Opternative allows patients to take an eye test via their computer or smartphone, which the American Optometric Association said could pose a risk to patient safety. The trade group wants FDA to require an approval for the service.
Online eye tests offered by Opternative
should be regulated as a medical device, the American Optometric Association said in an April 4 letter to...
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EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.
A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.
US Medicare has proposed national coverage of renal denervation for patients with uncontrolled hypertension. The treatment is seeing other advances as well, with Medtronic piloting a longer catheter and a multi-organ approach and a blood test to identify the best candidates fresh on the
