Latest news with #DeNovo
Otago Daily Times
18-06-2025
- Entertainment
- Otago Daily Times
Art seen: June 19
"Reflections on Time — Images Over Blueskin Bay", Angela Burns (Gallery De Novo) Readers who know Angela Burns' art may get a surprise looking at her latest exhibition at De Novo. While much of Burns' style is intact, these pieces are far more clearly representational than much of the artist's former oeuvre. The play of light, expressed in broad sweeps of colour, remains present, but distinctive landforms are also clearly depicted — islands, fences, and hillsides. Burns' strong gestural strokes are still the basis of much of the art, but the lure of the photographic has led the artist to produce more strongly grounded landscapes. Inspired by photographs of the view from Double Hill Rd above Waitati, the artist has created a series of images which move between the tangible and the intangible, with plays of light on the water framed by the hills around Blueskin Bay. At times, especially when focusing on the water and sky, such as Lavender Haze over Blueskin Bay , the images have the same free abstraction as Burns' earlier works. In other pieces, the land is clearly delineated without losing the airy impressionism of the more ethereal pieces. A major surprise is the use of acrylic on both canvas and paper; the latter pieces using deft washes of colour that give them more the feel of gouache or heavily applied watercolour. "Through the Fray" (Blue Oyster Art Project Space) "Through the Fray" brings together work by three recent graduates from Dunedin School of Art. All three explore personal, political, or cultural journeys towards coming of age. In the case of Zac Whiteside, the struggles to be seen as a "true Kiwi bloke" and "one of the team" are brought into focus by a washing line filled with rugby jerseys fashioned out of steel wool. The duality of the material — abrasive yet polishing — connects with the often brutal process by which young New Zealanders are shaped into adulthood. Jude Hanson Stevens asks questions of the tactics by which European settlers claimed land in New Zealand using the concept of "Terra Nullius" ("Uninhabited land"). The artist presents a prosaic fence constructed from items salvaged from farm land. The ubiquitous No 8 wire brings with it association of makeshift solutions, and the tōtara posts have echoes not only of farm demarcation but also of traditional pouwhenua. Isabella Lepoamo examines cross-cultural memories, turning a battered La-Z-Boy armchair and discarded beer bottles, the signs of adulthood on the decline, into a Samoan throne, decorated with siapo patterns and surrounded by lilies. There is sadness here, but also strength and pride in the memory of the artist's father and grandfather, trying to create a new home in a new land. "You Can Go Back to the Past, But No-one Will be Waiting for You There", Simon Attwooll (Hutch) Simon Attwooll presents an intriguing exhibition at the new Hutch Gallery in Moray Pl. Working from found photographs of the aftermath of a house fire, the artist creates images which honour a loving memory of the house as it was, while simultaneously using the remains from a house fire as his medium. Crushed and refined charcoal powder from a burnt-out property is used as the medium, rubbed in great clouds over images of fire sites. What emerges are smoky images that seem reminiscent of early daguerrotypes and tintypes, photographs blurred by distant memory and faded with dust. We experience the visceral feel of the destroyed properties, the detritus of what was once a home. In some cases, the work has been compartmentalised by the addition of empty matchbox drawers to the surface, making the image into an almost forensic grid. Are we supposed to be trying to find the source or cause of the conflagration? Among the sooty black, one pale work stands out, almost as a ghost of a house, presented in palest acrylic grey on white. It is as if the spirit of the house still haunts the site, waiting for a release that understanding of the fire alone can bring. By James Dignan
Business Wire
18-06-2025
- Business
- Business Wire
Virtual Incision Appoints Jim Alecxih as Chief Executive Officer
