…device resulting in harm to a user or patient. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on medical device…
…device resulting in harm to a user or patient. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on medical device…
The FDA has issued an update to the final guidance: Breakthrough Devices Program. The updates are intended to clarify how the Breakthrough Devices Program applies to certain innovative medical devices…
The FDA has issued an update to the final guidance: Breakthrough Devices Program. The updates are intended to clarify how the Breakthrough Devices Program applies to certain innovative medical devices…
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…
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…
Get Well, a provider of enterprise digital patient experience and navigation solutions for hospitals and communities, announced that it has achieved Federal Risk and Authorization Management Program (FedRAMP) authority to…
Get Well, a provider of enterprise digital patient experience and navigation solutions for hospitals and communities, announced that it has achieved Federal Risk and Authorization Management Program (FedRAMP) authority to…
The UK has released a draft of its proposed Post Market Surveillance Requirements for Medical Devices. If the draft regulations, “The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations…
The UK has released a draft of its proposed Post Market Surveillance Requirements for Medical Devices. If the draft regulations, “The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations…
The FDA Center for Devices and Radiological Health (CDRH) is seeking input from the medical device industry, the public, patient advocacy organizations, healthcare providers and clinical researchers on at-home use…
The FDA Center for Devices and Radiological Health (CDRH) is seeking input from the medical device industry, the public, patient advocacy organizations, healthcare providers and clinical researchers on at-home use…
On November 8-9, members of the Medtech community will gather in Washington, DC, for the MedTech Supply Chain Intelligence Summit. Hear from industry leaders and join in the discussion as…
On November 8-9, members of the Medtech community will gather in Washington, DC, for the MedTech Supply Chain Intelligence Summit. Hear from industry leaders and join in the discussion as…
On August 11, the FDA released the Final Guidance Off-the-Shelf Software Use in Medical Devices. The document, which supersedes Off-The-Shelf Software Use in Medical Devices issued September 27, 2019, provides…
On August 11, the FDA released the Final Guidance Off-the-Shelf Software Use in Medical Devices. The document, which supersedes Off-The-Shelf Software Use in Medical Devices issued September 27, 2019, provides…
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…
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…
…importantly, their patients. References: [i] “Healthcare cyberattacks led to worse patient care, increased mortality, study finds,” Healthcare Dive, September 8, 2023, https://www.healthcaredive.com/news/cyberattacks-hospitals-disrupt-operations-patient-care-Ponemon/631439/ [ii] [ii] “IBM: Average Cost of a Healthcare…
…importantly, their patients. References: [i] “Healthcare cyberattacks led to worse patient care, increased mortality, study finds,” Healthcare Dive, September 8, 2023, https://www.healthcaredive.com/news/cyberattacks-hospitals-disrupt-operations-patient-care-Ponemon/631439/ [ii] [ii] “IBM: Average Cost of a Healthcare…
