Lukas Hainz

Lukas Hainz

Biopharma Innovation Specialist
Lukas Hainz specializes in biopharmaceutical research and development. He unpacks research from clinical trials and explores regulatory affairs implications on the pharmaceutical industry, focusing on innovative therapies and patent development.
What Are FDA's Key 2026 Medical Device Guidance Priorities?
Regulatory & Compliance What Are FDA's Key 2026 Medical Device Guidance Priorities?

What if a tiny piece of software in your wearable health tracker could save your life—or fail due to outdated regulations? In 2025, as medical technology races forward with innovations like AI diagnostics and mobile health apps, the Food and Drug Administration (FDA) stands at a pivotal moment.

Clarius App Update Unveils AI-Powered Ultrasound Tools
Digital Health Clarius App Update Unveils AI-Powered Ultrasound Tools

Imagine a world where medical professionals, regardless of their experience level, can wield ultrasound technology with the precision of seasoned experts, transforming patient care through the power of artificial intelligence. Clarius Mobile Health has taken a monumental step toward this vision

Top 10 Clinical Trial Companies Shaping 2025 Innovations
Digital Health Top 10 Clinical Trial Companies Shaping 2025 Innovations

The clinical trial landscape in 2025 is experiencing a profound shift, propelled by groundbreaking technologies and an intensified focus on meeting patient needs in meaningful ways, with Contract Research Organizations (CROs) playing a central role in this transformation. These organizations act as

Radiomic Changes in Femoral Bone During Cancer Therapy
Imaging & Diagnostics Radiomic Changes in Femoral Bone During Cancer Therapy

In the evolving landscape of cancer treatment, a groundbreaking approach is emerging that could transform how the effects of radiation on the human body are understood and managed, particularly in areas beyond the targeted tumor. This exploration delves into the subtle yet significant alterations

AI Chatbot Self-Cav Supports South African Youth on HIV and Health
Digital Health AI Chatbot Self-Cav Supports South African Youth on HIV and Health

In South Africa, a staggering public health crisis looms large, particularly for young women aged 15 to 24, who bear the brunt of new HIV infections despite making up only about 8% of the population, and this demographic accounts for four out of every ten new cases. This disparity is fueled by

FDA Seeks Input on Monitoring AI Medical Device Performance
Infrastructure & Management FDA Seeks Input on Monitoring AI Medical Device Performance

As artificial intelligence continues to transform the landscape of healthcare, the U.S. Food and Drug Administration (FDA) has taken a significant step toward ensuring the safety and effectiveness of AI-enabled medical devices by initiating a public consultation process. This move comes in response

How Does Religiously Concordant Telehealth Boost Engagement?
Digital Health How Does Religiously Concordant Telehealth Boost Engagement?

Fixed version: Imagine a scenario where a single question during a patient intake could transform the therapeutic experience for religiously committed individuals, significantly increasing their engagement in mental health care. Telehealth has already revolutionized access by eliminating

What Causes Long COVID Brain Fog? A Breakthrough Study
Imaging & Diagnostics What Causes Long COVID Brain Fog? A Breakthrough Study

For millions around the globe, the aftermath of a SARS-CoV-2 infection has introduced a lingering challenge known as Long COVID, with brain fog emerging as one of its most debilitating and widespread symptoms, affecting over 80% of those diagnosed with this chronic condition. Brain fog clouds the

How Do Implementation Science Frameworks Boost Healthcare QI?
Infrastructure & Management How Do Implementation Science Frameworks Boost Healthcare QI?

In the ever-shifting landscape of healthcare, the pursuit of quality improvement (QI) remains a cornerstone for enhancing patient outcomes and streamlining operational efficiency, yet the challenge lies in ensuring these initiatives endure beyond their initial rollout. Too often, promising projects

Will Telehealth Flexibilities Survive the September Deadline?
Digital Health Will Telehealth Flexibilities Survive the September Deadline?

As the critical deadline of September 30 approaches, the fate of Medicare telehealth flexibilities and Hospital-at-Home waivers hangs in the balance, casting uncertainty over millions of Americans who rely on virtual care for essential medical services. These provisions, which have transformed

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