PRESS RELEASES

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The Neuronaute® (EEG) System and IceCap® is a wearable device thats allows physicians the ability to remotely monitor patients with epilepsy.

BioSerenity Announces FDA Clearance for Electroencephalography (EEG) Wearable Device System

BioSerenity, Inc., recently announced they received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Neuronaute® Electroencephalography (EEG) System and IceCap® EEG wearable device that allows physicians to remotely monitor patients with epilepsy. In general, EEG devices record the electrical activity of neurons in the brain through electrodes placed on the scalp (non-invasive) or

According to a new cardiac surgery market study by iData Research, the number of cardiac surgeries exceeds 900,000 procedures each year in the United States.

How Many Cardiac Surgeries Are Performed Each Year? – New Study by iData Research

According to a new cardiac surgery market study by iData Research, the number of cardiac surgeries exceeds 900,000 procedures each year in the United States. The US Cardiac surgery market is growing rapidly driven by the growth of many underlying procedures. The number of cardiac surgery procedures commonly includes: • Coronary Artery Bypass Grafting (CABG)•

New AI technology has the potential to boost success rates of in vitro fertilizations by as much as 3x compared to traditional methods.

Can AI Help Improve In-Vitro Fertilization Rates?

Although in vitro fertilization solely involves a sperm and an egg, the process leading to an embryo can be more challenging than just putting the two together. In 2019, the Centers for Disease Control and Prevention (CDC) reported that approximately 10% of women in the U.S. between the ages of 15-44 had difficulty either getting

According to a new atherectomy market study by iData Research, over 190,000 atherectomy procedures are performed each year in the United States.

Over 190,000 Atherectomy Procedures Performed Every Year In The United States

According to a new atherectomy market study by iData Research, over 190,000 atherectomy procedures are performed each year in the United States. Atherectomy is a procedure that consists of removing atherosclerotic plaque from diseased arteries and can be performed either on coronary or peripheral arteries. Atherectomy devices are used as the treatment of choice, as

Medtronic has announced that the U.S. Food and Drug Administration (FDA) has cleared the use of navigated interbody high-speed drills with the Robotic Guidance System.

Medtronic’s MIS Drill Received FDA Approval Ahead Of Schedule

Medtronic has announced that the U.S. Food and Drug Administration (FDA) has cleared the use of navigated interbody high-speed drills with the Robotic Guidance System. Even in the midst of the COVID19 pandemic the company has received the clearance earlier than anticipated. This system now integrates the surgical planning software with robotic guidance. Spinal instruments

Top Ventilator Companies In The World

As COVID19 is mainly affecting the respiratory system and develops the common flu-like symptoms, hospitals around the globe are facing shortages of many respiratory care devices, including ventilators. Since the breakout, the demand for ventilators has grown substantially and resulted in governmental and industrial support driving the pace of ventilator manufacturing. Due to the major

Looking at ow the pandemic has delayed or canceled surgeries impacting the US breast reconstruction and the US hernia repair market.

Understanding the COVID-19 Impact on Sales of Medical Devices at the SKU Level

Product managers are continuously looking for data and insights to support strategy and to find valuable market information. Companies in industries that are private and guarded find themselves in situations where their questions are usually longer and more complex than possible answers. In 2020 the emerging question is: “what is the impact of COVID-19 in

ormlabs has recently announced the integration of Draft Resin with orthodontic model 3D printing .

Carestream Validates 3D Printer created by Formlabs

Formlabs has recently announced the integration of Draft Resin with orthodontic model 3D printing . This material has been named a “groundbreaking material” for rapid orthodontic aligner and retainer production due to the speed at which it can print. Draft Resin not only incorporates being the stiffest material in Formlabs repertoire but also allows users

Caption: A nationwide study was performed in Turkey which analyzed the infection rate of women going through gynecologic cancer surgeries during the global COVID19 pandemic to determine if it is safe to continue with such procedures

Can Major Gynecologic Cancer Surgeries Continue Safely in the COVID-19 Era?

Gynecologic cancer or reproductive cancer refers to any part of the female reproductive system: cervical, ovarian, uterine, vaginal, and vulvar. The risk of gynecologic cancers increases with age. Like any other type of cancer, gynecology cancer is difficult to detect only by external symptoms; in some cases, early cancer may be detected during clinical exams

Based on the latest market analysis by iData Research, the European Transcatheter Aortic Valve Implantation (TAVI) market was valued at €836.2 million in 2020, which is a 29% decline from 2019 due to COVID19.

