Automation

Advantages of Workflow Automation in Healthcare: Minimizing Administrative Burden and Enhancing Compliance

By Ben Manning

AI-driven insights can provide valuable analysis by sifting through large volumes of data, aiding healthcare providers in making informed decisions and enhancing patient care. Automation and AI also pave the…

AI-driven insights can provide valuable analysis by sifting through large volumes of data, aiding healthcare providers in making informed decisions and enhancing patient care. Automation and AI also pave the…

Continue reading

LDT Development

The FDA’s final lab developed test rule places new burdens on manufacturers

By Laura Housman

…these tests. Additionally, the rule broadens the definition of LDTs to encompass tests developed by high-complexity laboratories and those intended for rare diseases, increasing the range of tests subject to…

…these tests. Additionally, the rule broadens the definition of LDTs to encompass tests developed by high-complexity laboratories and those intended for rare diseases, increasing the range of tests subject to…

Continue reading

Smith+Nephew logo

Smith & Nephew shares surge on activist Cevian building stake

By MedTech Intelligence Staff

…to reports by Reuters. According to LSEG data, Cervian is known for taking stakes in companies and calling for change. In recent years, Smith & Nephew has lost significant stock…

…to reports by Reuters. According to LSEG data, Cervian is known for taking stakes in companies and calling for change. In recent years, Smith & Nephew has lost significant stock…

Continue reading

Regulatory Survey 2024

SURVEY: Managing global regulatory strategy and compliance ā€“ assessing status, gaps, and needs.

By Celegence, MedTech Intelligence Staff

validates industry concerns of increasing workloads and overtime hours, and how many companies are finding it hard to recruit suitable skilled RA/QA associates. Many medical device companies are questioning their…

validates industry concerns of increasing workloads and overtime hours, and how many companies are finding it hard to recruit suitable skilled RA/QA associates. Many medical device companies are questioning their…

Continue reading

FDA

FDA publishes long-awaited clinical trial diversity guidance

By Hogan Lovells Engage

…26. The draft guidance states that compliance with the DAP initiative will not come into effect until 180 days after the future final guidance is published. Even so, sponsors should…

…26. The draft guidance states that compliance with the DAP initiative will not come into effect until 180 days after the future final guidance is published. Even so, sponsors should…

Continue reading

Thermal Solutions

Advanced Thermal Solutions in OEM Medical Device Design

By Andy Selvy

…medical devices brings a set of complex challenges that must be carefully managed. Ensuring safety and compliance is paramount, as medical devices are some of the most heavily regulated products…

…medical devices brings a set of complex challenges that must be carefully managed. Ensuring safety and compliance is paramount, as medical devices are some of the most heavily regulated products…

Continue reading

EU Commission

The impacts of the EU Data Act on medical and health devicesā€™ companies

By Anne-Gabrielle Haie, Maria Avramidou

…required to comply with the EU Data Act, medical and health devices’ companies would do well to already commence assessing what they will need to do to comply with it….

…required to comply with the EU Data Act, medical and health devices’ companies would do well to already commence assessing what they will need to do to comply with it….

Continue reading