Blog
RSS FeedPosted by Michael Wonder on 13 Oct 2022
Nevro announces FDA approval of HFX iQ spinal cord stimulation system to personalise the treatment of chronic pain
12 October 2022 - Next generation Senza HFX iQ is the first and only spinal cord stimulation system that uses ...
Posted by Michael Wonder on 12 Oct 2022
FDA will begin accepting breakthrough devices for TAP pilot in 2023
11 October 2022 - The US FDA will start accepting products into its total product lifecycle advisory program (TAP) pilot starting ...
Posted by Michael Wonder on 07 Oct 2022
Desktop Health receives FDA clearance for SmileGuard resin for durable and comfortable orthodontic and dental appliances
6 October 2022 - Dentists and labs can use proprietary SmileGuard resin to 3D print bite splints, night guards, and mouth ...
Posted by Michael Wonder on 20 Sep 2022
Stryker receives FDA clearance for OptaBlate bone tumour ablation system
20 September 2022 - Stryker's first bone tumour ablation system with patented microinfusion technology offers a reliable solution for people ...
Posted by Michael Wonder on 20 Sep 2022
XVIVO granted breakthrough device designation from the FDA for the liver assist device
20 September 2022 - XVIVO Perfusion has been granted breakthrough device designation from the US FDA for their liver assist device, ...
Posted by Michael Wonder on 15 Sep 2022
Opsens announces FDA clearance for the SavvyWire for use in transcatheter aortic valve replacement procedures
15 September 2022 - OpSens today announced that it has received 510(k) regulatory clearance from the US FDA for the SavvyWire, ...
Posted by Michael Wonder on 14 Sep 2022
Potrero Medical receives FDA breakthrough device designation for Accuryn AKI predict algorithm
13 September 2022 - Potrero Medical announced today that the FDA granted breakthrough device designation for their AKI Predict machine learning ...
Posted by Michael Wonder on 08 Sep 2022
Ceribell receives FDA breakthrough device designation for delirium indication
8 September 2022 - Breakthrough device designation recognizes Ceribell's point of care EEG as a first of its kind technology ...
Posted by Michael Wonder on 06 Sep 2022
Boston Scientific receives FDA approval for expanded labelling of Watchman FLX LAAC device for dual anti-platelet therapy as post-procedural medication option
6 September 2022 - Watchman FLX now the only LAAC technology in the United States that allows for either dual anti-platelet ...
Posted by Michael Wonder on 23 Aug 2022
FDA approves Abbott's new spinal cord stimulation device; provides tailored relief to multiple pain areas and adds more treatment options for evolving pain conditions
23 August 2022 - Abbott's new Proclaim Plus spinal cord stimulation system offers the next generation of stimulation therapy, giving physicians ...
Posted by Michael Wonder on 20 Aug 2022
Father invents balance treatment device for daughter; makes history with FDA clearance AND breakthrough device designation
18 August 2022 - GyroStim, a multi-axis rotational chair, was invented by a Colorado father in his garage to aid ...
Posted by Michael Wonder on 11 Aug 2022
The FDA’s ‘breakthrough’ medical devices are finally hitting the market in numbers
11 August 2022 - The Breakthrough Device Program is approaching terminal velocity. ...
Posted by Michael Wonder on 19 Jul 2022
NeuroStar advanced therapy for mental health receives FDA clearance for treatment of anxious depression
19 July 2022 - Indication demonstrates NeuroStar TMS safety and efficacy in improving anxiety symptoms in depressed patients. ...
Posted by Michael Wonder on 19 Jul 2022
Roche's Elecsys Amyloid Plasma Panel granted FDA breakthrough device designation to enable a timely diagnosis of Alzheimer’s disease
19 July 2022 - The Elecsys Amyloid Plasma Panel is intended to be used in conjunction with other clinical information in ...
Posted by Michael Wonder on 18 Jul 2022
Renuvion cleared by FDA for neck laxity procedures offering patients a minimally invasive option to eliminate sagging neck
18 July 2022 - Exclusive Apyx Medical device delivers state of the art plasma energy to improve appearance of loose ...