This week, Abbott, Click and Otsuka, Prenosis won the FDA nod respectively for an in vitro diagnostic to evaluate patients for concussion, the first prescription digital therapeutic to treat major depressive disorder and a software to predict sepsis. Also on the regulatory front, the FDA will now take 513(g)s forms via its eSTAR framework. In Europe, the debate of what personal information can be shared continues. 

Abbott’s weaker rapid diagnostic sales see the erstwhile industry leader slip down the global 2023 medtech rankings, while Johnson & Johnson passes it on the way up on the back of strong external and internal growth.

Abbott’s weaker rapid diagnostic sales see the erstwhile industry leader slip down the global 2023 medtech rankings, while Johnson & Johnson passes it on the way up on the back of strong external and internal growth.

This week, the FDA extended a comment period on digital health tools to detect diabetes; Theradaptive launched a trial of its spinal fusion device; and devices from Hologic and GE Healthcare won FDA clearance.