FDA classifies LivaNova’s recall of LifeSPARC system’s controller as Class I

By NS Medical Staff Writer

30 Jan 23

The US health regulator claimed that the device could reach critical failure mode due to a problem in…

RegulationRecalls

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

Micronoma Receives FDA Breakthrough Device Designation for OncobiotaLUNG, A Novel Liquid Biopsy Assay for Lung Carcinoma Detection

By NS Medical Staff Writer

11 Jan 23

The OncobiotaLUNG assay is the first blood microbiome-driven liquid biopsy with proven effectiveness, including identifying cancer in its…

DevicesCertificationsDiagnostic Devices

Opticyte gets FDA breakthrough designation for Cell O2 Patient Monitor

By NS Medical Staff Writer

10 Jan 23

The device uses the firm’s proprietary machine-learning technology to noninvasively diagnose organ dysfunction caused by inadequate cellular oxygenation…

Patient Care DevicesCertificationsPatient Care Monitoring

PRAPELA RECEIVES FDA’S BREAKTHROUGH DEVICE DESIGNATION TO INVESTIGATE THE USE OF STIMULATION TO TREAT APNEA OF PREMATURITY

By NS Medical Staff Writer

09 Jan 23

Prapela's stimulation pad could become available sooner as a new treatment option for preterm newborns experiencing apnea

RegulationCertificationsSurgical and Supplies

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