Medical Innovation Exchange

clinical trials

FDA Urges Medical Device Manufacturers to Scrutinize Third Party-Generated Data

FDA Urges Medical Device Manufacturers to Scrutinize Third Party-Generated Data      Following what it calls an “alarming” increase in medical device submissions containing unreliable data generated by third-party test labs, the FDA has issued a letter to industry urging sponsors of device studies and manufacturers of devices to carefully evaluate the third parties they engage …

FDA Urges Medical Device Manufacturers to Scrutinize Third Party-Generated Data Read More »

NIST Introduces Heart-on-a-Chip for Cardiovascular Research

NIST Introduces Heart-on-a-Chip for Cardiovascular Research     Researchers at the National Institute of Standards and Technology (NIST) have developed a tool for building a system known as heart-on-a-chip (HoC). This technology seeks to address the limitations of conventional cardiovascular drug development, which relies heavily on animal testing. By replicating humanlike models to study cardiovascular diseases, …

NIST Introduces Heart-on-a-Chip for Cardiovascular Research Read More »

AI and the Lack of Diversity in Data: Implications and the Path Forward for Rare Disease Research

AI and the Lack of Diversity in Data: Implications and the Path Forward for Rare Disease Research     Artificial intelligence (AI) and machine learning (ML) are poised to be play a pivotal role in clinical trials by automating patient recruitment, data collection and analysis. However, most AI algorithms primarily rely on databases from populations of …

AI and the Lack of Diversity in Data: Implications and the Path Forward for Rare Disease Research Read More »

The Power of AI to Enhance Clinical Trials

The Power of AI to Enhance Clinical Trials     Clinical trials are essential to the development and implementation of safer and more effective devices and medications, but clinical trial success rates have been shockingly low. The likelihood of a new drug advancing to the next trial stage or regulatory approval is less than 14% across …

The Power of AI to Enhance Clinical Trials Read More »

HiRO Enters U.S. with Acquisition of CRO Courante Oncology

HiRO Enters U.S. with Acquisition of CRO Courante Oncology     Harvest Integrated Research Organization (HiRO), a global contract research organization (CRO), has acquired Courante Oncology, a U.S.-based full-service clinical research provider specializing in oncology product development. HiRO is a boutique CRO serving the Asia-Pacific region. Its acquisition of Courante Oncology extends the organization’s presence into the …

HiRO Enters U.S. with Acquisition of CRO Courante Oncology Read More »

FDA CDRH To Host Virtual Workshop to Enhance Clinical Study Diversity

FDA CDRH To Host Virtual Workshop to Enhance Clinical Study Diversity     The FDA, in collaboration with the Clinical Trials Transformation Initiative (CTTI), is soliciting input on how to enhance clinical study diversity. They will be hosting a two-day virtual public workshop on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging …

FDA CDRH To Host Virtual Workshop to Enhance Clinical Study Diversity Read More »

FDA CDRH To Host Virtual Workshop to Enhance Clinical Study Diversity

FDA CDRH To Host Virtual Workshop to Enhance Clinical Study Diversity     The FDA, in collaboration with the Clinical Trials Transformation Initiative (CTTI), is soliciting input on how to enhance clinical study diversity. They will be hosting a two-day virtual public workshop on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging …

FDA CDRH To Host Virtual Workshop to Enhance Clinical Study Diversity Read More »

Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance

Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance     This week Huma Therapeutics received 510(k) clearance for its configurable Software as a Medical Device (SaMD) disease management platform, which previously received Class IIb approval in the EU. The FDA Class II clearance allows users to add AI algorithms to the disease-agnostic platform, potentially speeding …

Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance Read More »

FDA Announces Additional Steps to Modernize Clinical Trials

FDA Announces Additional Steps to Modernize Clinical Trials     On June 6, the FDA released E6(R3) Guideline for Good Clinical Practice, a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections. The updates …

FDA Announces Additional Steps to Modernize Clinical Trials Read More »

FDA Issues Draft Guidance on Use of Decentralized Clinical Trials

FDA Issues Draft Guidance on Use of Decentralized Clinical Trials     The FDA has published a new draft guidance on the use of decentralized clinical trials (DCT), which it defines as a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. “Decentralized Clinical Trials for …

FDA Issues Draft Guidance on Use of Decentralized Clinical Trials Read More »