FDA Premarket approvals; EU news; Recalls;

Novocure’s NovoTTF-100L System is a portable device with a generator, transducer arrays (insulated ceramic discs), connection cables, power supply, carrying bag, battery, and battery charger. Transducer arrays connected from the device to a patient’s chest deliver treatment to the patient. Used in conjunction with a standard two-drug chemotherapy, the system treats patients with malignant pleural mesothelioma (MPM) tumors that cannot be removed via surgery (unresectable).

TransMedics’ Organ Care System (OCS) Lung System, designed to preserve donor lungs prior to transplantation, received expanded FDA PMA approval. The system includes a portable enclosure with mechanical and electrical components to warm, ventilate, and perfuse the lungs.

Senseonics’ Eversense Continuous Glucose Monitoring (CGM) system provides real-time glucose monitoring every 5 minutes for up to 90 days. The system consists of an implantable fluorescence-based sensor, a smart transmitter, and a mobile app for displaying glucose values, trends, and alerts. This supplement expands indications for the Eversense CGM system to replace fingerstick blood glucose testing for diabetes.

RECALL

Teleflex Medical is recalling multiple models of the Hudson RCI Sheridan and Sheridan Endotracheal Tubes due to reports that the Sheridan’s 15mm connector disconnects from the breathing circuit.

CERTIFICATION

PrinterPrezz achieved ISO 13485:2016 certification. Its Medifacturing – connecting medicine and manufacturing – combines 3D printing, nanotechnologies, and surgical expertise for next-generation medical devices.

Transparency in MDR

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) continues to take steps to update its Medical Device Reporting (MDR) program and medical device transparency, according to a written statement from Dr. Jeffrey E. Shuren, M.D., J.D., director, FDA CDRH.

Since 2017, the FDA has gradually sunset the Alternative Summary Reporting (ASR) program to streamline medical device reporting as the Voluntary Malfunction Summary Reporting (VMSR) program was implemented. To formally end the program, revocation letters were issued to 13 remaining manufacturers with ASR exemptions that covered dental implants, implantable cardiac defibrillators, and pacemaker electrodes.

The VMSR Program reflects a pilot program conducted in response to changes made in the FDA Amendments Act of 2007 and goals agreed to as part of the Medical Device User Fee Amendments of 2017 (MDUFA IV) process. The FDA implemented the VMSR Program after a pilot study demonstrated the value of the program to public health.

Finally, the FDA also intends to make its Manufacturer and User Facility Device Experience (MAUDE) database and MDR data more user-friendly to increase transparency in medical device reporting, working since 2012 to develop the National Evaluation System for health Technology (NEST) – to systematically use real-world data to rapidly identify and help address safety signals once devices are on the market through active surveillance.