PolyNovo UK Ltd officially launch its NovoSorb® BTM synthetic dermal scaffold at MEDICA 2021 in November. Background Surgical and traumatic … continue reading “NovoSorb® BTM Synthetic Wound Matrix Launches at MEDICA”
Plastic/Reconstructive
Clearance and Launch for Mentor’s CPX4 Smooth Breast Tissue Expander
New tissue expander with smooth surface aids insertion and removal in breast reconstruction surgery
Ten Year Safety Data for MENTOR® MEMORYSHAPE® Gel Breast Implants
New publication adds to substantial supportive clinical data in primary and revision augmentation and reconstruction patients
RTI Surgical® Tissue Matrix Line Extensions for International Markets
RTI will now offer a more pliable version of its Fortiva Tissue Matrix
First US Cases for MIS Nasal Valve Collapse Device
Newly cleared minimally invasive device for lateral cartilage support in patients with nasal valve collapse, a major cause of nasal obstruction
AirXpanders Touts Positive Tissue Expander Data at Plastic Surgeon Congress
Seems patients like AeroForm, a novel, patient-controlled method of tissue expansion prior to breast reconstruction surgery
U.S. FDA Clearance for Two Pigmented Lesion Treatments
Two new clearances have been announced for technologies to treat a variety of aesthetic treatments
Otto Bock Claims New Michelangelo® Prosthesis Closest to a Human Hand
The most technologically advanced prosthetic hand in the world is changing the life of a 30 year amputee
FDA Approval for Varicose Vein Glue
Less than 18 months since submitting the first part of a modular PMA, the VenaSeal varicose vein treatment system has now gained FDA PMA approval
Expanded Clearance for Intact® Tissue Excision System
Intact Medical Corporation’s marketing clearance sees it usable for remove intact breast lesions up to 30mm in diameter.
FDA Nod for Allergan NATRELLE® 410 Silicone Breast Implant Range Adds
Allergan, Inc. has announced that it has received approval from the U.S. FDA to market two new styles, X and L, of the Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants for use in breast reconstruction, augmentation and revision surgery.
More Evidence Needed Before UK’s NICE will Support Spray-on Skin and Pressure Ulcer-Reducing Garments
Two technologies that promise a lot in burns treatment and wound care respectively need more evidence before UK’s NICE will support their adoption.
FDA Clears Premvia™ Hydrogel Scaffold for Regenerative Indications
BioTime, Inc. says its Premvia™ hydrogel tissue substitute has been cleared for marketing as a Class II medical device.
FDA Clears PicoSure™ for Treatment of Acne Scars
Cynosure, Inc., has received FDA 510(k) clearance for its flagship PicoSure Picosecond Laser Workstation for the treatment of acne scars.
EU Launch for KCI Cellutome™ Skin Graft Harvester
Kinetic Concepts, Inc. has announced the EU launch of its CelluTome™ Epidermal Harvesting System, delivering an automated, precise and reproducible process of harvesting autologous epidermal tissue for grafting.
FDA denovo Rules Pass Mind-Controlled Robotic Arm
The U.S. FDA has cleared for marketing the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes.