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 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 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 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 Network3d
MHRA approves trofolastat for prostate cancer diagnostic imaging
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for trofolastat (RoTecPSMA), a ...
Medical Device Network3d
King’s College London-led trial shows AI can reduce pregnancy scan duration
UK's King's College London has spearheaded a trial that demonstrates AI can minimise the time required for 20-week pregnancy ...
Medical Device Network4d
Pantheon Vision taps Eyedeal Medical for corneal implant manufacturing
Pantheon Vision has signed a deal with Eyedeal Medical to advance the manufacturing of its corneal implants for treating ...