The medical industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in numbers
1 Bn
Nearly one billion people worldwide suffer from some form of mental disorder, according to latest UN data – that includes around one in seven teenagers
392-28
By a 392-28 vote, the House passed legislation that would reauthorize the FDA’s user-fee programs for medical devices and drugs through 2027
$52.35 Bn
The global Wearable Healthcare/Medical Devices Market size is expected to reach $52.35 Billion in 2030 and register a revenue CAGR of 13.9%, according to Reports and Data
21%
The iShares U.S. Medical Devices ETF index has fallen 21% this year
$12.2 Bn
Medical device regulatory affairs market to reach $12.2 Bn, globally, by 2031 at 5.8% CAGR according to Allied Market Research
Latest news
FDA to order Juul to take e-cigarettes off the market in the US – report
The FDA is preparing to order Juul Labs to take its e-cigarettes off the market in the United States.
Shares in the tobacco giant Altria Group, which owns a 35% stake in the maker of vaping products, fell 8.5% following the report.
Juul has faced heightened scrutiny over the appeal of its nicotine products to teenagers.
Source: The Guardian
Lack of clinical evidence ‘major gap’ in digital health: study
Funding for US digital health companies surged last year despite studies finding little clinical validation and a lack of robust evidence that digital health solutions are effective, according to Rock Health, a seed fund that tracks the space.
Rock Health noted that digital health firms raised more than $29 billion in 2021, up from $15 billion in 2020 and $8 billion in 2019, though funding levels started to decline at the beginning of 2022.
Source: MedTech Dive
MHRA joins international partnerships to set global standards for medicines and medical devices regulation
The UK is set to play a greater international role in making sure medicines and medical devices are regulated safely and efficiently worldwide, the Medicines and Healthcare products Regulatory Agency (MHRA) announced after being accepted as a full member of three international work-sharing partnerships.
Through these partnerships, the MHRA will share expertise with other leading organisations, support the development of regulatory guidelines and drive greater harmonisation of regulation around the world.
Source: UK.gov
Clinical trials
SeaStar reports data from immunomodulator device study
SeaStar Medical and LMF Acquisition Opportunities have reported data from the SCD 005 clinical study of the use of SeaStar Medical’s Selective Cytopheretic Device (SCD) in treating Covid-19 patients suffering from multiple organ failure and admitted to the intensive care unit (ICU).
A cell-directed, patented, extracorporeal immunomodulator, the SCD has been designed to address hyperinflammation with selective targeting of activated neutrophils and monocytes.
The multi-centre pilot study has been designed to evaluate the SCD’s safety and efficacy in 22 Covid-19 patients either with acute kidney injury (AKI) or acute respiratory distress syndrome (ARDS).
Source: Medical Device Network
Neuspera Medical set to begin Nuvella system trial
Neuspera Medical has announced plans to begin the second phase of its SANS-UUI pivotal clinical trial of the Nuvella system. The company plans to start enrolling 145 subjects at 25 sites across the world.
The single-arm clinical study has been designed to assess the Nuvella system’s safety and efficacy for the treatment of overactive bladder (OAB) in patients who have urinary urgency incontinence (UUI) symptoms.
It is said to be the first sacral neuromodulation (SNM) device designed to provide a minimally invasive option, which could allow better procedural versatility and patient experience.
Source: Medical Device Network
Conformal Medical begins subject enrolment in CLAAS System trial
Conformal Medical has announced the enrolment of the first participants in the CONFORM pivotal trial of its CLAAS System. The first patients were enrolled at two sites in the US.
The CLAAS System has been designed to seal the left atrial appendage (LAA) in non-valvular atrial fibrillation (Afib) patients to reduce stroke risk without using anticoagulants.
It features a foam matrix implant, which is designed with two sizes to address a broader range of LAA anatomies. The new device is intended to simplify the procedure and eliminate the need for procedural transesophageal echocardiogram.
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
