Medical Device Newsletter


Philips blocks sale of sleep, respiratory devices in the US for FDA consent decree

Philips has agreed to cease selling new sleep therapy and respiratory care products in the U.S., following a significant recall launched about two-and-a-half years ago.


Metropolis collaborates with Singapore-based AI solutions provider ‘Qritive’ to revolutionize cancer detection

Metropolis Healthcare, India’s top diagnostic service provider, partners with Qritive, a global AI solutions leader for pathology labs, to bolster cancer diagnosi


Aster CMI Hospital’s neurology department devises AI Carpal Tunnel Syndrome to detect median nerve in ultrasound videos

Aster CMI Hospital emerges as a leading advocate for healthcare AI, pioneering innovative technology to support medical professionals in various treatment aspects. It i


StimLabs’ Corplex P, a human umbilical cord-derived medical device, receives US FDA 510(k) approval

StimLabs, founded in 2015 to advance regenerative medicine, announces FDA clearance of Corplex P, a groundbreaking medical device derived from human umbilical cord tiss


Edwards acquires FDA clearance for first transcatheter tricuspid valve replacement treatment.

Edwards Lifesciences has gained FDA approval for its Evoque tricuspid valve replacement system, marking a significant advancement as the first transcatheter treatment f


FDA receives additional reports of casualties linked to Philips’ recalled respiratory devices

The Food and Drug Administration (FDA) has observed a surge in medical device reports (MDRs) concerning Philips’ respiratory products, including instances of fata


Fresenius brings dialysis technology to the US with FDA approval

Fresenius Medical Care announced 510(k) clearance for its 5008X Hemodialysis System, a high-volume hemodiafiltration dialysis therapy device using diffusion and convect


Insulet acquires CE mark for integration of insulin pump with Abbott CGM

Insulet has secured a CE mark for integrating its Omnipod 5 insulin pump with Abbott’s Freestyle Libre 2 Plus continuous glucose monitor (CGM) sensor. This cleara


Hologic wins FDA approval for AI-enabled cervical cancer screening system

Hologic has gained regulatory approval to sell an AI-powered cervical cancer screening system in the U.S. Named the Genius Digital Diagnostics System, it digitizes Pap


Boston Scientific’s spinal cord stimulators endorsed for non-surgical back pain

Boston Scientific's Wavewriter spinal cord stimulator (SCS) systems have gained FDA approval for non-surgical back pain (NSBP) management. This expands the label to inc