Magnolia Medical launches Sterpaith Gen2 system

Magnolia Medical Technologies said yesterday it launched its Steripath Gen2 blood collection system.

The next-generation device features mechanical initial specimen diversion and improved usability based on input from end users, the Seattle-based company said.

“Our team is very pleased with the 83 percent reduction in blood culture contamination we have achieved using Steripath. Based on this success, we are now expanding and standardizing its use throughout all Lee Health hospitals,”  Jessica Plante of Lee Health said in a press release.

“At Magnolia, we are committed to eliminating blood culture contamination by empowering healthcare providers with the advanced technologies they need to significantly reduce false positive diagnostic results for sepsis, and the associated patient safety risks, global antibiotic resistance implications and avoidable costs to our healthcare system. Our customers have demonstrated reproducible, sustained results in hospital settings ranging from large academic and government institutions to small community hospitals. We look forward to continued partnership and support of our hospital customers in establishing a new standard of care in sepsis testing accuracy,” CEO Greg Bullington said in a prepared statement.

Last April, Magnolia Medical Tech said that it raised $7.3 million in a round of funding to support its Steripath blood collection system.

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Ortho start-up Embody raises $2m

Orthopedic-focused medtech startup Embody raised $1.5 million to help support its tendon and ligament-treating products, according to a Hampton Roads Business Journal report.

The round was led by 757 Angels and the Center for Innovative Technology, according to the report.

Embody is using proprietary manufacturing techniques to produce advanced collagen matrices intended for use in tendon and ligament repairs, according to the company’s website.

The company is pursuing FDA approval of its products and is hopeful for a launch next year, according to the Hampton Roads Business Journal report.

The new funds add to the $12 million in funding the company received from a Defense Advanced Research Projects Agency grant as well as a $150,000 loan from the Norfolk Economic Development Authority’s Innovation Fund, according to the report. The company also won $800,000 in funding from the Virginia Bioscience Health Research Corporation to work with the University of Virginia and Old Dominion University.

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BlueWind posts positive follow-up study results

BlueWind Medical’s implantable tibial stimulation device

Neurostim developer BlueWind Medical reported positive results from a follow-up study of patients using its implantable tibial nerve stimulator for overactive bladder (OAB).

Renova iStim is a leadless, miniature, wireless neurostimulation platform designed for the treatment of multiple clinical indications. Three years after implantation of the BlueWind’s Renova iStim device, 75% of patients experienced at least a 50% long-term reduction in symptoms. Patients experienced a durable, long-term, effect of urinary urge incontinence relief in “leaks” (50% of patients) and in “large leaks” (80% of patients). No severe adverse events were reported throughout the follow-up study, according to the Herzliya, Israel-based company.

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

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Nanovis raises $6m

Regenerative life sciences company Nanovis said this month it raised $5.5 million in a new funding round slated to support its nano-technology enhanced spinal implants.

The round was brokered by Commenda Securities and joined by key investors Elevate Ventures, 1st Source Capital Corporation, Purdue’s Foundry Investment Fund, Commenda Capital and Ellipsis Ventures, the Carmel, Ind.-based company said.

“Our investment in Nanovis is consistent with our mission to support the ongoing development and success of entrepreneurial businesses across Indiana. This latest round of funding will provide Nanovis the growth capital they need as a high-performing, high-growth business,” Elevate Ventures CEO Chris LaMothe said in a prepared statement.

Funds raised in the round will be used to support working capital and sales needs as the company looks to meet demand for its spinal implants.

“Investors recognized that Nanovis’ technology portfolio offers interbodies with the best combination of a deeply porous bone interface scaffold with a tailored nanotube surface and bridging bone visualization. Nanovis’ nanotube surface is the only nanotechnology in the spine market with which scientists can customize and control the spacing of the nanofeatures. Appropriate nanofeature design and control is important in optimizing bone growth. As a result, our distribution partners are already seeing rapid sales growth and hospital approvals for Nanovis’ FortiCore interbodies. In addition, we are receiving strong interest from surgeons in participating in our nanotube enhanced FortiCore interbody launch,” CEO Matt Hedrick said in a press release.

In March 2016, Nanovis said that it won a grant from the National Institute of Health’s National Institute on Aging to fund pre-clinical studies of its FortiCore interbody fusion device.

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Philips buys military health-monitoring software

Chief Master Sgt. Robert Bean, an Air Force pararescue jumper, demonstrates how Batdok can be worn on the wrist, displaying the health status of multiple patients. (Photo by
Richard Eldridge/US Air Force)

Philips Healthcare has signed a non-exclusive patent license agreement with the U.S. Air Force Research Laboratory for a mobile software application that provides integrated, real-time patient monitoring.

Known as Batdok, an acronym for Battlefield Assisted Trauma Distributed Observation Kit, the software application was developed by the 711th Human Performance Wing at Wright-Patterson Air Force Base. Designed as a wearable technology, it allows a medic to efficiently monitor multiple casualties in the field using a smartphone or tablet. Adaptation for civilian applications will advance telemedicine capabilities, the company said.

