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St. Jude Medical Inc.

Division of Abbott Laboratories Inc.

Latest From St. Jude Medical Inc.

US Approvals Analysis: Hits Just Keep On Coming. Can It Last?

2017 was another record year for novel device approvals in the US, with typical large numbers of cardiovascular and IVD go-aheads, along with notable successes in neurology, with noninvasive stimulation and digital-app solutions seeing success. There was also an increase in 510(k) clearances last year. Here's a look at some key FDA approvals and clearance trends from the past year, including in infographic form.

Approvals Research & Development

Sterilmed Recalls Reprocessed Heart Catheter Sheath

Improper reprocessing may pose a risk of air embolism due to a leaky valve, FDA said in the recall announcement.

Medical Device Cardiology

Medtech Supporter Sen. Orrin Hatch To Retire At Year's End

The medtech industry will lose a champion in Congress when Senate Finance Panel Chair Orrin Hatch, R-Utah, retires at the end of the 2018 congressional session. Author of the Americans with Disabilities Act and the Children's Health Insurance Program law, Hatch has been a perennial supporter of device-tax repeal, introduced market-based pricing for lab test reimbursements, and sponsored deep cuts in taxes for corporations in tax reform legislation signed into law just last month. Might former Massachusetts governor and failed 2008 US presidential candidate Mitt Romney run for the soon-to-be vacated seat?

Leadership Policy

Puerto Rico Tax-Haven Status, R&D Credit Weakened By Tax-Reform Bill

Under tax reform legislation recently passed by Congress, a 20% tax on products made in domestic territories will adversely affect the many device firms with Puerto Rican plants that currently enjoy a lower, 4% tax rate on profits. And a second tax provision usually relied upon by medtech companies, the R&D tax credit, also loses ground under the final Senate bill passed Dec. 2.

Legislation Policy & Regulation
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