The FDA has updated the CDRH portal to allow users to track the progress of their pre-submissions. As of October 23, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using FDA’s eSTAR portal.
The FTC argues that the $27.8 billion transaction would enable Amgen to use rebates on its existing blockbuster drugs to stifle competition for Horizon’s two monopoly products for thyroid eye disease and chronic refractory gout.
Medical technology companies are caught between rising costs and increasing inflation as well as stricter regulations due to the introduction of the EU Medical Device Regulation. A strategic price adjustment can help to face these challenges and secure the companies’ success in the long term.
Selecting a strong medical device contract manufacturer is critical to ensure supply chain resiliency, regulatory compliance, and long-term success for a medical device OEM. This article is a guide to the most important questions to ask yourself and your contract manufacturer to help ensure a successful partnership.
Business strategy and forecasting influence several functional areas within an organization, including R&D, pipeline planning, revenue planning, inventory, resource and budget allocation, project prioritization, compensation plans, market access efforts, and more. These varied uses reflect the first major challenge of forecasting: meeting the needs of varied and diverse stakeholders. Following are three steps to make your forecasting efforts more effective.
On Monday, March 20, the EU MDR extension approved on March 7 came into effect following its official publication in the Journal of the European Union.
How innovators in the femtech space can protect their inventions and defend market share.
The doctrine of assignor estoppel is intended to prevent an inventor who has sold or “assigned” a patent from then challenging the patent’s validity. Mauricio Uribe, a patent lawyer with Knobbe Martens, discusses what medical device inventors and acquiring companies should do to ensure they comply with the Supreme Court and Federal Circuit’s clarification of assignor estoppel.
LinkedIn has become the go-to social media platform for professionals to build their personal brands, promote their expertise and grow their careers or businesses. Following are key content characteristics and strategies shared by the leading medtech voices on LinkedIn that can help you harness the potential of the platform.
Akido is focused on addressing the systemic inequities that lead to chronic illness and vulnerability through early interventions designed around social determinants of health (SDoH), best-in-class care and human-centered technology.
