With its FDA approval, JenaValve intends to commence launch activity for the Trilogy System immediately with participating clinical study sites.
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. Food and Drug Administration’s (FDA) 510(k) premarket notification process, the primary pathway for new devices to enter the market.
Iran-linked hackers claim cyberattack launched against U.S. medtech company Stryker.
RadNet leadership says the acquisition of Biocare enhances Agilent’s pathology portfolio and reflects our strategy to drive long-term growth through customer-centric innovation and disciplined capital allocation.
Biotronik has received U.S. Food and Drug Administration (FDA) approval for its Solia CSP S pacing lead, growing access to a solution for Left Bundle Branch Area Pacing (LBBAP).
Trauma and Extremities partnership aligns disciplined approach to portfolio optimization and focuses on delivering long-term value for surgeons and patients
Quantum Surgical and NeuWave Medical, Inc. – both of which share an extensive focus on innovation to improve cancer patients’ outcomes – will operate as subsidiaries of Precision IO Group Inc., the newly created parent company led by medtech veteran Kurt Azarbarzin, who was recently appointed CEO.
Commercialization strategy in 2026 and beyond is more than a checklist. It requires a new mindset where cybersecurity is seen as a patient safety imperative, data is treated as a critical strategic asset, and product lifecycle is an intelligent process.
Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent regulatory strategy required by investors.
In the current Cyber Threat environment, companies must have strong cyber liability insurance. Policies must specifically account for cyber-physical risks and the substantial costs of post-market remediation, including mandatory software patches and patient notifications. Insurers are well aware of the 524B mandate and are increasingly requiring proof of compliance before issuing coverage or offering favorable rates. How do you assure your cyber risk plan insurable?