Dune Medical launches first-in-man Smart Biopsy trial

Dune Medical Devices said today that it launched a first-in-man trial of its Smart Biopsy device, touting that the first patients in the trial have already been treated.

The first-in-man cases were performed by Dr. Noemi Weissenberg of Kfar Saba, Israel’s Meir Medical Center, the Alpharetta, Ga.-based company said.

Dune Medical’s Smart Biopsy system is a percutaneous soft tissue biopsy device that uses miniaturized sensors in the core needle to generate electrical parameters on sampled tissue in real-time. Those electrical signals are compared to histopahtologic findings to improve diagnosis and read-out.

“The in-man phase is the continuation of a broader and more comprehensive clinical trial aimed at definitive tissue characterization in the breast, Dunes first application. The collective works will be published later this year as a revolutionary solution for enhancing accuracy in biopsy diagnosis and guide future development of RF Spectroscopy across the oncology spectrum. We’re thrilled to have met this important milestone in our strategy to offer multi-cancer applications,” CEO Lori Chmura said in a press release.

Last July, Dune Medical launched a reposable version of its MarginProbe radiofrequency spectropscopy device, which can help surgeons identify remaining cancer cells in real time during a lumpectomy.

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Masimo wins FDA 510(k) for Rad-67 pulse co-oximeter


Masimo (NSDQ:MASI) said today it won FDA 510(k) clearance for its Rad-67 pulse co-oximeter system.

The Rad-67 offers both Rainbow non-invasive hemoglobin measurement and measure-through motion and low perfusion SET pulse oximetry, and can be used with the Irvine, Calif.-based company’s Rainbow DCI-mini sensor for spot-check monitoring.

The system also features a rechargeable battery with a six-hour run time and a high-resolution color display with touchscreen navigation.

Masimo said that the combination of spot-check monitoring measurements of both oxygen saturation and non-invasive hemoglobin makes it viable as a single-device solution in clinical and non-clinical settings.

“The Rad-67 is incredibly easy to use and gives a quick result, perfect in our busy pre-operative clinic. We have found it particularly useful as it helps us target those patients who may need further testing,” Dr. Andrew Klein of Cambridge, U.K.’s Royal Papworth Hospital said in a press release.

The company clarified that the Rad-67 spot-check SpHb monitoring is not cleared for pediatric patients, pregnant patients or patients with renal disease, and that it is not intended to replace laboratory blood testing.

“We’re proud to launch Rad-67, Spot-check next generation SpHb monitoring, and the rainbow DCI-mini in the United States. Spot-check Next Generation SpHb monitoring represents a significant enhancement to the noninvasive measurement we invented a decade ago – a measurement we look forward to continuing to improve,” founder & CEO Joe Kiani said in a prepared statement.

Earlier this month, Masimo said that it won CE Mark approval in the European Union for its next-gen SedLine brain function monitor intended for pediatric patients.

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Omron wins FDA nod for combined blood pressure monitor, EKG


Omron Healthcare (TYO:6645) has won FDA 510(k) clearance for its Blood Pressure Monitor + Echocardiogram device, according to a recently posted FDA release.

The device, which was developed in collaboration with AliveCor, allows users to monitor both high blood pressure and atrial fibrillation, which the company said are critical risk factors for stroke.

The newly cleared device is designed to sync with the Omron Connect mobile application to store, track and share heart health data with physicians to improve outcomes, the company said in its original product release.

The combined product, under the moniker BP7900, was cleared by the FDA earlier this month after being found substantially equivalent, according to the FDA release.

Last December, Omron launched its HeartGuide wearable blood pressure monitor, touting it as the world’s first device of its kind.

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Baxter, Biomérieux ink acute kidney injury biomarker dev deal


Baxter (NYSE:BAX) said today that it inked a partnership deal with Biomérieux looking to develop biomarkers to identify acute kidney injury.

The partnership was announced at the International Symposium on Intensive Care and Emergency Medicine, Deerfield, Ill.-based Baxter said.

Both companies said they hope to develop the biomarkers to help rapidly identify and inform treatment of acute kidney injuries, which can lead to death if untreated.

“We’re committed to improving outcomes for critically ill patients across the continuum of care, which includes identifying opportunities to diagnose AKI earlier so a patient can receive the best therapy. By working with the team at Biomérieux, we’ll be able to combine their expertise in diagnostics with our experience in bringing the latest medical advancements to the ICU,” Baxter acute therapies biz GM Reaz Rasul said in a prepared statement.

“As a leader in pioneering diagnostic solutions, we’re looking forward to collaborating with Baxter to address the important challenges in critical care medicine such as AKI. In order to accomplish this, the team at the recently-acquired Astute Medical is committed to the development of additional high medical value biomarkers for improved patient care,” Biomérieux chief medical officer Mark Miller said in a press release.

In January, Baxter said that it acquired healthcare software developer True Process.

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Lessons learned from Lantheus CEO Mary Anne Heino

At MassMedic’s Women in Medtech event last month, Lantheus Medical Imaging CEO Mary Anne Heino spoke with MassDevice.com editor Sarah Faulkner about her career in life sciences, the power of mentorship and the necessity of courage.

When Mary Anne Heino first joined Lantheus Medical Imaging (NSDQ:LNTH) in 2013, she knew admittedly very little about the field of diagnostics.

“I was walking into a company where the average tenure was more than 25 years,” she said. “So these were people who knew what they were doing and had been doing it for so long…I was intent from day one to show that I was ready to learn and that I knew nothing and therefore was an open sponge for them to teach me.”

Six years later, Heino describes Lantheus as a “completely different company” – public, profitable and “one of the darlings of medtech.”

She came to Lantheus with 20 years of experience at Johnson & Johnson (NYSE:JNJ) and training as a nurse under her belt, so she certainly wasn’t new to the world of healthcare. But she believed that successfully transitioning to the C-suite at Lantheus would require showing her employees that she was willing and excited to learn from them.

“If people sincerely read that you want to learn and that you value them and what they can teach you, you get this incredibly different experience than if you come in trying to superimpose some kind of experience that you think is relevant on them,” Heino explained. “And I just left myself open to learning from them and to learning the entire field of diagnostics.”


The value of mentorship is clearly written out in Heino’s career – her first female mentor now sits on Lantheus’ board alongside a former J&J colleague whom Heino has known for two decades.

“I asked them to join my board and help me and they did. Because if you ask, you get more than you think,” she said.

“I met a lot of folks who were professional mentors and the commonality that you always find is that your mentor is right for you if they challenge you and don’t console you,” Heino added.

Offering advice to audience members seeking a mentor, the CEO noted that people need to keep in mind the commitment that they’re asking of a mentor.

“You’re asking for someone’s time and your asking for their commitment and their energy. We’re all incredibly busy; we all have very, very busy lives and so it is a request and it’s one that you should honor by bringing the type of conversation that has a goal that takes you forward in some direction for having had it and for having used somebody’s time,” she said.

But Heino also made sure to point out that, generally speaking, “people want to help and people want to feel like they have value and that’s what a great mentor can do for somebody.”


Beyond the relationships with mentors that she formed throughout her career, Heino found another way to learn from those around her.

“I looked around me my entire career and saw people doing great things. Either thinking different ways or coming at situations different ways and I modeled what I liked and what worked and I also learned what didn’t work for me,” she said.

Early on, Heino learned that if she wanted something, she needed to ask for it. She found herself constantly looking for and asking for new ways to grow within J&J, Heino explained.

“I quickly got myself into a pattern of looking for things that were different from what I had been doing that would stretch me in a different way,” Heino said.

This technique served her well over the course of her career, as she stepped into the new opportunities presented by J&J and later at Lantheus.

“My true belief about leadership is that the most important component of it is courage, because courage makes everything else possible,” Heino said. “What has to sit right behind it is your own confidence in yourself.”

“The world desperately needs leaders,” she added. “Our industry desperately needs leaders. So it’s almost our charge and our obligation to step up and fill in the spots.”

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T2 Biosystems shares tumble on 2018 earnings release

T2 Biosystems Logo

Shares in T2 Biosystems (NSDQ:TTOO) have fallen nearly 20% today after the diagnostics maker posted its full year 2018 earnings.

For the full year, the Lexington, Mass.-based company posted losses of $51.2 million, or $1.26 per share, on sales of $10.5 million, seeing losses shrink 18.1% while sales grew 125% compared with the previous year.

For its fourth quarter, T2 Biosystems reported total sales of $1.8 million, up 6% when compared to the same period during the previous year.

“2018 was a year of major achievements for the company highlighted by the FDA clearance of the T2Bacteria panel, which has driven record levels of new interest from hospitals and allowed us to accelerate the growth of our installed base. In the fourth quarter we secured a record 14 new system contracts, contributing to 25 secured in the second half of the year, which came in at the top of our expectations. The earliest of these new T2Bacteria panel customers have now completed the installation, validation and training processes and are beginning to test patients. Concurrently, we anticipate the body of clinical evidence supporting T2Bacteria Panel will grow this year, along with the sharing of best practices and experience between hospitals. We expect this steady increase of T2Bacteria panel activity to drive greater recurring revenue through 2019, and along with growing system contracts, will contribute to achieving our revenue growth guidance for 2019 and a doubling of revenue again in 2020. In 2019 we expect to further expand our market opportunity with the T2Resistance panel, which we expect to launch as a research-use only product in the U.S. and anticipate receiving a CE mark for commercial launch in Europe by the end of 2019. On the development front, we plan to collect data for our pivotal study for the T2Lyme Panel and are encouraged by pre-clinical data that shows the potential to improve patient outcomes,” prez & CEO John McDonough said in a prepared statement.

