Regulatory

XpandOrtho, Inc. Receives FDA 510(k) Clearance for Its Electronic Soft Tissue Balancing Instrument for Total Knee Replacement Surgery
Regulatory Top Stories

XpandOrtho, Inc. Receives FDA 510(k) Clearance for Its Electronic Soft Tissue Balancing Instrument for Total Knee Replacement Surgery

May 17, 2017 LA JOLLA, Calif.–(BUSINESS WIRE)–XpandOrtho, Inc., a designer of soft tissue balancing instruments, received FDA clearance on April 25th of 2017 for their electronic soft tissue balancing instrument for total knee replacement surgery. The US Food and Drug Administration (FDA) awarded XpandOrtho 510(k) clearance for its sterile-packaged wireless […]

Episurf Medical continues its communication with the US FDA for market acceptance in the U.S.
Regulatory Top Stories

Episurf Medical continues its communication with the US FDA for market acceptance in the U.S.

Press Release – 15.05.2017 In July 2016, Episurf Medical participated in a pre-submission meeting with the FDA in Washington. Following this meeting, Episurf Medical submitted a 513(g) Request for Information for obtaining FDA’s views about the classification and the regulatory requirements that may be applicable to the Episealer device. Episurf Medical […]

Exactech Receives 510(k) Clearance for Computer-Assisted Shoulder Arthroplasty Technology
Regulatory Top Stories

Exactech Receives 510(k) Clearance for Computer-Assisted Shoulder Arthroplasty Technology

GAINESVILLE, Fla.–(BUSINESS WIRE)– May 15, 2017 Exactech, Inc. (EXAC), a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced today it has received clearance from the U.S. Food and Drug Administration to market the ExactechGPS® Shoulder Application. Combining preoperative planning with […]

ZipLine® Medical Receives India Regulatory Approval for Non-Invasive Zip® Skin Closure System
Regulatory Top Stories

ZipLine® Medical Receives India Regulatory Approval for Non-Invasive Zip® Skin Closure System

May 09, 2017 CAMPBELL, Calif.–(BUSINESS WIRE)–ZipLine® Medical, Inc., an innovator in skin closure, today announced Central Drugs Standard Control Organization (CDSCO) approval of its Zip® Surgical Skin Closure device in India. This clearance will give the company access to the $3.5 billion medical device market in India, including growing specialties […]

3D4Medical Launches Complete Ortho – its Latest Clinical App for iPhone and iPad
Regulatory

3D4Medical Launches Complete Ortho – its Latest Clinical App for iPhone and iPad

May 09, 2017 DUBLIN–(BUSINESS WIRE)–3D4Medical, the world’s leading developer of 3D medical technology, today unveiled the first in its new suite of clinical solutions with the Complete Ortho app for iPhone and iPad, available exclusively on the App Store. “Complete Consultation” is the new range of clinical solutions from 3D4Medical that […]

Life Spine Announces 510(k) Clearance of the CRANIAL FUSION System with SOLSTICE® Screws for Cervical Spine Indications
Regulatory Spine

Life Spine Announces 510(k) Clearance of the CRANIAL FUSION System with SOLSTICE® Screws for Cervical Spine Indications

May 09, 2017 HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, is pleased to announce the FDA 510(k) clearance of the CRANIAL FUSION System. This clearance expands the indications for utilizing SOLSTICE Polyaxial Screws into the […]

CurveBeam Announces FDA 510(k) Clearance for InReach Cone Beam CT Imaging System for the Upper Extremities
Extremities Regulatory Top Stories

CurveBeam Announces FDA 510(k) Clearance for InReach Cone Beam CT Imaging System for the Upper Extremities

WARRINGTON, Pa., May 8, 2017 /PRNewswire/ — CurveBeam announced it has received FDA 510(k) clearance for the InReach, a Cone Beam CT imaging system primarily designed for the hand, wrist & elbow; & lower extremities in non-weight bearing position. The InReach is an ultra-compact CT scanner that provides high-contrast 3D datasets […]

Stryker Orthopaedics 2016 Settlement Program reaches milestone
Financial Regulatory Top Stories

Stryker Orthopaedics 2016 Settlement Program reaches milestone

Kalamazoo, Michigan – May 8, 2017- Stryker Corporation (NYSE:SYK) announced that Howmedica Osteonics Corp. (referred to as “Stryker Orthopaedics”), a subsidiary of Stryker Corporation, has informed the courts in the New Jersey Multicounty and Federal Multidistrict litigations that 95% of additional registered eligible patients have enrolled in the Settlement Program […]

Histogenics Agreement With Japan Pharmaceuticals and Medical Devices Agency and Regulatory Pathway for NeoCart®
Biologics Regulatory

Histogenics Agreement With Japan Pharmaceuticals and Medical Devices Agency and Regulatory Pathway for NeoCart®

WALTHAM, Mass., May 08, 2017 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced that it has successfully completed all formal consultations with the Office of Cellular and Tissue-based Products of the Japan Pharmaceuticals and Medical […]

HCA Announces Agreement to Acquire Three Houston Hospitals from Tenet
Financial Regulatory Top Stories

HCA Announces Agreement to Acquire Three Houston Hospitals from Tenet

May 01, 2017 NASHVILLE, Tenn.–(BUSINESS WIRE)–HCA (NYSE: HCA), which operates 171 hospitals, 119 freestanding surgery centers, and numerous other outpatient centers in 20 states and the United Kingdom, today announced an agreement to purchase three hospitals in Houston from Tenet Healthcare. The agreement includes 423-bed Houston Northwest Medical Center, 181-bed […]

Stricter Medical Device Regulations Will Improve Patient Outcomes, Says Infiniti Research
Regulatory

Stricter Medical Device Regulations Will Improve Patient Outcomes, Says Infiniti Research

May 04, 2017 LONDON–(BUSINESS WIRE)–Regulations for medical and diagnostic devices are changing in tune with advances in technology, new and innovative medical treatments, and the need for more effective diagnostic practices. Infiniti Research expects the market for medical devices to experience positive growth in the coming years as new rules […]