Abbott inks deal to test blood donations in Japan

Abbott (NYSE:ABT) said today that it has been selected by the Japanese Red Cross Society (JRC) to partner in screening the country’s blood donations.

The eight-year contract is for the exclusive supply of serological instrumentation, tests, and consumables used for blood and plasma screening. The JRC screens approximately 5 million blood donations each year, helping ensure a safe supply of products needed for blood transfusions and plasma therapies. Abbott products are used to screen more than 60% of the world’s blood and plasma supply, according to a company statement.

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OtoNexus raises $4.4 million for ear infection detection technology

OtoNexus OtoNexus (Seattle) has raised more than $4.4 million as it continues to develop its ultrasound medical device technology to diagnose middle ear infections, according to a U.S. Securities and Exchange Commission Form D filed this month.

OtoNexus has been seeking a nearly $8.3 million from the money-raise. It previously raised $7.8 million in 2017.

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

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Johnson & Johnson, Apple ink collab for AFib study

Johnson & Johnson‘s (NYSE:JNJJanssen and Apple (NSDQ:AAPL) said today that the two companies inked a deal to study if an app from J&J in combination with the Apple Watch’s ECG app and irregular rhythm notifications can improve outcomes for people living with atrial fibrillation.

The study is slated to measure the impact of the Apple Watch on the early detection and diagnosis of AFib, as well as the efficacy of a medication adherence program.

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

 

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Bioventus launches Osteomatrix+ bone graft

BioventusBioventus announced today that it has started selling Osteomatrix+ – a moldable bone graft substitute intended for a variety of orthopedic and spine bone remodeling applications.

Bioventus officials boast that Osteomatrix+ has improved moldability, flexibility and versatility versus its predecessor.

“Osteomatrix+ represents the first of several next-generation products that will be added to the Bioventus portfolio in the next five years,” Bioventus CEO Tony Bihl said in a news release.

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

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Henry Schein pushes back date for animal health spinout

Henry Schein One

Henry Schein (NSDQ:HSIC) said today that it is shifting the date for the spin-out of its animal health business, now dubbed “Covetrus,” from February 4 to February 7.

The change was implemented by the Melville, N.Y.-based company’s board of directors, according to company press release.

The new date reflects the new anticipated date for distribution of shares in the spinoff company to shareholders of Henry Schein, according to the release.

Each prior shareholder in Henry Schein will receive a 0.4 share dividend of Covetrus stock for each Henry Schein share held as of January 17. The newly spun-out company is slated to trade under the symbol “CVET,” Henry Schein said.

The company warned that it has filed an amended registration related to its recently announced spinoff ‘s merger with Vets First Choice, but that it now anticipates the amended statement “will become effective no later than February 4, 2019 (assuming a continuation of the U.S. federal government shutdown), rather than January 28, 2019,” according to a press release.

Last week, Henry Schein set an initial timetable for the spinout of its animal health business in a merger with Vets First Choice, branding the soon-to-be-public company as Covetrus. The spin-out was first announced last April.

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Brainsway registers for $30m IPO

Brainsway

Brainsway has registered for an upcoming initial public offering, looking to bring in $30 million to support its transcranial magnetic stimulation tech, according to a recently posed SEC filing.

The Israel-based company said that it plans to list on the Nasdaq Global Market under the symbol “BWAY,” according to the filing.

Brainsway develops and supports medical platforms based around deep transcranial magnetic stimulation, which use magnetic fields to stimulate nerves in the brain.

Last August, Brainsway won FDA de novo approval for its deep transcranial magnetic stimulation system with indications for treating obsessive compulsive disorder.

With the clearance, the company now has indications on its platform for treating depressive episodes in adult patients with major depressive disorder and for treating OCD in patients who have been non-responsive to traditional treatments.

For its fiscal year 2017, the company posted net losses of approximately $7.1 million, or 48¢ per share, on sales of of approximately $11.2 million for its fiscal year 2017, seeing losses grow 66% while sales shrunk approximately 3.4% when compared to the 2016 fiscal year, according to the SEC filing.

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RFPi wins FDA nod for non-contact blood flow imaging tech

RFPi’s iCertainty shows images of blood flow and perfusion without contact with the patient.

