The question is not whether AI will transform healthcare; it’s whether regulators can keep pace with that transformation.

Given the calls for change, criticism, and ongoing consultations, this article sets out the current status of developments ...

The IMDRF have recently published key concepts and principles for the development of high-quality medical devices which ...

D Systems (DDD) announced that in collaboration with the University Hospital Basel the Company’s point-of-care additive manufacturing solution ...

overcoming the limitations of standard medical devices. As a result, healthcare providers are improving outcomes1,2, increasing efficiency3, and lowering the cost of care4. Source: 3D Systems Inc ...

GAAP diluted EPS of $0.76; adjusted diluted EPS of $1.09 First-quarter reported sales growth of 4.0 percent; organic sales growth of 6.9 percent or ...

According to AMMA, the certification will apply to critical medical devices and PPE that meet U.S. manufacturing and safety standards, including compliance with OSHA, NFPA and ANSI. Manufacturers ...

12-Month Strategy and Outlook Finalize the registration of existing products under the European Medical Device Regulation (MDR). Reinvigorate the Company’s presence in the United States ...

This includes the novelty of ProSense as a medical device that destroys breast cancer ... to do a submission in other markets and under the MDR, so this is our future platform technology, which ...

Northwestern hopes the device allows it to ensure the quality of blood samples while dealing with an ongoing shortage of phlebotomists, said Dr. Gregory Retzinger, medical director of Pathology ...

LifeTech Scientific Corporation (the "Company" or "LifeTech", Stock code: 1302.HK), a company specializing in minimally ...

Eva Temkin, a lawyer at Arnold & Porter who advises clients on drug and medical device applications, said even if product reviewers are not terminated in the next round of layoffs, other FDA staff ...