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Medical Equipment, Supplies & Distribution

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FDA performs pre-approval inspection of Intersect ENT's menlo park facility

Monday, 6 Nov 2017 08:00am EST

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​.

Myomo Inc - ‍announced application for a canadian medical device license approved by Health Canada​

Friday, 3 Nov 2017 08:00am EDT

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​.

Second Sight receives FDA approval to begin first Orion human clinical study

Thursday, 2 Nov 2017 08:05am EDT

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​.

Getein Biotech to invest 20 mln yuan to set up medical examination unit in Nanjing

Tuesday, 31 Oct 2017 07:52am EDT

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 .

Cellumed receives patent

Monday, 30 Oct 2017 03:40am EDT

Oct 30 (Reuters) - Cellumed Co Ltd <049180.KQ> ::Says it received patent for U-shaped three-layer compression mold.

Integrum gets funding for cooperation project from DARPA

Friday, 27 Oct 2017 03:00am EDT

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.

Iradimed announces FDA 510(k) nod for MRI compatible patient vital signs monitor

Thursday, 26 Oct 2017 07:00am EDT

Oct 26 (Reuters) - Iradimed Corp :Iradimed corporation announces fda 510(k) clearance of MRI compatible patient vital signs monitor.

ZIMMER BIOMET ‍ANNOUNCES U.S. LAUNCH OF VITALITY+, VITAL SPINAL FIXATION SYSTEMS​

Wednesday, 25 Oct 2017 07:30am EDT

Oct 25 (Reuters) - Zimmer Biomet Holdings Inc :‍ANNOUNCES U.S. LAUNCH OF VITALITY+ AND VITAL SPINAL FIXATION SYSTEMS​.

Episurf Medical gets new patent in China

Wednesday, 25 Oct 2017 05:30am EDT

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"​.

‍Tandem Diabetes Care to provide all t:slim X2 insulin pump features approved in 2018 to users at no cost

Tuesday, 24 Oct 2017 04:30pm EDT

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​.

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