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Lunit Aims FDA Nod for Breast Cancer Risk Prediction Model

Lunit has gone ahead and announced the submission of a 510(k) premarket notification looking out for clearance from the US Food and Drug Administration –...

FDA Clears Upgrade of Omnipod 5 Algorithm from Insulet

Insulet has gone ahead and secured the clearance from the US Food and Drug Administration - FDA for an algorithm advancement in its Omnipod 5...

FDA Gives Clearance to Hugo RAS System, Confirms Medtronic

Medtronic, which is a global leader when it comes to surgical innovation, announced on December 3, 2025, that the U.S. Food and Drug Administration -...

FDA May Scrutinize Medical Device Cybersecurity More in 2026

The scrutiny by the US Food and Drug Administration - FDA around medical device cybersecurity is going to intensify prominently as one moves into 2026,...

Recon DL Tool from GE HealthCare Receives a PMA

Pristina Recon DL tool from GE HealthCare which uses two deep learning -DL models has gone on to receive a pre-market authorisation – PMA from...

Abbott to Acquire Cancer Test Maker for Around $21 Billion

In a recent move, Abbott has gone ahead and agreed to acquire Exact Sciences, the cancer test maker, for almost $21 billion. For the unversed, Exact...

New Policy to Boost Medical Device Industry in China

Beijing has gone on to release a new policy so as to promote the development when it comes to the medical device industry in China,...

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