FDA has cleared RFPi’s iCertainty real-time, noninvasive blood flow and perfusion imaging medical device for use during surgical procedures, the company said.

iCertainty is the first medical imaging device to show blood flow without interrupting a surgical procedure or requiring injections, dyes, radiation or direct patient contact, according to the Greenville, N.C. company. Use of iCertainty during surgery could reduce procedural complications or repeat surgeries, reduce hospital costs, and objectively measure and help to improve clinical outcomes, the company said in a prepared statement.

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JustRight Surgical rebrands to Bolder Surgical, raises $27m

Bolder Surgical

Bolder Surgical, formerly known as JustRight Surgical, said today that it raised $27 million in a new round of financing to support its laparoscopic surgical devices.

The round was led by River City Capital Funds and joined by Westwood Management, Providence Ventures and previous investors, the Louisville, Colo.-based company said. Funds raised in the round will support the company’s product innovation pipeline, increases in workforce and scaling commercialization.

In connection with the round, Westwood Management managing partner Lair Kennedy and River Cities Capital managing partner Carter McNabb will join the company’s board of directors.

The company announced its rebranding to Bolder Surgical along with the financing, saying that it hopes the move to the new moniker will “better align the company with its long-term vision of a robust product portfolio that expands beyond pediatric care.”

“I am extremely pleased with the investment led by River Cities Capital Funds, which will enable the company to continue to innovate and create safer procedural approaches that improve physician control and patient outcomes. Support from our highly respected investors further validates the company’s innovative technology and the positive impact our instruments have on patients, surgeons and the healthcare system. Bolder Surgical revolutionized minimally invasive surgery in children by providing right-sized instruments that improve access and visibility in the tiniest patients. While our name has changed from JustRight, we remain committed to leveraging our technical expertise in micro-device technology and energy delivery to elevate expectations for all surgical procedures. Bolder Surgical defines our evolved vision and increases the opportunity to impact the lives of more patients,” CEO Robert Kline said in a press release.

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Zoll Medical wins $400m DoD patient monitoring supply contract

Zoll Medical

Zoll Medical has won a $400 million contract with the U.S. Department of Defense to supply them with patient monitoring and capital equipment systems and accessories, according to a recently posted DoD release.

The deal comes through a five-year base contract with an additional single five-year option period, according to the release. A total of 36 responses for the competitive acquisition were received.

Patient monitoring and other systems from Zoll will be supplied to the Army, Navy, Air Force, Marine Corps and federal civilian agencies, according to the release, with the location of performance noted as Massachusetts. The contract has a performance completion date of January 13, 2024.

Chelmsford, Mass.-based Zoll Medical has not yet commented on the contract.

Earlier this month, Zoll Medical said that it acquired healthcare software solution developer Payor Logic for an undisclosed amount.

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Abbott to acquire mitral valve device maker Cephea Valve Tech

Abbott

Abbott (NYSE:ABT) said today that it plans to acquire mitral heart valve replacement tech developer Cephea Valve Technologies for an undisclosed amount.

The Chicago-area healthcare giant backed the Santa Clara, Calif.-based valve company in July 2015 and secured an option to purchase it outright, which it has now chosen to exercise.

Cephea is developing mitral valve tech designed to be delivered through a vein in the leg and remove the need for open-heart surgery, Abbott said. Neither company has released any details of the acquisition.

“The acquisition of Cephea builds on Abbott’s strong position in structural heart therapies and is consistent with our strategy to develop comprehensive treatments for people with mitral valve disease. Cephea’s novel approach to replace the mitral valve adds to our other catheter-based technologies and is being developed to provide an additional option for patients who suffer from this difficult-to-treat disease,” structural heart biz VP Michael Dale said in a press release.

The newly acquired tech from Cephea will join other mitral valve-focused devices the company previously scooped up, including its MitraClip tech acquired in 2009 from Evalve and minimally invasive mitral valve systems from Tendyne Holdings, which it acquired when it originally invested in Cephea, Abbott said.

Earlier this week, Abbott won FDA pre-market approval for its Amplatzer Piccolo occluder intended for treating a congenital heart defect in neonatal infants as small as two pounds.

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