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

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Alcon withdraws all CyPass micro-stents, says it will not affect spin-off

Novartis (NYSE:NVS)’s Alcon said this week it is voluntarily withdrawing its CyPass micro-stents from the global market, but that the withdrawal will not affect its planned spin-out.

The decision to pull the devices comes off the analysis of five-year post-surgery data from the Compass-XT study of the device, which showed that patients treated with the stent had statistically significant loss of endothelial cells as compared to a control group. Endothelial cells are believed to be vital in maintaining visual functionality.

The company advised surgeons to immediately cease further implantation of the devices and return any unused devices to Alcon, and added that it will be communicating with surgeons with recommendations for evaluating and managing patients who have already been implanted with the device.

“We believe that withdrawing the CyPass micro-stent from the market is in patients’ best interest and is the right thing to do. Although we are removing the product from the market now out of an abundance of caution, we intend to partner with the FDA and other regulators to explore labeling changes that would support the reintroduction of the CyPass Micro-Stent in the future,” chief medical officer Dr. Stephen Lane said in a press release.

The withdrawal won’t affect Alcon’s planned spin-off from Novartis, according to a Reuters report, and should be immaterial to the company’s total sales.

Novartis’ Alcon won FDA clearance for the CyPass micro-stent, with indications for reducing intraocular pressure in patients suffering from glaucoma, in July 2016.

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FDA warns of flesh-eating genital infection linked to diabetes drug

The FDA this week warned of serious flesh-eating bacterial infections, or necrotizing fasciitis, reported by patients taking sodium-glucose cotransporter-2 (SGLT2) inhibitors intended for treating type 2 diabetes.

The federal watchdog said that between March 2013 and May 2018, 12 cases of Fournier’s gangrene, a rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat and blood vessels of the perineum, were reported by users of the drug.

Read the whole story on our sister site, Drug Delivery Business News

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$3.8 million federal grant targets suicide research

This image is from Marcel Just and David Brent’s initial study and shows the brain activation pattern for ‘death’ in participants who had made a suicide attempt (left). The image on the right depicts the activation pattern for ‘death’ in control participants. (Image courtesy of Carnegie Mellon University)

Researchers using brain imaging to identify people with suicidal thoughts just landed a $3.8 million grant from the National Institute for Mental Health.

Marcel Just of Carnegie Mellon University and David Brent of the University of Pittsburgh will use the money to advance their research analyzing the alterations in how brains represent certain concepts, such as death, cruelty and trouble. Their initial study was published in Nature Human Behaviour in 2017.

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

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Philips acquires pulse oximetry sensor maker Xhale Assurance

Royal Philips (NYSE:PHG) said this week it acquired pulse oximetry sensor maker Xhale Assurance for an undisclosed amount.

Xhale Assurance produces a disposable pulse oximetry sensor designed to be placed on the wing of the nose to monitor heart rate and blood oxygenation under low perfusion conditions, which Amsterdam-based Philips said can be challenging with conventional fingertip sensors.

Philips said that the acquisition will differentiate its existing oxygen saturation monitoring solutions protfolio and allow it to expand into an underserved clinical segment.

“Xhale Assurance’s nasal alar sensor offers exceptional clinical capabilities and strengthens our patient monitoring offering with a next-generation pulse oximetry sensor technology. The sensor technology also offers opportunities to develop measurements of further physiologic parameters. I am excited that this will augment our ability to offer solutions that enhance patient safety, support clinical workflow, improve caregiver efficiency, and help our customers implement value-based healthcare,” Philips monitoring & analytics biz leader Felix Baader said in a press release.

Earlier this week, a report emerged suggesting Philips is looking to cut another 280 jobs from its Andover, Mass.-based facilities.

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Advanced Bionics wins FDA nod for MRI-safe HiRes Ultra 3D cochlear implant

Sonova Holding AG (SIX:SOON) subsidiary Advanced Bionics said yesterday that it won FDA approval for its HiRes Ultra 3D cochlear implant.

The newly approved implant is cleared for use during magnetic resonance imaging examinations as it features a new magnet design which provides alignment with an external magnetic field in any direction.

The magnet allows users to move freely around an MRI machine’s magnetic field without pain or discomfort, or the need for removal or head bandaging, Advanced Bionics said.

“After many years of research and development, the new magnet technology in our cochlear implants will improve the quality of life for our many recipients due to our hassle free and pain free magnet. We are leading the way and ensuring our recipients have the best possible experiences with our advanced technology. It’s a powerful innovation and makes our efforts so rewarding for patients,” Sonova cochlear implants group VP Hansjuerg Emch said in a press release.

Last December, Advanced Bionics said that it plans to integrate Sonova‘s Sword chip and wireless radio tech into its sound processors.

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Is your medical device affected by new EU regulations?

By Ronald Boumans and Stewart Eisenhart, Emergo Group

Now that the European Medical Device Regulation (MDR) is widely available in draft form, manufacturers and other industry participants can more accurately predict key issues that will affect them—including how and whether the scope of the new regulations covers their devices.

