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.
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.
AdvaMed has filed comments with the EPA regarding proposed regulations of ethylene oxide and their impact on patient care.
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.
The regulatory landscape for medical devices is rapidly evolving, catapulted most recently by European Union Medical Device Regulations (EU MDR). In this article, Monali Bhansali, Practice Lead of Regulatory Affairs at Tata Elxsi, highlights challenges and advancements in the MedTech regulatory landscape, and what the future has in store.
Smart hospitals are revolutionizing health care with the help of AI, IoT and robotics. Following are the latest technology and data analytics tools and trends that are helping these hospitals of the future provide safer, more personalized care.
The voluntary program is designed to help companies advance alternative and innovative ways to sterilize approved medical devices, including changing radiation sources, in a least burdensome regulatory approach.
Unified communication systems can improve staff efficiency, while enhancing patient outcomes and staff and patient safety.
New directives and guidance aim to connect patients, physicians and other stakeholders across the healthcare ecosystem with a consistently up-to-date information source for product and safety information that isn’t dependent on paper. Schlafender Hase’s Peter Muller explores the promise of e-labeling and practical next steps required to deliver on these directives.
As surgeries become increasingly complex and involve more sophisticated technology, the mental and physical demands on surgeons and their teams are expected to increase. As an industry, we need to thoughtfully consider how each piece of technology introduced into operating rooms will impact existing surgical workflow and workloads.
