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Intersect ENT gets FDA approval for SINUVA sinus implant Intersect ENT has received approval from the US Food and Drug Administration (FDA) for the SINUVA (mometasone furoate) Sinus Implant, a new targeted approach to treating recurrent nasal polyp disease in patients who have had previous ethmoid sinus surgery.
Patient Care > Patient Monitoring > News
FDA approves Boston Scientific's Vercise deep brain stimulation system By MDBR Staff Writer
Boston Scientific has secured approval from the US Food and Drug Administration (FDA) for its Vercise deep brain stimulation (DBS) system.
Patient Care > Patient Monitoring > News Stryker to buy US firm Entellus Medical for $662m By MDBR Staff Writer
Stryker has signed an agreement to acquire US medical technology firm Entellus Medical for around $662m.
Patient Care > Patient Monitoring > News
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LivaNova to buy remaining stake in ImThera Medical for $225m
By MDBR Staff Writer
UK-based medical technology firm LivaNova has agreed to purchase the remaining stake in US firm ImThera Medical for around $225m.
Patient Care > Patient Monitoring > News
Stimwave secures FDA 510(k) clearance for SandShark injectable anchoring system
Stimwave announced the SandShark Injectable Anchor System received the US Food and Drug Administration’s 510(k) clearance.
Patient Care > Patient Monitoring > News
FDA approves first study of Insightec’s Exablate Neuro to open blood-brain barrier in Glioblastoma patients
Insightec has received approval from the US Food and Drug Administration (FDA) to initiate a study to evaluate the safety and feasibility of the Exablate Neuro for disrupting the blood brain barrier (BBB) in patients with Glioblastoma.
Patient Care > Patient Monitoring > News
FDA approves first medical device system to adjust artificial lens after cataract surgery
By MDBR Staff Writer
RxSight has secured approval from the US Food and Drug Administration (FDA) for its light adjustable lens and light delivery device (LDD) to treat patients with pre-existing astigmatism of ≥ 0.75 diopters undergoing cataract surgery.
Patient Care > Patient Monitoring > News
Novocure’s trial shows increased compliance with Optune predicted enhanced survival in glioblastoma patients
Novocure has announced results from a retrospective post-hoc analysis of its phase 3 pivotal EF-14 trial data showing that increased compliance with Optune predicted increased survival in glioblastoma (GBM) patients.
Patient Care > Patient Monitoring > News
Cianna Medical gets FDA nod for wire-free radar breast tumor localization system
By MDBR Staff Writer
Cianna Medical has secured approval from the US Food and Drug Administration (FDA) for its wire-free radar breast tumor localization system.
Patient Care > Patient Monitoring > News
Lensar gets FDA and CE mark for IntelliAxis-L toric IOL alignment guidance
By MDBR Staff Writer
Lensar has secured 510(k) clearance from the US Food and Drug Administration and CE mark approval for IntelliAxis-L, which is an advanced data-driven reference marking capability to guide toric intralocular lens (IOL) alignment.
Patient Care > Patient Monitoring > News
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