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The Medical Industry Briefing
The latest news, approvals and clinical trials you need to know about this month
Data: News
in Numbers
6 million
The US FDA has released more than 6 million previously hidden medical device incident reports, from 1999 through 2019
$143.3bn
The implantable medical devices market is forecasted to grow from $96.6bn in 2018 to $143.3bn by 2024
€200m
Medtech company Stryker to invest €200m in R&D in Cork, Ireland facilities
$90m
Boston Scientific will sell its drug-loadable microsphere and bland embolic bead products to Varian Medical Systems for $90m
6.0%
The vitreoretinal surgery devices market is expected to expand at a 6.0% CAGR between 2019 and 2029
Top Stories
Crystallised drug formulation extends medical device function
Researchers from MIT have developed a way to embed crystallised immunosuppressant drugs into implantable devices, to eliminate localised immune reactions from medical devices, which can cause device failure.
Source: European Pharmaceutical Review
FDA warns of dangerous cybersecurity hacking risk
The US FDA has warned that a number of connected devices, including insulin pumps from Medtronic MiniMed could be at risk of a cybersecurity breach.
Source: Forbes
AMA updates recommendations for medical AI usage
The American Medical Association has passed a policy addressing augmented intelligence (not artificial intelligence) which provides recommendations to address stakeholders’ concerns.
Source: American Medical Association
CMS extends ambulatory blood pressure monitoring coverage
CMS has finalised changes to the coverage of ambulatory blood pressure monitoring (ABPM) to permit testing of patients with suspected masked hypertension.
Source: Med Tech News
Embracing Emerging Technologies
F.O.A.M.
The US FDA has granted breakthrough device designation for Critical Innovations’ Fast Onset Abdominal Management (F.O.A.M.) device, which is designed to deliver quickly-expanding foam to control severe intra-abdominal bleeding in critical trauma patients, when surgical intervention is not immediately available.
VUNO Med – DeepBrain
South Korea’s Ministry of Food and Drug Safety has approved the dementia diagnosis device VUNO Med – DeepBrain, according to Vuno, the company behind the technology.
CryoTherapeutics
German medtech startup CryoTherapeutics has raised €7m to fund the development of its cryotherapy system – a treatment that exposes the body to freezing temperatures – to prevent heart attacks.
Bluedrop Medical
The Ireland-based company has developed an AI system to help predict and prevent diabetic foot ulcers. The system performs a daily scan of the patient’s feet and sends the data to the cloud for analysis through advanced algorithms capable of detecting abnormalities.
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