Medical Devices DECODED
Latest edition: 22 May 2024
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Spotlight
Roche's Tina-quant Lp(a) test receives FDA breakthrough device designation
The Tina-quant Lp(a) RxDx assay is designed to identify patients who may benefit from therapies aimed at decreasing Lp(a) levels.
Latest news
AiM Medical Robotics partners with Harvard Hospital for DBS study
The study will take place at Harvard’s Brigham and Women's Hospital and will validate AiM’s robot for deep brain stimulation in Parkinson’s.
UK MHRA proposes international medical device recognition framework
As per the statement of policy intent, the UK intends to acknowledge regulatory approvals from specific countries.
Cochlear concludes Oticon Medical cochlear implant acquisition
Cochlear is set to integrate the acquired business over the coming months.
Vantis Vascular secures funding to advance intervention technologies
The company has secured a cumulative $24m from high-net-worth individuals and NIH grants to date.
SonarMD touts positive data from digital platform at DDW
SonarMD's digital platform uses predictive analytics to identify clinical deterioration in IBD patients before they become emergencies.
Guardant's tumour mutation profiling test gains EU IVDR certification
Guardant Health’s liquid biopsy was the first FDA-approved blood test for genomic testing of solid tumours.
GE HealthCare and Medis's strategic alliance for non-invasive coronary testing
The global market for robotic surgical systems will reach $10 billion by the end of 2024 and $15.8 billion by 2030.
In our previous edition
Medical Devices Decoded
RQM+ launches AI module to enhance MedTech regulatory documentation
21 May 2024
Medical Devices Decoded
Dexcom launches upgraded ONE+ device in UK
20 May 2024
Medical Devices Decoded
Elixir's focal stress system to treat calcified lesions hits success in trial
17 May 2024
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