Hologic touts win in trade secret case

gavel, legal

Hologic (NSDQ:HOLX) yesterday touted a win in a court case against a Chinese competitor and former employee the company accused of misappropriating trade secrets.

The Marlborough, Mass.-based company said that a Massachusetts Superior Court granted a preliminary injunction against Chinese X-ray device maker Direct Digital Imaging Technology and former employee Lawrence Ibbetson for alleged misappropriation of trade secrets.

In its case, Hologic alleges that DDIT and Ibbetson took trade secrets related to selenium coating technology used in the company’s breast scanning devices, including its Selenia Dimensions and 3Dimensions mammography systems.

The company filed a suit against DDIT in 2016 that alleged a breach in contract for failing to pay for general radiography panels treated with the coatings. This year, the complaint was amended to include trade secret misappropriation claims, the company said.

Hologic said that as part of the preliminary injunction, the court ruled that the company is “likely to succeed in its trade secrets claim,” according to a press release.

The injunction included an order that the plaintiffs stop using or disclosing selenium coating specifications Hologic claimed are misappropriated, and an order that DDIT and Ibbetson not develop an alternative selenium coating unless conditions, including independent monitoring, are met. The injunction is slated to be effective through the end of the trial.

“We are very pleased with the Superior Court’s ruling. As the world leader and innovator in mammography, we will continue to defend our intellectual property against what we believe to be unfair trade practices in order to protect the innovations that drive advances for our customers and outcomes for their patients,” breast and skeletal health prez Pete Valenti said in a press release.

Earlier this week, Hologic said that it launched its next-gen Omni hysteroscope in the U.S. after having received FDA 510(k) clearance earlier in the month.

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Imaging dev Lightpoint Medical raises $6m

Lightpoint Medical

Medical imaging dev Lightpoint Medical said today it raised approximately $6.4 million (GBP £5 million) in a new financing round slated to support the commercialization of the company’s robotic laparoscopic probe and its LightPath imaging system.

Money in the round came from Cambridge Capital Group, Venture Founders, Coutts Investment Club, Envestors, Fund Twenty8, SyndicateRoom and Oxford Technology, the Chesham, U.K.-based company said. It added that it has also raised more than $3.8 million (GBP £3 million) from Horizon 2020 SME instrument and Innovate UK.

“We are very proud to have supported Lightpoint Medical in this financing round and delighted that they have secured this growth finance. We have always been very impressed by their talented and experienced team and their revolutionary and groundbreaking technology, which will be transformative in improving patient outcomes in cancer surgery. Our focus on Series A through to Growth means that we are able to support companies, like Lightpoint, to fulfill their potential,” Venture Founders co-founder & managing director James Codling said in a press release.

Funds from the round will support continued commercialization of Lightpoint’s robotic laparoscopic probe designed to detect cancer and to support the commercial growth of its LightPath Imaging system, which has already been launched in Europe.

“We’re pleased to have secured this growth finance to prepare the company for commercial scale-up. In particular, it’s a pleasure to see the substantial number of our previous investors following on as well as to welcome our new shareholders. With this new funding, we’re looking forward to commercial launch of our laparoscopic probe which we believe will be game-changing for minimally invasive surgery,” Lightpoint Medical CEO Dr David Tuch said in prepared remarks.

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Spectrum Dynamics sues GE for trade theft

Spectrum Dynamics sues GESpectrum Dynamics said that it filed lawsuit today accusing GE (NYSE:GE) of trade theft and misappropriation of intellectual property over the patents covering its Veriton nuclear medicine device.

The New York City-based company said the suit alleges that the industrial conglomerate “deliberately, repeatedly and with fraudulent intent” misappropriated Spectrum’s technology and know-how concerning its Veriton single-photon-emission computed tomography device.

“The patents that GE filed relating to the technology and design of what would become the Spectrum Dynamics Veriton are based directly on Spectrum Dynamics’ trade secrets and inventions, which were stolen by GE,” the company alleged.

