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Kelyniam Global Inc.

7 medtech stories we missed this week: March 2, 2018

March 2, 2018 By Danielle Kirsh

From InspireMD’s new distribution deals to Kelynium’s distribution deal with a mystery partner, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. InspireMD inks distribution deals in Greece, Caribbean InspireMD announced in a March 1 press release that it has signed exclusive distribution agreements with T-Vascular IKE Medical Supplies […]

Filed Under: 510(k), Dental, Diagnostics, Food & Drug Administration (FDA), Hospital Care, Imaging, Patient Monitoring, Regulatory/Compliance, Ultrasound Tagged With: Biolase, dexalytic, Getinge, Hologic, iCad Inc., InspireMD, Kelyniam Global Inc., MedTech, meridianpm, s-ray

FDA warns craniofacial implant maker, dialysate producer

October 18, 2017 By Fink Densford

The FDA this week released warning letters it sent to 2 medical device manufacturers in response to letters related to previous inspections at craniofacial implant maker Kelyniam Global and dialysate maker Diasol. The federal watchdog said it was responding to a letter it received from Director Dr. Mark Smith at Kelyniam in June after having […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Diasol, Kelyniam Global Inc.

Zimmer slides on Q1 results | Earnings Roundup

April 26, 2012 By MassDevice staff Leave a Comment

MassDevice.com Earnings Roundup

Investors sent shares of Zimmer (NYSE:ZMH) down 5% this morning in pre-market trading after the orthopedic device maker reported sales and earnings in-line with Wall Street’s expectations, but lackluster sales of hip and knee implants.

Filed Under: MassDevice Earnings Roundup, News Well, Orthopedics Tagged With: 2012, Arrhythmia Research Technology Inc., ConMed Corp., EnteroMedics Inc., Grifols, Hillrom, Hips, Invacare, Kelyniam Global Inc., Knees, Merit Medical Systems, Natus Medical Inc., neovasc, Neurometrix, Palomar Medical Technologies Inc., Q1, Rochester Medical Corp., RTI Surgical, Shire Plc., Sorin Group, Spectranetics Corp., Utah Medical, Varian Medical Systems, vascularsolutions, Young Innovations, Zimmer Biomet

Boston Scientific, Medtronic extend atrial fibrillation treatment offerings with new approvals

May 3, 2011 By MassDevice staff Leave a Comment

Medtronic

Boston Scientific Corp. (NYSE:BSX) and Medtronic Inc. (NYSE:MDT) both announced regulatory approvals for new products that will expand their atrial fibrillation treatment offerings.

Natick, Mass.-based Boston Scientific won CE Mark approval for its Blazer open-irrigated, a radiofrequency ablation (RFA) catheter for treating atrial fibrillation and other arrhythmias.

Filed Under: 510(k), News Well, Pre-Market Approval (PMA) Tagged With: Boston Scientific, Femasys Inc., Idaho Technology Inc., Kelyniam Global Inc.

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