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Earlier this year, the FDA issued a new rule requiring seven types of medical gloves classified as “reserved” Class I devices to gain 510(k) clearance. Read More
The company is seeking further clearances for diagnosing or monitoring hypertension, chronic obstructive pulmonary disease, sleep apnea, worsening heart failure and post-surgical recovery. Read More
The test’s ability to predict how well bladder cancer patients will respond to therapy allows for “timely interventions that could result in more favorable outcomes,” the company said. Read More
The radial access selective catheter gained the CE mark for delivery of interventional devices into the peripheral, coronary and neuro vasculature. Read More
The device is currently under FDA review as part of the company’s rapid antimicrobial susceptibility test system for isolated bacterial colonies. Read More