The suit seeks to bar Boston-based GE from using or benefitting from the “trade secrets and novel ideas they egregiously stole,” Spectrum Dynamics said, and bids for preliminary and permanent injunctions “to prevent GE’s continued exploitation of Spectrum’s intellectual property.” The complaint includes claims for unfair competition and seeks to correct “inventorship” and take over the GE patents that allegedly claim Spectrum’s inventions.

The lawsuit, filed in the U.S. District Court for Southern New York, is under seal, a Spectrum Dynamics spokesman told MassDevice.com.

“By stealing Spectrum Dynamics’ inventions, GE avoided years of its own R&D efforts and considerable expense in an effort to hasten the development of its own directly competing device,” Spectrum president & CEO Michael Joos said in prepared remarks. “GE sought a shortcut to a technology that its own engineers were unable to develop. GE had no right to patent and produce technology it stole and should be prevented from going to market with it.

“The technology and knowledge that Spectrum Dynamics pioneered are incredibly valuable, as they bring the benefits of broad digital adoption to SPECT imaging, driving improved clinical patient outcomes and reduced costs for hospitals,” Joos added. “While it is regrettable that we are forced to file a lawsuit against GE, we were left with no choice. As a pioneer in full-body digital nuclear imaging systems, we will aggressively defend our inventions against these illegal actions by GE.”

Last month Spectrum won 510(k) clearance from the FDA for the Veriton-CT 64 SPECT/CT scanner.

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Subtle Medical wins FDA nod, CE Mark for SubtlePet AI-powered imaging system

Subtle Medical

Medical imaging tech developer Subtle Medical said today that it won both CE Mark approval in the European Union and FDA 510(k) clearance for its SubtlePET artificial-intelligence-powered positron emission topography imaging enhancement system.

The SubtlePET system is designed to enhance images and reduce scanning times to improve overall patient experience during imaging procedures, the Menlo Park, Calif.-based company said.

“Focusing Subtle Medical’s SubtlePET AI platform on faster image acquisition, we have been able to dramatically increase PET scan efficiency and provide a superior patient experience. SubtlePET technology allows us to scan a patient four times faster than normal, yet maintain equal image quality, not otherwise impacting work flow. This creates immediate ROI benefit for our hospital and a compelling value proposition.  I’m looking forward to seeing more groundbreaking technology from the Subtle team,” Dr. Michael Brant-Zawadzki of Newport Beach, Calif.-based Hoag Hospital said in a prepared statement.

Subtle Medical said that the system is currently in pilot clinical use in multiple university hospitals and imaging centers in the US and internationally, the company said.

The company added that it is developing additional products it will seek FDA clearance for, including the SubtleMR for MRI scanning uses and the SubtleGAD for gadolinium dosage during imaging procedures.

“This FDA clearance is a key milestone in Subtle Medical’s mission to bring novel and empathetic deep learning to improve patient satisfaction. The accomplishment of having the first AI cleared for use in nuclear medicine applications validates our team’s strength and the commitment of our collaborators.  Our focus on image acquisition and workflow differentiates us from other AI companies that are working on post-processing and computer-aided diagnosis products.  We are not replacing radiologists–we are addressing the tremendous cost to U.S. healthcare by leveraging deep learning in imaging at the infrastructure level to enable better and higher quality care,” founder & CEO Enhao Gong said in a press release.

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Neural Analytics adds $10m for robot-assisted brain ultrasound

Neural AnalyticsNeural Analytics yesterday reported raising nearly $10 million in for the robot-assisted brain ultrasound device it’s developing.

Los Angeles-based Neural Analytics’ NeuralBot is designed to work with its Lucid M1 transcranial doppler utrasound to provide non-invasive blood flow monitoring. In June the company won CE Mark approval in the European Union for NeuralBot.

In a funding round begun in May, Neural Analytics said it raised $9.5 million from 18 unnamed investors in an offering of debt, options, warrants and other securities, according to a Nov. 28 regulatory filing.

In January the company raised $15 million in a Series B round led by Alpha Edison.

