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Information about leveraging validation data to support COVID-19 test approvals has now been added to the FDA’s COVID-19 Test Development and Review FAQ page. Read More
Several advocacy groups have written to the House Energy and Commerce Committee and its Subcommittee on Health to defend the “right to repair” devices and push back against what they view as moves to restrict it. Read More
The catheter can be an effective option for patients who could not previously be treated with intravascular shockwave therapy, according to one user. Read More
The FDA granted the implants its premarket approval based on the results of a pivotal, two-year investigational device exemption clinical study. Read More
German device manufacturer Fresenius Kabi is acquiring Massachusetts-based infusion system manufacturer Ivenix in a purchase deal that includes $240 million upfront and future milestone payments. Read More
The FDA recently approved the first drug-eluting contact lens for the relief of allergies — and the delivery method is showing potential for the treatment of other eye conditions. Read More
The company has also received FDA-clearance for seven other software products that can detect suspected pathologies in computed tomography (CT) exams. Read More