LINCOLN, Neb.--(BUSINESS WIRE)-- Virtual Incision Corporation, the developer of the MIRA Surgical System authorized by the FDA through the De Novo regulatory pathway, today announced the appointment of Jim Alecxih as chief executive officer. Alecxih, a recognized commercial leader in the medical device industry, brings more than 30 years of experience advancing transformative surgical technologies worldwide, including a distinguished tenure at Intuitive Surgical, where he played a pivotal role in the adoption and growth of the da Vinci Surgical System. Virtual Incision is now preparing for the accelerated development and commercialization of their next system, M2, with plans for a series of FDA submissions in various specialties. M2 is a miniaturized, single port surgical robotic system designed to be smart, simple and small, with the potential to minimize the cost and complexity of current mainframe cart-based surgical robotic systems. M2 will be optimized to bring robotic-assisted surgery to hospitals and surgical settings that lack access to surgical robotics technologies. Mr. Alecxih previously served as CEO of DH Medical, an AI software company, and has held executive leadership roles across multiple healthcare startups and growth-stage companies. At Intuitive Surgical, he led U.S. sales and was instrumental in driving adoption of robotic-assisted surgery among hospitals and health systems nationwide. 'The opportunity to lead Virtual Incision at this pivotal time is an extraordinary honor,' said Jim Alecxih, CEO of Virtual Incision. 'I believe deeply in the benefits of robotic-assisted surgery to both patients, surgeons and hospitals. M2 has the potential to dramatically expand access to robotic-assisted surgery in rural hospitals, HOPD and ASC settings, and around the world. Virtual Incision's visionary approach is to ensure that robotic-assisted surgery is more accessible, flexible and scalable for a broader range of operating environments. I'm thrilled to join this talented team and help accelerate our impact on patients and providers.' 'We are delighted to welcome Mr. Alecxih to Virtual Incision at this significant stage in the company's growth,' said Tyler Stowater, partner at Bluestem Capital and Virtual Incision board member. 'Mr. Alecxih's exceptional leadership skills and deep industry knowledge make him the ideal person to lead us into our next phase of growth and innovation.' Mr. Alecxih joins Virtual Incision at a time of significant momentum. In 2025, the company has been honored as a finalist or winner in three prestigious innovation awards: Fast Company's World's Most Innovative Companies SXSW Innovation Award Fierce MedTech's Fierce 15 Virtual Incision's MIRA Surgical System is designed to offer a portable, scalable solution for minimally invasive procedures with a small footprint and a simple setup. With M2, the company aims to expand clinical capabilities and will continue redefining the future of robotic-assisted surgery. About the MIRA Surgical System MIRA is the world's first miniaturized robotic-assisted surgery (RAS) system. Its small, sleek form factor is designed to offer the benefits of RAS during colectomy procedures without the logistical inefficiencies of traditional mainframe robotics. The easily accessible device weighs approximately two pounds (less than one kg) and offers internal triangulation with shoulders, arms, and infinite wrist roll inside of the body. It can be used in any operating room – a dedicated operating room is unnecessary. With its drape- and dock-free design and portability, MIRA is quick to set up, clean up, and move between cases. Its conveniently accessible design positions it to be used as a standalone system or a complementary tool for facilities that already own a legacy surgical robotic system. With MIRA, every operating room is RAS-ready. About Virtual Incision Virtual Incision is on a mission to simplify robotic-assisted surgery (RAS), so more patients and their surgeons can access its benefits every day. Headquartered in Lincoln, Nebraska, and holding over two hundred patents and patent applications, the company developed MIRA, the first-of-its-kind miniature RAS system. Virtual Incision's goal is to make every operating room RAS-ready. For more information, visit our website or follow us on LinkedIn. Important Safety Information The MIRA Surgical System is intended for prescription use only. Patients should talk to their doctor to decide if surgery with a MIRA Surgical System is right for them. For important safety information, indications for use, risks, and warnings, please refer to Cautionary Note Regarding Forward-Looking Statements This communication contains statements that constitute 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include but are not limited to, statements regarding our plans, beliefs, expectations, assumptions, and other statements that are not necessarily historical facts. You are cautioned that these forward-looking statements are only predictions and involve risks and uncertainties. Further, any forward-looking statement speaks only as of the date on which it is made, and we do not intend to update or revise any forward-looking statements. This communication also contains market data related to our business and industry which includes projections that are based on several assumptions we believe are reasonable and most significant to the projections as of the date of this communication. If any of our assumptions prove to be incorrect, our actual results may significantly differ from our projections based on these assumptions.