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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Bovie Medical closes $97m sale of core electro-cautery biz to Symmetry Surgical

Bovie Medical (NYSE:BVX) said today it closed the $97 million sale of its core electro-cautery business, including the Bovie brand, to Symmetry Surgical.

The all-cash sale comes as Clearwater, Fla.-based Bovie looks to pivot toward the cosmetic surgery market, and includes transition services, patent licensing, disposables supply and generator manufacturing agreements. The deal also includes terms which will position Bovie as an OEM supplier to Symmetry for at least 10 years.

The sale, originally announced last month, leaves the advanced energy business and a pair of sites in Clearwater and Sofia, Bulgaria under the company’s belt as it looks to commercialize its J-Plasma and Renuvion offerings.

Bovie said that shareholders voted to approve the divestiture at an annual meeting today.

“The closing of the divestiture and sale of our core business segment to Symmetry is an important milestone for our organization as it allows us to further focus on our strategic objective of commercializing our J-Plasma technology under the Renuvion brand in the cosmetic surgery market. We believe this transaction has already created significant value for our shareholders and positions us to aggressively pursue the extremely compelling opportunity our Advanced Energy business has in serving the cosmetic surgery market. We look forward to sharing more details about the future growth and profitability profile of our Company – as well as updating our fiscal year 2018 financial guidance – on our corporate update call on September 5, 2018,” CEO Charlie Goodwin said in a press release.

Shares in Bovie Medical are up approximately 5.7%, at $5.24 as of 2:37 p.m. EDT.

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Report: Boston Scientific to expand Clonmel, Ireland-based facilities

Boston Scientific (NYSE:BSX) is planning on expanding its Clonmel, Ireland-based facilities at the end of the year, according to a new report from The Nationalist.

The expansion is dependent upon final planning approval which is slated for September, according to the report.

The Marlborough, Mass.-based company plans to add an approximately 34,000 square-foot administration building to its facilities in the area, as well as an additional 155 parking spaces.

Boston Scientific has already won conditional approval from the Tipperary County Council for the expansion, according to The Nationalist.

“We are very positive about this substantial investment in the site’s future,” the company said, according to the report.

Earlier this month, Boston Scientific said that it plans to submit the final technical module for the FDA premarket approval application for its Lotus Edge aortic heart valve system by the end of next week.

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Healthcare data analytics firm Tempus raises $110m in Series E

Medical data analytics company Tempus said today it has raised $110 million in a Series E financing round.

The Chicago-based company uses advanced machine learning, sequencing and AI-assisted image recognition to build medical and healthcare databases.

Funds in the round came from Bailie Gifford, accounts managed by T. Rowe Price, Revolution Growth, New Enterprise Associates and other existing investors. Funding raised will be used to expand operations into new therapeutic areas and geographies, Tempus said.

“Our mission is to help usher in precision medicine, in the United States and abroad. We couldn’t be more thrilled with our progress to date, and we’re honored to be surrounded by world class investors, collaborators, partners and an incredibly talented team here at Tempus,” founder & CEO Eric Lefkofsky said in a prepared statement.

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Avinger asks for FDA approval of small-vessel PAD device

Avinger (NASDAQ:AVGR) has filed for 510(k) clearance of its Pantheris small-vessel “lumivascular” atherectomy device for treatment of peripheral artery disease (PAD).

The Pantheris small vessel (SV) device extends the company’s line of  Pantheris catheters, the first and only image-guided atherectomy devices for the treatment of PAD, which is estimated to affect over 12 million people in the U.S. and over 200 million worldwide. Designed with a lower profile and longer length, Pantheris SV is intended to expand the number of addressable procedures for Pantheris by allowing physicians to target lesions in smaller-diameter vessels and more distal regions of the vasculature.

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

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Report: Sotera Health exploring possible $5B sale

Private-equity owned sterilization company Sotera Health is considering a potential sale that could be worth as much as $5 billion, according to a recent Reuters report.

Company owners Warburg Pincus and GTCR are working with investment banks in pursuit of a sale of the company, though the process is still in its early stages and there is no guarantee that a deal will emerge, according to the report.

Warburg Pincus declined to comment, while GTCR and Sotera did not immediately respond to requests for comment, Reuters reports.

Sotera was picked up by GTCR in 2011 from Silverfleet Capital and PPM America Capital Partners, and sold a majority stake to Warburg Pincus in 2015, according to the report.

In April, Sotera Health said that it inked a deal to sell the medical isotopes segment of its Nordion business to a subsidiary of BWX Technologies for an undisclosed amount.

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Pixium Vision’s novel Prima chip helps patients see the light

Pixium Vision said today that its Prima miniature wireless photovoltaic sub-retinal implant has been activated in the first five patients.

The patients all have severe vision loss from atrophic dry age-related macular degeneration. They are enrolled in a three-year clinical study in France to evaluate the safety and function of the Prima chip in eliciting visual light perception, the company said in a statement. All five reported seeing useful light patterns in areas where they had had no remaining light perception. The current study patients will be taught how to interpret their new artificial central macular perception.

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

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Otsuka inks collab deal to bring Abilify Mycite drug-device combo to US

Otsuka Pharmaceutical (TYO:4578) said today it inked a collaborative deal with health management group Magellan Health to distribute its drug-device combo Abilify Mycite in the US.