“We are committed to advancing brain healthcare through transformative technology that empowers neurologists with the critical information needed to make clinical decisions and improve patient outcomes,” co-founder & CEO Leo Petrossian said in June. “Our products provide clinicians with a cost effective and non-invasive assessment of a patient’s brain health, and can help clinicians diagnose brain disorders, potentially without the need for more invasive testing.”

“This technology allows us to look inside the brain, evaluate blood flow characteristics and track emboli in patients. It provides us with critical information on brain health in real-time to help us diagnose neurological disorders, prior to the need for additional, more invasive testing,” added Dr. Claudio Baracchini of Italy’s University of Padua.

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This total body scanner shows 3D images of the whole body

UC-Davis-full-body-scanA University of California Davis-developed medical imaging scanner has produced the first 3D picture of the whole human body at once.

The scanner, known as the Explorer, is a combination of a positron emission tomography (PET) and X-ray computed tomography (CT). It is able to image the entire body using both scanning methods and can produce the image in as little as one second. Over time, Explorer can make videos that can track specially tagged drugs as they move through the body.

UC Davis scientists Simon Cherry and Ramsey Badawi developed the scanner and suggest that the technology could be used in a number of applications that include improving diagnostics, tracking disease progression and researching new drug therapies. Explorer was developed in a partnership with Shanghai-based United Imaging Healthcare and will manufacture the devices for a broader healthcare market.

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

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Samsung’s NeuroLogica, MaxQ AI ink collab distro deal

Samsung's NeuroLogica, MaxQ AI

Samsung Electronics (LON:BC94) subsidiary NeuroLogica said today that it inked a distribution deal with MaxQ AI to integrate its artificial intelligence software with NeuroLogica’s medical imaging tech in the U.S. and EU’s acute care marketplace.

Through the deal, NeuroLogica said that it will offer MaxQ’s Accipio IX, part of the AI-company’s FDA-cleared and CE Mark approved Accipio Insight intracranial hemorrhage platform intended to support acute care physicians by identifying patients with suspected intracranial hemorrhage using non-contrast head computed tomography imaging.

“We are honored to partner with MaxQ and their flagship product Accipio Ix. AI is an exciting development in healthcare, and through our joint efforts, we are working to improve diagnostic accuracy and reduce time to treatment for stroke. AI has the potential to revolutionize diagnostics, and this collaboration will bring that potential into the patient’s room through our point of care CT systems,” NeuroLogica COO David Webster said in a prepared release.

The Accipio IX solution will be offered as an additional tool for NeuroLogica’s OmniTom mobile 16-slice CT scanner. NeuroLogica said it will make MaxQ’s AI solutions available for integration into into its mobile stroke units as well.

“Following the recent FDA clearance and CE Mark approval of Accipio Ix, our expanded partnership with Samsung NeuroLogica will further accelerate the commercialization of our AI-powered solutions for the acute care market. Designed for seamless integration into CT and PACS systems, our platform coupled with the unique mobile CT offering of Samsung Neurologica, will bring critical life-saving decisions directly to patients in Mobile Stroke Units and to the bed-side of acute care hospital departments. Intelligent imaging, empowering physicians to make more accurate assessments in any location, at any time,” MaxQ AI commercial operations senior VP Chris Schnee said in a press release.

In August, NeuroLogica won a $250 million maximum firm-fixed-price contract to supply the US Dept. of Defense with radiology systems, accessories and training.

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GE Healthcare closes out field inspection of Millennium radiation therapy systems

General Electric

GE Healthcare (NYSE:GE) said last week that it closed out a full field inspection of all of its Millenium MG, MC and Myosight nuclear medicine systems after an incident in which the system malfunctioned.

The company said that in September, it received notice that the top detector on on of its Millenium MG nuclear medicine systems detached and fell onto the detector below. No patients were involved and no one was injured as a result of the incident, GE said.

GE Healthcare said it launched a thorough investigation and determined that the cause of the incident was the lack of a mechanical stopper that limits detector travel and the malfunction of another primary motion stopper.

