Integra LifeSciences has received US regulatory clearance to market its Integra Titan Reverse Shoulder System, which offers greater flexibility for shoulder replacement surgery. The company plans to begin a limited market release in the ...
Tags: Integra Lifesciences
US-based health monitoring systems provider Ambio Health has received 510(k) clearance in the US for its Ambio Remote Health Monitoring System, a wireless tool that allows patients to take the readings on high blood-pressure, heart disease ...
CryoLife has announced the first European clinical implant of its HeRO (Haemodialysis Reliable Outflow) graft following its CE Mark in June 2013. The procedure was performed at the University of Leuven Hospital in Belgium by Professor ...
Tags: CryoLife, Outflow Graft
Hotspur Technologies, a subsidiary of US-based Teleflex, has secured FDA 510(k) clearance to market its ARROW GPSCath Balloon Dilatation Catheters in higher rated burst pressure (RBP) and 80 cm lengths. These products allow several ...
Techne has completed the acquisition of Bionostics Holdings and its operating subsidiary Bionostics for approximately $104m in cash. Bionostics is a developer and manufacturer of control solutions that verify the correct operation of ...
Tags: Techne, Bionostics Acquisition
US-based Cook Medical has introduced Biodesign ENT Repair Graft, which acts as an adjunct to help in the healing process following nasal and sinus mucosal surgery. The latest Biodesign offering from Cook Medical's Otolaryngology-Head and ...
Tags: Cook Medical, Medicine
SynGen has received 510(k) approval from the US Food and Drug Administration (FDA) to market its SynGenX-1000 System, CryoPRO-2 Cryopreservation/Storage Bag Set, SynGen DataTrak software products to process cord blood. Previously, the ...
Tags: Cord Blood Processing, Syngen
Merit Medical, US-based cardiology, radiology and endoscopy disposable devices manufacturer and distributor, has received multiple regulatory approvals from various regulatory bodies. Merit's advanced high-pressure inflation device, ...
Tags: Merit Medical, Medical Devices
Teleflex, a US-based firm that provides medical devices for critical care and surgery, has won US FDA 510(k) clearance for its Arrow NextStep retrograde femoral length dialysis catheter. The catheter adds to the company's existing ...
Tags: Teleflex, Dialysis Catheters
GE Healthcare has obtained 510(k) clearance from the US Food and Administration (FDA) for its Brivo Plus C-arm, which is made available now in the US. The approval is expected to transform healthcare in private practices and rural ...
Tags: Healthcare, Health&Medicine, FDA
US-based spine technology company Spinal Elements have licensed a portfolio of patents necessary for accessing the lumbar spine from a lateral approach and placing implants from that approach. The lateral approach to the spine offer ...
Patient monitoring and respiratory care devices provider Covidien's Nellcor Pulse Oximeters has obtained 510(k) clearance with labeling from US Food and Drug Administration (FDA). Nellcor Pulse Oximeters facilitates in noninvasive ...
Tags: Covidien's Nellcor, Medicine
Traumatic injury medical devices developer iTraumaCare has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its iTClamp Hemorrhage Control System. iTClamp is designed to control severe bleeding, in seconds, and ...
Tags: Itraumacare, FDA Approval
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Varian Medical's diagnostic X-ray image processing workstation that integrates radiography/fluoroscopy (RF) and digital radiography (DR) capabilities. The company's ...
Tags: X-ray Image, Medicine
Covidien has announced that its Nellcor pulse oximetry portfolio received the US Food and Drug Administration (FDA) 510(k) clearance for motion claims. The Nellcor pulse oximetry portfolio, which is used to measure arterial oxygen ...
Tags: Covidien, Motion Claims