The medical industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in numbers
22%
According to a gender equality report by the UN Women and the United Nations, women make up only 22 per cent of artificial intelligence workers globally.
44%
A global analysis of 133 AI systems across industries found that 44.2 per cent demonstrate gender bias.
86%
Consultants in England could soon face a formal ballot on industrial action about pay and pensions, after the BMA’s consultative ballot showed 86 per cent in favour of strike action. The ballot, which was launched at the beginning of February to get a sense of the profession’s stance, saw more than 17 000 senior hospital doctors say they were ready to strike. The turnout for the ballot was 61 per cent.
Latest news
Abbott reports positive data from TriClip TEER system trial
Abbott has reported positive late-breaking data from the TRILUMINATE Pivotal trial of its TriClip transcatheter edge-to-edge repair (TEER) system. The randomised, controlled clinical trial was designed to assess the effectiveness and safety of transcatheter repair with the TriClip system against medical therapy as a treatment for severe, symptomatic tricuspid regurgitation (TR) patients who are at greater risk for open-heart surgery.
The findings showed that the TriClip system established superiority compared to the control group, and the trial met its composite primary endpoint. In the trial, 87% of patients treated with the TriClip system had a significant reduction in TR, to moderate or less, at 30 days compared to 4.8% of patients in the control group. Additionally, 50% of the patients who received the device achieved significant improvement in quality of life. The TriClip device also demonstrated a strong safety profile, with no device embolisation or thrombus reported in the trial.
Source: Medical Device Network
Vigilant Medical Solutions develops new mobile app for anaesthesiologists
Vigilant Medical Solutions has developed a new mobile app, named Guardian, that provides anaesthesiologists with real-time visibility of critical patient vital signs. Guardian is a first-of-its-kind medical device solution that sends alerts regarding real-time changes in patients’ vitals straight to anaesthesiologists’ smartphones.
It allows anaesthesiologists to monitor and quickly respond to changes in the vital signs of their patients across several operating rooms (ORs). The artificial intelligence (AI)-driven remote monitoring app offers patient-specific parameters as well as proactive updates on patients’ vitals that help to decrease the risk of adverse outcomes, such as stroke, postoperative delirium, acute kidney injury (AKI) and death.
It provides care for patients undergoing surgery and improves the anaesthesia practice by providing real-time alerts and enabling quick and more efficient communication between anaesthesia care team members.
Source: Medical Device Network
GE HealthCare and Advantus unveil healthcare technology management deal
GE HealthCare and Advantus Health Partners have announced a multi-year agreement of up to $760m to expand access to healthcare technology management services. Under the agreement, which will cover more than ten years, the healthcare technology management (HTM) services of GE HealthCare will be offered to Advantus’ clients.
Together, the companies aim to provide healthcare companies with a holistic programme that is beyond the traditional break-fix approach for medical device maintenance. Advantus intends to use the expanded partnership to support quality care and sustainable cost reductions for its clients.
The comprehensive HTM programme has been designed to provide complete medical equipment management, including maintenance, monitoring and addressing recalls, as well as disinfection and distribution, in clients’ health care facilities.
Source: Medical Device Network
Approvals
Convatec gets FDA approval for extracellular matrix medical device
The US Food and Drug Administration (FDA) has approved the InnovaBurn placental extracellular matrix (ECM) medical device from Convatec. This device is intended to manage complex surgical wounds and burns, including partial-thickness second-degree burns.
Part of the InnovaMatrix platform, InnovaBurn is a xenograft controlled for genetic variability as well as environmental and lifestyle factors, such as diet and activity levels. The new device can be used to manage traumatic lacerations, dehisced incisional wounds, pressure and venous ulcers, post-surgical incisions, post-Mohs surgical wounds, and diabetic ulcers. According to the company, InnovaBurn does not need preparation, specific placement orientation, tissue tracking or special storage. Furthermore, the device is said to adhere and conform to wound sites.
Source: Medical Device Network
FDA approves SpectraWAVE’s HyperVue intravascular imaging system
SpectraWAVE has received 510(k) clearance from the US Food and Drug Administration (FDA) for its intravascular imaging system, HyperVue. The easy-to-use system is designed to help physicians enhance coronary stenting in cardiac catheterisation labs by integrating next-generation DeepOCT images and near-infrared spectroscopy (NIRS).
HyperVue is claimed to be the first system to combine two significant imaging technologies to boost image quality and procedural efficiency in catheterisation labs.
The company’s Starlight Imaging Catheter offers ‘rapid pullbacks’ of both imaging modalities in a single, low-profile and no-flush form factor. Both the image acquisition and artificial intelligence-enabled image review can be controlled from the sterile field by the physician, creating a workflow that helps optimise percutaneous coronary intervention (PCI).
Source: Medical Device Network
Lucira Health receives FDA EUA for at-home COVID-19 & Flu test
Lucira Health has received US Food and Drug Administration (FDA) emergency use authorization (EUA) for its COVID-19 & Flu over-the-counter (OTC) at-home test. The new single-use at-home test kit has been designed to detect and differentiate influenza A and B, which are commonly known as the flu, as well as the SARS-CoV-2 virus.
It uses self-collected nasal swab samples and provides test results in approximately 30 minutes. The Lucira COVID-19 & Flu Home Test is indicated for use by people who have signs and symptoms that are consistent with a respiratory tract infection, including Covid-19. It does not require a doctor’s prescription.
According to the FDA, the test correctly identified 90.1% of positive and 99.3% of negative influenza A samples, 99.9% of negative Influenza B samples, and 88.3% of positive and 100% of negative Covid-19 samples in symptomatic individuals.
The regulatory agency stated that the EUA requires Lucira to continue collecting samples to evaluate the ability of the test to detect influenza B in real-world settings.
Source: Medical Device Network
Nines
US-based company Nines is a tele-radiology and artificial intelligence startup. Its product NinesAI is FDA-cleared to triage time-critical, life-threatening indications of mass effect and intracranial hemorrhage.
Source: Nines
Lucira Health
Biotechnology company Lucira Health offers disposable at-home test kits to detect infectious diseases, such as Covid-19.
Source: Lucira Health
Bloomlife
US-based company Bloomlife is using technology, data science and medical expertise to address issues in maternal health.
Source: Bloomlife