Yahoo
17-06-2025
- Health
- Yahoo
Materna Medical Announces Ellora™ and Additional Close on $20M Series B2
MOUNTAIN VIEW, Calif., June 17, 2025--(BUSINESS WIRE)--Materna Medical, Inc., a leading innovator in women's pelvic health solutions, has announced the completion of a recent close within an ongoing $20 million Series B2 financing round. The round welcomed new funds GLIN Impact Capital, Wealthing VC Club, and Citrine Angels, and was led by InnovaHealth Partners and other key existing investors Wavemaker Three-Sixty Health, Kimera Limited, Women's Venture Capital Fund, and Golden Seeds. "As we celebrate the addition of these new funds to our investment team, we are also excited to announce the new commercial name for our second product, Ellora™ (formerly Materna Prep), aiming to transform the standard of care in labor and delivery," commented Tracy MacNeal, Chief Executive Officer for Materna Medical "Over 20 of the top hospitals in the US have been incredible partners in the EASE trial for Ellora™, which will be the basis of our FDA De Novo submission this summer." For more information on Materna Medical, visit About Materna Medical Materna Medical is a novel OBGYN platform company defining a $25B market with core technologies addressing unmet needs in women's pelvic health. With headquarters in Mountain View, California, Materna pulls from the top minds in MedTech to truly transform the standard of care in OBGYN. With a diverse team of engineers, scientists, researchers, and commercial leaders, Materna Medical's mission is to empower women to protect their pelvic health. Our first product, Milli™, is vaginal dilator to support patients suffering from vaginismus and related painful sex. In 2019, the Milli device launched as a wellness trainer and, in 2023, received FDA clearance to sell over the counter, enabling streamlined access to people suffering from vaginismus. Milli outcomes have been studied in a post-market prospective virtual study named POMPOM. Materna's second product, Ellora™, is an investigational device used during labor and is intended to reduce pelvic floor muscle injury during vaginal delivery. This product is being studied in the EASE trial, a large, randomized controlled trial in 20 top US hospitals. Materna aims to transform the standard of care in labor and delivery by protecting pelvic floor health for moms. View source version on Contacts Debbie DonovanHead of Commercial OperationsMaterna Medical, Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
02-06-2025
- Business
- Yahoo
ADDING MULTIMEDIA Clairity Becomes the First FDA-Authorized AI Platform for Breast Cancer Prediction – Historic Milestone for Women's Health
CLAIRITY BREAST provides clinicians with a first-in-class, novel platform for identifying future risk of breast cancer A milestone in equitable healthcare, with potentially life-saving insights from a screening mammogram alone FDA grants De Novo authorization for new device for future five-year breast cancer risk prediction, based on an image alone BOSTON & CHICAGO, June 02, 2025--(BUSINESS WIRE)--Clairity, Inc., a digital health innovator advancing AI-driven healthcare solutions, has received U.S. Food and Drug Administration (FDA) De Novo authorization for CLAIRITY BREAST, a novel, image-based prognostic platform designed to predict five-year breast cancer risk from a routine screening mammogram. With this authorization, Clairity is planning to launch among leading health systems through 2025 – propelling a new era of precision medicine in breast cancer. Each year, more than 2.3 million new cases of breast cancer are diagnosed worldwide1, including over 370,000 cases in women in the United States2. Early detection and risk reduction are powerful tools to save lives, but their most effective deployment depends on accurate risk assessment. Most risk assessment models rely heavily on age and family history to predict risk. However, 85% of women diagnosed with breast cancer have no family history, and nearly half have no identifiable risk factors3,4. In addition, traditional risk models, built on data from predominantly European Caucasian women, have not generalized well to women of diverse racial and ethnic backgrounds5. CLAIRITY BREAST analyzes subtle imaging features on screening mammograms that correlate with future breast cancer