Infervision announced that it received FDA 501(k) clearance for its InferRead Lung CT.AI system which uses AI to automatically perform lung segmentation. InferRead Lung CT.AI is designed to use AI and deep learning technology to support concurrent reading and aid radiologists in pulmonary nodule detection during the review of chest CT scans, increasing accuracy and […]
FDA clears Nonin Medical flagship product
Nonin Medical (Plymouth, Minn.) announced today that it has received 510(k) clearance for its flagship product — the CO-Pilot wireless handheld multi-parameter system. The handheld, wireless CO-Pilot is meant to make it easier for EMS, firefighters and military personnel to measure a person’s key vital signs following a cardiac arrest, traumatic injury, carbon monoxide or […]
Medtronic Linq II insertable cardiac monitor gets OK in U.S., Europe
Medtronic (NYSE:MDT) announced today that its Linq II insertable cardiac monitor has received FDA clearance in the U.S., as well as a CE Mark in the EU. The Linq II boasts remote programming. That means a person with the Linq II implanted inside of them doesn’t need to return to the doctor’s office or hospital to […]
CoreLink wins FDA clearance for standalone cervical spine system
CoreLink announced today that it received FDA 510(k) clearance for its F3D-C2 standalone cervical system for ACDF procedures. The F3D-C2 standalone cervical device eliminates the need for a supplemental fixation plate to make ACDF (anterior cervical discectomy and fusion) procedures easier to complete and a faster process overall. St. Louis-based CoreLink’s system includes its 3D-printed […]
FDA clears Orthofix Firebird SI fusion system
Orthofix (NSDQ:OFIX) announced today that it received FDA 501(k) clearance for its Firebird SI 3D-printed titanium bone screw. Lewisville, Texas-based Orthofix touts its Firebird SI as the first 3D-printed titanium bone screw to launch in the U.S. for treating sacroiliac (SI) joint dysfunction. The fusion system is designed to both compress and stabilize the SI joint, […]
FDA clears Preceptis Medical’s in-office ear tube placement for kids
Preceptis Medical today announced FDA clearance that allows placement of its Hummingbird tympanostomy tube system in an ENT surgeon’s office. Officials at Maple Grove, Minn.–based Preceptis say the Hummingbird system significantly reduces trauma and procedure time for ear tube placement in young children. Kids receiving the ear tubes don’t need general anesthesia, and they don’t […]
3NT Medical lands FDA clearance for Colibri endoscopy system
3NT Medical announced that it received FDA 510(k) clearance for its Colibri micro ENT single-use endoscope used for otology. In a news release, the Short Hills, N.J.-based company touted the Colibri scope as the world’s first single-use endoscope specifically designed for otology. It features a lightweight, ergonomic handpiece, a 2.2mm diameter tip and a built-in […]
Gynesonics lands FDA clearance for fibroid-removal system
Gynesonics announced that it received FDA 510(k) clearance for its next-generation Sonata System 2.1 for transcervical fibroid ablation (TFA). Redwood City, Calif.-based Gynesonics’ Sonata platform integrates what the company touts as the first and only intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device. The system provides an incision-free, uterus-preserving transcervical treatment for symptomatic […]
Smart Medical wins FDA clearance for G-Eye colonoscope
Smart Medical Systems yesterday said it received FDA 510(k) clearance for its G-Eye Colonoscope. The device is a standard colonoscope that installs the company’s G-Eye balloon on the distal bending section of the colonoscope. The G-Eye is then inserted using the standard technique with an inflated balloon. The balloon is inflated to engage the colon […]
FDA clears Propeller Health sensor to work with Symbocort inhaler
Propeller Health announced that it received FDA 510(k) clearance for connecting patients using its Symbicort Inhaler to its digital health platform. The Madison, Wis.-based company’s digital health platform already connects to inhalers used by asthma and COPD patients, including ones manufactured by Boehringer Ingelheim, GlaxoSmithKline, Novartis and Orion, along with other generic equivalents. Get the […]
Philips wins 510(k) for sensor to detect COVID-19 patient deterioration
Royal Philips (NYSE:PHG) announced that it has won FDA 510(k) clearance for a wearable biosensor to help manage confirmed and suspected COVID-19 patients in the hospital. The Amsterdam-based company described the BX100 biosensor as a wireless wearable sensor designed to help healthcare providers detect when COVID-19 patients in lower-acuity units are at risk for deterioration so […]
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