Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
3. CardioDx resurrects IPO
More than 5 months after ditching efforts to open on public markets, California-based CardioDx is ready to take another swing at an initial public offering.
In regulatory documents filed this week the molecular diagnostics maker assigned new underwriters, named a couple of new executives and added 2 members to its board of directors. CardioDx has not yet revealed exact timing or terms for the revived IPO. Read more
2. J&J shelves surgical morcellators following FDA cancer warning
Johnson & Johnson’s and its Ethicon subsidiary suspended sales of laparoscopic power morcellators, used in fibroid removal surgery, following FDA warnings that they may unwittingly help spread undetected cancers.
The company stopped short of issuing a recall, telling customers that federal healthcare regulators continue to view morcellation as an important option for some patients. Ethicon noted that the devices have always carried a label warning of the “potential spread of malignant tissue,” according to a letter obtained by Reuters. Read more
1. Report: Anthem Blue Cross Blue Shield denies CoreValve coverage
The FDA may have approved both Edwards Lifesciences’ Sapien and Medtronic’s CoreValve replacement heart valves, but Anthem Blue Cross & Blue Shield will reportedly only cover the Sapien transcatheter aortic valve implant – and only for patients who are too sick to undergo open heart surgery.
The insurer’s decision leaves 2 cohorts of patients without reimbursement for the TAVI devices: The extreme-risk group and high-risk patients whose aortic valves are too large for the Sapien device, according to heartwire. Read more