The Tokyo-based pharmaceutical company touted the Abilify Mycite system as the first FDA-approved drug-device combo designed to track drug ingestion, and said that the tracking data will be integrated into Magellan Health’s mental health provider network.

Read the whole story on our sister site, Drug Delivery Business News

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Henry Schein to settle anti-trust class action for $39m

Henry Schein (NSDQ:HSIC) said today it expects to pay approximately $38.5 million to settle an anti-trust class action suit related to dental supplies.

The case, which was filed in the US District Court for the Eastern District of New York, alleges that the defendants violated anti-trust rules by fixing prices on dental equipment and supplies, as well as other claims.

The Melville, N.Y.-based company said that it expects to incur a charge of $38.5 million in pre-tax money, or 19¢ per share, to settle the case.

The charges are slated to go on the books for the company’s third quarter, though the settlement is subject to a definitive agreement amongst all engaged parties, as well as court approval. Co-defendants Patterson (NSDQ:PDCO) and Benco Dental also expect to settle, Henry Schein said in its press release.

“We categorically and emphatically deny any wrongdoing, and we have made a business decision in the best interests of the Company to engage in settlement discussions to avoid long, distracting litigation and the additional use of resources. We have a long history of serving customers with integrity and honesty, and we have earned our reputation for doing business ethically in a competitive business environment,” board chair & CEO Stanley Bergman said in a press release.

Shares in Henry Schein have fallen 4.6% so far today, at $77.34 as of 11:04 a.m. EDT.

In February, the U.S. Federal Trade Commission filed a complaint against Henry Schein, Patterson and Benco alleging violations of US antitrust law by conspiring to refuse to provide discounts to or to serve buying groups representing dental practitioners.

The three companies, which the FTC claims control more than 85% of all dental product distributor sales in the US, face allegations that they denied independent benefits of such buying groups to dental practices mostly composed of small businesses, including solo or small groups of dentists.

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FDA gives nod to Eden Spine’s Sphynx

Eden Spine’s Sphynx plating system has won FDA clearance, the company said today.

Sphynx was designed to complement the company’s Giza titanium vertebral body replacement with rotatable endplates, introduced in 2012. The Giza is intended to replace and fuse a collapsed, damaged, or unstable vertebral body due to a tumor or a fracture and provides multiple angulation options by rotating the endplates.

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

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Stryker to acquire K2M for $1.4B

Stryker (NYSE:SYK) said today it inked a definitive agreement to acquire K2M (NSDQ:KTWO) for approximately $1.4 billion.

In the deal, Kalamazoo, Mich.-based Stryker said it will pay $27.50 per share for each outstanding share of K2M, for a total of approximately $1.4 billion.

The purchase price represents a 27% premium over K2M’s average closing price during the 90 days of trading ended August 29, and will position K2M as a wholly owned subsidiary of Stryker after closing.

Stryker said that the acquisition will strengthen its spinal division’s offerings in the core spinal segment and complex spine market, as well as adding “an attractive minimally invasive spine portfolio.” The addition will also improve Stryker’s additive manufacturing capabilities and global footprint, the company said.

K2M chair & CEO Eric Major is slated to serve as Stryker’s spine division president to lead the combined business, with current Stryker spine prez Bradley Paddock assisting in the transition and integration efforts.

“Joining Stryker will be a very exciting next chapter for our global team and surgeon customers around the world. Stryker’s established leadership in the orthopedic and neurosurgical market, combined with K2M’s culture of innovation and leadership in complex spine and minimally invasive solutions, represent a powerful opportunity for Stryker to strengthen its leadership in the $10 billion global spine market,” K2M CEO Major said in a press release.

The deal, which has already won approval from both company’s board of directors, is slated to close in the fourth quarter.

The acquisition is expected to have an immaterial dilutive impact on Stryker’s earnings per share this year. Stryker said it is not changing its adjusted net earnings per diluted share guidance for the year, expected to be between $7.22 and $7.27, and that it is reaffirming its previous guidance.

“This acquisition underscores our commitment to the spinal market, which is the largest segment of Orthopaedics with significant unmet needs. We believe K2M will significantly enhance our presence with surgeons, patients and employees in both the spine and related neurotechnology markets,” Stryker chair & CEO Kevin Lobo said in a press release.

Shares in K2M have risen 25.4% so far today, at $27.38 as of 10:19 a.m. EDT. Shares in Stryker have fallen slightly, down 0.8% at $169.95.

In late July, Stryker posted second quarter earnings that topped expectations on Wall Street and lifted its guidance for the remainder of the year.

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J&J’s DePuy Ortho on the hook for $246m in Pinnacle hip implant bellwether

Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics is on the hook for approximately $246.1 million in damages in a bellwether case over its allegedly defective Pinnacle metal-on-metal hip implants, according to recently released court documents.

Judge Ed Kinkeade of the Texas Northern District Court entered approximately $246.1 million in final judgements for plaintiffs in the bellwether case after a jury ruled in their favor, finding J&J liable for the defects and fraud.

