Nov 6 (Reuters) - Intersect ENT Inc :FDA performs pre-approval inspection of Intersect ENT's menlo park facility.Intersect ENT Inc - FDA has set a pdufa target action date of January 7, 2018.Intersect ENT Inc - at conclusion of inspection, FDA issued a form 483 with four inspectional observations.Intersect ENT Inc - does not expect inspectional observations to impact timeline for a decision from FDA on approval of sinuva implant.
Nov 3 (Reuters) - Myomo Inc :Myomo Inc - announced that its application for a canadian medical device license has been approved by Health Canada.Myomo Inc - Myomo and its distribution partner, Ottobock, are now entering canadian market for commercial sale of Myopro Myolelectric Arm Orthosis.
Nov 2 (Reuters) - Second Sight Medical Products Inc :Second Sight receives full FDA approval to begin first Orion human clinical study.Second sight-completed additional device testing, addressed remaining questions requested by FDA in prior conditional approval announced on Aug 28.Second Sight Medical Products Inc - approval for Orion human clinical study allows two U.S. Sites to enroll up to five total patients.
Oct 31 (Reuters) - Getein Biotech Inc <603387.SS>:Says it will invest 20 million yuan to set up a wholly owned medical examination unit in Nanjing .
Oct 30 (Reuters) - Cellumed Co Ltd <049180.KQ> ::Says it received patent for U-shaped three-layer compression mold.
Oct 27 (Reuters) - INTEGRUM AB ::RECEIVED FUNDING FOR COOPERATION PROJECT FROM DARPA.TOTAL ORDER VALUE AMOUNTS TO USD 310,000 EQUIVALENT TO ABOUT SEK 2.5 MILLION.
Oct 26 (Reuters) - Iradimed Corp :Iradimed corporation announces fda 510(k) clearance of MRI compatible patient vital signs monitor.
Oct 25 (Reuters) - Zimmer Biomet Holdings Inc :ANNOUNCES U.S. LAUNCH OF VITALITY+ AND VITAL SPINAL FIXATION SYSTEMS.
Oct 25 (Reuters) - EPISURF MEDICAL AB ::NEW PATENT IN CHINA FOR EPISURF MEDICAL.IS OBTAINING ANOTHER NEW PATENT IN CHINA..PATENT IS ENTITLED "METHOD AND NODE FOR MANUFACTURING A SURGICAL KIT FOR CARTILAGE REPAIR".
Oct 24 (Reuters) - Tandem Diabetes Care Inc ::Tandem Diabetes Care to provide all t:slim x2 insulin pump features approved in 2018 to users at no cost, expands existing dexcom welcome offer for animas customers.Tandem diabetes care inc - tandem and Dexcom are now extending terms of their welcome programs for animas customers through march 31, 2018.