Blog
RSS FeedPosted 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 06 Sep 2022
PHARMAC capable of managing medical devices supply chain, it says
6 September 2022 - PHARMAC says it has saved $100 million since 2014 by doing deals to cut the price ...
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 22 Aug 2022
New handbook on health economic assessments of medical devices
18 August 2022 - TLV carries out health economic assessments of medical technology products at the request of the Medical Technology ...
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 12 Aug 2022
NICE publishes first draft guidance from its Early Value Assessment pilot project recommending smartphone linked ECG device
12 August 2022 - It is the first recommendation to be issued by NICE’s diagnostics advisory committee via its Early Value ...
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 27 Jul 2022
MSAC publishes agenda for November 2022 meeting
27 July 2022 - 12 agenda items for consideration at the 24-25 November 2022 meeting. ...
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 ...