risk, making early risk prediction feasible based on a screening mammogram alone. The result is a validated five-year risk score delivered to healthcare providers through existing clinical infrastructures, supporting more personalized follow up care. "For more than 60 years, mammograms have saved lives by detecting early-stage cancers. Now, advancements in AI and computer vision can uncover hidden clues in the mammograms – invisible to the human eye – to help predict future risk," said Dr. Connie Lehman, Founder of Clairity, who is also a breast imaging specialist at Mass General Brigham. "By delivering validated, equitable risk assessments, we can help expand access to life-saving early detection and prevention for women everywhere." "Personalized, risk-based screening is critical to improving breast cancer outcomes, and AI tools offer us the best opportunity to fulfill that potential," said Dr. Robert A. Smith, Senior Vice President of Early Cancer Detection Science at the American Cancer Society. "By integrating AI models that assess individual risk, we can better identify women at higher risk, and those who may benefit from supplemental screening methods, such as MRI, improving early detection and more effective prevention strategies." "Clairity's FDA authorization is a turning point for more women to access the scientific advances of AI-driven cancer risk prediction," said Larry Norton, Founding Scientific Director of the Breast Cancer Research Foundation. "Breast cancer is rising, especially among younger women, yet most risk models often miss those who will develop the disease. Now we can ensure more women get the right care at the right time." "What makes the availability of CLAIRITY BREAST a true sea change is that we're now predicting risk of future cancer from patterns in breast tissue, in an otherwise normal screening, before it's even there," said Jeff Luber, CEO of Clairity. "CLAIRITY BREAST is designed to fit seamlessly into the current clinical infrastructure to help providers scale precision prevention – with the goal of reducing late-stage diagnoses, lowering costs, and saving more lives." The FDA De Novo authorization positions CLAIRITY BREAST as a first-in-class platform within the $63 billion global breast cancer prediction market, ushering in a new standard for personalized, risk-based screening and cancer prevention. Be the first to know when it launches, and how you can get it: About CLAIRITY BREAST CLAIRITY BREAST, authorized under the name Allix5, is a mammography-based AI risk prediction platform that analyzes imaging data at the pixel level to identify individuals at elevated risk of future breast cancer. The AI model behind CLAIRITY BREAST was trained on millions of images and validated across more than 77,000 mammograms from five geographically distinct screening centers – including hospital-based and free-standing facilities – that collectively serve a diverse patient population, with validation anchored in five-year outcome data. To learn more about indications for use, visit: Clairity's first-in-class platform was designed to complement existing clinician workflows, making it uniquely positioned to address, at scale, the widespread shortfalls in breast cancer risk assessment and cancer prevention. About Clairity Founded in 2020 and headquartered in Boston, Massachusetts, Clairity, Inc. is transforming healthcare risk assessment through the power of artificial intelligence and deep learning. Founded by Dr. Connie Lehman, backed by Santé Ventures and ACE Global Equity, Clairity's technology can uncover subtle patterns in routine images that are invisible to the human eye, enhancing risk prediction to empower clinicians and their patients with actionable, personalized insights. Clairity's mission is to shift the standard of care from late-stage treatment to proactive prevention. To learn more, visit us at | LinkedIn ____________________ References: 1 2 3 4 5 View source version on Contacts Media Contact: Nina GillLaVoieHealthScience781-856-3103ngill@ Investor Interest: Sam LibbyTCB Capital Advisors973-563-3141samlibby@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
30-05-2025
- Health
- Business Wire
FDA Grants De Novo Clearance for Reflow Medical's Spur ® Peripheral Retrievable Stent System
