Posts by rw-admin
FDA Grants Breakthrough Device Designation for Spiderwort Spinal Cord Technology
Spiderwort Inc., a Canadian medical device company developing innovative biomaterials for regenerative medicine, is pleased to announce that the U.S. Food and Drug Administration (FDA) has designated CelluBridgeTM, Spiderwort’s Spinal Cord Scaffold Implant, as a “Breakthrough Device”. The FDA Breakthrough Devices program creates a path for innovators to get their medical devices to market faster. The program…
Read MoreFreudenberg Medical Opens New Global Headquarters and Facility Expansion in Massachusetts
Freudenberg Medical, member of the Freudenberg Group and a global developer and manufacturer of specialty components and finished devices for the medical device industry, has completed construction of a new medical manufacturing operation in Beverly, Massachusetts. Freudenberg Medical has established the facility as its new global headquarters and the location will manufacture medical devices and components in…
Read MoreItamar Medical Wins National Sleep Foundation 2020 SleepTech Award
The National Sleep Foundation (NSF) named Itamar Medical Ltd. (NASDAQ and TASE: ITMR) winner of the 2020 SleepTech Award. The SleepTech Award recognizes the year’s most innovative efforts in advancing sleep technology. Itamar Medical is a technology company focused on the development and commercialization of non-invasive medical devices and solutions to aid in the diagnosis of…
Read MoreCerapedics Announces Commercial Launch of i-FACTOR+ Matrix in Canada
Cerapedics, a private ortho-biologics company, today announced the full commercial availability of i-FACTOR+ MATRIX for surgical implantation in Canada. “We are excited to announce that i-FACTOR+ Matrix is now fully available in Canada through our distributor Surgi-One and can be used in both spine and general orthopedic applications,” said Glen Kashuba, Chief Executive Officer of Cerapedics. “Canada will be the…
Read MoreStryker Will Divest Total Ankle Business to get FTC Blessing for Wright Medical Acquisition
The Federal Trade Commission will require medical device companies Stryker Corp. and Wright Medical Group N.V. to divest all assets related to Stryker’s total ankle replacements and finger joint implant products to remedy concerns that Stryker’s proposed $4 billion acquisition of Wright will harm competition in those markets. Under the terms of the consent agreement, the companies…
Read MoreIlluminOss Medical Receives FDA Clearance for Use in Femur and Tibia Fractures as a Supplement to Approved Hardware
IlluminOss Medical, a medical device company focused on minimally invasive orthopedic fracture repair, today announced an expanded U.S. Food and Drug Administration (FDA 510k) clearance for its Photodynamic Bone Stabilization System. The new clearance allows IlluminOss to be used in femur and tibia fractures as supplemental fixation to FDA-cleared fracture fixation systems. “Femur and tibia fractures can…
Read MoreMedical Microinstruments Announces CE Mark for Robotic Microsurgery with the World’s Smallest Wristed Surgical Instruments
MMI SpA, an Italian company dedicated to improving clinical outcomes for patients undergoing microsurgery, announced today the CE Mark, launch and first human use of its Symani® Surgical System in Europe for open microsurgical procedures. The first four robotic surgeries were successfully performed in Florence, Italy, including three complex, post-traumatic lower limb reconstructions as well as a post-oncological reconstruction…
Read MoreSiemens X-Ray System Gains FDA Clearance
Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the YSIO X.pree, a ceiling-mounted radiography system with the MyExam Companion intelligent user interface. In addition to this easy-to-use interface that guides the radiologic technologist through the exam workflow, the YSIO X.pree has a new 3D camera for patient positioning and advanced collimation,…
Read MoreBristol Myers Squibb to Acquire MyoKardia for $13.1 Billion in Cash
Bristol Myers Squibb (NYSE: BMY) and MyoKardia, Inc. (Nasdaq: MYOK) today announced a definitive merger agreement under which Bristol Myers Squibb will acquire MyoKardia for $13.1 billion, or $225.00 per share in cash. The transaction was unanimously approved by both the Bristol Myers Squibb and MyoKardia Boards of Directors and is anticipated to close during the…
Read MoreEzra Receives FDA Clearance for Prostate Cancer Artificial Intelligence
Ezra, the New York-based startup transforming early cancer screening using MRI, announced today that it has received FDA 510(k) clearance for its Artificial Intelligence designed to assist radiologists in analyzing and segmenting prostate MRI. Use of the innovative AI technology can help reduce the time and cost of MRI-based prostate cancer screening. It is the first…
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