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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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. ...

Read more →

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. ...

Read more →

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, ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →