Regulatory and Compliance

10 Important Updates from FDA

The CDRH Townhall at The MedTech Conference provided key updates on several programs.

Aethlon Takes Big Steps in Oncology with New IDE

The San Diego-based company said it was granted an IDE to initiate an early feasibility study of the Hemopurifier in patients with head and neck cancer in combination with standard of care pembrolizumab (KeyTruda).

Zimmer Biomet Strikes Out at the US Supreme Court Over Hefty Infringement Award

Zimmer Biomet was found in 2017 to have willfully infringed Stryker's patent which led to a tripling of a $70 million damage award against it. The judgment was one of the largest ever awarded for enhanced patent damages.

Roche Packs New FDA-Approved Test in Its Arsenal

The Basel, Switzerland-based company’s cobas Babesia test is a qualitative in vitro nucleic acid screening test for the direct detection of Babesia DNA and RNA in whole blood specimens from individual human blood donors.

What's the Worst Case Scenario for AtriCure's Federal Investigation?

Given renewed concerns about a Department of Justice investigation that AtriCure disclosed last year, an analyst has reviewed prior medical device industry investigations.

Is FDA's Special 510(k) Program Appropriate for Your Medical Device?

FDA issued a new guidance document on its Special 510(k) Program. We condensed the 36-page document into a handy checklist to help you determine if changes made to your medical device can be reviewed under the program, based on the agency's final guidance published Sept. 12, 2019.

Weigh In on FDA's Weight-Loss Device Paper

Previously FDA-approved weight-loss devices are all indicated for “weight loss.” However, under the concept being proposed in FDA's discussion paper, future medical devices intended for weight loss may have indications that are more specific to the measured benefit, such as “short-term limited...

Shockwave Gets a Little Pep in Its Step with Breakthrough Device Designation

The Santa Clara, CA-based company, which raised $110 million in an IPO in March, is developing technology that uses sonic pressure waves in order to facilitate stent delivery, deployment, and optimal expansion, thereby improving blood flow to the heart muscle.

FDA Is Still Trying to Tackle the Dirty Duodenoscope Problem

FDA wants all healthcare facilities to move away from fixed-endcap scopes and start using duodenoscopes with disposable parts. The agency also ordered more post-market studies and warns against illegally-marketed test strips that claim to assess the cleanliness of these devices.

Titan Medical Now Set to File 510(k) Submission in 2020

The Toronto-based company’s decision to delay its surgical robot comes right on the heels of significant movements in the space from both Medtronic and Intuitive Surgical.

How to Survive Medtech's 'Death Valley'

A medical device CEO shares lessons learned from his company's 14-year journey from FDA approval to reimbursement in the U.S. market.

Burst Balloons Prompt Edwards to Add Warning to Sapien 3 Ultra Delivery Instructions

The FDA safety notice comes less than a week after FDA expanded indications of transcatheter aortic valves made by both Edwards Lifesciences and Medtronic, making the devices available for use in younger and lower-risk patients.

New Expanded Indication Could Change the TAVR Narrative

Now Edwards and Medtronic’s transcatheter aortic valve replacement devices can be used in patients with low-risk for death or major complications associated with open-heart surgery. One analyst said the conversation will eventually shift toward TAVR being the “preferred treatment method.”