The FDA’s oversight of medical device recalls continues to be plagued by staffing challenges—forcing some activities to be placed on…

After securing Medicare reimbursement for its pacemaker-like heart failure (HF) implant, Impulse Dynamics has raised more than $158 million to…

After receiving word late last month that the FDA would not be issuing a 510(k) clearance to its cable-free electrocardiogram,…

Lumos Labs has obtained a clearance from the FDA for its popular Lumosity brain training platform, greenlighting a version of…

The FDA has approved its first at-home, nondrug therapy for depression, a wearable brain stimulation headset developed by Flow Neuroscience. …

Francis Medical is heating up with a 510(k) clearance from the FDA for its water vapor ablation therapy aimed at…

After announcing plans to split up the company near the top of this year, Teleflex said it has found new…

Medline has put forward terms for an absolutely massive IPO, which could see the medical device manufacturing and distribution giant…

Resmed believes its artificial intelligence-powered approach to personalizing the settings of its connected CPAP machines can lead to better sleep…

Stryker, with its eye on tuck-in acquisitions and streamlining its business core, has promoted 27-year veteran Spencer Stiles to president…