The ruling included a total of approximately $43.7 million for plaintiff Hazel Miura, $36.8 million for Eugene Stevens, $37.8 million for Michael Stevens, $39.8 million for Ramon Alicea, $39.4 million for Uriel Barzel and $48.6 million for Karen Kirchner, according to court documents.

The amount is approximately $1 million lower than the $247 million in damages initially listed in the ruling released last November, but is in line with the amounts the plaintiffs were seeking, according to court documents from earlier this month.

Last November, the jury ruled that the controversial metal-on-metal hip implants were defectively designed and that patients did not receive appropriate warning about the risks associated with them, according to the report.

The six plaintiffs and patients in the case claimed that after implantation, the devices led to injuries including tissue death, bone erosion and other negative health effects, according to Reuters.

In the case, plaintiffs said that the companies falsely promoted the device with claims that it would last longer than more basic implants which featured plastic or ceramic materials.

The verdict is the fourth test trial in Dallas federal court over the metal-on-metal Pinnacle hips, with over 9,000 cases pending.

In December 2016, a federal jury in Dallas ordered J&J and DePuy Orthopedics to pay more than $1 billion to 6 plaintiffs claiming to be injured by its Pinnacle metal-on-metal hip implants, according to the plaintiffs lawyers.

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FDA proposes Class I designation for some medical device accessories

By Stewart Eisenhart, Emergo Group

US medical device regulators have published a list of medical device accessories for which they are proposing classification as Class I devices.

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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Seikowave Dental raises $1m

Seikowave Dental has raised $1.2 million in a new round of equity financing, according to a recently posted SEC filing.

Money in the round came from 19 anonymous investors, with the first sale noted on June 27, according to the filing.

Seikowave Dental is reportedly developing a dental 3D imaging platform intended to for intra-oral 3D measurements of teeth, according to a brief on the company posted on OrthopaedicSeminar.com.

Parent company Seikowave also produces an industrial 3D scanning device intended for the field inspection of corrosion, dents and other infrastructure damage, according to the company’s website.

The company is looking for an additional $1.3 million before closing the round, aiming to bring the total raised up to $2.5 million, according to the SEC filing.

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Progenerative Medical closes $2m seed round

Progenerative Medical said earlier this month it closed a $1.5 million seed round to help support its Regenn Therapy product.

The Regenn Therapy product is a negative-pressure technology intended for use in spine and orthopedic indications, and will be initially applied in spinal fusion procedures, Progenerative Medical said.

The system is based off technology licensed from Kinetic Concepts, the San Antonio, Texas-based company said. First-in-human testing of the Regenn Therapy system is slated to begin later this year.

“Our team now has the resources to continue the translation of our promising technology, which has been proven in extensive preclinical studies, into clinical use. This clinical experience, along with completed product design and well-crafted regulatory and reimbursement strategies, will position Progenerative for a Series A raise in 2019,” co-founder & CEO James Poser said in a prepared statement.

In September 2016, Progenerative Medical said that it inked an exclusive licensing agreement with Acelity subsidiary Kinetic Concepts Inc. for a negative-pressure technology portfolio it aims to develop for spine and general orthopedic procedures.

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Atlantic Therapeutics touts muscle stimulation device for urinary incontinence

Atlantic Therapeutics‘ Innovo shorts beat intravaginal probe devices at keeping women with stress urinary incontinence dry in an FDA-designed clinical trial.

An externally worn electrical muscle stimulation device, Innovo demonstrated greatly reduced risk of infection and improved user tolerability over the intravaginal devices, according to research presented this week at the International Continence Society meeting in Philadelphia.

Get the whole story at our sister site, Medical Design & Outsourcing.

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Appeals court resuscitates LifeWatch anti-trust suit against Blue Cross

The US Court of Appeals this week reinstated a suit from LifeWatch (SWX:LIFE) Services claiming that Blue Cross Blue Shield and associated plans conspired to deny coverage to devices it produces.

LifeWatch claims that BCBS and associated groups “shielded themselves from patient demand for the seller’s device by agreeing to deny coverage as ‘not medically necessary’ or ‘investigational,’ even while the medical community, other insurers, and independent arbiters viewed it as befitting the standard of care,” according to court documents.

Judges for the Third Circuit court of appeals, after examining the case, ruled that LifeWatch had “plausibly pled an agreement between the Blue Plans and the Association that unreasonable restrains trade in the national market for outpatient cardiac monitors,” and reversed a previous dismissal of the case.

Third Circuit Judges commented that while they reversed the dismissal, they believed that Blue Cross “may be exempt from liability under the McCarran-Ferguson Act,” and remanded it so that BCBS’s associated argument could be considered, according to court documents.

In March 2016, LifeWatch said that an arbitrator from the International Centre for Dispute Resolution ruled against the firm and in favor of Highmark Blue Cross Blue Shield to the tune of $18.7 million.

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SynCardia responds to FDA note warning of high rates of stroke, mortality risk with TAH-t C2 Driver

SynCardia Systems this week responded to an FDA notice warning about a higher mortality risk and stroke rate with the company’s Temporary Total Artificial Heart Companion 2 Driver System noted as part of a post-approval study of the device.

