The U.S. Food and Drug Administration (FDA) is a federal agency that protects and promotes public health by ensuring the safety, efficacy, and security of a wide range of products that are critical to human and animal health. FDA regulations extend to human and veterinary drugs, biological products, medical devices, food supply, cosmetics, tobacco products, and radiation-emitting devices.
Obtaining FDA approval is a significant milestone for manufacturers. It demonstrates that their products adhere to safety and efficacy standards, as well as meet legal requirements for market access. Furthermore, the FDA approval provides consumers with the confidence that the products they use have undergone rigorous scrutiny to ensure their safety and effectiveness.
In this article, we explore 10 notable FDA-approved medical devices in 2023, discussing their impact on the healthcare landscape and their significance for patients.
1. VENTANA PD-L1 (SP263) Assay
Sponsor company name: Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
Date of approval: March 1, 2023
This test is used to detect the PD-L1 protein in patients with non-small cell lung cancer. The detection of PD-L1 indicates those individuals who may potentially benefit from treatment with Libtayo® (cemiplimab-rwlc) or other PD-L1 inhibitors.
2. RelayPro Thoracic Stent-Graft System
Sponsor company name: Bolton Medical, Inc.
Date of approval: March 7, 2023
This medical device was designed to repair damage to the descending thoracic aorta. It consists of a delivery catheter and stent grafts. A doctor inserts the delivery catheter, carrying the stent graft, through the femoral artery to the damaged area behind the heart, where the stent graft expands and remains permanently implanted, facilitating normal blood flow.
This system, which includes two types of implants (the proximal bare stent and the non-bare stent), is used for endovascular repair of various aortic lesions, including aneurysms, transections, and dissections. Clinical studies have demonstrated its effectiveness, with a low incidence of major adverse events in patients treated for aortic dissection or transection.
3. Eversense E3 Continuous Glucose Monitoring System
Sponsor company name: Senseonics, Inc
Date of approval: March 29, 2023
This prescription device is approved for use in adults with diabetes, providing real-time glucose readings, trend information, and predictive alerts to assist with treatment decisions and diabetes management. It involves a small sensor implanted under the skin that generates light based on interstitial glucose levels. This information is transmitted wirelessly to a mobile app on a smart device every five minutes. The app provides alerts for low or high glucose levels, and it can also predict dangerously abnormal levels. Calibrations are required initially and periodically.
4. Lava Liquid Embolic System
Sponsor company name: BlackSwan Vascular, Inc. (Grand Pharmaceutical Group)
Date of approval: April 4, 2023
This medical device is used to stop severe arterial bleeding in the blood vessels of the torso, arms, legs, hands, and feet (peripheral blood vessels). It consists of a delivery catheter that is inserted into an artery through a small incision and guided to the bleeding site using fluoroscopy imaging. When the liquid embolic is injected, it solidifies, forming a spongy material that effectively stops the bleeding. This system is employed in cases of active arterial bleeding caused by injury or vascular damage and has shown a 94% success rate in a study of 113 patients.
5. MiniMed 780G System
Sponsor company name: Medtronic MiniMed, Inc.
Date of approval: April 21, 2023
This is an automated insulin delivery system designed for managing type 1 diabetes in individuals aged 7 years and older. It uses a continuous glucose monitoring system to track glucose levels and automatically adjusts insulin delivery through an insulin pump. The glucose sensor is implanted under the skin to measure glucose in bodily fluid and sends data wirelessly to the pump, which displays glucose values, trends, and alerts. The system can warn users about high or low glucose levels and assists in maintaining safe glucose levels.
The MiniMed 780G System can be used with a blood glucose meter for precise readings. While the continuous glucose monitoring provides guidance, it is not meant for direct manual insulin adjustments.
6. xT CDx
Sponsor company name: Tempus Labs, Inc.
Date of approval: April 28, 2023
This laboratory test is designed to identify mutations in 648 different genes in individuals previously diagnosed with solid malignant tumors. It specifically detects mutations in KRAS and NRAS genes to determine if a person with colorectal cancer is suitable for personalized treatment with ERBITUX® (cetuximab) or VECTIBIX® (panitumumab). To perform the test, a person’s tumor sample and a matched blood or saliva sample are sent to Tempus Labs, Inc. The DNA is extracted, and reagents are used to identify gene sequence changes. Medical professionals review the results and send a report to the ordering doctor, who uses this information to design a treatment plan.
7. ADVIA Centaur XP/XPT HBc Total 2
Sponsor company name: Siemens Healthcare Diagnostics Inc.
Date of approval: April 28, 2023
ADVIA Centaur XP/XPT HBc Total 2 (HBcT2), also ADVIA Centaur XP/XPT HBc Total 2 Quality Control (HBcT2 QC), ADVIA Centaur CP HBc Total 2 (HBcT2), ADVIA Centaur CP HBc Total 2 Quality Control (HBcT2 QC), Atellica IM HBc Total 2 (HBcT2), and Atellica IM HBc Total 2 Quality Control (HBcT2 QC) is a test that detects antibodies to the hepatitis B core antigen (HBc) in a patient’s blood. A blood sample is sent to a clinical laboratory, where it is processed to extract plasma or serum. This sample is then analyzed to check for the presence of HBc antibodies. The test results, when combined with clinical information and other lab findings, help healthcare providers determine the status of an infection.
8. REFLECT Scoliosis Correction System
Sponsor company name: Globus Medical, Inc.
