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Medical Equipment, Supplies & Distribution

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Kolen receives patent

Wednesday, 12 Jul 2017 04:08am EDT

July 12 (Reuters) - Kolen Co Ltd <078650.KQ> ::* Says it receives patent on July 12, for photographing lens and photographing apparatus.* Patent number is 2015-0015569 .

Bonesupport receives SEK 8 mln grant from Vinnova Sweden

Wednesday, 12 Jul 2017 02:00am EDT

July 12 (Reuters) - BONESUPPORT HOLDING AB :BONESUPPORT™ - PIPELINE PROJECT TARGETING BIOCERAMICS CAPABLE OF ENHANCING BONE GROWTH AWARDED SEK 8 MILLION GRANT FROM VINNOVA SWEDEN.

Biocartis' Idylla Instrument and Idylla Console exempt from FDA 510(k) notification requirements

Wednesday, 12 Jul 2017 01:00am EDT

July 12 (Reuters) - BIOCARTIS GROUP NV ::REG-BIOCARTIS GROUP NV: BIOCARTIS' IDYLLA(TM) INSTRUMENT AND IDYLLA(TM) CONSOLE EXEMPT FROM US FDA 510(K) NOTIFICATION REQUIREMENTS.‍ALL OTHER US 510(K) REQUIREMENTS REMAIN IN EFFECT​.‍CAN NOW WITHDRAW PENDING 510(K) SUBMISSION FOR IDYLLA(TM) INSTRUMENT AND IDYLLA(TM) CONSOLE​.BIOCARTIS - ‍EXEMPTION DOES NOT CHANGE ONGOING UNDERTAKING OF BIOCARTIS AND JANSSEN DIAGNOSTICS TO OBTAIN 510(K) CLEARANCE FOR JANSSEN IDYLLA RESPIRATORY (IFV-RSV) PANEL TEST​.

Ocular Therapeutix receives complete response letter from FDA for Dextenza NDA

Tuesday, 11 Jul 2017 05:00pm EDT

July 11 (Reuters) - Ocular Therapeutix Inc :Ocular Therapeutix™ receives complete response letter from fda for dextenza™ nda.Ocular Therapeutix inc says outstanding items pertain to form fda-483 close-out of manufacturing deficiencies and analytical testing.Ocular Therapeutix inc says complete response letter states that fda has determined that it cannot approve nda in its present form.Ocular Therapeutix -crl acknowledges receipt of co's nda amendment dated july 10, 2017 and states amendment was not reviewed prior to fda's action of crl.Ocular Therapeutix Inc says as a result, fda did not have opportunity to review company's close-out response prior to issuing crl.Ocular Therapeutix -FDA indicated applicable sections of amendment submitted by ocular could be incorporated when responding to deficiencies noted in crl.Ocular Therapeutix Inc says satisfactory resolution of manufacturing deficiencies detailed in form fda-483 is required before nda may be approved.Ocular Therapeutix -fda's letter did not identify any efficacy or safety concerns with respect to clinical data for dextenza provided in nda.Ocular Therapeutix -fda's letter did not identify any need for additional clinical trials for nda approval.

Zeiss says co enters the semiconductor process control market

Monday, 10 Jul 2017 11:55am EDT

July 10 (Reuters) - Zeiss ::‍Zeiss says expanding into a new market in semiconductor industry through its new Process Control Solutions (PCS) business unit​‍​‍​.Zeiss says new business unit will be part of Zeiss Semiconductor Manufacturing Technology business group .

Medtronic announces expanded FDA approval of self-expanding Corevalve Evolut TAVR platform​

Monday, 10 Jul 2017 11:35am EDT

July 10 (Reuters) - Medtronic Plc : :Medtronic expands TAVR access to more patients with symptomatic, severe aortic stenosis upon intermediate risk FDA approval.Medtronic Plc- ‍expanded U.S. FDA approval of self-expanding Corevalve Evolut Transcatheter Aortic Valve Replacement platform​.Medtronic - ‍Expanded FDA approval to include patients with symptomatic severe aortic stenosis who are at an intermediate risk for open-heart surgery​.

Jiangxi Sanxin Medtec to use 2 mln yuan to set up pharma equipment unit

Friday, 7 Jul 2017 11:01am EDT

July 7 (Reuters) - Jiangxi Sanxin Medtec Co Ltd <300453.SZ> ::* Says it plans to use 2 million yuan to set up a pharma equipment subsidiary .

L&K Biomed receives patent

Thursday, 6 Jul 2017 10:28pm EDT

July 7 (Reuters) - L&K Biomed Co Ltd <156100.KQ> ::* Says it receives patent about anti-emap ⅱ antibody and use thereof.* Says patent number is 10-2017-0038706 .

Hanza signs agreement with Getinge

Thursday, 6 Jul 2017 06:40am EDT

July 6 (Reuters) - HANZA AB :HANZA SIGNS AGREEMENT WITH GETINGE.

Soleno Therapeutics announces completion of FDA meeting for DCCR in Prader-Willi syndrome

Wednesday, 5 Jul 2017 08:00am EDT

July 5 (Reuters) - Soleno Therapeutics Inc :Soleno Therapeutics announces successful completion of FDA meeting for DCCR in Prader-Willi syndrome.Soleno Therapeutics Inc says positive guidance received on key elements of phase III program.Soleno Therapeutics Inc says expects to initiate pivotal phase III clinical trial by year-end 2017.Soleno Therapeutics -FDA expressed support for change in hyperphagia score, without a change in weight, compared to placebo as primary endpoint for study.

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