The company also launched a full, free inspection of all Millenium MG, MC and Myosight systems, advising users to discontinue use of the devices until the inspection was complete, according to a press release.

With the investigation complete, GE advised users that it found no related issues in all of its other global systems, though it added that the FDA classified the device recall as a Class I, its most extreme recall labeling indicating possible serious injury or loss of life is possible.

In its recall notice, the FDA identified the Millennium nuclear medicine systems, including the MG, MC and Myosight, manufactured between January 1, 1997 and July 1, 2012 and distributed between January 1, 1997 and September 1, 2018, with model numbers NMH817, NMH816, NMH815, NMH814, NMH803, NMH802, NMH801, NMH800, NGS014, NGS012, NGS009, NGS005 and NG00.

A total 996 units were identified in the recall, according to the FDA, who echoed the company’s reasoning for the initial error.

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HeartFlow wins Japanese reimbursement for FFRct analysis


HeartFlow said yesterday that it won reimbursement coverage from the Japanese Ministry of Health, Labor and Welfare for its HeartFlow FFRct fractional flow reserve analysis.

The Redwood City, Calif.-based company said that it has already received approval from the Japanese Pharmaceuticals and Medical Devices Agency, and that reimbursement will go into effect beginning on December 1.

“When a patient presents with symptoms suggesting CAD, we want to be able to quickly and effectively diagnose patients while reducing the need for unnecessary tests or invasive procedures. In clinical studies, we were able to see firsthand how the HeartFlow Analysis can help to improve patient management and avoid invasive procedures in some patients. The reimbursement approval will enable more physicians and patients to obtain benefits from this ground-breaking technology,” Dr. Takashi Akasaka of Wakayama Medical University said in a prepared statement.

The HeartFlow analysis is a non-invasive, personalized cardiac test that applies artificial intelligence to image data taken from standard coronary computed tomography scans to produce a digital 3D model of a patient’s arteries. The system then applies algorithms to assess the impact of blockages on blood flow to the heart, the company said.

“Adding the HeartFlow Analysis to the anatomical information provided by a coronary CT angiogram enables us to better detect and treat CAD. With the broader availability of the HeartFlow Analysis, physicians in Japan will be able to more efficiently diagnose CAD while minimizing unnecessary tests or delaying care for patients,” Dr. Hiroyoshi Yokoi of the Fukuoka Sanno Hospital said in a prepared release.

The company touted that its technology has been shown to reduce unnecessary and invasive diagnostic coronary angiography procedures which are raise costs and are associated with bleeding, stroke, major blood vessel damage and other serious complications.

“The reimbursement approval in Japan is an important milestone for HeartFlow as we work to make our state-of-the-art technology available to more patients around the world. Our commercial launch will begin immediately and we look forward to giving clinicians in Japan a new tool to help them confidently diagnose CAD and determine the optimal treatment path for patients,” prez & CEO Dr. John Stevens said in a press release.

In August, HeartFlow released data from two studies of its HeartFlow fractional flow reserve FFRct analysis system, touting that the system allows for the more effective differentiation of patients who need coronary stenting or bypass surgery and those who can be managed on medications alone.

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Canon Medical wins FDA nod for Vantage Orion 1.5T MRI

Canon logo

Canon (NYSE:CAJ) Medical Systems said today that it won FDA 510(k) clearance for its Vantage Orian 1.5 Tesla magnetic resonance imaging system.

The Japan-based company said that the clearance of the Vantage Orian “represents a new standard in the premium wide bore 1.5T market,” and touted that the device includes new technology intended to improve productivity, patient comfort and diagnostic clinical confidence.

“We are committed to offering our customers the premium diagnostic imaging tools they need to deliver accurate, confident and effective patient care. The Vantage Orian was designed to increase productivity while ensuring patient comfort and delivering uncompromised clinical confidence,” CT, PET/CT and MR biz units senior director Dominic Smith said in a press release.

In April, Canon Medical Systems said that it won FDA clearance for its Aquilion Precision ultra-high resolution computed tomography system.

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