BIBA Briefings

02/12/2019

Terumo Medical Corporation has decided to acquire Aortica corporation, which is a US-based company dedicated to advancing the science of personalised vascular therapy.

Terumo has decided to acquire Aortica corporation, which is a US-based company dedicated to advancing the science of personalised vascular therapy. Aortica has developed an automated case planning software known as “AortaFit”, which is designed to precisely match fenestrations on an endograft wi...

19/09/2019

30/08/2019

Medtronic’s chairman and CEO Omar Ishrak is to retire on 26 April 2020, following the end of the company’s current fiscal year. ow.ly/lKxz50vPv1X

Omar Ishrak Omar Ishrak, Medtronic’s chairman and CEO is to retire on 26 April 2020, following the end of the company’s current fiscal year. Also, the Medtronic Board of Directors has announced key leadership appointments as part of its multi-year, leadership succession planning process. A

27/08/2019

Approvals & refusals for 19 August to 23 August, includes Class I recall of delivery system of Sapien 3 Ultra and FDA Breakthrough Device Designation for PiCSO system. ow.ly/utOS50vLhn9

Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe and the USA. It also covers recalls, safety notices, and indication withdrawals. This report covers from Monday 19 August to Friday 23 August. FDA

23/08/2019

The FDA issues a Class I recall for the delivery system of Sapien 3 Ultra, The recall comes within a week of the device being FDA approved for low-risk AS patients. ow.ly/JP0t50vGBCr

The FDA has issued a Class I recall—which it describes as “the most serious type of recall”—for the delivery system of the Sapien 3 Ultra transcatheter aortic valve implantation (TAVI) system. The recall follows Edwards Lifesciences receiving reports of burst balloons during implantation pro...

21/08/2019

Each week, BIBA Briefings seeks to cover the key market approvals of the medical device industry, It also covers recalls, safety notices, and indication withdrawals. This week's report covers 12 August to 16 August. ow.ly/7LfK50vECqq.

21/08/2019

BIBA Briefings Insights reports provide in-depth analysis of data from the Monitors (TAVI, Aortic, and PCI). They also review the latest device news relevant to the MedTech Industry. Read this free "taster" PCI Insights report (Q1 2019): ow.ly/2HBM50vEaDr

20/08/2019

Data from indicates that 52% of neurointerventionalists say no to other specialities performing thrombectomy. Of those who say yes, 58% propose interventional radiologists: ow.ly/PQUS50vDlnd

Source: BIBA MedTech Insights According to a BIBA MedTech survey, 52% of neurointerventionalists believe that they are the only specialists who have the relevant skills and experience to perform interventional stroke procedures (e.g. mechanical thrombectomy). However, of those who believe other

20/08/2019

The FDA has approved both the Evolut range and the Sapien 3 range for low-risk AS patients. This means, in the USA at least, TAVI (or "TAVR") is now approved for patients at all levels of surgical risk. http://ow.ly/T1D850vDhIR