Ascensia Diabetes Care said today that it won FDA 510(k) clearance for its Contour Next One blood glucose monitoring system. The connected device features a blood glucose meter that links to mobile devices using Bluetooth through the Contour Diabetes app. The app can collect, store and analyze the patient’s blood glucose measurements for patterns and […]
510(k)
Olympus wins FDA nod & launches new power morcellator with tissue capture
Olympus (TYO:7733) said today it won FDA 510(k) clearance for its next-gen laparoscopic PK morcellator with tissue containment designed as a laparoscopic surgery option to avoid open hysterectomy and myomectomy for uterine fibroid removal The company’s newly launched morcellator includes the company’s PneumoLiner contained tissue extraction system. “Contained tissue extraction is continually evolving. As surgeons, it […]
Cellnovo files 510(k) for connected diabetes management system
Cellnovo (EPA:CLNV) said today that it has filed for 510(k) clearance from the FDA for its diabetes management system. Paris-based Cellnovo touts its system as the 1st mobile, connected diabetes management system. Tubeless and compact, the company’s insulin pump has a mobile touchscreen controller with an integrated blood glucose meter. Data from insulin injections and blood-glucose levels are […]
FDA clears CapsoVision’s CapsoCam Plus for small bowel endoscopy
Miniature medical device developer CapsoVision said today it won FDA 510(k) clearance for its novel CapsoCam Plus small bowel capsule endoscope system. The Saratoga, Calif.-based company’s system is designed to provide a 360 degree panoramic lateral image of the small bowel for the detection of small bowel abnormalities. The full system consists of a capsule […]
Propeller wins FDA nod for connected GSK Ellipta inhaler
Propeller Health said today that it won 510(k) clearance from the FDA to market its Propeller platform with GlaxoSmithKline‘s (NYSE:GSK) Ellipta inhaler. A sensor for the dry powder inhaler was built as a part of a 1 year-long development and R&D collaboration between Propeller and GSK. This marks the 8th clearance for Propeller’s connected inhaler […]
FDA releases September 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD September 2016 TOTAL 510(k)s THIS PERIOD 257 TOTAL WITH SUMMARIES 250 TOTAL WITH STATEMENTS 7 DEVICE: BBX1, BBX2, BBX1MO, BBX1MC GLOBALDENTAL, INC. 510(k) NO: K142846(Traditional) ATTN: EBLESS V BAEZ ALERS PHONE NO : 787 8440345 SAN ANTONIO DRAMA ST. 2067 SE DECISION MADE: […]
FDA releases August 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD August 2016 TOTAL 510(k)s THIS PERIOD 252 TOTAL WITH SUMMARIES 235 TOTAL WITH STATEMENTS 17 DEVICE: CompleClear Plastic Orthodontic Bracket and Wire Appliance ORACREW 510(k) NO: K150830(Traditional) ATTN: PAWAN GAUTAM PHONE NO : 1 760 2370163 210 E Flamingo Rd. #217 SE DECISION […]
Spineology wins FDA 510(k) for Rampart Duo interbody fusion device
Spinal tech developer Spineology said today it won FDA 510(k) clearance for its Rampart Duo interbody fusion system. The St. Paul, Minn.-based company said its newly-cleared Rampart Duo is the 1st device of its kind to combine PEEK, titanium and graft containment mesh elements. “Rampart Duo is an innovative interbody fusion device that builds upon Spineology’s OptiMesh […]
Medtronic wins FDA nod for lower-profile HawkOne atherectomy device
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for a new lower profile version of its HawkOne directional atherectomy system, designed for treating patients with peripheral artery disease. The Fridley, Minn.-based company’s HawkOne is a directional atherectomy device designed to treat severely calcified lesions in the blood vessels of the lower extremities. The device […]
FDA clears pediatric spine implants from Medicrea
Medicrea (EPA:ALMED) said today it won FDA 510(k) clearances for is Pass XS posterior fixation and LigaPass XS band connector components designed for pediatric spinal deformities in small stature patients. The New York City and Lyon, France-based company said it worked with a team of pediatric spinal surgeons to develop the low profile implants specifically designed […]
Philips wins FDA nod for Lumify S4-1 transducer
Royal Philips (NYSE:PHG) said today it won FDA 510(k) clearance for an S4-1 cardiac transducer for its Lumify smart-diagnostic ultrasound device. The newly cleared S4-1 transducer is pocket-sized and lightweight, Philips touted, designed to improve sensitivity and provide high-resolution 2D images. “Our vision for smart-device ultrasounds is focused on putting high-quality devices in the hands […]