Medical Metaverse Company, apoQlar, Receives FDA 510(k) Clearance for its Mixed Reality Surgical Planning Platform, VSI HoloMedicine® – Yahoo Finance
HAMBURG, Germany, Dec. 5, 2022 /PRNewswire/ — apoQlar, a German medical technology company, today announced it has received FDA 510(k) Class II clearance for VSI HoloMedicine®, a pioneering mixed reality software device enabling surgeons to plan complex procedures using the power of immersive 3D holographic technology. With this clearance, the USA becomes the 30th country for apoQlar to receive medical certification in. apoQlar will extend its distribution of VSI HoloMedicine® in the USA for clinical use through its subsidiary in Miami, Florida, with availability expected in the second quarter of 2023.
Following this major achievement, apoQlar is now raising a Series A round, its first ever fundraising campaign, to scale VSI Holomedicine® as the foundation of modern surgical care.
“With mixed reality, we are no longer bound to physical objects in a physical world. We can leverage digital objects and services on top of the real world for equal or greater utility and usually at a fraction of the cost. Mixed Reality is a completely new way for people, and in our case surgeons, physicians and technologists, to continue to experience the real world around them but with an entire virtual layer placed on top” says Sirko Pelzl, Co-Founder & CEO of apoQlar.
VSI HoloMedicine® gives surgeons an almost “x-ray vision” perspective in surgical planning processes using 3D holographic technology. Physicians across any medical field can now plan surgeries in 3D and visualize medical data inside or outside of the operating room. Using Microsoft’s HoloLens 2, a mixed reality head-mounted display (HMD), surgeons can transform otherwise flat CT, Angio CT, MRI, CBCT, PET, and SPECT sources into interactive 3D holograms. Sirko continues to say that “we are excited to finally offer VSI HoloMedicine® to improve surgical outcomes for patients and to provide surgeons with sophisticated surgical planning tools to enhance their overall planning process.”
“FDA clearance marks a major milestone for us. We are a young company, but this serves as a true testament of our collective team mindset and diligence” says Liliana Duarte, COO of apoQlar. This is the latest achievement for apoQlar in their global expansion plan and serves as a tailwind for further market expansion efforts into South-East Asia, India, and the Gulf Coast States for 2023.
Please visit www.apoQlar.com or www.linkedin.com/company/apoQlar/ to learn more.
apoQlar was founded in 2017 in Hamburg, Germany to give healthcare a new perspective. apoQlar developed an affordable medical metaverse technology, VSI HoloMedicine®, that brings the crucial third dimension to surgical planning, remote consultation, patient education and medical training. VSI HoloMedicine® holds FDA 510(k), CE Class I and HSA Class A medical certifications for clinical use in 30 countries. The full intended use description of VSI HoloMedicine can be found here.
If you would like more information about VSI HoloMedicine® for your clinical & education institution or interested in learning more about apoQlar’s Series A round, please contact press@apoQlar.com.
Photo – https://mma.prnewswire.com/media/1959036/apoQlar_3D_holograms.jpg
Logo – https://mma.prnewswire.com/media/1959037/apoQlar_Logo.jpg
View original content:https://www.prnewswire.co.uk/news-releases/medical-metaverse-company-apoqlar-receives-fda-510k-clearance-for-its-mixed-reality-surgical-planning-platform-vsi-holomedicine-301691732.html
Top-line data from a phase IIb/III study shows that Anave's (AVXL) lead drug exhibited statistical and clinical improvement in cognition and function in patients with early Alzheimer's disease.
Provention Bio (NASDAQ: PRVB) is a small-cap biotech whose shares have doubled in the past three months. The company can thank the expected and eventual approval of Tzield for that performance. In mid-November, Tzield became the first and only treatment approved by the U.S. Food and Drug Administration (FDA) for the delay of the onset of type 1 diabetes (T1D) in at-risk patients.
GSK and Roche have pulled drugs approved on an accelerated basis, while other drugmakers win speedy approvals only after starting confirmatory studies.
(Bloomberg) — Verve Therapeutics Inc. shares fell the most in five months, pulling down shares of rival drugmakers, after the biotechnology company said US regulators requested additional information before allowing a test of its gene therapy to begin. Most Read from Bloomberg‘Huge, Missing and Growing:’ $65 Trillion in Dollar Debt Sparks ConcernStocks Down Across the Board as Bond Yields Spike: Markets WrapAmbitious Plans to Build Indonesia a Brand New Capital City Are Falling ApartChina’s Cov
By Exec Edge Editorial Staff Until recently, DNA tests have been costly and inaccessible for many individuals, researchers, and clinicians. But, over the past seven years, Andrea Riposati and Mattia Capulli’s global genomics and precision medicine company, Dante Labs, has made these tests more accessible to people all over the world. Dante Labs uses the […]
The FDA lifts the clinical hold on BEAM's investigational new drug application for BEAM-201 to treat relapsed/refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma. Stock up.
