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The FDA issued new recommendations on 510(k) submissions for peripheral vascular atherectomy devices used to remove plaque from diseased arteries. Read More
May 26 marks the effective date of the EU’s Medical Device Regulation (MDR), requiring new devices to comply before they can be sold in the bloc — although many currently certified devices have another three years to comply. Read More
The European clearance offers a treatment option for patients who cannot undergo surgery or who have a dilated aortic annulus, a large coaptation gap or a pacemaker. Read More
The implant uses an hourglass shape designed specifically for placement in the frontal sinuses between the eyebrows after sinus surgery for chronic rhinosinusitis. Read More
"These tools unlock the ability to track the progression of disease over time for each tooth and make the case for evidence-based treatment supported by unbiased software and clear visuals for patients,” said Chris Balaban, clinical director for Overjet. Read More
Testing is important because of electromagnetic interference risks both from the magnetic resonance system as well as the sensitivity of MR systems to radiofrequency noise from active devices, the agency said. Read More
Clinicians and care providers can view the data collected by the device and manage vital sign alert settings using a remote monitoring dashboard. Read More
The implant features a highly porous collagen matrix and resorbable poly-L-lactide microfilaments that enable the scaffold to reinforce tendon and ligament repairs and encourage healing. Read More
The ventilator device can be easily moved within the hospital and is ready to go out of the box for day-to-day clinical use or overflow ventilation demands. Read More