Medical Device Network1h
FDA’s LDT rule struck down in Texas court
A Texas judge has ruled against the US Food and Drug Administration (FDA) in a court case that challenged the agency’s plans ...
Medical Device Network2h
Medtronic recalls flow-diverting stents
Medtronic’s latest recall of the Pipeline Vantage 027 and 021 products is likely to result in revenue losses in the ...
Medical Device Network4h
FDA grants expanded 510(k) clearance for Epitel’s wireless EEG system
The US Food and Drug Administration (FDA) has granted expanded 510(k) clearance for Epitel’s REMI Wireless ...
Medical Device Network3h
Medtronic reports late-breaking data from TAVR system trial for aortic stenosis
Medtronic has reported late-breaking data from the Evolut Low Risk Trial’s five-year outcomes of the Evolut TAVR system.
Medical Device Network4h
Cleerly CONFIRM2 study finds women with CAD at higher risk of MACE
Results from the company’s trial of 3,500 patients found that disease burden was higher in men but women were at higher risk ...
Medical Device Network21h
FDA authorises Visby Medical’s at-home test for common STIs
The US Food and Drug Administration (FDA) has authorised the first at-home PCR STI test for chlamydia, gonorrhoea, and ...
Medical Device Network22h
WHO warns that faint lines on rapid tests may cause malaria misdiagnosis
All malaria rapid diagnostic tests have been implicated in the WHO product alert, as manufacturer investigations continue.
Medical Device Network1d
GE HealthCare launches new advanced CT system
GE HealthCare is rolling out a new computed tomography (CT) system to support practitioners in diagnosing complex CAD cases.
Medical Device Network3d
Sigrid’s Carb Fence tech targets patients being left behind by GLP1s
Swedish company Sigrid’s weight loss product Carb Fence has been recognised by the US Food and Drug Administration as a ...
Medical Device Network5d
Supira Medical nets $120m to advance ventricular support device
Supira Medical has completed a $120m Series E funding round, with plans to use the capital to advance its position in the ...
Medical Device Network4d
Bausch + Lomb announces intraocular lens recall
Bausch + Lomb has reported a “voluntary recall” of certain intraocular lenses (IOLs) on its enVista platform due to ...
Medical Device Network5d
MedCAD secures FDA 510(k) clearance for AccuStride foot and ankle system
MedCAD has received 510(k) clearance from the US Food and Drug Administration (FDA) for its AccuStride Foot and Ankle System.