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RSS FeedPosted by Michael Wonder on 10 Jan 2023
Four types of bias in medical AI are running under the FDA’s radar
9 January 2023 - Although artificial intelligence is entering health care with great promise, clinical artificial intelligence tools are prone ...
Posted by Michael Wonder on 09 Jan 2023
Opticyte earns FDA breakthrough device designation for the first cell O2 patient monitor for organ failure
9 January 2023 - Opticyte leverages proprietary machine learning to non-invasively assess organ dysfunction due to low cellular oxygenation in ...
Posted by Michael Wonder on 04 Jan 2023
Burning Rock received FDA breakthrough device designation for its OverC multi-cancer detection blood test
3 January 2023 - Burning Rock today announced that its OverC Multi-Cancer Detection Blood Test (MCDBT) has been granted breakthrough device ...
Posted by Michael Wonder on 03 Jan 2023
US FDA grants breakthrough designation for blood test to help diagnose inaccessible brain tumours
2 January 2023 - Datar Cancer Genetics now has three breakthrough designations granted by the US FDA, including liquid biopsies ...
Posted by Michael Wonder on 30 Dec 2022
The FDA’s ‘breakthrough’ program for medical devices keeps gaining steam
28 December 2022 - For medical devices in the Breakthrough Devices Program, 2022 has been a breakout year. ...
Posted by Michael Wonder on 28 Dec 2022
EOFlow submits application to the US FDA for its wearable insulin pump 'EOPatch'
27 December 2022 - Plans to finalise its US distribution strategy in 2023. ...
Posted by Michael Wonder on 30 Nov 2022
Swiss National Council votes to accept FDA approved medical devices
29 November 2022 - On November 28, the Swiss Parliament National Council voted to adapt its national laws, allowing Switzerland to ...
Posted by Michael Wonder on 04 Nov 2022
AVITA Medical announces FDA breakthrough device designations for the Recell system
3 November 2022 - AVITA Medical announced today that the FDA granted the Recell system designations as a breakthrough device for ...
Posted by Michael Wonder on 20 Oct 2022
Sinaptica Therapeutics announces FDA breakthrough device designation for its novel non-invasive neurostimulation treatment for Alzheimer’s disease
19 October 2022 - Breakthrough designation is based on positive outcomes from a Phase 2 clinical trial in mild to ...
Posted by Michael Wonder on 18 Oct 2022
Axoft brain implant technology is granted FDA breakthrough device designation
18 October 2022 - Axoft today launched and announced FDA breakthrough device designation for its brain-machine interface to better treat ...
Posted 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, ...