FDA Issues Final Guidance on Surveying, Leveling, and Alignment Laser Products
The guidance defines SLA and non-SLA laser products and provides information on how to request a variance or exemption from SLA class limits.
Connected Care: Overcoming Roadblocks and Identifying Opportunities
Leaders in digital health development and regulation look at best practices, pitfalls and what’s next for connected medical devices and technologies.
Instilling Trust in AI
Rama Chellappa, PhD, John Hopkins University Bloomberg Distinguished Professor in electrical, computer, and biomedical engineering, and co-author of “Can We Trust AI?” looks at the promise of AI in health care and how we can best utilize this extraordinary tool to save lives and improve health equity.
FDA Seeks Input on Advancing Use of Real-World Data and Evidence
The FDA is asking stakeholders to submit public comments on how it should use any portion of the user fee funding that may be distributed to external organizations—other than NEST—to support premarket RWE in medical device evaluation and development.
Intricon Launches Biosensors Center of Excellence
The Intricon Biosensor CoE team has expertise in high-density microelectronics, miniaturization, ultra-low power, miniature molding, firmware development, and wireless communication.
European Commission Proposes Extended Timeline for EU MDR/IVDR Compliance
The European Commission developed the new proposal following a December 9, 2022, meeting of the EPSCO Council, where EU Ministers of Health called on the Commission to swiftly submit a proposal to extend the transition period in the Medical Device Regulation. The proposal will now be negotiated by the European Parliament and the Council.
King Joins KMM Group as Healthcare Industry Advisor
“We are extremely fortunate to have the opportunity to engage with Mark King in this particular phase of the company’s growth. My partner, Eric Wilhelm, and I hope to leverage Mark’s knowledge and experience to help realize the exciting vision we have had for more than a decade as individual business owners and for KMM Group.”
PTC to Acquire SaaS Field Service Management Provider ServiceMax
The acquisition is expected to strengthen PTC’s closed-loop product lifecycle management offerings by extending the digital thread of product information into downstream enterprise asset management and field service management capabilities.
Liver-Chip Successfully Identifies Drug Toxicity, Outperforms Animal and 3D Models
“The Liver-Chip detected nearly 7 out of every 8 drugs that proved hepatoxic in clinical use despite having been deemed to have an appropriate therapeutic window by animal models.”
FDA Highlights Exemptions for Real World Data-identified AEs
The FDA has granted several exemptions to its Medical Device Reporting requirements related to events identified in certain real-world data sources, such as medical device registries.
Unified Medical Imaging Solutions:
