The Medical Industry Briefin g
The latest news, approvals and clinical trials you need to know about this month
The reported number of non-sterile medical devices recalled by the Swiss Agency for Therapeutic Products between 2005 and 2018
The drug delivery devices market in North America comprises roughly half of the global market according to GlobalData
The predicted value the wearables market will reach by 2028
The amount Olympus Medical Systems Corporation has agreed to pay after failing to file reports with US regulators about infections connected to its duodenoscopes
The amount that the emerging medical device market is expected to exceed by 2023
'Virtual tumour' new way to see cancer
Scientists in Cambridge have developed a virtual reality 3D model of cancer, providing a new way to look at the disease.
Researchers say it will increase our understanding of cancer and help in the search for new treatments.
Child given world’s first drone-delivered vaccine in Vanuatu
A one-month-old became the world’s first child to be given a vaccine delivered commercially by drone in a remote island in the South Pacific country of Vanuatu.
The vaccine delivery covered almost 40km of rugged mountainous terrain from Dillon’s Bay on the west side of the island to the east landing in remote Cook’s Bay.
‘Pacemaker for the brain’ could help people with epilepsy, Parkinson’s
A new neurostimulator developed by engineers at the University of California, Berkeley, can listen to and stimulate electric current in the brain at the same time, potentially delivering fine-tuned treatments to patients with diseases like epilepsy and Parkinson’s.
Source: Medical Design and Outsourcing
FDA grants breakthrough device status to healthcare AI software
Healthcare AI software being developed by Bayer and Merck for chronic thromboembolic pulmonary hypertension pattern recognition has been granted breakthrough device designation by the US FDA. The software processes image findings of cardiovascular, lung perfusion and pulmonary vessel analysis with the patient’s history of pulmonary embolism.
Source: Hit Infrastructure
Embracing Emerging Technologies
BrainScope, a medical neuro-technology company focused on concussion and mild traumatic brain injury assessment has received FDA clearance to include additional language in its product’s indications for use (IFU), adding key terminology related to “multi-modal, multi-parameter assessment” of “concussion” and “mild Traumatic Brain Injury”, as well as an expanded and clarified overall IFU.
Founded by Anita Finnegan in 2015 and based in Ireland, Nova Leah is the first of its kind, providing medical device manufacturers with an automated solution for implementing and maintaining cybersecurity requirements across medical device product portfolios.
AuriGen Medical is an Irish electrophysiology and structural heart company dedicated to transforming the management of longstanding persistent atrial fibrillation by developing the first cardiac implant to treat both the stroke and arrhythmia risk associated with this devastating condition.
NightWare, a Minneapolis-based medical device startup founded in 2015, has developed an Apple Watch app which tracks the sleeping patterns of those suffering from nightmare disorder, a common side effect for those dealing with post traumatic stress disorder.
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