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RSS FeedPosted by Michael Wonder on 16 Jun 2021
VoluMetrix's NIVA|HF for heart failure patients designated as breakthrough device by U.S. FDA
15 June 2021 - NIVA|HF is an investigational device designed to monitor the venous waveform, a novel physiologic signal, in heart ...
Posted by Michael Wonder on 15 Jun 2021
Medtronic announces FDA approval of its next generation recharge-free spinal cord stimulation platform
10 June 2021 - Vanta implantable neurostimulator offers up to 11 year battery life and personalised pain relief. ...
Posted by Michael Wonder on 10 Jun 2021
CyMedica Orthopedics announces FDA clearance for IntelliHab, a novel drug free, non-invasive modality for treatment of knee osteoarthritis pain
9 June 2021 - CyMedica Orthopedics today announced the U.S. FDA has cleared the submission of its latest technology for ...
Posted by Michael Wonder on 09 Jun 2021
Ibex granted FDA breakthrough device designation
9 June 2021 - Ibex's Galen AI powered platform is recognised by the FDA as breakthrough technology with the potential to ...
Posted by Michael Wonder on 08 Jun 2021
Alpha Tau receives breakthrough device designation from the FDA for Alpha DaRT
8 June 2021 - Alpha Tau Medical is pleased to announce that it has received a breakthrough device designation for Alpha ...
Posted by Michael Wonder on 02 Jun 2021
FDA authorises marketing of diagnostic aid for autism spectrum disorder
2 June 2021 - Today, the U.S. FDA authorised marketing of a device to help diagnose autism spectrum disorder. ...
Posted by Michael Wonder on 31 May 2021
FDA grants breakthrough device designation for smart orthopaedic implants
28 May 2021 - Intelligent Implants has announced today that its SmartFuse system has received breakthrough device designation by the ...
Posted by Michael Wonder on 27 May 2021
FDA grants Micro Interventional Devices breakthrough device designation for the MIA-T percutaneous tricuspid annuloplasty system
27 May 2021 - Micro Interventional Devices has received breakthrough device designation from the U.S. FDA for its MIA-T percutaneous ...
Posted by Michael Wonder on 26 May 2021
FDA announces draft guidances to help increase transparency, assist reporting and timely completion for certain medical device studies after FDA approval or clearance
26 May 2021 - Today, the U.S. FDA issued two guidances regarding the surveillance of certain medical devices. ...
Posted by Michael Wonder on 26 May 2021
Woebot Health receives FDA breakthrough device designation for post partum depression treatment
26 May 2021 - WB001 is the first digital therapeutic designed to reduce the burden of post partum depression. ...
Posted by Michael Wonder on 26 May 2021
Varian receives FDA breakthrough device designation for its cardiac radioablation system for treatment of refractory ventricular tachycardia
26 May 2021 - Varian's CRA system has been designated a "breakthrough device" by the FDA because of its potential to ...
Posted by Michael Wonder on 26 May 2021
Unity HA awarded breakthrough device designation for implantable neurostimulation technology to treat cluster headache pain
25 May 2021 - Unity HA announced today that the U.S. FDA has granted breakthrough device designation to the Pulsante SPG ...
Posted by Michael Wonder on 25 May 2021
Spinal Stabilization Technologies earns FDA breakthrough designation for PerQdisc nucleus replacement system for degenerative disc disease
25 May 2021 - Spinal Stabilization Technologies announced today that it has earned the CE Mark and the FDA's breakthrough ...
Posted by Michael Wonder on 18 May 2021
Essilor receives FDA breakthrough device designation for Essilor Stellest, its new generation of spectacle lens solutions in the fight against myopia
17 May 2021 - Essilor today announced that the U.S. FDA has granted breakthrough device designation to its Essilor Stellest spectacle ...
Posted by Michael Wonder on 14 May 2021
Molzym announces FDA breakthrough device designation for its molecular diagnostic test system – sepsis, ioint & implant infections, infective endocarditis, bacterial meningitis
10 May 2021 - Molzym’s unique technology for molecular microbial diagnostics was granted breakthrough device designation by the FDA in light ...