Tag: #medicaldevices

Boston Scientific Says Cybersecurity Incident Likely Material, Will Miss 2026 Guidance

Boston Scientific says an Aug. cyber incident is likely material, disrupted global manufacturing and shipments and makes meeting 2026 sales and EPS guidance unlikely.

$BSX, #bostonscientific, #cybersecurity, #medicaldevices, #earnings

FDA Clears Abbott’s Libre Duo 10 Day, First U.S. Wearable to Continuously Monitor Ketones and Glucose

FDA authorizes Abbott’s Libre Duo 10 Day, the first U.S. wearable to continuously monitor ketones and glucose for ages 2 and up.

#diabetes, #fda, #medicaldevices, #abbott

MHRA warns parents to stop using infant rectal 'gas' catheters and dispose of unused devices

MHRA warns parents and clinicians to stop using infant rectal catheters marketed for colic or gas and to dispose of unused devices, citing unknown risks.

#health, #mhra, #infants, #medicaldevices, #colic

UK regulator warns hospitals to check Dräger Atlan anaesthesia workstations after expanded safety action

Britain's MHRA on Aug. 4 told hospitals to check Dräger Atlan anaesthesia workstations after an expanded safety action over a ventilator motor defect.

#medicaldevices, #patient-safety, #drager, #mhra

EMA launches pilot program for ‘breakthrough’ medical devices in EU

EMA launched a pilot to give priority regulatory support to highly innovative Class III and IIb medical devices, testing a potential EU breakthrough pathway.

#medicaldevices, #ema, #healthpolicy, #innovation