The MedTech industry has grown too comfortable with “essential use” exemptions and is ignoring the growing liability, supply chain and regulatory risk of PFAS use in medical devices and manufacturing facilities.
Beginning October 1, 2023, the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot will expand to include the Office of Neurological and Physical Medicine Devices (OHT5).
The use of artificial intelligence in medical device design is already transforming health care. In this article we look at areas of greatest promise as well as the challenges that must be addressed to realize the promise of AI in device design and engineering.
In response to safety concerns and proposed regulatory action related to industrial use of ethylene oxide (EtO), the FDA Center for Devices and Radiological Health is taking additional steps to advance innovation in medical device sterilization, including recognition of new standards and updates to technical information reports.
The recent Supreme Court ruling in Amgen v. Sanofi reminds patent practitioners that the scope of disclosure defines what has been enabled and that purely functional claiming can be problematic.
A recent study from Ethicon and the Cleveland Clinic outlined opportunities and barriers to better sustainability practices in operating rooms. We spoke with Vishnu Kalra, President, U.S. Ethicon, to learn more about the study’s findings, Ethicon’s efforts to develop more sustainable products and practices, and how other companies can get started.
Maria Shepherd, president and founder of Medi-Vantage and co-founder of MedExecWomen, discusses her career in the medical device industry, what led her to launch her own company and the joy of “finding her tribe” among fellow female executives committed to bringing up the next generation of women leaders in MedTech.
Shuvo Roy, Ph.D., Professor of Bioengineering at UCSF and Technical Director of The Kidney Project, and his research partners have developed an artificial kidney constructed of semiconductor silicon wafers that remove waste and toxins from the blood and a cell therapy unit that replicates other kidney functions. Their prototype, powered entirely by blood pressure, filtered blood and created urine in a pre-clinical trial.
As technology component pricing continues to rise, MedTech manufacturers are applying proven methods and exploring new approaches to maintain profitability and extend product lifecycles.
When considering use cases and data classification methods for machine learning, image quality, power consumption and latency must be considered.
