Varian gets FDA nod, CE Mark for HyperSight-equipped Halcyon and Ethos systems

By NS Medical Staff Writer

03 Feb 23

The firm has also announced the first patient treatment with a Halcyon system equipped with HyperSight at Penn…

Diagnostic DevicesApprovalsDiagnostic Imaging

Etiometry gets FDA clearance for AI-based IDO2 Index risk algorithm

By NS Medical Staff Writer

25 Jan 23

Hospitals in the US can now use Etiometry’s IDO2 Index to quickly identify changes in the conditions of…

Patient Care DevicesApprovalsPatient Care Monitoring

icotec ag Receives FDA Clearance for the Ø 4.5mm VADER Pedicle Screws

By NS Medical Staff Writer

25 Jan 23

The extended VADER Pedicle System maintains its proven indication and versatility for open, MIS and cement-augmented surgical techniques…

ApprovalsPatient Care DevicesSurgical and Supplies

Varian secures FDA IDE for cardiac radioablation RADIATE-VT trial

By NS Medical Staff Writer

20 Jan 23

The FDA’s initial approval for the cardiac radioablation trial has been given for 80 patients at 10 US…

RegulationApprovals

Abbott secures FDA approval for Navitor TAVI device to treat aortic stenosis

By NS Medical Staff Writer

18 Jan 23

The company's latest-generation Navitor device has some upgrades to improve patient care, including reducing or eliminating the risk…

DevicesApprovalsCardiovascular

MedAlliance’s SELUTION SLR gets coronary de novo IDE approval from FDA

By NS Medical Staff Writer

12 Jan 23

With the latest approval, the Swiss medical technology firm will start its clinical trial for which the enrolment…

RegulationApprovals

Imperative Care Announces FDA Clearance and Initial Cases of Zoom RDL, the First Stroke-Specific Radial Access Platform for Mechanical Thrombectomy

By NS Medical Staff Writer

05 Jan 23

Newest Addition to Company’s Zoom Stroke Solution Provides an Additional Option for Achieving Intracranial Access to Treat Patients…

DevicesApprovalsDiagnostic Devices

Bresotec’s BresoDX1 secures FDA clearance for at-home sleep apnea testing

By NS Medical Staff Writer

04 Jan 23

BresoDX1 is indicated for use in the diagnosis of moderate to severe sleep apnea in adults in an…

Patient Care DevicesApprovalsPatient Care Monitoring

Venus Concept Receives 510(k) Clearance for Use of its AI.ME Next Generation Robotic Technology for Fractional Skin Resurfacing

By NS Medical Staff Writer

22 Dec 22

The AI.ME robotic system utilizes an advanced visualization system, machine vision, and Artificial Intelligence algorithms to target the…

Lasers & PhotonicsApprovalsDermatology and Plastic Surgery

Sofwave Medical secures FDA clearance for SUPERB Technology for cellulite

By NS Medical Staff Writer

20 Dec 22

The FDA clearance is backed by the results of a trial involving 68 women at four sites in…

Lasers & PhotonicsApprovalsAesthetic Devices