In its response, the Tucson, Ariz.-based company said that the FDA letter, which warned of risks associated with the next-gen C2 driver, was not a recall notice, and that hospitals should continue to use the C2 driver without restriction.

SynCardia also said that the C2 Driver had not been identified as the root cause of the issues, which included higher rates of mortality and cerebrovascular accidents.

“None of the primary causes of death in the C2 Cohort was the result of a device malfunction. The Device Malfunction Adverse Event (AE) analysis revealed that the reliability of the C2 Driver is consistent with the reliability of the CSS Console as demonstrated by non-statistically significant rates of occurrence per 100 patient months of Device Malfunction AEs at three months (CSS: 1.8 vs. C2: 3.8) and six months (CSS: 1.8 vs. C2: 3.3) post-implant,” the company wrote in its response letter.

SynCardia said that data from the post-approval study also showed that most cerebrovascular accidents occurred within the first three months of TAH support, which the company believes “is due to patient pre-implant condition” and that patient duration on the C2 Driver does not result in a higher rate of adverse events.

The company said that it performed an in-depth multivariable logistic regression analysis under the post-approval study looking to identify pre-implant risk factors associated with mortality or CVAs compared to 70cc TAH-t patients initially supported by the C2 Driver, and found that neither had a statistically significant impact on mortality or CVAs.

“The C2 Driver System is pulsatile, pneumatic and operates in the same manner as the CSS Console. We stand behind the C2 Driver as the hospital driver used to support SynCardia TAH-t patients. As required by FDA, a summary of the results of Phase I of our PAS will be added to product labeling, and surveillance of our products will continue in Phase II of our PAS. We look forward to collaborating with FDA on study design improvements for Phase II, during which we will scrutinize patient pre-implant condition in more detail. Phase II will also include the subset of patients who transfer to Freedom Driver support,” Syncardia said in a press release.

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Here’s how you can teach the FDA a thing or two

Medical device manufacturers, the FDA would like to pay you a visit.

As part of its experiential learning program, the agency’s Center for Devices and Radiological Health (CDRH) wants to send its premarket review staff out in the field to learn about industry practices, innovative technologies, regulatory impacts and needs, and how patient perspective and quality systems management advance the development and evaluation of innovative devices, and monitor the performance of marketed devices.

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

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ivWatch wins CE Mark for continuous IV site monitor

ivWatch said today that it won CE Mark clearance for its intravenous infiltration/extravasation monitoring device.

The company’s ivWatch Model 400, which has FDA clearance, is sold in the U.S. through group purchasing contracts with Premier and Vizient.

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

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How AI can diagnose a leading cause of blindness

Photo by Victor Freitas on Unsplash

The study that led the FDA to approve an AI system for diagnosing diabetic retinopathy came out today, revealing how one of the leading causes of blindness can be detected in a primary care physician’s office.

Published in the journal Nature Digital Medicine, the pivotal study of IDx-DR on 900 adults with diabetes showed 87% sensitivity, 90% specificity, and a 96% imageability rate, demonstrating the AI system’s ability to bring specialty-level diagnostics to primary care settings. Primary care staff at the 10 study sites received four hours of training on IDx-DR.

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

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BioSig raises $4m

BioSig Technologies (OTCQB: BSGM) has raised $4.1 million in a new round of equity and warrants financing, according to a recently posted SEC filing.

The Santa Monica, Calif.-based company is looking for an additional $5.9 million before closing the round, aiming to raise a total of $10 million in the round.

Funding in the round came from 72 unnamed investors, with the first sale dated on August 13, according to the SEC filing.

BioSig has not yet stated how it plans to spend funds raised in the round.

Earlier this month, BioSig said that it won FDA 510(k) clearance for its Pure EP electrophysiology system.

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FDA releases Zimmer Biomet warning letter

The FDA yesterday released the warning letter it sent last week to Zimmer Biomet (NYSE:ZBH)over quality violations found during 2016 and 2018 inspections at a plant in Warsaw, Ind.

Zimmer revealed its receipt of the August 24 letter earlier this week, saying it doesn’t expect to take a material hit from resolving the issues flagged in the letter and that it doesn’t bar the company from selling any devices made at the plant.

The FDA inspected the North Campus facility in Warsaw just before Thanksgiving 2016, documenting numerous violations in a Form 483. The company’s lengthy reply that December detailed its actions in remediating the problem, noting that company-wide audits put in place after the $14 billion merger of Zimmer and Biomet had already turned up problems at the site. Zimmer said it cleaned house after the inspection, replacing five operations and quality executives as it sought to bring the facility back into compliance.

But a re-inspection last April resulted in another Form 483 and now a warning letter flagging “continuing, significant violations of the quality system regulations” found during the most recent inspections conducted from April 9 to April 24.

The letter flagged Zimmer Biomet for not being able to show that its process for corrective and preventive actions can ensure that the plant meets finished product specifications.

“We are concerned about your firm’s ability to verify the effectiveness of the corrective actions included in this CAPA, when errors are not being identified in your interim processes,” the agency wrote in the letter, which also cited validation and sterilization issues.

