The medical industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in numbers
India’s Drug Controller General has classified 60 medical devices pertaining to rehabilitation, under the country’s provisions of Medical Devices Rules (2017)
TE Connectivity opened a €5m rapid prototyping centre for medical devices in an existing manufacturing site in Galway, Ireland
Around 30 million US adults could benefit from hearing aids, with the FDA announcing it will allow access to such devices over the counter
The global market size for wearable medical devices is forecasted to reach $188.4bn by 2030, according to a report by Acumen Research and Consulting
More than 20 billion devices sold in the US are sterilised with ethylene oxide yearly, which is estimated as 50% of all devices that need to be sterilised
Medical devices hit by ransomware for the first time in US hospitals
When the NSA cyber weapon-powered WannaCry ransomware spread across the world recently, it infected as many as 200,000 Windows systems, including those at 48 hospital trusts in the UK and so-far unnamed medical facilities in the US.
It wasn't just administrative PCs that were hacked, though. Medical devices themselves were affected too.
Medical device industry confident it can ride out recession, wary of slowing capital sales
Analysts at RBC Capital Markets are reassured that the medical device sector is equipped to weather an economic downturn as the industry’s latest earnings season comes to an end.
However, MedTech companies are still facing challenges like hospital staffing shortages and supply chain constraints that have been ongoing for several quarters.
Source: MedTech Dive
UK government calls for evidence on discrimination in medical devices
The UK government is aiming to tackle healthcare inequalities by collecting new evidence on how medical devices and technologies may be biased against patients of different ethnicities, genders, and other socio-demographic groups.
The call for evidence will be open for eight weeks, with the hope of hearing from those who work most closely with medical devices such as oxygen measuring devices, infrared scanners and related software and hardware including databases and instructions.
Source: Digital Health
C₂N Diagnostics reports positive data for new Alzheimer’s blood test
C₂N Diagnostics has reported positive data from a study that showed a new blood test improves testing performance in identifying Alzheimer’s brain pathology. The test which combines a unique p-tau217 ratio with an Amyloid beta (Aβ) 42/40 ratio.
The combination increases accuracy compared to more complex amyloid PET imaging and invasive cerebrospinal fluid tests.
The study was conducted on 221 difficult-to-diagnose individuals with cognitive impairment of unclear aetiology. The addition of the new ratios enabled the identification of Alzheimer’s brain pathology patients, even at the earliest stages of the disease.
Source: Medical Device Network
Vial unveils EMR Interface with ModMed to boost trial recruitment
Vial has unveiled the VialConnect interface with ModMed to boost patient recruitment into clinical trials. Research clinics that utilise ModMed’s electronic health record (EHR) EMA could filter their patient databases using VialConnect to simplify trial recruitment. All clinics conducting clinical trials using VialConnect have access to the ModMed interface.
The interface also offers an adjustable clinical trial management system (CTMS) that drives key workflows and an electronic medical record (EMR) filtering tool to classify potential trial participants from the patient database of a clinic. VialConnect’s EMR filtering allows complicated queries within a user-friendly user interface.
Source: Clinical Trials Arena
Smartphone-linked blood pressure monitors fail to beat traditional devices, study finds
Some 23 health systems participating in PCORnet, the National Patient-Centered Clinical Research Network, randomised 2,101 people with uncontrolled hypertension to use a standard home blood pressure monitor or a smartphone-linked device with an associated app.
After six months, systolic blood pressure had fallen 10.8 mm Hg from baseline in the cohort that used the smartphone-linked device. The reduction in systolic blood pressure in the control cohort was 10.6 mm Hg, causing the clinical trial to miss its primary endpoint.
The researchers concluded smartphone-linked devices are no better than traditional monitors at reducing blood pressure.
Source: MedTech Dive
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.
Biotechnology company Lucira Health offers disposable at-home test kits to detect infectious diseases, such as Covid-19.
Source: Lucira Health
US-based company Bloomlife is using technology, data science and medical expertise to address issues in maternal health.