Thanks to well-received clinical trial data for its investigational Alzheimer's therapy, lecanemab, shares of Biogen (NASDAQ: BIIB) are up by more than 51% in the past three months — and the company hasn't even made a single dollar from the positive findings yet. Including lecanemab, Biogen has a dozen programs in late-stage clinical trials, all but four of which are being developed for indications in neurology. Its areas of focus within neurology are Alzheimer's disease and Parkinson's disease, though it also has a trio of programs for multiple sclerosis (MS) in development.
Novartis' (NVS) phase III PSMAfore study evaluating Pluvicto for treating patients with PSMA-positive metastatic castration-resistant prostate cancer meets primary endpoint.
The data will be submitted for regulatory approval next year to the U.S. Food and Drug Administration , Novartis said.
Medtronic (NYSE:MDT) today announced the completion of enrollment and final treatment in the SPHERE Per-AF Trial, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial designed to evaluate the safety and effectiveness of the first-of-its kind Sphere-9™ pulsed field (PF) and radiofrequency (RF) ablation, and high density (HD) mapping catheter with the Affera cardiac mapping and navigation platform for the treatment of persistent atrial fibrillation (AF).
The end result could be “hundreds of millions” of infected Chinese, Dr. Ali Mokdad, a professor at the University of Washington’s Institute for Health Metrics and Evaluation, said.
NEW YORK (AP) — The U.S. flu season keeps getting worse. Health officials said Friday that 7.5% of outpatient medical […] The post Flu season worsens as 44 states report high activity appeared first on TheGrio.
For those prone to seasonal affective disorder, a shift in the sleep cycle can impact energy levels. Ben Akiba/E+ via Getty ImagesThe annual pattern of winter depression and melancholy – better known as seasonal affective disorder, or SAD – suggests a strong link between your mood and the amount of light you get during the day. To put it simply: The less light exposure one has, the more one’s mood may decline. Wintertime blues are common, but about 10 million Americans are affected every year by
Drug patents don't necessarily spur companies to innovate so much as restrict access to their IP. Andrii Zastrozhnov/iStock via Getty Images PlusBiomedical innovation reached a new era during the COVID-19 pandemic as drug development went into overdrive. But the ways that brand companies license their patented drugs grant them market monopoly, preventing other entities from making generics so they can exclusively profit. This significantly limits the reach of lifesaving drugs, especially to low-
Masimo's (MASI) SpHb is likely to enhance transfusion management and post-operative patient outcomes on patients.
Less well known pain-inducing conditions include trigeminal neuralgia- often described as an electric shock shooting through the face
China’s decision to soften COVID-19 restrictions in the face of widespread protests cheered markets while also raising worries about a surge in infections
SimpleImages / GettyThe fight against COVID seems to have fallen into a ping-ponging rhythm at this point, where every step forward seems undercut by one backward. Vaccines are available, and hospitalization rates have fallen dramatically from previous peaks. But just a sliver of eligible Americans have received the most recent bivalent shot, and the specter of a new, somehow worse variant looms large in our collective psyche. Elsewhere, such as in China, we seem to be losing ground to the virus
Two daughters and one grandson of Brazilian soccer great Pelé said the three-time World Cup winner has been hospitalized since Tuesday to treat a respiratory infection aggravated by COVID-19. Kely and Flavia Nascimento and Arthur Arantes do Nascimento said in an interview aired Sunday night that Pelé, who is also undergoing chemotherapy in his fight against cancer, is expected to leave the Albert Einstein hospital in Sao Paulo once he fully recovers from the respiratory infection. The hospital said Saturday that Pelé is responding well to treatment for the infection and his health condition had not worsened over the previous 24 hours.
Have your healthcare needs and personal finances changed since 2019? The answer is probably yes, especially if you’re a Medicare beneficiary. As I reach my first anniversary leading eHealth Inc., a company that serves Medicare beneficiaries, and as a Medicare-age person myself, I’ve learned how important it is to reassess your coverage options each year.
Leave a Comment
You must be logged in to post a comment.