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Visby Medical’s in-office test for sexually-transmitted infections (STIs) in women that delivers 97 percent accurate results in 30 minutes — not the usual two to five days with laboratory testing — just received FDA clearance, enabling diagnosis and treatment in the same office visit.
The FDA has cleared the first medical device under the agency’s Safer Technologies Program (STeP) — Endolumik’s fluorescence-guided gastric calibration tube, which uses near infrared light to allow surgeons to see the tube through the gastric wall during gastric and bariatric surgical procedures.