Broncus Medical, Inc., talks of the publication of results from the VAPORIZE study in the current issue of Respiration. The paper’s authors conclude that, … continue reading “Positives for Broncus BTVA System”
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Japan Approves LimFlow Study
Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved LimFlow’s Clinical Trial Notification (CTN) for the Japanese cohort of the … continue reading “Japan Approves LimFlow Study”
SINUVA® Sinus Implant Reimbursement Picture Clears
ENT technology company Intersect ENT®, Inc., has announced that the U.S. Centers for Medicare and Medicaid Services (CMS) have published … continue reading “SINUVA® Sinus Implant Reimbursement Picture Clears”
Fourth FDA Breakthrough Device Award for Sirolimus DEB
The FDA has awarded MedAlliance breakthrough status for its SELUTION SLR™ sustained limus release Drug Eluting Balloon (DEB) catheter, in … continue reading “Fourth FDA Breakthrough Device Award for Sirolimus DEB”
FDA Approves Expanded Labeling of Medtronic MRI Leads
Medtronic plc says it has received approval from the U.S. FDA for expanded MRI labeling of its InterStim™ II and InterStim™ … continue reading “FDA Approves Expanded Labeling of Medtronic MRI Leads”
FDA Clears Vetex ReVene Thrombectomy Catheter
Vetex Medical Ltd. tells us that the U.S. FDA 510(k) has cleared its the ReVene® Thrombectomy Catheter. Vetex expects to make the … continue reading “FDA Clears Vetex ReVene Thrombectomy Catheter”
Q‑Flow™ 2021 Targets Perfect Surgical Site Illumination
Surgical light technologist Merivaara has revealed its new improved Q-Flow™ 2021 offering. The system has been reformed in key features … continue reading “Q‑Flow™ 2021 Targets Perfect Surgical Site Illumination”
CairnSurgical Breast Cancer Locator Trial Begins
The first patient has been treated in a U.S. pivotal trial of CairnSurgical’s Breast Cancer Locator (BCL) System. The system is … continue reading “CairnSurgical Breast Cancer Locator Trial Begins”
CE Mark for Robotic Cancer Detection Probe
Now with CE mark approval, Lightpoint Medical’s SENSEI® becomes the first robotic gamma probe to be commercially available to European … continue reading “CE Mark for Robotic Cancer Detection Probe”
CMS Code for Intersect ENT PROPEL® Sinus Implant
Ear, nose and throat (ENT) specialist Intersect ENT®, Inc. tells us about a new Centers for Medicare and Medicaid Services (CMS) … continue reading “CMS Code for Intersect ENT PROPEL® Sinus Implant”
De Novo FDA Nod for Miach ACL Healing Implant
Miach Orthopaedics, Inc., has announced that the U.S. FDA has granted the company’s De Novo Request for the Bridge-Enhanced® ACL Repair (BEAR®) Implant.
FDA Clearances Enhance Mazor™ Robotic Guidance System
The U.S. FDA has cleared the use of navigated interbody and Midas Rex™ high speed drills with the Mazor™ Robotic Guidance System earlier than originally anticipated
Scalp Cooling Gains Support for Prevention of Chemo-Induced Alopecia
The European Society for Medical Oncology (ESMO) has recommended scalp cooling for the prevention of chemotherapy-induced alopecia (CIA). Background Chemotherapy-induced … continue reading “Scalp Cooling Gains Support for Prevention of Chemo-Induced Alopecia”
MedShape Launches DynaNail Mini® for Medial Column Fusion
Additional size offerings expands company’s portfolio of limb salvage surgical solutions. Background MedShape, Inc., the industry leader in orthopedic devices … continue reading “MedShape Launches DynaNail Mini® for Medial Column Fusion”
FDA OKs ReCor Paradise™ Ultrasound Renal Denervation
ReCor Medical’s Paradise™ Ultrasound Renal Denervation System has received Breakthrough Device Designation from the U.S. FDA for the treatment of patients with uncontrolled hypertension who are inadequately responsive to anti-hypertensive medications.
Carpediem™ First Cardio-Renal Pediatric Dialysis Launch
Medtronic plc has announced the U.S. commercial launch of the Carpediem™ Cardio-Renal Pediatric Dialysis Emergency Machine, the first and only … continue reading “Carpediem™ First Cardio-Renal Pediatric Dialysis Launch”