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Stryker Launches New Tendon Fixation Device System

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Citrelock™ Differentiated Design Features Citregen™, A Bioresorbable Material

MAHWAH, N.J.–(BUSINESS WIRE)– Stryker’s Trauma & Extremities division has launched its Citrelock™ Tendon Fixation Device System. The new system provides surgeons a differentiated design via a tendon thread featuring a resorbable technology, known as Citregen™, that has unique chemical and mechanical properties for orthopaedic surgical applications. Stryker will debut Citrelock at the American Orthopaedic Foot & Ankle Society (AOFAS) Annual Meeting, Sept. 22-25, 2021, in Charlotte, N.C.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210915005253/en/

Stryker's new Citrelock™ Tendon Fixation Device System provides surgeons a differentiated design via a tendon thread featuring a resorbable technology, known as Citregen™, that has unique chemical and mechanical properties for orthopaedic surgical applications. (Photo: Business Wire)

Stryker’s new Citrelock™ Tendon Fixation Device System provides surgeons a differentiated design via a tendon thread featuring a resorbable technology, known as Citregen™, that has unique chemical and mechanical properties for orthopaedic surgical applications. (Photo: Business Wire)

“Our customers are looking for a more predictable and effective bioresorbable material than what is currently on the market,” said Michael Rankin, VP Marketing and Medical Education, Stryker Foot & Ankle. “The Citrelock Tendon Fixation Device System helps fill that need with its innovative material technology and unique design. Citregen is an exciting addition to Stryker’s existing biomaterial portfolio and will be expanded for use in additional Stryker Trauma & Extremities indications in the future.”

The Citrelock Tendon Fixation Device System offers surgeons:

  • A controlled and homogeneous resorption process that prevents bulk degradation and chronic inflammation.1
  • Compressive strength that is comparable to cortical bone with a modulus comparable to cancellous bone.1,2
  • Citregen contains citrate, calcium, and phosphate molecules that are inherent to the bone anatomy.1
  • Material polymer structure that mimics the extracellular matrix protein network.1
  • Citregen maintains structural integrity during the healing phase, while the implant is replaced by host tissue over time.1

“By leveraging Citregen’s unique material properties, the Citrelock Tendon Fixation Device System introduces design features to ease insertion and secure fixation without damaging the tendon during placement,” said Wayne Berberian, MD, orthopaedic surgeon at HMH Hackensack University Medical Center. “It has been exciting to observe the development of a biomaterial for use in orthopaedic applications. I’m excited to start using Citrelock in my practice.”

Citrelock will be featured during one of Stryker’s industry sessions at AOFAS on September 24. The company is also hosting a new product reception highlighting the benefits of Citrelock along with other recent additions to its Foot & Ankle portfolio. For more information, visit www.stryker-trauma.live/aofas-2021/ or stop by the Stryker booth (No. 425).

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

Follow Stryker Foot & Ankle on LinkedIn and Stryker’s Trauma & Extremities division on Twitter.

  1. FDA 510(k) K200725
  2. TM-190301

A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker’s product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any of Stryker’s products. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your sales representative if you have questions about the availability of products in your area.

CITE-BL-1, 08-2021

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Source: https://www.biospace.com/article/releases/stryker-launches-new-tendon-fixation-device-system/?s=93

Medical Devices

Types of hearing aids – comparison of models. What to choose?

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Everyone with hearing problems has their own individual hearing aid selection needs. These needs result from the type of ailments and the lifestyle, the expected level of comfort, and discretion. What types of hearing aids are on sale? How to choose the best model for yourself?

When is it advisable to wear a hearing aid?

A properly selected hearing aid allows you to improve your hearing and the comfort of everyday life. When is it advisable to wear a hearing aid?

Most often, hearing problems affect people over 50 and people exposed to noisy environments. 

Deterioration of hearing may be observed by frequent requests to repeat sentences or words, difficulties with understanding speech in noise, turning up the volume of the TV and radio, and speaking loudly via phone.

You can also find out about any hearing impairment using the online hearing test. When it indicates the probability of hearing deterioration, it is worth going to a specialist for a professional examination.

Types of hearing aids

Hearing aids are divided into two main product categories:

– custom hearing aids

– behind-the-ear hearing aids

These types of hearing aids differ in terms of their design and the way they are used. Which hearing aid should I choose?

Custom hearing aids

Custom hearing aids are placed directly inside the ear, making them almost invisible. They come in many colors. The main disadvantages of this type of hearing aids are their high price and greater susceptibility to damage. They also require regular cleaning from moisture and earwax.

