…news for wearable device developers is, we have decades of experience and entire families of stick-to-skin PSAs to draw on as we attempt to address the latest challenges presented by…
…news for wearable device developers is, we have decades of experience and entire families of stick-to-skin PSAs to draw on as we attempt to address the latest challenges presented by…
On May 10, the FDA released two discussion papers on the use of artificial intelligence and machine learning (AI/ML) in drug development and manufacturing. In a statement introducing the papers,…
On May 10, the FDA released two discussion papers on the use of artificial intelligence and machine learning (AI/ML) in drug development and manufacturing. In a statement introducing the papers,…
The FDA has published a new draft guidance on the use of decentralized clinical trials (DCT), which it defines as a clinical trial where some or all of the trial-related…
The FDA has published a new draft guidance on the use of decentralized clinical trials (DCT), which it defines as a clinical trial where some or all of the trial-related…
…long run. References: [1] DIHK (2022). Gesundheitswirtschaft unter Druck. https://www.dihk.de/resource/blob/73350/4912206cdf7717fd3e770a3927f58537/gesundheitsreport-fruehsommer-2022-data.pdf [2] Obelis Group (2022): What are the effects of the implementation of MDR on the EU medical device market? https://www.obelis.net/news/what-are-the-effects-of-the-implementation-of-mdr-on-the-eu-medical-device-market/…
…long run. References: [1] DIHK (2022). Gesundheitswirtschaft unter Druck. https://www.dihk.de/resource/blob/73350/4912206cdf7717fd3e770a3927f58537/gesundheitsreport-fruehsommer-2022-data.pdf [2] Obelis Group (2022): What are the effects of the implementation of MDR on the EU medical device market? https://www.obelis.net/news/what-are-the-effects-of-the-implementation-of-mdr-on-the-eu-medical-device-market/…
On the heels of the EPA’s announcement of two new proposed rules to reduce ethylene oxide (EtO) emissions, Jeff Shuren, M.D., J.D., director of the FDA CDRH, announced a radiation…
On the heels of the EPA’s announcement of two new proposed rules to reduce ethylene oxide (EtO) emissions, Jeff Shuren, M.D., J.D., director of the FDA CDRH, announced a radiation…
Earlier this month, the UK Medicines & Healthcare Products Regulatory Agency (MHRA) issued the guidance document, “Software and Artificial Intelligence as a Medical Device.” The guidance brings together current guidances,…
Earlier this month, the UK Medicines & Healthcare Products Regulatory Agency (MHRA) issued the guidance document, “Software and Artificial Intelligence as a Medical Device.” The guidance brings together current guidances,…
…and sales will never promote or infer an off-label intended use, even if it is common practice. The good news is that if the manufacturer collects sufficient clinical, safety, and…
…and sales will never promote or infer an off-label intended use, even if it is common practice. The good news is that if the manufacturer collects sufficient clinical, safety, and…
…and monitoring patients. While these technologies have significantly improved the standard of care, they have also introduced a range of challenges for healthcare practitioners, administrators, and patients. The good news…
…and monitoring patients. While these technologies have significantly improved the standard of care, they have also introduced a range of challenges for healthcare practitioners, administrators, and patients. The good news…
3M Health Information Systems (HIS) has announced a collaboration with Amazon Web Services (AWS) to accelerate the innovation and advancement of 3M M*Modal ambient intelligence. As part of the collaboration,…
3M Health Information Systems (HIS) has announced a collaboration with Amazon Web Services (AWS) to accelerate the innovation and advancement of 3M M*Modal ambient intelligence. As part of the collaboration,…
On March 30, the FDA’s Center for Devices and Radiological Health (CDRH) published a draft guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled…
On March 30, the FDA’s Center for Devices and Radiological Health (CDRH) published a draft guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled…
