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Medical Equipment, Supplies & Distribution

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Trovagene Submits Protocol To FDA For Phase 2 Clinical Trial Of Pcm-075 In Combination With Zytiga®

Thursday, 14 Dec 2017 08:00am EST

Dec 14 (Reuters) - Trovagene Inc ::TROVAGENE SUBMITS PROTOCOL TO FDA FOR PHASE 2 CLINICAL TRIAL OF PCM-075 IN COMBINATION WITH ZYTIGA® FOR METASTATIC CASTRATION-RESISTANT PROSTATE CANCER.TROVAGENE INC - ‍LOOKING FORWARD TO A DECISION FROM FDA PERMITTING STUDY TO PROCEED, INITIATING MCRPC CLINICAL TRIAL IN PROSTATE CANCER IN 2018​.

Ekso Bionic Partners With HASOMED To Launch Functional Electrical Stimulation For The EksoGT Exoskeleton

Thursday, 14 Dec 2017 08:00am EST

Dec 14 (Reuters) - Ekso Bionics Holdings Inc ::EKSO BIONICS HOLDINGS INC - ‍LAUNCH OF EKSOGT EXOSKELETON'S FUNCTIONAL ELECTRICAL STIMULATION INTERFACE CAPABILITY THROUGH A PARTNERSHIP WITH HASOMED​.

Karolinska Development's Portfolio Company Gets FDA Approval

Thursday, 14 Dec 2017 02:00am EST

Dec 14 (Reuters) - Karolinska Development Ab ::KAROLINSKA DEVELOPMENT'S PORTFOLIO COMPANY PROMIMIC RECEIVES FDA APPROVAL FOR HANANO SURFACE FOR USE ON DENTAL IMPLANTS.

Kawanishi Holdings to dissolve and liquidate wholly owned unit

Thursday, 14 Dec 2017 01:15am EST

Dec 14 (Reuters) - Kawanishi Holdings Inc <2689.T> ::Says it plans to dissolve its Okayama-based wholly owned subsidiary which is mainly engaged in medical device wholesale business, on Dec. 31.Says the unit will be liquidated on March 31, 2018.

IRRAS Announces Voluntary Recall On IRRAflow Device

Wednesday, 13 Dec 2017 01:25am EST

Dec 13 (Reuters) - IRRAS AB ::IRRAS ANNOUNCES VOLUNTARY RECALL ON ITS IRRAFLOW™ DEVICE DUE TO AN ISOLATED INCIDENT OF A BATTERY MANUFACTURING FAILURE.IRRAS BELIEVES THIS IS AN ISOLATED INCIDENT OF A MANUFACTURING FAILURE.RELEVANT REGULATORY BODIES WILL BE NOTIFIED OF VOLUNTARY RECALL.‍DOES NOT ANTICIPATE LONG-TERM IMPACT IN ADOPTION AND CLINICAL USE OF IRRAFLOW DEVICE DUE TO ISOLATED INCIDENT​.VOLUNTARY RECALL WILL AFFECT 2017 SALES OF IRRAFLOW™ ON TWO FRONTS.‍2020 OBJECTIVE OF SALES EXCEEDING 250 MSEK REMAINS INTACT​.

Wuhan Thalys Medical Technology to invest 10.2 mln yuan to set up medical technology company with partners

Tuesday, 12 Dec 2017 04:10am EST

Dec 12(Reuters) - Wuhan Thalys Medical Technology Inc <603716.SS> ::Says it will invest 10.2 million yuan to set up a Inner Mongolia-based medical technology company with partners.Says it will hold 51 percent stake in the target company.

Senzime: CE Mark For The Tetragraph Approved

Tuesday, 12 Dec 2017 02:30am EST

Dec 12 (Reuters) - Senzime Ab (Publ) ::PRESS RELEASE; SENZIME RECEIVES CE MARK APPROVAL FOR THE TETRAGRAPH.

Fisher & Paykel Healthcare Files A Patent Infringement Proceeding Against Resmed In Australia

Monday, 11 Dec 2017 07:49pm EST

Dec 12 (Reuters) - Fisher & Paykel Healthcare Corporation Ltd ::FISHER & PAYKEL HEALTHCARE FILES A PATENT INFRINGEMENT PROCEEDING AGAINST RESMED IN AUSTRALIA.EARNINGS GUIDANCE FOR 2018 FY RESULTS, AS PROVIDED ON 21 NOV, REMAINS UNCHANGED​.

Sernova Receives Us Fda Ind Allowance To Initiate A Us Clinical Trial Of Its Cell Pouch

Monday, 11 Dec 2017 06:00am EST

Dec 11 (Reuters) - Sernova Corp ::SERNOVA RECEIVES US FDA IND ALLOWANCE TO INITIATE A US CLINICAL TRIAL OF ITS CELL POUCH FOR THE TREATMENT OF TYPE 1 DIABETES.SERNOVA- PLANS TO INITIATE CLINICAL TRIAL UNDER US IND TO INVESTIGATE CELL POUCH FOR TREATING TYPE 1 DIABETES IN PERSONS WITH HYPOGLYCEMIA UNAWARENESS.

BRIEF-Asit Biotech Receives Positive Feedback From FDA On Development Plan Of Gp-Asit+ In US

Wednesday, 6 Dec 2017 01:01am EST

Fixes headline and adds 2-4 bullet points.:ASIT BIOTECH SIGNIFICANTLY MOVES FORWARD IN THE PREPARATION OF THE CLINICAL DEVELOPMENT PLAN OF GP-ASIT+™ IN THE US.‍RECEIVED POSITIVE FEEDBACK FROM FDA ON PREPARATION OF CLINICAL DEVELOPMENT PLAN FOR GP-ASIT+™ IN US.‍FEEDBACK FROM FDA INCLUDES A FEW COMMENTS AND REQUEST FOR SOME CLARIFICATION ON MASTER FILE.‍ONCE ASIT BIOTECH HAS ANSWERED FINAL QUESTIONS AND UPDATED MASTER FILE IT WILL REQUEST PRE-IND MEETING​​.

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