Types of custom hearing aids:

– ITE FS hearing aids that completely fill the auricle – they are designed to fit inside the auricle, are noticeable due to their design, but can offer additional functions and longer work time thanks to a larger battery

– ITE HS hearing aids partially fill the auricle – they are smaller than ITE FS hearing aids, therefore they are less noticeable, but still offer wide functionality

– intra-canal ITC hearing aids – placed in the ear canal, small and barely noticeable in the ear

– Completely in-the-canal CIC hearing aids – smaller than ITC hearing aids, fitted to the ear canal, therefore almost invisible

– IIC hearing aids invisible in the canal – these are currently the smallest hearing aids, which are practically invisible when put on, recommended mainly for people with mild and moderate hearing loss

Behind-the-ear hearing aids

These are hearing aids that you place behind the ear. They are recommended especially for seniors with more severe hearing loss because they are easy to use. They also have high-capacity batteries and are not as vulnerable to moisture and earwax damage as custom devices.

Types of behind-the-ear hearing aids:

– BTE hearing aids – classic behind-the-ear hearing aids that can be used universally, equipped with an earpiece and a thin tube – sound conductor

– Open-dome hearing aids – do not use an earmold, resulting in a more natural sound

– RITE or RIC hearing aids – equipped with a temple and a receiver placed in the ear canal, they are more discreet than classic BTE hearing aids

To find the right hearing aid for you, visit your hearing care professional, who will show you the options available and advise you on the best model.

Source: Plato Data Inteligence

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Apollo Endosurgery Announces Positive MERIT-Trial Outcomes

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Trial Results Demonstrate ESG Procedure Offers Significant and Durable Weight Loss, with Improvements in Obesity-Related Health Conditions

  • MERIT-Trial met its primary endpoints for safety and efficacy, with patients undergoing the Endoscopic Sleeve Gastroplasty (ESG) procedure achieving excess body weight loss of 49.2% at 12 months and a serious adverse event rate of 2%
  • Patients undergoing ESG also had clinically significant reductions in diabetes, hypertension and metabolic syndrome at 12 months

AUSTIN, TX / ACCESSWIRE / October 22, 2021 / Apollo Endosurgery, Inc.  (“Apollo”) (NASDAQ:APEN), a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, today announced that study investigators of the Multi-Center ESG Randomized Interventional Trial (MERIT) presented positive outcomes.

Dr. Barham Abu Dayyeh, Professor of Medicine and Director of Advanced Endoscopy at the Mayo Clinic, presented the data at the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) during the “Top 10 Papers at IFSO” session.

Key highlights include:

  • Study Methods: The trial enrolled 208 patients across nine US centers. Patients were randomized between ESG and moderate lifestyle modification controls. Average BMI at enrollment was 35.7 ±2.6 kg/m2. The primary efficacy endpoint was Percent Excess Weight Loss (%EWL) and responders were defined as those achieving at least 25% EWL at 12 months. The study targeted a serious adverse event rate of <5%, which was the primary safety endpoint. Patients were followed for 24 months, with control subjects given the option to cross over at 12 months.
  • Efficacy: Patients undergoing Endoscopic Sleeve Gastroplasty (ESG) demonstrated an excess body weight loss (EWL) of 49.2% (+32%) at 12 months, which was a 45% difference in %EWL compared to patients undergoing moderate intensity lifestyle modification. Furthermore, 77% of subjects undergoing ESG achieved at least 25% EWL, and percent total body weight loss (%TBWL) for this responder group was 16.3% (+7%).
  • Impact on Co-Morbidities: Patients undergoing ESG demonstrated improvements in diabetes, hypertension, and metabolic syndrome compared to controls, as well as improvement in, and no onset of, gastroesophageal reflux disease (GERD).
  • Safety: ESG met the primary safety endpoint with a rate of serious adverse events of 2.0% (3/150), all of which resolved and did not require intensive care or surgical intervention[i].
  • Durability: Despite the Global Pandemic during year-two, cross-over patients achieved similar results to the initial treatment group and those that had undergone treatment maintained the vast majority of their weight loss at 24 months.

“The MERIT outcomes are compelling, and the medical community is eager to embrace new treatment options to address the global obesity problem,” said Dr. Abu Dayyeh. “Endoscopic Sleeve Gastroplasty offers a scalable, safe, effective, organ-sparing solution that can be performed in an outpatient facility by either a gastroenterologist or a bariatric surgeon. In addition, the ESG procedure can be combined with other therapeutic options to further enhance patient outcomes.”

