MTI Regulatory Roundup: global medical device regulatory update
Global look at regulatory compliance, guidance, trends and deadlines.
FDA Launches Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot for Chronic Disease Technologies
The FDA announced the TEMPO pilot, an approach to encourage the use of digital technologies that meet people where they are. The pilot supports innovative tools and a health care delivery model that could improve care for millions of Americans managing chronic disease.
EndoQuest to Advance Next-Generation Surgical Robotics powered by NVIDIA IGX Thor
The collaboration aims to deliver real-time image processing, robotic control and cloud-enabled intelligence in a unified architecture.
AtriCure Announces the First Patient Treated in the BoxX-NoAF Clinical Trial
Trial will evaluate the safety and effectiveness of the AtriCure Isolator® Synergy™ EnCompass® clamp and AtriClip® Left Atrial Appendage Exclusion System to reduce the occurrence of new-onset atrial fibrillation in cardiac surgery patients.
Thermo Fisher Scientific to Acquire Clario to Provide Deeper Clinical Insights
Acquisition is expected to strengthens Thermo Fisher’s position in delivering clinical information to pharma and biotech customers.
Hologic to be Acquired by Blackstone and TPG for up to $79 per Share
Transaction Expected to Help Hologic Strengthen its Leadership in Women’s Health and Accelerate Growth
AAMI and TechNation Collaborate to Survey Healthcare Technology Field
Survey will assess demographics, salary rates, more.
AMA Launches Center for Digital Health and AI Innovation
AMA CEO says, “Augmented Intelligence will be a defining force in the future of health care, but right now we are barely scratching the surface of its potential.”
Merit Medical to Purchase Pentax Medical C2 CryoBalloon Technology
Asset acquisition expected to expand Merit’s Endoscopy portfolio with an innovative device to treat patients suffering from Barretts esophagus and other gastrointestinal disorders.
Nalu Medical PNS System Acquired by BSCI
Boston Sci acquisition expected to expand the neuromodulation offerings for people living with chronic pain.