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FDA-approved surgical robots trend toward autonomy, study finds

A systematic review in npj Digital Medicine categorizes FDA-approved surgical robots by their levels of autonomy, highlighting a need for standardized definitions and greater regulatory clarity as these systems evolve towards higher autonomy.

United-states , Gorodenkoff-shutterstock , Drug-administration , Digital-medicine , United-states-food , Surgical-robotics , Automated-endoscopic-system , Optimal-positioning , Premarket-notification , Vinci-surgical-system , Intuitive-surgical , Robot-assistance

Oral Device Maker ProSomnus Reports Record Revenue for 2023

Oral Device Maker ProSomnus Reports Record Revenue for 2023
sleepreviewmag.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from sleepreviewmag.com Daily Mail and Mail on Sunday newspapers.

Len-liptak , Drug-administration , Prosomnus-inc , Somnus-inc , Premarket-notification , Severe-obstructive-sleep-apnea ,

ProSomnus Reports Record Fourth Quarter and Fiscal Year 2023 Financial Results

PLEASANTON, Calif., March 26, 2024 -- ProSomnus, Inc. , the leading non-CPAP therapy™ for the treatment of Obstructive Sleep Apnea , today announced financial results for the fourth quarter and...

United-states , Len-liptak , Mike-cavanaugh , Heather-whalen , Drug-administration , Nasdaq , Exchange-commission , Securities-exchange , Prosomnus-inc , Company-next-generation-remote-patient-monitoring , Obstructive-sleep-apnea , Next-generation-remote-patient-monitoring

ProSomnus Reports Record Fourth Quarter and Fiscal Year 2023 Financial Results

ProSomnus Reports Record Fourth Quarter and Fiscal Year 2023 Financial Results
streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.

United-states , Len-liptak , Heather-whalen , Mike-cavanaugh , Prosomnus-inc , Exchange-commission , Drug-administration , Company-next-generation-remote-patient-monitoring , Securities-exchange , Nasdaq , Obstructive-sleep-apnea , Next-generation-remote-patient-monitoring

FDA Finalizes EtO Sterilization Guidance - Life Sciences, Biotechnology & Nanotechnology

A series of town halls will support the medical device industry by sharing the current sterilization landscape, including alternatives to ethylene oxide.

Illinois , United-states , Eto-tiger-team , Drug-administration , File-pilot-program , Environmental-protection-agency , Sterility-information , Premarket-notification , Devices-labeled , Radiation-sterilization-master , Mondaq

A Copy of a Copy of a Copy: the Story of FDA Medical Device Clearances

Uncovering medical device ancestry from the FDA's 510k data and creating a free website for exploring it.

United-states , America , Drug-administration , Bleeding-edge-poster , Brief-history , Medical-device , Federal-food , Cosmetic-act , Premarket-notification , Optical-character-recognition , Directed-graph

Premarket Notifications and Patents for Breast Pumps Before and After the ACA

This study investigates whether ACA policies to increase access to breast pumps and lactation care were associated with innovation in the market for breast pump

Washington , United-states , Jodyw-zylke , Kristin-walter , Oluwarantimi-adetunji , Karen-lasser , Trademark-office , Cigna-group , Human-services , Drug-administration , Office-of-the , Us-department-of-health

Are Higher Standards for Expedited FDA Approvals Needed?

Many clinicians have reported a lack of understanding of the FDA approval process and a desire for strong premarket evidence to support these approvals.

Sanket-dhruva , University-of-california-san-francisco , Health-affairs , Health-aff-millwood , California-san-francisco , Breakthrough-therapy , Innovation-act , Into-priority-review , Accelerated-approvals , Prescription-drug-user-fee-act , Humanitarian-device-exemption , Premarket-notification

Navigating Sterility: FDA's Comprehensive Guidelines on 510(k) Submissions for Sterile Devices

FDA's latest guidance on 510(k) submissions for sterile devices outlines priorities and updates for traditional and novel sterilization methods, ensuring a comprehensive approach to information inclusion.

Maryland , United-states , Devices-in-health-care-settings , Drug-administration , Image-credit , Adobe-stock , White-oak-campus , Silver-spring , Sterility-information , Premarket-notification , Devices-labeled

FDA Recognizes Vaporized Hydrogen Peroxide (VHP) as Established Sterilization Method for Medical Devices

FDA designates vaporized hydrogen peroxide (VHP) as an Established Category A sterilization method, reducing reliance on Ethylene Oxide. Boosting innovation for safer, effective medical device sterilization.

United-states , American , Suzanne-schwartz , Maureen-spencer , Drug-administration , Radiological-health , Office-of-strategic-partnerships , Dmitry-kovalchuk-hydrogen , Technology-innovation , Adobe-stock , Dmitry-kovalchuk , Sterility-information