Date of approval: May 15, 2023
This non-fusion spinal device was designed to treat idiopathic scoliosis in children and adolescents whose bones have not fully matured. During orthopedic surgery, the system components are used to partially straighten the curved spine by applying tension to the cord. The cord continues to straighten the spine as the person grows. Clinical data suggests that the REFLECT Scoliosis Correction System is likely to prevent the progression of the spinal curve and avoid the need for spinal fusion, which is currently the standard treatment.
9. AAV5 DetectCDx
Sponsor company name: ARUP Laboratories
Date of approval: June 29, 2023
This lab test identifies antibodies to the adeno-associated virus serotype 5 (AAV5) in individuals. It helps doctors determine if adults with severe hemophilia A lack pre-existing AAV5 antibodies and could benefit from personalized treatment with the AAV5-based gene therapy ROCTAVIANTM (valoctocogene roxaparvovec-rvox). A plasma sample from a patient with severe hemophilia A is sent to ARUP Laboratories, where it is processed to detect AAV5 antibodies. The results are reviewed by a medical professional and shared with the ordering doctor to guide treatment planning for individuals with severe hemophilia A.
10. CRCdx® RAS Mutation Detection Kit
Sponsor company name: EntroGen, Inc.
Date of approval: September 29, 2023
The CRCdx® RAS Mutation Detection Kit is a laboratory test used to identify genetic mutations in colorectal cancer tumor tissue. It helps doctors determine whether a patient is a suitable candidate for treatment with panitumumab (Vectibix®). The test specifically detects RAS gene mutations in the tumor tissue. If a mutation is found, panitumumab is not recommended, but if no mutation is detected, panitumumab may be a suitable treatment option. The test involves taking a small tumor tissue sample, embedding it in wax, and isolating DNA, which is then analyzed for genetic changes. The results aid doctors in guiding treatment decisions.
Impact on Healthcare Landscape and for Patients
Overall, the approved medical devices could contribute to better patient outcomes and healthcare efficiency. They offer more precise diagnostics and treatment options, ultimately leading to an improved quality of life for patients.
As of September 2023, the FDA has given its approval to 37 medical devices and has cleared thousands more. Among the clearances is the first sterilization system for 3D-printed devices in healthcare facilities, the V-PRO maX 2 Low-Temperature Sterilization System.
Additionally, Huma Therapeutics has received FDA Class II clearance for its disease-agnostic Software as a Medical Device (SaMD) platform, enabling remote patient monitoring and enhancing disease management. This means that Huma’s platform can be used to monitor patients of all ages with any condition, including pregnancy. This platform’s versatility and integration with various third-party devices signal a new era in patient care.
“We are delighted to see our software as a medical device platform cleared for Class II use by the U.S. FDA so that we can provide next-generation health insights and predictions. This clearance adds to the platform’s recent EU MDR Class IIb approval, making it one of the best-regulated such technologies globally. Now, our partners can launch Class II regulated software for new diseases and use cases in a matter of weeks on our platform, rather than the years they may have taken to develop and regulate their own solution. We are really excited to see how regulated SaMD, validated algorithms, and GenerativeAI can enable our partners to care for more patients with less,” said Dan Vahdat, CEO and founder of Huma.
Moreover, regulatory advancements are underway, as Huma’s FDA clearance demonstrates—one of the first applicants to be successful through the interactive joint eSTAR program with Health Canada. This initiative aims to facilitate the preparation of comprehensive medical device submissions.
Additionally, Additionally, the FDA has recently taken significant steps to update its guidance documents, including “Breakthrough Devices Program, Guidance for Industry and Food and Drug Administration Staff” and Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”, as well as released a proposed rule on laboratory developed tests.
Furthermore, the FDA has announced the creation of a new Digital Health Advisory Committee, which will assist in exploring scientific and technical challenges associated with digital health technologies. These include domains like artificial intelligence/machine learning, augmented reality, virtual reality, digital therapeutics, wearables, and remote patient monitoring.
Conclusion
Altogether, these developments illustrate the FDA’s ongoing commitment to advancing healthcare technology. By continually expanding the range of approved medical devices, the FDA ensures that healthcare providers have access to the latest tools and technologies, ultimately benefiting patients and the healthcare system as a whole.
These technological advances not only enhance the precision of medical interventions but also lead to more efficient and cost-effective healthcare delivery. Patients can expect more personalized and effective treatment plans, while healthcare providers can make better-informed decisions, leading to improved patient care and overall health outcomes.
As technology continues to advance, it is likely that even more medical devices will receive FDA approval. The projections from analysts at BTIG Research & Strategy forecast approximately 3,075 FDA clearances, 31 premarket approvals, and 35 de novo classifications by the end of the year. These medical devices will certainly revolutionize the healthcare sector, bringing positive impacts to patients’ lives.
Vial
Contract research organizations (CROs) like Vial are essential partners in the medical device industry, offering a range of crucial services, from pre-clinical testing to clinical trials. CROs play a pivotal role in guiding the entire process of medical device development. Their expertise not only ensures adherence to regulatory standards but also enhances safety and ensures a successful market entry.
Vial is a tech-powered medical device CRO that combines cutting-edge technology with clinical expertise to transform medical device research. In Vial, we combine our knowledge with digital tools for efficient file management, streamlined data collection, and improved patient recruitment.
To learn how Vial’s CRO can support your oncology study, please visit our website or get in touch with a Vial representative today!
