According to a company press release, RadNet, Inc. has acquired Gleamer SAS, a leading radiology AI company based in Paris, France. The acquisition will be integrated into DeepHealth, RadNet’s wholly owned subsidiary and further expands DeepHealth’s AI-powered health informatics solutions and services. With more than 130 professionals, Gleamer is a fast growing, cloud-first, radiology AI…
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?
Global look at regulatory compliance, guidance, trends and deadlines.
How is software-enablement — connected devices and artificial intelligence — reshaping how products are conceived, developed, and deployed in clinical practice? Fragmented operations in large MedTech organizations are not keeping pace with the complexity of products in their pipelines.
The initial fear that the artificial intelligence and machine learning evolution will replace humans is shifting. A new narrative recognizes the potential for an AI-enabled workforce — one where the technology is a jobs creator, enabling us all to be more productive rather than making millions of people redundant or obsolete — actually giving rise to the multi-disciplinary, power employee.
