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FDA Charts Course for Regulating AI Used in Medical Products | McDermott Will & Emery

On March 15, 2024, four of the US Food and Drug Administration’s (FDA) medical products centers released a joint paper, titled “Artificial Intelligence & Medical Products: How CBER,...

Drug-administration , Office-of-combination-products , Development-of-standards , Radiological-health , Us-congress , Centers-point , Foster-collaboration-to-safeguard-public-health , Development-of-regulatory-approaches-that-support-innovation , Mcdermott-will , Medical-products , Working-together

Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines

The federal court entered a consent decree of permanent injunction against Philips Respironics following a recall of certain sleep therapy machines manufactured by the company.

Murrysville , Pennsylvania , United-states , California , Philips-respironic , Brian-boynton , Philips-respironic-mt , Philips-respironics , Roy-jakobs , Jeff-shuren , Philips-rs-north-america , Human-services

Consent Decree Finalized Against Philips Respironics

The consent decree, with limited exceptions, restricts the production and sale of new CPAPs, BiPAPs, and other devices at several Philips Respironics facilities in the United States until certain requirements are met.

California , United-states , Pennsylvania , Murrysville , Philips-respironics , Jeff-shuren , Roy-jakobs , Philips-respironic-mt , Brian-boynton , Philips-respironic , Department-of-justice , Radiological-health

CloudWave Renews Partnership with the FDA to Share Threat Intelligence for Medical Device Security

Healthcare

United-states , John-gomez , Cloudwave-opsus , Drug-administration , Cybersecurity-insider-program , Cloudwave-cybersecurity-insider-program , Radiological-health , Analysis-organization , United-states-food , Information-sharing , Sensato-cybersecurity , Chief-engineering

FDA Announces Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines

FDA Announces Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines
wtva.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from wtva.com Daily Mail and Mail on Sunday newspapers.

California , United-states , Murrysville , Pennsylvania , Silver-spring , Jeff-shuren , Roy-jakobs , Philips-respironic-mt , Philips-respironics , Brian-boynton , Carly-kempler-pflaum , Philips-respironic

ROUNDUP: Court Bars Philips Respironics From Making Sleep And Respiratory Devices

ROUNDUP: Court Bars Philips Respironics From Making Sleep And Respiratory Devices
finanznachrichten.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from finanznachrichten.de Daily Mail and Mail on Sunday newspapers.

Pennsylvania , United-states , Washington , Dennis-riedl , Roy-jakobs , Philips-respironics , Jeff-shuren , Philips-holding-united-states-inc , Philips-rs-north-america , Department-of-justice , Us-district-court , Radiological-health

Court Bars Philips Respironics From Making Sleep And Respiratory Devices

A federal court has ordered Philips RS North America LLC (Philips Respironics) to stop manufacturing many of its sleep and respiratory devices at three Pennsylvania facilities, until certain requirements are met.

Pennsylvania , United-states , Jeff-shuren , Philips-respironics , Roy-jakobs , Philips , Philips-holding-united-states-inc , Philips-rs-north-america , Radiological-health , Department-of-justice , Respironics-california , Us-district-court

Company BehindCPAP Machines Must Make ChangesBefore Production Resumes

The company responsible for a recall of sleep apnea machines will be barred from resuming production at U.S. facilities until it meets a number of safety requirements.

United-states , Ohio , Pennsylvania , Marysville , Phillips-respironics , Jeffrey-reed , Jeff-shuren , Associated-press , Radiological-health , Philips , Drug-administration , Healthday-news

Company Behind Defective CPAP Machines Must Make Changes Before U.S. Production Resumes

Company Behind Defective CPAP Machines Must Make Changes Before U.S. Production Resumes
usnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from usnews.com Daily Mail and Mail on Sunday newspapers.

Marysville , Ohio , United-states , Pennsylvania , Jeff-shuren , Los-angeles , Jeffrey-reed , Phillips-respironics , Robin-foster-healthday , Davido-carter , Drug-administration , Philips

Cybersecurity roundup: MedSec offers hospitals risk support; global study links cyber performance to financial success

Also: CloudWave and FDA extend their threat intelligence partnership to offer an open-source vendor assessment framework.

Germany , France , Japan , Australia , Canada , John-gomez , Derek-vadala , Debra-bruemmer , Dottie-schindlinger , Diligent-institute , Drug-administration-center , Health-sector-coordinating-council