ESG is a minimally-invasive (nonsurgical) weight loss procedure that uses the OverStitch™ Endoscopic Suturing System to reduce the volume of a person’s stomach. The MERIT data adds to a larger body of evidence for ESG of more than 200 publications and abstracts reporting positive outcomes in over 6,500 patients[ii].

Worldwide obesity has nearly tripled since 1975, with more than 650 million people now considered obese[iii]. In the U.S., more than 100 million adults are obese, greater than 40 percent of the adult population[iv]. Obesity related conditions including heart disease, stroke, type 2 diabetes, and certain types of cancer are among the leading causes of preventable, premature death. Obesity costs the U.S. health care system more than $170 billion a year[v]. Yet, less than one percent of obese patients are treated with bariatric surgical weight loss procedures each year.

“This is a significant milestone for Apollo in our mission to dramatically impact chronic obesity and obesity-related health conditions that continue unabated around the world,” said Chas McKhann, president and CEO of Apollo Endosurgery. “The results of MERIT support that the ESG procedure offers a compelling value proposition of clinically significant weight loss from a safe, convenient, outpatient procedure. We look forward to our continued work with the FDA, following our recent De Novo 510(k) submission, as we seek regulatory clearance to recognize ESG as a potential treatment option for those living with obesity.”

About the MERIT Study

The MERIT study (NCT03406975, FDA IDE G190189) is a multi-center, prospective randomized clinical trial evaluating the safety and effectiveness of the ESG procedure, a minimally invasive, endoscopic weight loss procedure performed with Apollo Endosurgery’s OverStitch® Endoscopic Suturing System compared to a medically monitored regimen of diet and healthy lifestyle. The co-principal investigators are Dr. Erik Wilson, University of Texas at Houston (Houston, TX), and Dr. Barham Abu Dayyeh, Mayo Clinic, (Rochester, MN) under a collaborative research agreement sponsored by Apollo Endosurgery. The study’s primary efficacy endpoint is to achieve at least 25% excess body weight loss (%EBWL) at 12 months and at least 15% EWL vs. control at 12 months, and the primary safety endpoint is a serious adverse event rate of less than 5%. Serious adverse events were those that scored a ‘3′ or more using the Clavien-Dindo classification. Additionally, patients undergoing ESG are being evaluated for improvement in hypertension and type 2 diabetes at 24 months.

About Apollo Endosurgery, Inc.

Apollo Endosurgery, Inc. is a medical technology company focused on development of next-generation, minimally invasive devices to advance therapeutic endoscopy designed to treat a variety of gastrointestinal conditions including closure of gastrointestinal defects, managing gastrointestinal complications, and the treatment of obesity. Apollo’s device-based therapies are an alternative to invasive surgical procedures, thus lowering complication rates and reducing total healthcare costs. Apollo’s products are offered in over 75 countries today and include the X-Tack® Endoscopic HeliX Tacking System, the OverStitch® Endoscopic Suturing System, the OverStitch Sx® Endoscopic Suturing System, and the ORBERA® Intragastric Balloon.

Legal Notice Regarding Forward-Looking Statements

Certain statements in this press release are forward-looking statements that are subject to risks and uncertainties that could cause results to be materially different than expectations, including Apollo’s expectations regarding the final publication of the MERIT-Trial data supporting the presentation and Apollo’s utilization of the MERIT-Trial results in a submission to the FDA to potentially add a new indication for ESG. Important factors that could cause actual results to differ materially include: further analysis and full publication of the MERIT-Trial data may result in additional information, conclusions or characterization of the achievement of trial objective and endpoints; the impact of the ongoing COVID-19 pandemic and the effect it may have on Apollo’s operations, the demand for the Apollo’s products, Apollo’s liquidity position, global supply chains and economic activity in general; reports of adverse events related to our products, outcomes of clinical studies related to our products; development of competitive products or procedures; regulatory approvals and extensive regulatory oversight by the FDA or other regulatory authorities; unfavorable media coverage related to our products or related procedures; coverage and reimbursement decisions by private or government payors; Apollo’s ability to support the adoption of its products and broaden its product portfolio; the potential size of Apollo’s addressable markets; the execution of our gross margin improvement projects; the availability of cash for Apollo’s future operations as well as other factors detailed in Apollo’s periodic reports filed with the Securities and Exchange Commission, or SEC, including its Form 10-K for the year ended December 31, 2020 and its Form 10-Q for the period ending June 30, 2021. Copies of reports filed with the SEC are posted on Apollo’s website and are available from Apollo without charge. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Apollo disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

[i] There were three serious adverse events (2%): a peri-gastric abscess, bleeding, and malnutrition. All were treated successfully by endoscopy without need for intensive care or formal surgery. In addition, while most patients received the ESG as an outpatient procedure, six patients (4%) were briefly hospitalized for non-serious adverse events to manage their difficulties with accommodation of reduced gastric volume.

