Medical Devices DECODED
Latest edition: 17 May 2024
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Spotlight
Elixir's focal stress system to treat calcified lesions hits success in trial
Elixir reported high rates of clinical success with its LithiX Hertz Contact IVL system at EuroPCR 2024.
Latest news
FX Shoulder obtains FDA 510(k) clearance for glenoid baseplates
The glenoid baseplates offer full-wedge options at 7.5° and 15° angles, with lateralisation choices of 0mm, +3mm, or +6mm.
Axonics secures Australia's TGA approval for F15 SNM system
The sacral neuromodulation system features a primary cell battery with an expected lifespan of over 15 years.
British device manufacturer Entaco secures £1m investment following buyout
The buyout was led by managing director Steve Brown, who will now serve as group CEO of the Redditch-headquartered company.
Teltonika's TeltoHeart smart wristband obtains CE MDR certification
The TeltoHeart wristband can assist individuals with heart rhythm disorders and detect various arrhythmias, including atrial fibrillation.
Claritas HealthTech's iPETcertum device to extend Claritas iPET capability
The iPETcertum software device is anticipated to receive 510k clearance by the fourth quarter of this year.
Karius wins FDA breakthrough device designation for lung infection test
The DNA-based blood test detects over 1,000 pathogens that cause infections.
‘Gaza was already in a coma' before 7 October - Amnesty International
Israel’s blockade of food and medical supplies into Gaza began long before Hamas’ 7 October attack.
In our previous edition
Medical Devices Decoded
Atraverse receives approval for HOTWIRE Left Heart Access Device
16 May 2024
Medical Devices Decoded
FDA issues recall notice for Philips after another respiratory device fails
15 May 2024
Medical Devices Decoded
FDA warns users not to use Cue Health's at-home Covid-19 tests
14 May 2024
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