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 ...

Traditionally, contract negotiation has been viewed as a financial or legal responsibility, typically led by finance teams, legal counsel, or executive leadership, with operations stepping in ...

With the acquisition of Amplitude Vascular Systems announced recently, Stryker joins the IVL technology race with Johnson & Johnson and Boston Scientific. Industry analysts noted cardiovascular ...

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 ...

A persistent tension exists between the drive for rapid technological advancement, the mandate for government oversight, and the paramount importance of patient safety. It is a foundation for the U.S.

Serenity Medical announced FDA Humanitarian Device Exemption (HDE) approval for its novel River stent. The River stent is for the treatment of severe idiopathic intracranial hypertension (IIH) in ...

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 ...

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 – ...

DiscGenics transformed its quality management process with ETQ Reliance, replacing manual workflows, streamlining document control, and supporting growth from research to commercialization. Discover ...

The Problem: A Rigid, Risk-Prone Development Model The industry’s heavy reliance on waterfall project management has resulted in long, siloed, and high-risk product development cycles. This model does ...

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 ...