Will Covid-19 tests with EUA need to seek FDA approval once pandemic passes?
The FDA has issued emergency use authorisation (EUA) for medical tests that diagnose Covid-19, but what is an FDA EUA?…
05 Jan 2021
Covid-19 had a negative impact on general surgery device markets in 2020
The Covid-19 pandemic had a significant impact on the sale of medical devices in 2020. Many general surgery device markets were negatively impacted due to elective procedures being cancelled or…
05 Jan 2021
Renal denervation market moves forward with FDA nod to ReCor Medical’s Paradise Ultrasound Renal Denervation system
On 10 December 2020, ReCor Medical, Inc, a wholly-owned subsidiary of Otsuka Medical Devices, announced it had received Breakthrough Device Designation from the FDA for its Paradise Ultrasound Renal Denervation…
04 Jan 2021
Largest players in MedTech industry embrace artificial intelligence
According to GlobalData forecasts, the market for artificial intelligence (AI)/machine learning (ML) platforms will reach $52B in 2024, up from $29B in 2019. The Covid-19 pandemic has triggered a rapid…
04 Jan 2021
Assisted reproductive technology consumable devices market set for steady growth following tumultuous 2020
According to GlobalData’s latest market model, the assisted reproductive technology devices market is set to grow at a compound annual growth rate of 3%, resulting in a global market value…
25 Dec 2020
At-home Covid-19 test kits provide relief for testing centres and show glimpse of potential decentralised healthcare model
The Covid-19 pandemic continues to worsen, as case numbers continue to rise globally. Vaccines have started to roll out, but widespread adoption is expected to take months. In the meantime,…
24 Dec 2020
FDA grants breakthrough device designation for two renal denervation devices as companies race to be first on the market
On 9 and 11 December 2020, SoniVie and ReCor Medical both received FDA breakthrough device designation, for their TIVUS and Paradise Renal Denervation Systems, putting these two companies ahead of…