FDA awards Breakthrough Device Designation to Impella ECP 

On August 18, 2021, Abiomed received breakthrough device designation from the United States Food and Drug Administration (FDA) for its Impella ECP expandable percutaneous heart pump, the world’s smallest heart pump and the first to be compatible with small-bore access and closure techniques.  

This designation was based on positive clinical data from the first 21 Impella ECP patients treated as part of an FDA-regulated early feasibility study and will give priority during the Impella ECP’s regulatory review processes comprising of design iterations, clinical study protocols, and pre-market approval (PMA) application.

Chuck Simonton, MD, Abiomed’s chief medical officer, informed that this is yet another confirmation from the FDA of the clinical benefits of Impella technology and an assertion of the innovative nature of Impella ECP because of its smaller vascular access size, has the potential to proffer even safer procedures and be accessible to more patients who need hemodynamic support for coronary revascularization.

According to DelveInsight’s analysis, it is estimated that in the United States, around 440,000 patients suffer from high-risk percutaneous coronary interventions (PCI) and have undergone multiple heart procedures. The small size of Impella ECP will allow more physicians to provide critical hemodynamic support to coronary artery disease patients who need it. It is expected to treat certain advanced heart failure patients undergoing elective and urgent PCI, such as stenting or balloon angioplasty, to reopen blocked coronary arteries.

Helius Medical Technologies, Inc. receives FDA Breakthrough Device Designation for the treatment of Dynamic Gait and Balance Deficits Following a Stroke 

On August 17, 2021, the US Food and Drug Administration (FDA) granted Breakthrough Device Designation for Helius Medical Technologies’ Portable Neuromodulation Stimulator (PoNS) device, used in the treatment of dynamic gait and balance deficits due to symptoms from a stroke. 

The device delivers electrical stimulation to the tongue’s surface and is to be used as an assistant to a supervised therapeutic exercise program in patients 22 years of age and over.

Dane Andreeff, Helius CEO, said they are delighted to announce the receipt of Breakthrough Designation for their PoNS device to treat stroke-induced gait and balance deficits. Securing Breakthrough Designation represents a vital milestone in their path to providing this underserved patient population with a non-drug, a non-implantable treatment option that has the potential to improve their gait and balance significantly, their ability to walk and perform daily tasks. They look forward to building on this achievement by utilizing the Breakthrough Devices Program to facilitate their pursuit of US regulatory clearance for treatment of stroke-induced symptoms in close collaboration with the FDA.”

According to DelveInsight’s Neuromodulation Devices Market Analysis, the approval of this device will drive the market growth as around seven million people in the United States are currently living with stroke-related complications, and more than 80% of stroke survivors are estimated to develop gait impairment. The treatment through neurostimulation is expected to improve the living of these stroke survivors. With the Breakthrough Devices Program, Helius Medical Technologies, Inc. will get an opportunity to interact with FDA’s experts and will get priority during the premarket review phase.

Delfi Liquid Biopsy demonstrates promise for reducing lung cancer deaths 

On August 20, 2021, Delfi Diagnostics Inc.’s lung cancer screening technology which could help detect early-stage lung cancer, revealed promising results in a study published in Nature Communications. According to the results, the technology detected around 90% of cancer cases in a group of nearly 800 individuals who underwent lung cancer screening with a low-dose CT (LDCT) scan.

Delfi CMO Peter B. Bach, MD., informed that these results hint that the Delfi lung cancer screening technology could decrease lung cancer deaths by offering a convenient, high-performing test to USPSTF eligible people. They have already initiated enrollment of a 1,700-patient, prospective, case-control study (DELFI-L101) to generate the clinical evidence, which would underpin a commercial lung screening test.

As per the analysts, hundreds of thousands of deaths could be prevented worldwide through improved screening and early detection, as only 6% of high-risk individuals receive the recommended screening. 

According to the study published in Nature Communications, the Delfi technology was utilized as a pre-screen to determine if an LDCT should be performed; the combined approach led to the detection of 90% of lung cancers, including 80% of stage I cancers, and decreased the number of LDCT induced unnecessary procedures by 50%.

According to DelveInsight, the Liquid Biopsy in Cancer Diagnostics Market is anticipated to be driven by the increasing number of cancer cases, technological advancements in diagnosis, and approval of new products based on better clinical efficacy.

In this case, Delfi is developing a highly sensitive and specific assay intended for comprehensive and cost-effective distribution and adoption by utilizing an advanced machine learning algorithm to the circulating DNA fragment patterns, which can be evaluated through low-cost sequencing.

BD obtains Emergency use authorization for the first at-home COVID-19 test to use a smartphone to interpret, deliver results 

On August 25, 2021, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the BD Veritor™ At-Home COVID-19 Test, which is the first at-home COVID-19 rapid antigen test to use computer vision technology in a smartphone and offer a digital display of testing results. 

The test is designed to be used by people above the age of 14 years and is a simple, pain-free nasal swab linked with an easy-to-use mobile app Scanwell Health. It offers results within 15 mins. Children can also use it as young as two years with the help of an adult. 

The rise in COVID-19 cases from the Delta variant has raised the requirement for at-home testing. The BD Veritor™ At-Home COVID-19 Test is an easy-to-use test with definitive digital results, ideal for use in the home, as said by Dave Hickey, president of Life Sciences for BD. New mandates from governments and businesses specify the need for periodic testing for those who cannot or chose not to be vaccinated. This new test may help companies, governments, or schools fulfill those requirements.

As per analysts, the company will gain a significant market share as it is the first of its kind. The schools and workplaces are opening around the globe and will drive the demand for COVID-19 diagnostics and tests. BD Veritor™ At-Home COVID-19 Test is a rapid test and will help limit the spread of the virus.

Smart Meter announces introduces iGlucose Blood Glucose Monitoring (BGM) System for use in managing Gestational Diabetes 

On August 24, 2021, Smart Meter, the leader in cellular-connected remote patient monitoring (RPM) devices, data, and services, launched a iGlucose monitor for managing gestational diabetes. iGlucose offers a solution for patients with gestational diabetes as an easy and reliable way to test, monitor, and manage their blood glucose levels.

According to the Centers for Disease Control and Prevention (CDC) data, around 700,000 pregnancies in the United States are affected by gestational diabetes every year. This can be successfully controlled if blood glucose is monitored and a provider oversees care.

Casey Pittock, the CEO, Smart Meter, said in a statement that they had seen great success with their iGlucose monitors in other markets, such as long-term care (LTC), and they are thrilled to now offer the solution to support women with gestational diabetes. Pregnancy can be a stressful time. iGlucose can help offer peace of mind that patients are getting the best care and support possible.

According to DelveInsight’s analysis, Gestational Diabetes Market is expected to be driven by the rising number of gestational diabetes cases in pregnant women. The Smart Meter is expected to improve clinical efficiency by reducing barriers and enabling real-time data sharing, and optimizes patient engagement between visits with alerts, messaging, and notifications. 

XACT Robotics declares completion of enrollment in a pilot trial evaluating the use of its Robotic System to perform CT-Guided percutaneous procedures in the Lung 

On August 30, 2021, XACT Robotics®, the XACT ACE™ Robotic System developer, completed patient enrollment in the first US study evaluating XACT ACE™ for use in percutaneous lung procedures, including biopsies to diagnose cancer. 

It is the world’s first and only hands-free robotic system that helps in improving accuracy, efficiency, and consistency in CT-guided percutaneous procedures comprising ablations, biopsies, and targeted drug delivery. It delivers instruments to the desired target in the body with less than 1.7mm accuracy on average. 

Chen Levin, the CEO, XACT Robotics®, said that using the XACT ACE™ Robotic System to aid radiologists reach tiny areas of interest in the lung is another major milestone displaying the potential benefits of this technology for patients and clinicians. The spectacular work of the radiologists at LHMC and Sarasota Interventional Radiology significantly expands their comprehension of the potential of the technology to set the new standard in percutaneous procedures in the lung with the potential to decrease risks for patients while supporting earlier diagnosis and treatment.

As per the analysts, millions of percutaneous procedures are performed in the lung each year. There are times when physicians have to wait for the lesion to become more prominent and easier to access. With the help of the XACT ACE™ Robotic System, this problem can be solved, and better results can be achieved.  The XACT ACE Robotic System has FDA clearance for CT-guided percutaneous procedures as well as a CE Mark.