[ii] Apollo Endosurgery internal meta-analysis of published ESG studies

[iii] World Health Organization (June 2021)

[iv] Centers for Disease Control and Prevention (February 2020)

View source version on accesswire.com:
https://www.accesswire.com/669346/Apollo-Endosurgery-Announces-Positive-MERIT-Trial-Outcomes

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Source: https://www.biospace.com/article/apollo-endosurgery-announces-positive-merit-trial-outcomes/?s=93

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Medical Devices

Pixium Vision announces its cash position at 30 September 2021 and provides an update on its activities and financial outlook until the end of 2022

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Pixium Vision announces its cash position at 30September 2021 and provides an update on its activities and financial outlook until the end of 2022.

Paris, 22October 2021 – 7:00 a.m. CEST – Pixium Vision (Euronext Growth Paris – FR0011950641 – ALPIX), a bioelectronics company that develops innovative bionic vision systems to enable patients who have lost their sight to live more independently, announces a cash position of €16.9 million at 30 September 2021 and reports on its key developments.

Statement of cash flows summary
In thousands of euros (YTD)   30/09/2021 30/09/2020
Opening cash and cash equivalents   10,566.0 6,791.5
(Decrease)/Increase in cash position   6,310.7 6,515.3
O/W net cash flows from operating activities   (6,500.1) (4,213.2)
O/W net cash flows from investment activities   (99.5) 222.5
O/W net cash flows from financing activities   12,909.0 10,506.0
Impact of changes in exchange rates   1.3 0
Closing cash and cash equivalents   16,876.7 13,306.8

Net cash outflow from operating activities in the first nine months of 2021 totalled €6.5 million, compared to €4.2 million the previous year. The increased cash outflow was primarily due to the launch of the PRIMAvera clinical trial in Europe, the continuation of the Europe and US feasibility studies, as well as spendings associated with the preparation of the business combination with Second Sight Medical Products, Inc.

Until 30.9.2021, investments in fixed and intangible assets remain low leading to a net cash outflow from investment activities of €0.1 million.

At 30 September 2021, net cash provided by financing activities totalled €12.9 million, primarily following the drawdown of a 5 ORNAN tranches for a total of €6.25 million (in gross proceeds) of the financing set up with ESGO and a capital increase for a gross amount of €8.0 million from US institutional investors.

In total, at 30 September 2021, Pixium Vision’s cash position amounted to €16.9 million, compared to €10.6 million on 1 January 2021. Given its current cash position, the Company believes that it is able to finance its operations until the end of 2022.

In addition, Pixium Vision is continuing to explore various avenues that will enable the Company to secure its cash flow necessary to pursue its strategic ambitions. In particular, the Company is considering several financing proposals it recently received, is evaluating further sources of financing and, at the appropriate time, will disclose to the market the main terms of any financing it accepts and will submit for the relevant approval of the shareholders, if needed.

Key developments in the thirdquarter of 2021

In the third quarter of 2021 Pixium Vision continued its positive momentum of the PRIMAvera study, its partnership with Stanford and the successful fundraising leading to a capital increase of approximately €8m in a private placement primarily from US institutional investors.

On 23 September 2021, Pixium Vision announced the enrolment of 5 clinical sites (Bonn, Sulzbach, Hamburg, Munich and Ludwigshafen) to the PRIMAvera study in Germany as well as the successful implantation of the first patient in Germany, with one further clinical sites expected to follow.

The PRIMAvera study further expanded to the United Kingdom by initiating Moorfields Eye Hospital as a clinical site as reported on 13 August 2021.

On 8 September 2021, Pixium Vision announced the successful expansion of its collaboration with Stanford University on the next generation implants leveraging the existing PRIMA design, mainly targeting an improved implant resolution.

