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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
2020
Japanese regulators have extended participation in the Medical Device Single Audit Programme through to early 2020
5.4%
The US FDA has reported that 5.4% of samples taken from reprocessed duodenoscopes manufactured by Olympus, Fujifilm and Pentax tested positive for “high concern” organisms.
5.0%
The US medical device manufacturers market is expected to exhibit a CAGR of 5.0% between 2019 and 2025, according to Grand View Research
$72bn
The internet of medical things market is expected to reach $72bn by 2021.
$3.4bn
The amount that the Computer-Aided Manufacturing market is expected to reach by 2023
Top Stories
NICE launches online resource to help development and adoption of new health technologies
HealthTech Connect, a new online resource provided by NICE to help identify and support new health technologies as they move from inception to adoption in the UK health and care system has been formally launched.
Source: NICE
FDA permits marketing of first medical device for treatment of ADHD
The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is indicated for patients’ ages 7 to 12 years old that are not currently taking prescription ADHD medication and is the first non-drug treatment for ADHD granted marketing authorization by the FDA.
Source: FDA
FDA sounds alarm on unregulated brain injury devices
Called CRISPR-Chip, the device combines a deactivated clustered regularly interspaced short palindromic repeats Cas9 protein with electronic transistors to identify genetic mutations in DNA samples without the need for amplification or replication of the DNA segment using the polymerase chain reaction.
Source: Medical Device
Artificial intelligence for future agile manufacturing
At Karlsruhe Institute of Technology (KIT), an interdisciplinary group of researchers from mechanical engineering, electrical engineering, information technology, and computer science is now working on an agile production system that autonomously and dynamically adapts to changing product specifications in remanufacturing.
Source: Today’s Medical Developments
Embracing Emerging Technologies
Xvivo Perfusion System
FDA has approved the Xvivo Perfusion System with Steen Solution Perfusate device, which cantemporarily ventilate, oxygenate, and pump preservation solution through lungs that were initially thought to be unacceptable for transplant.
Breezing
By measuring how much oxygen has been turned into carbon dioxide in your breath, the Breezing device can work out the speed of the user's metabolism and determine how many calories should be consumed to lose, maintain or gain weight.
Obsidio
an early stage medical device company with technology intended to stop undesired blood flow through vessels anywhere in the body.
BioRegentech
BioRegentech rapidly regenerates chronic wound tissue and closes wounds in limbs which are currently routinely recommended to be amputated such as diabetic foot and leg ulcers.
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