T2 Biosystems provided guidance for 2019, saying it expects to post revenue of approximately $21 million for the full year with sales of between $1.3 million and $1.5 million for the first quarter.

Operating expenses, excluding product revenue costs, are expected to be between $10.5 million and $11.5 million for its first quarter, the company said.

Shares in T2 Biosystems have fallen approximately 18.9% so far today, at $2.54 as of 2:45 p.m. EST.

Late last month, T2 Biosystems said that it won FDA breakthrough device designation for its T2Resistance Panel diagnostic designed to detect 13 drug resistance genes from a blood sample.

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Masimo wins CE Mark for next-gen SedLine pediatric brain monitor


Masimo (NSDQ:MASI) said today that it won CE Mark approval in the European Union for its next-gen SedLine brain function monitor intended for pediatric patients.

The Irvine, Calif.-based company said that with the clearance, its next-gen SedLine monitoring tech is now available for all patients one year and older in CE Mark countries.

Masimo said that the SedLine system is designed to allow clinicians to monitor the state of the brain while patients are under anesthesia. The company added that the system features a pediatric-specific signal processing engine intended to improve the performance of the company’s processed electroencephalogram parameter when monitoring pediatric patients.

The newly cleared system also features improvements over the first-gen SedLine including a reduced susceptibility to electromyography interference and a multitaper density spectral array.

“Next Generation SedLine is doing for brain function monitoring what Masimo SET did for pulse oximetry. We believe Next Generation SedLine is the best and most advanced way to monitor depth of sedation, crucial to helping ensure patients with even the most challenging brains are appropriately anesthetized. We are gratified that its benefits are now available to those younger patients whose brains are particularly delicate and to whose wellbeing Masimo has always been so committed,” founder & CEO Joe Kiani said in a press release.

In late January, Masimo said it won FDA clearance for its respiration rate measurement from the pleth RRp on its MightySat Rx spot-check fingertip pulse oximeter.

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Abbott wins $35m Defense contract for TBI assay

AbbottAbbott (NYSE:ABT) landed a contract with the U.S. Defense Dept. to develop a diagnostic assay to detect traumatic brain injuries, the Pentagon said yesterday.

The Chicago-area healthcare giant was the lone bidder for the $35.2 million fixed-price contract, with an estimated completion date of Aug. 31, 2022.

The deal also comes with an immediate $12 million R&D, test and evaluation award for fiscal 2019, according to the Defense Dept.

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T2 Biosystems wins FDA breakthrough nod for drug resistance blood test

T2 Biosystems Logo

T2 Biosystems (NSDQ:TTOO) said yesterday that it won FDA breakthrough device designation for its T2Resistance Panel diagnostic designed to detect 13 drug resistance genes from a blood sample.

The T2Resistance Panel is designed to identify 13 genes that the Lexington, Mass.-based company said include “the most clinically important.” This includes genes that indicate a resistance to antimicrobial drugs that can significantly affect the treatment of bacterial infections and several genes listed on the CDC’s Urgent Threat list for antibiotic resistance, T2 said.

The system is intended for use on both gram-positive and gram-negative pathogens from a single patient blood sample and eliminates the need to wait for blood culture, the company added.

“Under the current standard of care, diagnosing bloodstream infections caused by antimicrobial resistant pathogens requires a positive blood culture and subsequent analyses to determine exactly what medication will most effectively treat the infected patient. These conventional methods, including blood cultures and antimicrobial susceptibility testing, take 3 or more days to provide an actionable result. This leads doctors to start their patients on broad spectrum antibiotics before they even know exactly what they need,” medical affairs VP Sandy Estrada said in a prepared statement.

T2 Biosystems said that it expects the T2Resistance Panel to be available for research use only in the U.S. later this year, and that it is hopeful for CE Mark approval in the European Union and commercial availability in the region during the same time frame.

“We’re grateful to the FDA for bringing us one step closer to getting the T2Resistance Panel in the hands of clinicians across the country. With the introduction of this panel, the T2 product portfolio will continue to expand to enable clinicians to make fast, accurate treatment decisions for the more than 2 million people who get an antibiotic-resistant infection each year in the United States alone,” prez & CEO John McDonough said in a press release.

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FDA clears Mauna Kea Technologies system for lung cancer detection

Mauna Kea Technologies’ Cellvizio system

Paris-based Mauna Kea Technologies (ENT:MKEA) said that it has received  510(k) clearance from FDA for the use of the Cellvizio AQ-Flex 19 Confocal Miniprobe through existing bronchoscopes, transbronchial needles, and other bronchoscopic accessories to detect lung cancer.

Cellvizio is a multidisciplinary probe-based and needle-based confocal laser endomicroscopy (pCLE/nCLE) platform designed to aid clinicians in the diagnosis and treatment of cancer and other diseases using real-time, in vivo microscopic visualization, according to the company. This marks the 16th 510(k) clearance of the Cellvizio platform and its entry to the interventional pulmonary market.

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

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