Posts by cstephenson@legacymedsearch.com
CrossBay Medical Receives FDA Clearance for CrossGlide ETS Plus
CrossBay Medical, Inc., a health technology company focused on improving the delivery of women’s healthcare, announced it has received clearance from the Food and Drug Administration (FDA) to market its CrossGlide ETS Plus. Similar to the CrossGlide ETS, Endometrial Tissue Sampler (which received FDA clearance this summer), the ETS Plus also enables medical providers to perform…
Read MoreCartiHeal Receives FDA “Breakthrough Device Designation” for the novel Agili-C Implant
CartiHeal, developer of Agili-C, a proprietary implant for the treatment of cartilage lesions in arthritic and non-arthritic joints, announced today that FDA has granted Breakthrough Device Designation for the Agili-C implant. FDA’s Breakthrough Device Program is reserved for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases…
Read MoreSteris to acquire Key Surgical for $850 Million
STERIS plc (NYSE: STE) (“STERIS” or the “Company”) today announced that the Company has signed a definitive agreement to purchase Key Surgical, a portfolio company of Water Street Healthcare Partners, LLC, through a U.S. subsidiary for $850 million. STERIS anticipates that the acquisition will qualify for a tax benefit related to tax deductible goodwill. Adjusting for the present value of…
Read MoreJ&J’s Biosense Webster gets FDA Nod for Ablation Catheter for Atrial Fibrillation
Johnson & Johnson Medical Devices Companies today announced the United States Food and Drug Administration (FDA) approval of Biosense Webster, Inc.’s THERMOCOOL SMARTTOUCH SF Ablation Catheter for the treatment of persistent atrial fibrillation (persistent AF). The approval is based on results of a prospective, multi-center study (PRECEPT) which met primary safety and effectiveness endpoints and…
Read MoreSimplify Medical Receives FDA Approval for 1-Level Simplify Disc PMA
Simplify Medical, a privately-held company focused on cervical spinal disc arthroplasty and developer of the Simplify® cervical artificial disc, today announced U.S. Food and Drug Administration (FDA) Approval for the Simplify Disc Pre-Market Application (PMA) for 1-level indications. Simplify Disc achieved superiority to the fusion control on the composite primary endpoint. David Hovda, President and CEO…
Read MoreFDA Grants GI Windows Medical Breakthrough Device Designation for Magnetic Anastomosis Technology
GI Windows Medical Corp, a clinical-stage, privately-held medical device company pioneering new advancements in anastomosis technology announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the self-forming magnetic compression anastomosis device indicated for small bowel end to end anastomosis for ileostomy reversal or tissue resection. The Breakthrough Devices Program is…
Read MoreSmith+Nephew Acquires Integra Lifescience’s Extremity Orthopedics Business for $240
Smith+Nephew, the global medical technology business, announces that it has agreed to acquire the Extremity Orthopaedics business of Integra LifeSciences Holdings Corporation for $240 million. The acquisition supports Smith+Nephew’s strategy to invest in higher-growth segments. This acquisition will significantly strengthen Smith+Nephew’s extremities business by adding a combination of a focused sales channel, complementary shoulder replacement and upper…
Read MoreFDA Allows At-Home Administration for CapsoVision Capsule Endoscope
CapsoVision, an innovator in the gastroenterology diagnostics market, today announced that the U.S Food & Drug Administration (FDA) will apply enforcement discretion which allows at-home administration of the CapsoCam Plus® small bowel capsule endoscope during the COVID-19 pandemic for patients who are determined eligible for at-home administration. The labeling addendum permits a fully remote capsule endoscopy…
Read MoreNOUS Imaging Receives 510(k) Clearance from FDA for Real Time MRI Software
NOUS Imaging, a medical imaging software company, today announced that the FDA has cleared its 510(k) submission for FIRMM, Framewise Integrated Real-Time MRI Monitoring. FIRMM provides real-time monitoring and biofeedback that addresses the significant problem of patient motion during brain MRI. This is the Company’s first FDA clearance and represents the initial piece of a…
Read MoreTHINK Surgical and Total Joint Orthopedics Announce Collaboration on Robotic Knee Surgery
Total Joint Orthopedics (TJO) announced today a new collaboration with THINK Surgical®, Inc., an advanced orthopedic robot technology company based in Fremont, CA. Under the terms of the agreement, THINK Surgical will develop software allowing TJO’s Klassic® Knee System to be implanted using THINK’s TSolution One® Total Knee Application and both companies will co-market the solution upon…
Read More