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

Tests on recalled DreamStation devices show limited risks to health, says Philips

By NS Medical Staff Writer

22 Dec 22

The tests were performed to assess potential health risks with the polyester-based PE-PUR sound abatement foam in specific…

RegulationRecalls

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

Click Therapeutics’ CT-132 gets FDA breakthrough status in episodic migraine

By NS Medical Staff Writer

19 Dec 22

Presently under development, the CT-132 digital therapeutic candidate has secured the FDA designation in patients of age 18…

DevicesRegulationRegulatory Policy

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

FDA classifies Baxter’s recall of WatchCare IMS systems as Class I

By NS Medical Staff Writer

24 Nov 22

The recall is based on reports of interference to other nearby critical medical devices by radiofrequency emissions from…

RegulationRecallsPatient Care Monitoring