Blog
RSS FeedPosted by Michael Wonder on 30 Nov 2020
FDA approves device for treatment of osteoid osteoma in the extremities
27 November 2020 - The FDA approved the Sonalleve MR-HIFU system (Profound Medical) for the treatment of osteoid osteoma in ...
Posted by Michael Wonder on 22 Nov 2020
Device vital for monitoring diabetes should be funded 'immediately'
23 November 2020 - Ben Hoy and Anne Marie Guiney would not be able to cope with having two type ...
Posted by Michael Wonder on 20 Nov 2020
FDA grants breakthrough designation to 4D Path for novel cancer diagnostic solution
18 November 2020 - 4D Path today announced that the U.S. FDA has granted the company breakthrough device designation for ...
Posted by Michael Wonder on 20 Nov 2020
Lumicell granted fast track designation approval by the FDA for breast cancer treatment
18 November 2020 - Fast track designation augments previously granted breakthrough device designation. ...
Posted by Michael Wonder on 17 Nov 2020
Sommetrics receives FDA breakthrough device designation for its aerSleep II product to treat sleep apnea
17 November 2020 - Sommetrics today announced its lead sleep apnea product, aerSleep II, has received FDA breakthrough device designation. ...
Posted by Michael Wonder on 12 Nov 2020
FDA grants a breakthrough device designation for Spiderwort spinal cord technology
12 November 2020 - Spiderwort is pleased to announce that the U.S. FDA has designated CelluBridge, Spiderwort’s spinal cord scaffold implant, ...
Posted by Michael Wonder on 09 Nov 2020
FDA permits marketing of new device designed to reduce sleep disturbance related to nightmares in certain adults
6 November 2020 - Today, the U.S. FDA permitted marketing of a new device intended for the temporary reduction of sleep ...
Posted by Michael Wonder on 06 Nov 2020
ICER publishes evidence report on digital therapeutics for opioid use disorder
6 November 2020 - The available evidence on the benefits of reSET-O, Connections, and DynamiCare has substantial limitations and can ...
Posted by Michael Wonder on 04 Nov 2020
Salvia BioElectronics receives FDA breakthrough device designation for innovative neurostimulation solution
3 November 2020 - Salvia BioElectronics announced today that the U.S, FDA has granted breakthrough device designation for its implantable ...
Posted by Michael Wonder on 22 Oct 2020
AppliedVR receives FDA breakthrough device designation to treat pain with digital therapeutic
21 October 2020 - AppliedVR today announced its EaseVRx product received breakthrough device designation from the U.S. FDA for treating ...
Posted by Michael Wonder on 12 Oct 2020
NICE proposes simplifying how medicines and medical devices are selected for evaluation
12 October 2020 - As part of the work underway to review the methods and processes NICE uses to develop guidance ...
Posted by Michael Wonder on 06 Oct 2020
PixCell Medical announces regulatory approval from Australian TGA for HemoScreen point of care hematology analyser
5 October 2020 - PixCell Medical announced today that it has received regulatory approval from the Australian TGA for the ...
Posted by Michael Wonder on 01 Oct 2020
Genetron Health receives U.S. FDA breakthrough device designation for its blood based NGS test for early detection of hepatocellular carcinoma
30 September 2020 - Genetron Holdings today announced that its blood-based next-generation sequencing test, HCCscreen, has been granted breakthrough device designation ...
Posted by Michael Wonder on 03 Sep 2020
CMS grants additional reimbursement for the Eluvia drug eluting vascular stent system
3 September 2020 - Boston Scientific announced that the U.S. Centers for Medicare and Medicaid Services granted a new technology add-on ...
Posted by Michael Wonder on 01 Sep 2020
FDA approves first-of-its-kind automated insulin delivery and monitoring system for use in young paediatric patients
31 August 2020 - Today, the U.S. FDA approved the MiniMed 770G System, a hybrid closed loop diabetes management device that ...