The federal safety watchdog’s inspectors also found that the plant lacked adequate training procedures.

“During the inspection, we observed five separate operations in which employees on the production line were not following production procedures adequately,” according to the letter.

The inspectors also found problems with the North Campus facility’s design validation processes, its handling of non-conformance reports and its CAPA implementation, according to the warning letter.

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Ceterix Ortho wins expanded FDA nod for NovoStitch Pro

Ceterix Orthopaedics said yesterday it won expanded FDA 510(k) clearance for its NovoStitch Pro meniscal repair system, clearing the system for use with a size 0 suture cartridge.

The Fremont, Calif.-based company’s NovoStitch Pro system is designed to allow surgeons to place stitches arthroscopically in tight joint compartments to treat meniscal tears that had previously been unrepairable.

“The considerable strain placed on the knee’s meniscus during common physical activities makes it particularly prone to injury. Having access to a larger suture provides additional possibilities for meniscal repair,” Dr. David Flanigan of the Ohio State University Wexner Medical Center said in a prepared statement.

The additional clearance of the new 0 suture cartridge gives surgeons extra options in suture size that can allow them to pass a complete stitch within the knee joint without having to remove the device to reload a suture, Ceterix said.

“Ceterix continues to bring advanced technology to orthopaedic surgeons who are looking for better ways to preserve the meniscus. This latest innovation will be especially beneficial to those surgeons who prefer an ‘all-inside, all-suture’ procedure with a stronger suture for the more-demanding meniscal root repairs,” prez & CEO John McCutcheon said in a press release.

In April, Ceterix Orthopaedics said that it won FDA clearance for its next-gen NovoStitch Pro meniscal repair system.

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ALR Technologies inks Indian distribution deal for diabetes management device

ALR Technologies and Aspire Cerebro Advertising have inked a marketing deal in India for the ALRT diabetes management system.

Aspira Cerebro Advertising plans to create a comprehensive marketing plan for the ALRT Diabetes Solution system, with the intent of bringing the technology to India’s estimated 100 million diabetes patients.

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

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UK MHRA issues new guidance for medtech and IVD companies in wake of Brexit

By Ronald Boumans, Emergo Group

In early August 2018 the UK Medicines & Healthcare products Regulatory Agency (MHRA) issues three new guidance documents for medical device, IVD and related healthcare sectors to prepare for ramifications of Brexit.

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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Ra Medical re-ups $86m IPO registration

Ra Medical has re-upped its registration for an upcoming initial public offering looking to bring in approximately $86.3 million, according to a recently posted SEC filing.

Ra Medical produces the Dabra atherectomy catheter laser designed to treat patients with peripheral artery disease. The system is designed to destroy arteriosclerotic blockages through the use of radiation ablation, which the company touts as having significant advantages over traditional balloon angioplasty systems.

Ra Medical won FDA 510(k) clearance for the system last May, and CE Mark approval in the European Union in 2016.

The Carlsbad, Calif.-based company originally registered for the IPO in July, saying it plans to list on the New York Stock Exchange under the symbol “RMED,” according to the filing.

Piper Jaffray and Cantor Fitzgerald are acting as joint book runners for the offering, according to the newly posted filing.

The company has not yet released details on the IPO, but had initially planned to launch the offering in February this year.

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Climb every mountain, armed with cardiac info

Credit: NPS Photo / Mary Lewandowski

Cardiac Insight’s Cardea Solo wearable electrocardiogram sensor was put to the test in May when a climbing team scaled North America’s highest peak to gather previously limited high-altitude cardiac data.

The mountaineering team, comprised of military members, veterans and a physician from non-profit organization U.S. Expeditions and Explorations (USX) and Cardiac Insight, climbed Denali in Alaska to measure the effects of high-altitude exercise on the heart.

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

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Outset Medical closes $132m Series D funding round

Outset Medical said today it raised $132 million in a Series D round of equity financing, with funds slated to accelerate the commercial expansion of its Tablo hemodialysis system.

The San Jose, Calif.-based company develops and produces the Tablo hemodialysis system, an all-in-1 dialysis machine designed to handle water purification and dialysate production and be used in a variety of different settings.

The round was led by the newly invested Mubadala Investment Company and joined by existing investors Baxter Ventures, Fidelity Management and Research Company, Partner Fund Management LP, Perceptive Advisors, funds advised by T. Rowe Price Associates and Warburg Pincus.

“Our investment in Outset Medical represents an exciting opportunity for Mubadala, as it is aligned with our goal of improving people’s lives while meeting a major global market need. We selected Outset Medical as our first U.S. private medtech investment because of Tablo’s ability to significantly improve global dialysis care and address one of the biggest areas of worldwide healthcare spend with very disruptive and innovative technology,” Mubadala pharma & medtech senior VP Camilla Languille said in a prepared statement.

Funds from the round will be used to help support production capabilities and to accelerate the commercial expansion of its Tablo system in acute and chronic care markets in the US, Outset said.

