Monthly Archives: November 2018

OrthoPediatrics Corp. Enhances Product Offering with Upgraded PediLoc® Femur Plate System

WARSAW, Ind., Nov. 27, 2018 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (NASDAQ: KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today the U.S. launch of its new PediLoc® Femur Plate System. Building on the success of the existing PediLoc franchise, this upgraded offering boasts a lower profile screw to minimize soft tissue irritation,

By |2018-11-27T21:27:25+00:00November 27th, 2018|Extremities|

Stryker announces pricing of €2.25 billion senior notes offering

Kalamazoo, Michigan, Nov. 27, 2018 (GLOBE NEWSWIRE) -- Stryker (NYSE:SYK) announced today that it has priced the following notes: (i) €550 million aggregate principal amount of the Company’s 1.125% Notes due 2023 (the “2023 Notes”), (ii) €750 million aggregate principal amount of the Company’s 2.125% Notes due 2027 (the “2027 Notes”), (iii) €650 million aggregate

By |2018-11-27T21:02:27+00:00November 27th, 2018|Financial|

UK firm sold spinal implants that disintegrated

26 Nov 2018 / Hilary Osborne A UK company’s spinal implants that allegedly moved and eroded in patients, and which are at the centre of legal action, have highlighted potential weaknesses in the way in which some medical devices enter the market, an investigation has revealed. Documents seen by the Guardian show the plastic discs were

By |2018-11-27T20:49:46+00:00November 27th, 2018|Regulatory, Spine|

Medicrea Announces $30 Million Senior Secured Notes Issue and a Warrants Issue wholly subscribed by Perceptive Advisors

November 27, 2018 LYON, France & NEW YORK--(BUSINESS WIRE)--The Medicrea Group (Euronext Growth Paris: FR0004178572- ALMED ; OTCQX Best Market – MRNTY & MRNTF), pioneering the transformation of spinal surgery through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD™ ASI (Adaptive Spine Intelligence) proprietary software platform, services and technologies, today announced the

By |2018-11-27T20:18:12+00:00November 27th, 2018|Financial|

Viseon, Inc. Announces First US Clinical Use of the Voyant System for Minimally Invasive Spine Surgery Access, Illumination and Visualization

November 27, 2018 IRVINE, Calif.--(BUSINESS WIRE)--Viseon, Inc. today announced the first U.S. clinical human use of the Voyant System for Minimally Invasive Spine Surgery access, illumination and visualization. The case was performed by Neurosurgeon John J. Knightly, MD of the Atlantic NeuroSurgical Specialists in Morristown, New Jersey. The Voyant System is composed of a sterile

By |2018-11-27T19:01:01+00:00November 27th, 2018|Spine|

Astura Medical Receives FDA 510(k) Clearance For OLYMPIC MIS Posterior Spinal Fixation System

CARLSBAD, CA – November 26, 2018 – Astura Medical, a high-growth, innovative spine technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Olympic Minimally Invasive Surgery (MIS) Posterior Spinal Fixation System. The Olympic MIS system delivers a new level of intraoperative flexibility and efficiency

By |2018-11-27T18:31:27+00:00November 27th, 2018|Regulatory, Spine|

Verrix Completes Initial Close on $8 Million Funding Round to Advance Sterility Assurance Technology for Hospitals

November 27, 2018 SAN CLEMENTE, Calif.--(BUSINESS WIRE)--Verrix, a medical device company developing solutions for rapid and accurate sterilization confirmation, has completed an initial close on a Series B funding round for $8 million, which will bring the company’s total funds raised to $17.5 million. The Series B funding will allow the company to finalize development,

By |2018-11-27T17:18:49+00:00November 27th, 2018|Financial|

TRIA Orthopedics First in Minnesota to Test Breakthrough GelrinC™ Implant to Regenerate Knee Cartilage

November 27, 2018 MINNEAPOLIS--(BUSINESS WIRE)--Regentis Biomaterials today announced that Twin Cities-based TRIA Orthopedics is the first in Minnesota to perform a procedure using the GelrinC™ implant to treat damaged articular cartilage causing knee pain. GelrinC (pronounced “gel-rin-cee”) is an investigational device being evaluated as a treatment to help the body regrow cartilage in the knee. TRIA

By |2018-11-27T16:46:43+00:00November 27th, 2018|Biologics, Top Stories|

Osiris Therapeutics, Inc. Appoints Samson Tom, PhD, MBA to Serve as President and Chief Executive Officer

COLUMBIA, Md., Nov. 26, 2018 (GLOBE NEWSWIRE) -- Osiris Therapeutics, Inc. (NASDAQ: OSIR), a regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, is pleased to announce that its Board of Directors appointed Samson Tom, PhD, MBA to serve as President and Chief Executive Officer, effective November 26,

By |2018-11-26T22:56:12+00:00November 26th, 2018|Biologics|

FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on new steps to modernize FDA’s 510(k) program

November 26, 2018 / FDA Statement Forty-two years ago, Congress passed the law establishing the framework for evaluating the safety and effectiveness of medical devices. Today, we’re announcing changes to modernize the FDA’s 510(k) clearance pathway, which accounts for the majority of devices that the FDA reviews. We’re pursuing these changes to help keep pace

By |2018-11-26T21:51:26+00:00November 26th, 2018|Regulatory|