The U.S. FDA has given Medtronic plc a green light for its In.Pact AV drug-coated balloon, the second application for the Dublin-based company’s In.Pact DCB platform. The paclitaxel-coated balloon is now indicated for the treatment failing arteriovenous (AV) access in patients undergoing dialysis due to end-stage renal disease (ESRD). In.Pact AV leverages technology from Medtronic’s In.Pact Admiral DCB, which first snagged FDA approval in 2015 for treatment of superficial femoral artery (SFA) lesions above the knee. Read More
London-based Livanova plc is exiting its Caisson transcatheter mitral valve replacement (TMVR) program as it looks to restructure its heart valve business. According to the company, the heart valve business line represented nearly $130 million in revenue for full-year 2018 and experienced a revenue decline over the last five years. It attributed the declines to multiple market conditions. Read More
A total of 18 med-tech companies that have gone public on U.S. exchanges this year are showing a positive percentage change in stock value on average of 43%, despite large price drops for Personalis Inc. and Guardion Health Sciences Inc. Read More
The FDA’s safety and performance-based pathway for 510(k) devices promises to streamline premarket filings, and the FDA’s Jason Ryans said on a recent webinar that any changes to the related product-specific guidances would be applicable only prospectively. Ryan made no mention of a grace period for impending applications, however, suggesting that any such devices may have to be reworked or resubmitted into a more conventional premarket channel if they do not meet the new requirements. Read More
HONG KONG – Lucence Diagnostics Pte Ltd., a genomic medicine company headquartered in Singapore, has secured $20 million in series A investment. The company is focused on inventing liquid biopsy tests for cancer screening and personalizing care. Read More
