is the premier annual program for the laboratory diagnostics community. Gain insight into how the industry addresses regulatory and business...more

Hogan Lovells

[Virtual Event] AI – A brave new world? - December 1st, 11:00 am - 12:15 pm EST

Hogan Lovells on

Life Sciences and Health Care Horizons virtual event series - The fast pace of innovation in the life sciences and health care industry has reached an all-time high in 2020 as the industry grapples with the new reality of...more

Mintz - Health Care Viewpoints

An Update on FDA’s Contribution to COVID-19 Diagnostic Testing

Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more

Womble Bond Dickinson

AI Predicts Aggressiveness of Early Stage Breast Cancer

Womble Bond Dickinson on

Approximately 20% of new breast cancers are diagnosed before they have spread from milk ducts into surrounding breast tissue. Breast cancer at this early stage is known as ductal carcinoma in situ (DCIS) or stage 0 breast...more

McDermott Will & Schulte

[Ongoing Program] Life Sciences Dealmaking Symposium 2020 - November 17th, 8:00 am - 2:00 pm EST

McDermott Will & Schulte on

In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more

McDermott Will & Schulte

[Ongoing Program] Life Sciences Dealmaking Symposium 2020 - Part 3 - November 10th, 12:00 pm - 1:00 pm EST

McDermott Will & Schulte on

In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more

McDermott Will & Schulte

[Ongoing Program] Life Sciences Dealmaking Symposium 2020 - Part 2 - October 27th, 12:00 pm - 1:00 pm EDT

McDermott Will & Schulte on

In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more

McDermott Will & Schulte

[Ongoing Program] Life Sciences Dealmaking Symposium 2020 - Part 1 - October 20th, 12:00 pm - 1:00 pm EDT

McDermott Will & Schulte on

In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more

McDermott Will & Schulte

[Webinar] Diagnostics, Antibody Testing and Vaccines: Global Outlook on Life Sciences COVID-19 Advances and Evolving Deal Trends -...

Across the US and EU, life sciences companies are pushing diagnostics, antibody testing, vaccines and other efforts forward to flatten the Coronavirus (COVID-19) curve. Our multidisciplinary cross-border life sciences team...more

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