FDA takes cautious approach to new regulations for OEM and third-party device servicers

By Joel Domanowski, Emergo Group

The US Food and Drug Administration has cited insufficient evidence regarding public health concerns to warrant new regulatory requirements for original equipment manufacturers (OEM) and third-party servicers of medical devices, but will take less formal steps to ensure safety and effectiveness of these entities’ products and services.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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Spectrum Plastics Group acquires soon-to-be Adam Spence

Spectrum Plastics Group said today that it has completed its acquisition of Fermatex Vascular Technologies, which is going back to its old Adam Spence name.

Financial terms of the deal were not disclosed.

Get the full story on our sister site Medical Design & Outsourcing. 

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Imricor raises $2m

Imricor Medical Systems has raised $1.5 million in a new round of debt and securities financing, according to an SEC filing posted this week.

Money in the funding round came from 19 unnamed investors, with the date of the first sale reported on April 4, 2018.

The company is not looking to raise any more money in the round, according to the SEC filing. but has not stated how it plans to spend funds raised.

Earlier this month, Imricor released results from a clinical study of its Vision-MR ablation catheter designed for treating atrial flutter under real-time MRI guidance.

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Imagen Tech wins de novo clearance for OsteoDetect wrist fracture software

Intelligence-based medical imaging diagnostic group Imagen Technologies today won FDA de novo clearance for its OsteoDetect computer-aided diagnosis software designed to detect wrist fractures in adult patients.

The New York-based company’s OsteoDetect software is designed to analyze wrist radiographs using machine learning algorithms to identify regions of distal radius fracturing during the review of posterior-anterior and medial-lateral X-ray images of adult wrists, according to an FDA release.

Approval came based off a retrospective study of 1,000 radiograph imagines assessing independent performance of the image analysis algorithm for detecting wrist fractures, as well as the accuracy of fracture localization in the software against the performance of three board certified orthopedic hand surgeons, the FDA said. The company also submitted a retrospective study of 200 patient cases as reviewed by 24 providers.

Both studies reportedly showed that use of the software improved the reader’s ability to detect wrist fractures and increased sensitivity, specificity and positive and negative predictive values as compared to unaided performance.

“Artificial intelligence algorithms have tremendous potential to help health care providers diagnose and treat medical conditions. This software can help providers detect wrist fractures more quickly and aid in the diagnosis of fractures,” FDA Center for Devices and Radiological Health Office of In Vitro Diagnostics and Radiological Health acting deputy director Robert Ochs said in an FDA release.

Last March, Imagen Technologies reportedly raised $14.3 million in a round of equity financing, according to an SEC filing.

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Cook Medical loses Houston-based IVC suit, plans to appeal

Cook Medical said today it lost a suit related to its Celect vena cava filters in Houston, but that it plans to appeal the decision.

The ruling came from a jury in Houston, which ruled in favor of a plaintiff, though the Bloomington, Ind.-based company did not release any detailed information related to the case.

“We are dedicated to providing life-saving treatment options for patients and will continue to defend all of our IVC filters. Our filters have saved thousands of lives, are clinically successful and are critical to patient well-being,” Cook Medical vascular division VP Mark Breedlove said in a prepared statement.

Cook Medical said that it was successful in the first two cases over its IVC filters, winning a complete jury verdict in its favor in the first and through a complete summary judgement verdict in the second.

“We are disappointed in this outcome and do not believe this verdict is supported by the facts or the law. This one case does not change our position on continually defending this important, life-saving technology,” Cook Medical GC & VP Cynthia Kretz said in a press release.

Earlier this month, Cook Medical said it won FDA de novo clearance for its Hemospray endoscopic hemostat designed for treating bleeding in the gastrointestinal tract.

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Reva Medical’s Fantom bioresorbable scaffold succeeds in two-year trial

Reva Medical (ASX:RVA) touted sustained safety and efficacy results for its Fantom bioresorbable scaffold at this year’s EuroPCR meeting.

The company also revealed new information about its suite of Fantom Encore products, noting that the devices will have strut profiles of 95 microns, 105 microns and 115 microns.

Get the full story at our sister site, Drug Delivery Business News.

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Biotronik touts two-year study comparing drug-eluting stents

Biotronik yesterday presented two-year data from a trial comparing Boston Scientific‘s (NYSE:BSX) Synergy biodegradable polymer everolimus-eluting stent, Biotronik’s Orsiro sirolimus-eluting stent and Medtronic‘s (NYSE:MDT) Resolute Integrity zotarolimus-eluting stent.

Results from the 3,514-patient trial showed no significant difference between the various stents regarding the rate of target vessel failure after two years. But analyses of one-year data found differences between the rates of target lesion revascularization and target lesion failure for patients treated with Orsiro compared to Resolute Integrity, according to Biotronik.

Get the full story at our sister site, Drug Delivery Business News.

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