SAN CLEMENTE, Calif.--(BUSINESS WIRE)--Reflow Medical, Inc., a leading developer of innovative medical devices focused on complex cardiovascular disease, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo clearance for the company's Spur Peripheral Retrievable Stent System, a unique clinical solution for the treatment of de novo or restenotic lesions following predilatation in patients with infrapopliteal arterial disease. This first-of-its-kind technology offers a truly novel approach to treating patients with BTK CLTI disease. Share The Spur Stent System is the first and only retrievable stent system that features a self-expanding stent with an integrated dilatation balloon catheter on an over-the-wire system. It is designed for controlled lesion penetration and treatment through a series of radially expandable spikes. Known as Retrievable Scaffold Therapy (RST), the spikes on the Spur Stent penetrate the lesion to increase the acute luminal diameter and modify the lesion morphology to change vessel compliance and reduce vessel recoil effect. Results of the recently concluded DEEPER REVEAL clinical trial (NCT05358353) to evaluate the Reflow Medical Spur Stent System for below-the-knee (BTK) treatment of chronic limb-threatening ischemia (CLTI), demonstrated that following predilatation, the Spur Stent System achieved a 99.2% technical success 1 rate and 97.0% freedom from MALE 2 and POD 3 at 30 days. 'Clinical data submitted to the FDA demonstrated the safety and efficacy of the Spur Stent System,' said Mahmood K. Razavi, MD, FSIR, FSVM, who serves as Director of the Clinical Trials and Research Center at St. Joseph Heart and Vascular Center in Orange, California. 'This novel device will be a valuable and innovative expansion of our treatment toolbox as a unique device for the treatment of complex BTK disease,' he added. S. Jay Mathews, MD, MS, FACC, FSCAI, the Cath Lab Director at Bradenton Cardiology/Manatee Memorial Hospital in Bradenton, Florida, commented, 'It's exciting to see the clinical success of the DEEPER REVEAL trial enabling the De Novo clearance of the Spur Stent System. This first-of-its-kind technology offers a truly novel approach to treating patients with BTK CLTI disease. As an adjunct to standard balloon angioplasty, Spur RST enables us to address this complex disease in a more effective way, achieving these outcomes that go beyond what PTA alone can deliver.' Both Dr. Mathews and Dr. Razavi were lead Principal Investigators for the study, which was conducted at 49 centers in the U.S. and enrolled 130 patients. 'Extensive research and development, which laid the groundwork for the DEEPER REVEAL trial, enabled the creation and clinical validation of the Spur Stent System, an innovative mechanical endovascular device engineered to enhance lesion penetration and optimize the treatment of BTK peripheral arterial disease,' said Teo Jimenez, Senior Vice President of R&D at Reflow Medical. According to Reflow Medical CEO and Co-Founder, Isa Rizk, 'The FDA's De Novo clearance, following positive clinical trial results in patients with CLTI, enables us to provide physicians with an effective therapeutic option for this growing patient population. We are fully prepared to launch our innovative technology through our dedicated sales force, ensuring it promptly reaches physicians to support patients.' The FDA decision will be available on their website under DEN240048. About Reflow Medical, Inc. Reflow Medical is a global company that partners with leading physicians to develop innovative technologies addressing unmet clinical needs in the endovascular treatment of complex cardiovascular disease. The company's portfolio includes coronary and peripheral microcatheters, crossing catheters, and a revolutionary system known as Retrievable Scaffold Therapy (RST). Products include the CoraCatheters line, available in the U.S. only; the Wingman™, Spex ® and Spex LP, available in the U.S., CE Mark and CE Mark-accepting countries and selected markets; and the Spur ®. Spur received CE Mark approval for the treatment of restenotic lesions in below-the-knee arteries, when used in conjunction with a commercially available drug-coated balloon. Reflow Medical is headquartered in San Clemente, California. 1. Technical success defined as less than 30% residual stenosis by visual estimation; 2. Major adverse limb events; 3. Perioperative death
