Regulatory

Proposed US FDA User Fee Increase would Impact Smaller Medical Device Firms the Most
Regulatory Top Stories

Proposed US FDA User Fee Increase would Impact Smaller Medical Device Firms the Most

March 20, 2017 by Stewart Eisenhart EMERGO SUMMARY OF KEY POINTS: The Trump Administration has proposed user fee increases for drug, medical device and other FDA registrants in 2018. Few specifics on the proposed increases make it difficult to determine exactly how medical device firms would be impacted. Smaller manufacturers […]

First Ray Receives FDA 510(k) Clearance for Expanded Stealth Staple™ Product Line
Extremities Regulatory

First Ray Receives FDA 510(k) Clearance for Expanded Stealth Staple™ Product Line

LOGAN, Utah, March 15, 2017 /PRNewswire/ — First Ray, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures, announces that it has received FDA 510(k) clearance for new additions to the Stealth Staple™ System product family. Previously, the company received clearance for its […]

OMNIlife science™, Inc. Announces First Clinical Use of Novel Robotic Tissue Balancing Device for OMNIBotics® Technology Platform
Regulatory Robotics Top Stories

OMNIlife science™, Inc. Announces First Clinical Use of Novel Robotic Tissue Balancing Device for OMNIBotics® Technology Platform

RAYNHAM, Mass., March 13, 2017 /PRNewswire/ — OMNIlife science, Inc. (“OMNI™”), a privately-held, established medical technology company targeting the $15 billion global hip and knee replacement device market, announced today the first clinical use of a novel robotic tissue balancing device for use with OMNI’s market-leading OMNIBotics® robotic-assisted total knee replacement […]

Spineology® Announces Expanded FDA Clearance of Elite™ Expandable Interbody Fusion System
Regulatory

Spineology® Announces Expanded FDA Clearance of Elite™ Expandable Interbody Fusion System

March 13, 2017 MINNEAPOLIS & ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology, Inc. the innovator in Anatomy-Conserving Surgery™, is excited to announce expanded FDA clearance of the Elite Expandable Interbody Fusion System. Included in the clearance is the addition of a narrower, 10mm, version of the device and an indication to utilize the […]

Invibio: FDA reclassified semi-rigid spinal stabilization systems providing new possibilities for treating patients
Regulatory Spine

Invibio: FDA reclassified semi-rigid spinal stabilization systems providing new possibilities for treating patients

THORNTON CLEVELEYS (UK) (PRWEB) MARCH 08, 2017 The US Food and Drug Administration (FDA) has recently reclassified semi-rigid spinal stabilization systems from Class III to Class II (*) offering a regulatory pathway to 510(k) clearance in the United States for innovative devices using PEEK-OPTIMA™ polymer based rods from Invibio Biomaterial […]

Vertos Medical’s mild® Procedure Receives Broad Coverage From Centers For Medicare & Medicaid Services
Regulatory Spine Top Stories

Vertos Medical’s mild® Procedure Receives Broad Coverage From Centers For Medicare & Medicaid Services

ALISO VIEJO, Calif., March 7, 2017 /PRNewswire/ — Vertos Medical, a medical device company committed to developing innovative, minimally invasive treatments for lumbar spinal stenosis (LSS), has received national coverage for its mild® Procedure through a recently approved study under the Centers for Medicare & Medicaid Services’ (CMS) Coverage with Evidence […]

Intellijoint Surgical® Announces intellijoint HIP® Anterior Application FDA Clearance
Regulatory

Intellijoint Surgical® Announces intellijoint HIP® Anterior Application FDA Clearance

WATERLOO, ON, March 7, 2017 /PRNewswire/ – Intellijoint Surgical® Inc., a privately-held Canadian medical technology company, announces FDA clearance of intellijoint HIP® Anterior, the newest application to the intellijoint HIP suite. intellijoint HIP Anterior is a 3D mini-optical navigation solution that provides quantifiable, intraoperative measurements for cup position, leg length, […]

Medical device makers stand to gain if Neil Gorsuch approved for Supreme Court
Regulatory

Medical device makers stand to gain if Neil Gorsuch approved for Supreme Court

By Jim Spencer Star Tribune  – March 5, 2017 WASHINGTON – When hearings on Supreme Court nominee Neil Gorsuch begin later this month, questions will likely center on hot-button issues like women’s reproductive rights, travel bans, immigrant deportations and state voter identification laws. But one of the most strongly expressed opinions […]

Emergo Survey: Regulatory Issues Remain Biggest Challenge for Most Medical Device Companies
Regulatory

Emergo Survey: Regulatory Issues Remain Biggest Challenge for Most Medical Device Companies

February 27, 2017 by Stewart Eisenhart EMERGO SUMMARY OF KEY POINTS: Regulatory issues continue to be the biggest business challenge for medical device companies of all sizes. Managers at smaller firms report greater concern for funding and capital issues, while largest firms are more challenged by pricing and competition pressures. […]

Amend Surgical Announces 510(K) Clearance for NanoFUSE® BA
Regulatory Top Stories

Amend Surgical Announces 510(K) Clearance for NanoFUSE® BA

March 02, 2017 ALACHUA, Fla.–(BUSINESS WIRE)–Amend Surgical, Inc., a medical device company focused on enhancing the regenerative capacity of bone replacement products, announced today that they have received 510(K) clearance to market NanoFUSE® BA as a bone graft extender for spine and orthopedic applications. NanoFUSE BA is a novel composite […]