Delcath’s Hepatic Delivery System Approved in Brazil
Delcath received medical device approval from Brazil’s National Health Surveillance Agency for its Chemosat hepatic delivery system.
The platform delivers chemosaturation therapy to the liver, making it possible to administer melphalan hydrochloride, a chemotherapeutic agent, to the liver while limiting toxicity.
The system isolates the liver’s blood flow using catheters and lowers the agent’s concentration after it leaves the target organ using proprietary filters.
FDA Approves Grifols’ Babesia Test
The FDA approved Grifols’ Procleix Babesia assay for use on the company’s Procleix Panther system, a fully automated blood screener for use by blood banks.
The Spanish devicemaker’s assay detects ribosomal RNA from four Babesia species — B. microti, B. duncani, B. divergens and B. venatorum. Babesia is a malaria-like parasite that can infect red blood cells.
The approval was based on a successful multi-center clinical trial by the American Red Cross, Creative Testing Solutions, and the Rhode Island Blood Center.
FDA Clears First-in-Class Insulin Pump
The FDA granted de novo marketing clearance to Tandem Diabetes Care’s t:Slim X2 insulin pump, a new type of interoperable pump that allows patients to control their diabetes management.
The alternate controller enabled (ACE) infusion pump can be used with compatible medical devices, including automated insulin dosing systems, continuous glucose monitors, blood glucose meters or other electronic devices used for diabetes management.
The FDA’s action creates a new regulatory classification, so future ACE insulin pumps will be able to go through the 510(k) review process.
Altona Gains CE-IVD Mark for Hep C Diagnostic Kit
Altona Diagnostics received the CE Mark for its AltoStar hepatitis C virus reverse transcription polymerase chain reaction (RT-PCR) diagnostic kit.
The kit uses real-time PCR technology to detect and quantify virus-specific RNA with genotypes one to six.
The diagnostic device is for use with the AltoStar automation system and Bio-Rad Laboratories’ CFX96 real-time PCR detection system.
Orchestrate Orthodontics’ 3D Printing Software Cleared for Marketing
Orchestrate Orthodontics’ 3D Treatment Planning Software System received 510(k) clearance from the FDA for use in manufacturing clear aligner appliances.
The software works with a range of scanners and 3D manufacturing equipment and will accept any scanner that produces an STL file for 3D printing.
The system allows dentists to design and produce their own orthodontic clear aligner appliances. Treatment planning and simulations can be shared with patients through an online web viewer.
OrthoFix’s Cervical Disk Approved
The FDA approved OrthoFix’s artificial M6-C cervical disk, the orthopedic and spine regenerative device company announced.
The disc replaces an intervertebral disc damaged by cervical disc degeneration and is designed to restore physiologic motion in the patient’s spine.
The device uses an artificial viscoelastic and annulus fiber design to imitate the structure of a natural disc and is designed to enable shock absorption.
FDA Clears Wearable Patient Monitoring Device
Current Health’s vital sign monitor, a wireless device that can be worn on the patient’s upper arm, gained 510(k) clearance from the FDA.
The device monitors a patient’s vital signs, including pulse rate, oxygen saturation, movement, posture and temperature, and notifies a healthcare professional when a variable goes above defined parameters.
The monitor non-invasively measures the patient’s vital signs up to every two seconds and transmits the data to the electronic health record.
FDA Approves Cook Medical’s Dissection Endovascular Device
The FDA approved Cook Medical’s Zenith dissection endovascular system for repairing a part of the aorta.
The device offers physicians an alternative to open surgery for repairing Type B dissections of the lower thoracic aorta, an area of the aorta that is located in the thorax. It will be on sale in the U.S. “in the coming months,” the company said.
The Zenith system is composed of a proximal stent-graft and a distal bare stent and is less invasive than open surgery.
Teleflex Gains Premarket Approval for Vascular Closure Device
Teleflex’s MANTA, a vascular closure device, received premarket approval by the FDA, and the company plans to launch the device this year.
MANTA is indicated for closing femoral artery access sites while reducing time to hemostasis after the use of sheaths in endovascular catheterization procedures.
The company said a clinical trial of the device successfully hit all primary and secondary endpoints and showed that the product achieves fast, reliable biomechanical closure with rapid hemostasis.