The medical industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in numbers
$73m
MicroTransponder raised $73 million through a Series E funding round for its Vivistim vagus nerve stimulation device.
437
As of today, 437 COVID-19 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs).
17 million
The FDA recalled 17 million masks developed by Philips Respironics used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP or BPAP) machines and continuous positive airway pressure machines due to a serious safety concern.
12 billion
WHO and the International Labour Organization (ILO) called for concrete actions to address mental health concerns in the working population. An estimated 12 billion workdays are lost annually due to depression and anxiety costing the global economy nearly $1 trillion.
30%
The European Union and other regions across the globe are expected to face rapidly ageing populations this century. By the end of the century, more than 30% of the region’s population is expected to be 65 or older.
Latest news
CIONIC, the San Francisco-based bionic clothing company behind the innovative Cionic Neural Sleeve, announced that it has received $12.5 million in Series A financing.
Founded in 2018 as a labor of love by tech innovator Jeremiah Robison, who was motivated by his young daughter’s struggles with cerebral palsy – the Cionic Neural Sleeve is quite unlike anything else on the market today.
Source: Forbes
The FDA proposed the precertification program to adapt regulatory processes originally intended for hardware to the faster development and update cycles of software as a medical device.
The plan was to offer a streamlined regulatory review to some organizations, based on their quality culture and commitment to monitoring the real-world performance of their products.
To pilot the model, the agency enrolled nine participants. The report published by the FDA this week sets out what happened in the pilot program, concluding the initiative in the process, and describes what the agency thinks needs to happen next.
Source: MedTech Dive
A £1.7billion contract to provide an integrated workforce management solution for the NHS in England and Wales has been published.
According to a notice, NHS Business Services Authority (NHSBSA) is looking for a solution which includes an electronic staff record (ESR).
The notice states that the solution “will fulfil the ambition of providing the NHS with a user centred digital workforce solution to empower people from both national and local organisations to carry out their roles effectively and efficiently, supporting them through their journey with the NHS”.
Source: Digital Health
Clinical trials
The US Food and Drug Administration (FDA) has granted two approvals related to the clinical research of Abiomed’s Impella heart pumps.
The regulator has approved the on-label RECOVER IV randomised controlled trial (RCT) of Impella heart pumps in acute myocardial infarction (AMI) cardiogenic shock patients.
Abiomed noted that the two-arm study protocol received FDA approval to use the Exception from Informed Consent (EFIC) pathway for subject enrolment.
It will evaluate whether Impella support initiated before percutaneous coronary intervention (PCI) is superior to PCI without Impella.
All-cause mortality at 30 days will be the study’s primary endpoint.
Major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days, left ventricular function recovery, days alive after hospital discharge at six months, and need for durable ventricular assist device (VAD) or heart transplant will be some of the secondary endpoints of the study.
Source: Medical Device Network
ConcertAI and the National Cancer Institute Community Oncology Research Program (NCI NCORP).
Designated Louisiana State University (LSU) Health New Orleans have entered a five-year collaboration to boost clinical trial diversity.
The alliance will also aid in guaranteeing wider access to clinical trials throughout the Gulf South region.
The latest partnership complements the Engaging Research to Achieve Cancer Care Equality (ERACE) programme of ConcertAI.
Leveraging real-world data (RWD) and advanced technologies, this programme provides all patients equitable access, care, and outcomes.
With a $5.6m NCI grant, LSU Health New Orleans could set up a clinical trials network in the Gulf South region.
Source: Clinical Trials Arena
Multiple research groups have sought to use smartphone cameras for pulse oximetry.
Either by adding hardware such as a color filter or by using software to process the signal. However, the authors of the npj Digital Medicine article found the earlier efforts had only tested saturation levels down to 80%, whereas the Food and Drug Administration requires developers to validate their oximeters from 70% to 100%.
To evaluate their software-based approach, the researchers enrolled six subjects to wear gas masks that delivered a controlled mix of oxygen and nitrogen to slowly lower their oxygen saturation. The subjects put one finger over a smartphone camera and another in a conventional pulse oximeter.
The design allowed the researchers to compare the results generated by the smartphone and standalone device over a wider range of saturation levels than other studies. Using a deep learning model, the team found the smartphone detected cases of sub-90% saturation with 81% sensitivity and 79% specificity. At sea level, blood oxygen levels are 96% to 98% in healthy individuals.
Source: MedTech Dive
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
