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RSS FeedPosted 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 ...
Posted by Michael Wonder on 14 Jul 2022
FDA clears DyAnsys neurostimulation device first relief to treat diabetic neuropathic pain
14 July 2022 - First Relief, a PENS (percutaneous electrical neurostimulation) device, has been cleared by the US FDA for ...
Posted by Michael Wonder on 13 Jul 2022
Ancora Heart receives breakthrough device designation from FDA for the AccuCinch ventricular restoration system
12 July 2022 - Designation allows for expedited review of transcatheter therapy designed to improve left ventricular structure and function ...
Posted by Michael Wonder on 13 Jul 2022
Abbott receives FDA breakthrough device designation to explore use of deep brain stimulation to manage severe depression
12 July 2022 - Each year, 2.8 million Americans will fail multiple depression therapies and be diagnosed with treatment-resistant depression. ...
Posted by Michael Wonder on 11 Jul 2022
T2 Biosystems receives FDA breakthrough device designation for the T2Lyme panel
11 July 2022 - Molecular diagnostic test for early detection of Lyme disease. ...
Posted by Michael Wonder on 11 Jul 2022
US FDA grants Spectral Medical breakthrough device designation for Toraymyxin for the treatment of endotoxemic septic shock
11 July 2022 - Breakthrough designation expected to help accelerate regulatory review. ...
Posted by Michael Wonder on 22 Jun 2022
FDA grants breakthrough device designation to VR mental illness treatment
22 June 2022 - A British startup that uses virtual reality to help deliver cognitive behaviour therapy has been granted a ...
Posted by Michael Wonder on 14 Jun 2022
FDA should step in to help spur AI/ML standards
13 June 2022 - The US FDA should support the burgeoning integration of artificial intelligence and machine learning in medical ...
Posted by Michael Wonder on 26 May 2022
Revolutionary wearable ultrasound device gains FDA approval
26 May 2022 - ManaMed has been granted FDA approval on its latest orthopaedic recovery device, ManaSport. ...