Dan Fischer at Knobbe Martens

The Medical Device Tax Lives On

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

8/25/2017 / Affordable Care Act , Legislative Agendas , Medical Device Tax , Medical Devices , Repeal , Trump Administration

Medtronic's Recent Interactions with the FDA

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

6/19/2017 / FDA Approval , Food and Drug Administration (FDA) , Medical Devices , Medical Software , Medtronic , Product Recalls

Potential Repeal of Medical Device Tax

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

1/17/2017 / Affordable Care Act , Innovation , Legislative Agendas , Medical Device Tax , Medical Devices , Repeal , Trump Administration

Isto Holdings Acquires Arteriocyte To Form Isto Biologics

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

11/17/2016 / Biologics , Medical Devices , Mergers

FDA Releases Draft Guidance for Unique Device Identifiers

The FDA has just released draft guidance for unique device identifiers (UDIs) tracking medical devices from their manufacturers to the end users.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

7/30/2016 / Draft Guidance , Food and Drug Administration (FDA) , Medical Devices , Unique Device Identifiers

Abbott to Acquire St. Jude Medical for $25 Billion

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

5/2/2016 / Abbott Laboratories , Acquisitions , Medical Devices , Mergers

Class Action Lawsuit Filed Against Fitbit

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

3/29/2016 / Class Action , Fitbit , Health IT , Medical Devices , Product Defects

Edwards Completes Acquisition of CardiAQ

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

9/14/2015 / Acquisitions , Food and Drug Administration (FDA) , Life Sciences , Medical Devices

UW Donation to Morgridge “Fab Lab” For Medical Device Innovations

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

7/10/2015 / Clinical Laboratories , Innovation , Medical Devices , Universities

Medical Device Tax Repeal Heating Up

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

5/20/2015 / Affordable Care Act , Legislative Agendas , Medical Device Tax , Medical Devices

Shift Labs Continues Trend Toward Consumer Wireless Healthcare Devices

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

4/1/2015 / Food and Drug Administration (FDA) , Healthcare , Medical Devices , Wearable Technology , Wireless Technology

First Flexible Tip Ablation Catheter To Receive FDA Approval

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

2/11/2015 / Food and Drug Administration (FDA) , Healthcare , Medical Devices

Dan Fischer

Knobbe Martens

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