Approvals

FDA OK’s 3mm Micro Instruments for Senhance’s Digital Laparoscopy Device

The FDA has cleared new 3mm micro instruments for the Senhance Surgical System, a digital laparoscopy platform.

The clearance of the instruments allows the system to be used for microlaparoscopic surgeries in which surgeons can make tiny incisions in patients.

The capability of the instruments to make very small incisions mean that patients will experience virtually no scarring for many surgical procedures.

Hologic’s Bordetella Assay Earns CE Mark

Hologic received a CE Mark for its Panther Fusion Bordetella assay, expanding the menu of the molecular testing device.

The real-time PCR assay can detect and differentiate between B. pertussis and B. parapertussis from samples collected from the patient’s nasopharynx.

Because the assay can differentiate between the two bacteria, which are known to cause whooping cough, it enables physicians to prescribe the right antibiotic for the patient.

Transseptal Access System Cleared by FDA

The FDA granted 510(k) clearance for Transseptal Solutions’ TSP Crosser, a transseptal access system used for placing cardiovascular catheters in the left heart chambers.

Transseptal punctures are used to access the left side of the heart without having to place catheters in the aorta, by puncturing the septum that separates the left and right atria.

The device is comprised of a sheath, dilator and flexible puncturing needle, with a radiopaque loop wire at the end. The sheath can turn 180 degrees in either direction.

Health Canada Gives Green Light to Medtronic’s Insulin Pump

Health Canada has approved Medtronic’s MiniMed 670G insulin pump system for use by Type 1 diabetes patients.

The device automatically adjusts basal insulin delivery to stabilize glucose levels and meet the patient’s real-time needs. It was specifically approved for patients seven years of age or older with Type 1 diabetes.

The company said that it expects to launch the insulin pump in Canada this fall. About 300,000 Canadians have Type 1 diabetes.

FDA Shoots Down Clear TearLab Dry-Eye Test for 510(k) Clearance

The FDA determined that the 510(k) application for Clear TearLab’s point-of-care TearLab Discovery MMP-9 test did not pass its criteria and the agency declined to clear it.

The platform is designed to allow eyecare professionals to analyze multiple biomarkers contained in human tears with nanoliter-volume collection.

The agency said that the dry-eye test did not adequately demonstrate substantial equivalence based on the data and information provided.

South Korea Health Regulator Clears Non-Small Cell Lung Cancer Diagnostic

South Korea’s Ministry of Food and Drug Safety granted approval for AmoyDx’s ROS1 fusion assay as an accompanying diagnostic for Pfizer’s non-small cell lung cancer medicine Xalkori (crizotinib).

The PCR-based assay received the CE Mark in 2013 and was approved in China and Japan in 2014 and 2017, respectively.

The assay analyzes tumor messenger RNA from tissue or body fluids to identify 14 ROS1 gene fusions that can lead to cancer.

Tandem’s Insulin Pump Receives Health Canada Licensing

Tandem Diabetes Care has received a medical device license from Health Canada for its t:slim X2 insulin pump.

The pump is expected to be launched province-by-province in the coming months depending on the product’s registration with local health programs.

The device is up to 38 percent smaller than other insulin pumps and can hold up to 300 units of insulin.

CIVCO Radiotherapy’s Immobilization System Cleared in U.S. and EU

CIVCO Radiotherapy received 510(k) clearance from the FDA and a CE Mark in Europe for its Solstice SRS immobilization system, which positions the head and neck for radiotherapy treatments.

The system is customizable to position and immobilize a patient’s head and neck for radiotherapy, enabling more precise treatment.

The device includes a carbon fiber head support, thermoplastic mask and a customizable cushion.

CIVCO said the product will be available for shipment later this month.

Centric Medical’s External Fixation System Cleared by FDA

The FDA granted Centric Medical 510(k) clearance for its Saturn external fixation system, a device used to stabilize the foot, ankle and long bone segments.

The device is made up of rings, struts, threaded rods, pins, wires and connectors, and can be used for fusions, fractures and deformity constructions.