Episurf Submits IDE Application for Episealer Knee
By the end of 2Q18, Episurf Medical will file for its Investigational Device Exemption with FDA to initiate a U.S. study of the Episealer® knee implant. Jun 28, 2018
GS Medical Launches AnyPlus MIS Pedicle Screw System
GS Medical commenced U.S. launch of the AnyPlus® Extended Tab system for minimally invasive pedicle screw placement. Jun 28, 2018
Renovis Surgical Gains FDA Clearance for New Tesera ALIF System
Renovis Surgical Technologies received FDA 510(k) clearance to market Tesera® SA Hyperlordotic ALIF, a standalone interbody fusion system. Jun 28, 2018
Globus Medical Milestone: 3,000 Screws Implanted with ExcelsiusGPS
Globus Medical marked a milestone with successful implantation of >3,000 screws with ExcelsiusGPS® robotic guidance and navigation since late-2017 launch. Jun 27, 2018
Ceterix Orthopaedics Awarded US Patent for Circumferential Suturing Method in Meniscus Repair
Ceterix Orthopaedics was issued a new U.S. patent for a method of placing a suture around a tear to repair damaged meniscus. Jun 27, 2018
Medigus Enters Orthopaedic Market, Partners with AM Surgical
Medigus entered into a development agreement with A.M. Surgical to develop an integrated visualization device to complement Stratos, A.M. Surgical's product for endoscopic carpal tunnel release. Jun 27, 2018
Orthofix Reorganizes Business Units
Orthofix realigned its four strategic business units into Global Orthofix Extremities and Global Orthofix Spine. Jun 26, 2018
Zimmer Biomet Responds to FDA Form 483
Zimmer Biomet published a response to the Form 483 issued by FDA in April 2018, related to inspectional observations at the Warsaw North Campus manufacturing facility. Jun 26, 2018
Public Orthopaedic Companies: 1Q18 Revenue
Alongside their 1Q18 results, numerous players reaffirmed or updated their full-year revenue guidance. Globus Medical increased its numbers based on adoption of ExcelsiusGPS, K2M grew its range by $3MM following a distributor partnership and Orthofix upped guidance by about $9MM in acquisition-related contributions. After the quarters close, Wright Medical announced FDA premarket approval for AUGMENT injectable bone graft, and will update its full-year guidance in the 2Q18 call. Jun 21, 2018
Hospitals, Surgeons Provide Insight into Purchasing Priorities
The OMTEC 2018 opening Keynote Panel offered perspective on hospital actions and priorities while addressing critical industry topics including pressure from public and private payors, bundled payments, value analysis committees and outpatient surgeries. Jun 21, 2018
