For opponents of the 2.3 percent medical device tax, it looked like the repeal/replacement of the Affordable Care Act would alleviate their concerns. However, following the failure of repeal legislation that would have...more
It has been a busy couple of months between Medtronic and the Food and Drug Administration (FDA), with Medtronic experiencing both recalls and approvals from the government agency. Below is a brief summary of some recent of...more
With the upcoming Republican-dominated Presidency and Congress in 2017, the Affordable Care Act, or at least parts of it, look to be on the chopping block. One of the changes that may be forthcoming is a repeal of the 2.3%...more
Isto Holdings, the parent company of Isto Technologies, has acquired Massachusetts based Arteriocyte Medical Systems Inc. and the two companies will be combined under the name Isto Biologics under the current CEO of Isto...more
The FDA has just released draft guidance for unique device identifiers (UDIs) tracking medical devices from their manufacturers to the end users. Specifically, the FDA is providing guidance to device the content and form of...more
A burst of potential acquisitions and consolidations occurred on April 28th in the medical device world, the largest being Abbott Laboratories‘ deal to acquire St. Jude Medical Inc. The deal is for $25 billion dollars and...more
Fitbit, Inc., a manufacturer of wearable health technology, is involved in a national class action lawsuit filed on January 5, 2016 in the Northern District of California over two of its wristbands, the Charge HR and the...more
According to PRNewswire, Edwards Lifesciences Corporation recently completed its acquisition of CardiAQ Valve Technologies, Inc, a developer of transcatheter mitral valve replacement systems, which follows from Edwards’...more
University of Wisconsin-Madison alums, Dr. James Berbee and Karen Walsh, have agreed to a five-year, $300,000 gift to the Morgridge Institute for Research through their Berbee Walsh Foundation. According to the press...more
Following up on the hearing from B. Braun Medical Inc. advocating for the repeal of the medical device tax, according to news sources, more than a dozen House Democrats are pressuring leadership to advance a bill repealing...more
The medical device market is expanding into more private healthcare products in hopes of bringing healthcare directly to the user. For example, the increase in popularity of wearable diagnostic devices, such as FitBit,...more
St. Jude Medical, Inc. recently announced that the U.S. Food and Drug Administration (FDA) has approved its FlexAbility Ablation Catheter for use by electrophysiologists to treat cardiac arrhythmia....more