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

FDA approves Agilent Resolution ctDx FIRST as liquid biopsy CDx for NSCLC

By NS Medical Staff Writer

13 Dec 22

Agilent Resolution ctDx FIRST is said to offer NSCLC patients and their oncologists a new minimally invasive blood…

DevicesApprovalsDiagnostic Devices

Shineco, Inc Subsidiary, Granted USPTO Patent and FDA Marketing Approval for Its In-situ Fecal Specimen Sampling Device

By NS Medical Staff Writer

08 Dec 22

This product provides a massager-like fingertip swab, a collection tube and a lid with unidirectional sampling inlet

DevicesApprovalsDiagnostic Devices

AVAVA Receives FDA 510(k) Clearance for its First-in-Class High Energy Skin Renewal Platform – MIRIA Skin Treatment System

By NS Medical Staff Writer

08 Dec 22

The MIRIA system is the only FDA cleared laser product that more than doubles the current therapeutic energy…

InnovationsApprovalsCoatings & Surface Treatments

Health Canada approves Novocure’s Optune for treatment of glioblastoma

By NS Medical Staff Writer

30 Nov 22

The wearable and portable Optune device delivers TTFields therapy to the region of the tumour

RegulationApprovals

Zimmer secures FDA clearance for Persona OsseoTi knee replacement system

By NS Medical Staff Writer

22 Nov 22

Persona OsseoTi is said to have a new porous version of the Persona anatomic tibia that uses the…

RegulationApprovalsOrthopedic