“Tablo offers patients and healthcare providers a new option for more flexible and convenient dialysis treatment, improving the dialysis experience while at the same time reducing overall dialysis spend. We are grateful to our investors for the opportunity to significantly impact the future of dialysis care,” CEO Leslie Trigg said in a press release.

Last month, Outset Medical raised $4.3 million in a round of mixed financing, according to an SEC filing.

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First patients receive Centinel’s 3-D printed titanium spinal implants

Centinel Spine (New York) has completed the initial cases with three different implant portfolios within its FLX platform of integrated interbody and non-integrated interbody fusion devices.

FLX devices are 3D-printed, all-titanium implants with a combination of solid and porous radiolucent sections designed to reduce mechanical stiffness and improve visibility, as compared to solid titanium implants. The devices also have a proprietary “fuse-thru” trabecular scaffold designed to allow for bony in-growth and on-growth throughout the implant. Centinel Spine received FDA-clearance for multiple cervical and lumbar interbody fusion device families in May of this year.

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

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Masimo touts study exploring ORi’s ability to detect oxygenation during moderate hyperoxia

Masimo (NSDQ:MASI) today released results from a study exploring the ability of the company’s Oxygen Reserve Index (ORi) to show trends in oxygenation during moderate hyperoxia.

The company’s ORi measure is intended to serve as a non-invasive, relative indicator of an individual’s oxygen reserve during moderate hypoxia. The measurement can be trended and can be used to notify of changes in oxygenation, the Irvine, Calif.-based company said.

Investigators in the trial collected data from 20 adult volunteers who breathed a series of standardized oxygen concentrations ranging from mildly hypoxic to extremely hyperoxic. Both ORi and SpO2 were measured by sensors on both the second and fourth fingers and displayed on a Masimo Radical-7 Pulse Co-Oximeters, the company said.

Arterial blood samples were taken for blood gas analysis and PaO2 was measured invasively using a Siemens Rapidpoint 405 co-oximeter, the company said.

Researchers examined 1,090 paired data points of simultaneous ORi and PaO2 values, and found that correlation between ORi and PaO2 was positive at all points. To assess ORi’s trending ability, researchers used a 4-quadrant plot and calculated that ORi trending and PaO2 within the range of 100-200 mmHg had a 94% concordance rate.

“In this prospective volunteer validation study, a strong and positive correlation between PaO2 and ORi was found, together with a good trending ability. Based on these data, the future use of ORi as a continuous noninvasive monitoring tool for assessing oxygenation status in patients receiving supplemental oxygen might be supported. […] In healthy volunteers, ORi provides reasonable trending information of PaO2 around the moderate hyperoxic range of PaO2 for which its use is intended. Also, changes in PaO2 are well reflected by changes in ORi, with good concordance. The trend in ORi can be used to track changes in PaO2 levels in the moderate hyperoxic region, and absolute values should not be interpreted for PaO2 levels,” study researchers wrote.

“ORi fills a gap in the monitoring of patients receiving supplemental oxygen by noninvasively and continuously trending the course of arterial oxygen tension. It may help to better titrate oxygen therapy to avoid both hypoxia and unintended hyperoxia,” study co-author Thomas Scheeren said in a prepared statement.

Study investigators noted a number of study limitations, including the need for additional studies to confirm the findings in a clinical setting and the influence of factors such as patient comorbidity and clinical circumstances requiring further research.

Earlier this month, Masimo and rival Dominion settled a suit over blood monitoring patents, according to court documents.

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Teleflex launches CleanSweep closed suction ventilation study

Teleflex (NYSE:TFX) said today it launched a US-based clinical study of its CleanSweep closed suction system and that it enrolled the first patient in the trial.

The Wayne, Penn.-based company’s CleanSweep system uses both balloon sweeping tech and traditional suction collection to remove secretion build-up on the insides of endotracheal tubes. In early bench top testing the system was shown to remove 2.5 times more secretions than leading, traditional closed suction devices, the company said.

“Evaluating the effectiveness of closed suction devices further supports Teleflex’s commitment to developing technologies that help to advance respiratory care. CleanSweep closed suction system has the potential to make a positive impact to airway management of the critical care patient,” Teleflex respiratory VP Michael DiGiuseppe said in a press release.

The trial will take place at Durham, N.C.’s Duke University Hospital, Teleflex said, and will explore the system’s ability to treat patients who are receiving pressure or volume assist control ventilation who require endotracheal tube suctioning more frequently than once every 2.5 hours.

Patients will be randomized to treatment with the CleanSweep system or standard closed suctioning. Prior to suctioning and within 15 minutes after research investigators will measure respiratory system mechanics, hemodynamics and gas exchange, Teleflex said.

“During mechanical ventilation, secretions accumulate and microbial biofilm may form inside the ET tube. Even small reductions in ET tube radius can increase airflow resistance significantly. The CleanSweep closed suction system may offer significant advantages in reducing ET tube obstruction,” Dr. Neil MacIntyre of Duke University Hospital said in a prepared statement.

Earlier this month, Teleflex saw shares fall after the medical device maker beat earnings per share expectations on Wall Street but missed on sales consensus with its second quarter results.

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