With more than 50 years in the medical device space, SERF SAS is recognized for its innovations in hip implants, including the invention of the original Dual Mobility Cup.
Digital vehicle reimbursement solutions not only ensure fair compensation for employees, but also aid companies in managing costs.
Predicting the potential of cell and gene therapy pipelines presents unique challenges. Following are considerations for forecasters working with novel technologies.
Cardio Diagnostics announced issuance of new U.S. Patent for “Compositions and Methods for Detecting Predisposition to Cardiovascular Disease.”
“We’re excited to have Naomi in this role. With her FDA experience, her visionary approach will pave the way for success, ensuring that businesses not only meet the FDA’s stringent requirements but also thrive in an environment where cybersecurity is a fundamental business value.”
AI-driven regulatory platforms support SaMD organizations by proactively monitoring and adapting to the dynamic global regulatory landscape. The technology alerts users to anticipated regulatory updates worldwide, facilitating improved foresight and trend detection. It also provides guidance on addressing potential lapses in product compliance, integrates with existing workflows and streamlines regulatory tasks from classification to registration and market entry.
While billion-dollar deals are common in the medtech industry, multi-billion-dollar megadeal acquisitions were still notable in 2022. Often, these deals result in a ripple effect on the industry when two large companies merge. Here we look at some recent examples, the growth drivers behind them and what they mean for the medtech industry.
The COVID-19 pandemic pushed digital health to the forefront of care delivery, spurring massive innovation and investment. As the capital markets cool, investors are looking for companies with a proven return on investment, customer retention and good market fit.
AI not only improves data collection and analysis, it impacts which products are engaged in clinical trials, determines necessary medical criteria, helps design the trials and can even choose the best participating facilities. The result is, organizations that leverage AI will be more successful and will go to market faster than those that don’t.
The updated guidance clarifies how the program applies to medical devices that may address health inequities, as well as those that may increase access to care or provide a non-addictive treatment option to treat pain or addiction. It also clarifies the FDA’s current interpretation of the Breakthrough Device designation criteria.