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).

Livanova unveils plans to restructure heart valve business, end TMVR program

London-based Livanova plc is exiting its Caisson transcatheter mitral valve replacement 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.

No apparent grace period for 510(k)s under safety and performance framework

The FDA’s safety and performance-based pathway for 510(k) devices is one of several steps that promise to streamline premarket filings for both regulator and the regulated. The agency said on a recent webinar that any changes to the performance standards would apply only prospectively and not retroactively, but the FDA’s Jason Ryans made no mention of a grace period for any impending 510(k) applications, suggesting that any such devices may have to be reworked.

Med-tech IPO 2019 stocks up 43% led by aesthetics company Inmode

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. San Diego-based Guardion (NASDAQ:GHSI) is one of the worst performing IPO stocks of 2019 so far, losing 96% of its value, having fallen from its $4 IPO price to only 18 cents on Nov. 19. The medical device company focused on ophthalmics raised $5 million through the sale of 1.25 million shares in its April IPO. In contrast, the best performer is Lake Forest, Calif.-based Inmode Ltd. (NASDAQ:INMD), which has seen its stock climb 299% since its August debut raising $70 million through 5 million shares. The stock started at $14 and closed Tuesday at $55.84.

Lucence attracts $20M in series A led by IHH Healthcare

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.

Also in the news

Astellas, Atmo Biosciences, Attune Medical, Axonics, Avedro, Biosense Webster, Biosig, Blink Health, Clinical Innovations, Combinostics, Emphysys, Essilorluxottica, Exagen, Glaukos, Masimo, Merit Medical, Nuvasive, Onduo, Revian, Siemens Healthineers, Soliton, Spark Biomedical, Spineovations, Welldoc