Subsequent to the closing as of 30 September 2021, continued success of the feasibility study that Pixium is conducting in France were announced. In the frame of the event the Eye and The Chip held virtually 3-5 October 2021 the positive long-term follow-up scientific data on PRIMA implant from Prima System French feasibility study were presented, mainly stating a positive safety profile 36 months after implantation, stability with no lifetime deteriorations and reiteration that PRIMA is able to provide meaningful visual acuity.

Contacts

Pixium Vision

Offer Nonhoff
Chief Financial Officer [email protected]

Media Relations

LifeSci Advisors
Sophie Baumont
[email protected]

+33 6 27 74 74 49

Investor Relations
LifeSci Advisors
Guillaume van Renterghem
[email protected].com

+41 76 735 01 31

ABOUT PIXIUM VISION

Pixium Vision’s mission is to create a world of bionic vision for those who have lost their sight, enabling them to regain partial visual perception and greater autonomy. Pixium Vision’s bionic vision systems are associated with a surgical intervention and a rehabilitation period.

Pixium Vision is conducting clinical feasibility studies of its Prima system, its miniaturised wireless sub-retinal implant, in patients who have lost their sight due to retinal degeneration associated with the dry form of Age-Related Macular Degeneration (AMD). Pixium Vision works closely with world-renown academic partners, such as Stanford University in California, Institut de la Vision in Paris, Moorfields Eye Hospital in London, Institute of Ocular Microsurgery (IMO) in Barcelona, and UPMC in Pittsburgh, USA. The company is EN ISO 13485 certified. Pixium Vision has been qualified as an “Innovative Company” by Bpifrance.

For more information: http://www.pixium-vision.com/fr

Follow us on @PixiumVision; www.facebook.com/pixiumvision

www.linkedin.com/company/pixium-vision

Disclaimer

This press release, implicitly or expressly, contains certain forward-looking statements concerning Pixium Vision and its business. Such statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, financial conditions, performance or achievements of Pixium Vision to be materially different from the results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. Pixium Vision issues this press release as at this date and does not undertake to update any forward-looking statements contained herein, whether in response to new information, future events or otherwise. For a description of the risks and uncertainties that could cause the actual results, financial conditions, performance or achievements of Pixium Vision to differ from those contained in the forward-looking statements, please refer to section 3 “Risk Factors” of the Company’s reference document, which was filed with the Autorité des Marchés Financiers under number D.20-0350 on 24 April 2020, and which can be viewed on the websites of the Autorité des Marchés Financiers – “AMF” (www.amf-france.org) and Pixium Vision (www.pixium-vision.com).

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Source: https://www.biospace.com/article/releases/pixium-vision-announces-its-cash-position-at-30-september-2021-and-provides-an-update-on-its-activities-and-financial-outlook-until-the-end-of-2022/?s=93

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Align Technology to Host Investor Day on October 29, 2021

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TEMPE, Ariz., Oct. 22, 2021 (GLOBE NEWSWIRE) — Align Technology, Inc.  (Nasdaq: ALGN), a leading global medical device company that designs, manufactures, and sells the Invisalign system of clear aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative dentistry, announced today that the Company will host a hybrid Investor Day on Friday, October 29, 2021, beginning at 4:00 p.m. Eastern Time.

Meeting Schedule: The hybrid meeting will take place between 4:00 p.m. – 8:30 p.m. Eastern Time. Participants attending virtually are advised to register in advance here.

Location: The event will be broadcast live using the same registration link on Align’s dedicated website here, under Events. The webcast console will be available to registered attendees 15 minutes prior to the scheduled event start time.

A replay of the webcast will be available after the meeting on Align’s website and will remain on the website for approximately three months following the event.

If you have any questions, please contact Courtney Clemons at [email protected] or call 408-591-0379.

About Align Technology, Inc.
Align Technology designs, manufactures and offers the Invisalign® system, the most advanced clear aligner system in the world, iTero® intraoral scanners and services, and exocad CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for over 200 thousand doctor customers, and is key to accessing Align’s 500 million consumer market opportunity worldwide. Align has helped doctors treat approximately 10.9 million patients with the Invisalign system and is driving the evolution in digital dentistry through the Align Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. Visit www.aligntech.com for more information.

For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about the iTero systems and services, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.

Align Technology Zeno Group 
Madelyn Valente Sarah Johnson
(408) 470-1180 (828) 551-4201
[email protected] [email protected]


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Source: https://www.biospace.com/article/releases/align-technology-to-host-investor-day-on-october-29-2021/?s=93

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