AdaptHealth is investigating a material cyberattack after attackers used a social engineering scheme to compromise a ...

Zimmer Biomet will hire 500 professionals over the next three years for its new Bengaluru technology centre, expanding its AI ...

Insights shared by industry relative to healthcare and the advancement of medical technology. Jaimon Jose, senior director of engineering and compliance at CharmHealth, is a software architect and ...

Market Access is now the central input into M&A and value-driven divestitures, enabling MedTech leaders to reshape portfolios for strategic advantage, long-term growth, and greater value to patients - ...

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. Stryker has completed its ...

Because of the environmental and health risks that PFAS ─ per- and polyfluoroalkyl substances ─ pose, they are subject to a potential ban across the European Union. Such a ban would introduce a need ...

To avoid delays in timelines, companies should develop IFU cleaning instructions with the worst-case clinical use and contamination method in mind. The FDA and International Organization for ...

Many challenges of designing and validating pediatric digital health devices are over-looked across developmental stages. Regulatory strategy, human factors, software architecture, and algorithm ...

The MedTech industry has seen significant growth and raised expectations as it adapts to evolving healthcare needs in the wake of the COVID-19 pandemic. The industry’s ability to make technology a ...

Orthogonal worked with Brian Binkowski, to gain a clearer picture of the state of SaMD approvals in the U.S. Following is what they learned about the rate of FDA approvals and clearances and which ...

Medtronic is overhauling its cardiovascular business in a major restructuring that includes new operating divisions, ongoing acquisitions, and a strategic push into higher-growth cardiac technologies.

Artificial intelligence is already inside regulatory affairs functions across the medtech industry. Teams are using it to summarize guidance documents, support first-pass drafting, compare labeling ...