Top TAVR Companies in Europe

Based on the latest market analysis by iData Research, the European Transcatheter Aortic Valve Replacement (also known as TAVR/TAVI) market was valued at €836.2 million in 2020, which is a 29% decline from 2019 due to COVID19. TAVR is a minimally invasive procedure to replace the diseased aortic valve in patients with severe aortic stenosis. 

3Shape has released a new and improved version of their old TRIOS 3 with the TRIOS 4

Innovative Dental Scanning System by 3Shape

3Shape has released a new and improved version of their old TRIOS 3 with the TRIOS 4. The TRIOS system is a complete in-house product that includes a scanner and extensive design software to create a digital impression of the tooth’s anatomy. Digital impressions offer patients the convenience of not having to endure traditional impressions

For the past 5 years, the US Dental Cements market size was valued at over $200M, which comprises permanent (87%) and temporary (13%) dental cements market segments.

Top Dental Cements Companies in the United States

We have already looked at the top companies in the Dental Materials Market overall but now we go deeper to look into the dental cements market in particular. Dental Cements are sealing agents that are predominantly used to fill any gaps between restorations and the natural tooth.  For the past 5 years, the US Dental

Azure™ with BlueSync™ Technology Improves Device Longevity and Provides Automatic, Wireless Remote Patient Monitoring

Medtronic’s Newest Form of Communication with the Heart

Medtronic has released its first-ever app-connected pacemaker called Azure. A pacemaker is an implantable device designed to regulate the electrical impulses of the heart. They are used to correct uneven heartbeats. Millions of patients have pacemaker implants to treat arrhythmia or heart failure. However, many patients do not understand how these devices function. This smartphone-connected

Over 182,000 Heart Valve Replacements Per Year in the United States

According to the latest Cardiac Surgery market study by iData Research, over 182,000 heart valve replacements are performed every year in the United States. Heart valve replacements are one of the most common procedures performed in cardiac surgery market, and they make up nearly a quarter of the total procedure volume. Heart valve replacement procedures

Stryker has announced it has cleared all regulatory hurdles previously in the way of its planned $4 billion acquisition of Wright Medical.

Stryker Goes to Extrem(iti)es with Wright Medical Acquisition

Stryker has announced it has cleared all regulatory hurdles previously in the way of its planned $4.7 billion acquisition of Wright Medical. The tender offer was initiated back in November 2019 and has now been completed as of November 11, 2020.  “Wright Medical has built a successful business, and together we look forward to working

Syringe, medical injection in hand, palm or fingers. Medicine plastic vaccination equipment with needle. Nurse or doctor. Liquid drug or narcotic. Health care in hospital.

Top 3 Syringe and Needle Companies in the United States

As we progress through the global pandemic and drive closer to having a vaccine available, companies are now preparing supplies such as needles and syringes. We have compiled the top three companies to watch as distributors for needles and syringes in the United States. Becton Dickinson  Cardinal Health Novo Nordisk Becton Dickinson Becton Dickinson produces

Transcatheter Aortic Valve Replacement (TAVR) market

FDA Approval of TAVR in Low-Risk Patients Set to Drive Market Growth

Register to receive a free TAVR Market Report Suite for the US 2020-2026 synopsis Based on the latest market analysis by iData Research, the Transcatheter Aortic Valve Replacement (TAVR) market was valued at $2,424 million in 2020, which is a 13% decline from 2019 due to COVID19. TAVR is a minimally invasive procedure to replace

Large Volume Infusion Pump

Best-Selling Large Volume Infusion Pumps in the United States

Based on the latest market study by iData Research, the US infusion pump market was valued at almost $1,176 million in 2019. However, due to COVID, the market size is expected to shrink by an astonishing 51% and reach a valuation of $572 million in 2020, before rebounding in 2021. The infusion pump market is

Anika Announces New Wrist Replacement Technology – WristMotion System

Anika Announces New Wrist Replacement Technology – WristMotion System

Anika Therapeutics, Inc. announced that the WristMotion Total Arthroplasty System received 510(k) clearance from the U.S. Food and Drug Administration. The WristMotion System is used in procedures to replace painful wrist joints due to rheumatoid arthritis, osteoarthritis, or post-traumatic arthritis, allowing a patient to maintain native biomechanics. This replacement implant is an entirely new approach

Pump Infusions Projected to Be Taking Over the European Market by 2026

According to the latest market study by iData research, the European Infusion Therapy market size was estimated at around $926 million in 2020 which is almost a 10% decline from the previous year. COVID-19 is expected to play a significant role in this market due to elective procedure deferrals as well as restrictions limiting sales

Over 13 Million Laparoscopic Procedures are Performed Globally Each Year

Over 13 Million Laparoscopic Procedures are Performed Globally Every Year

Based on the recent market study performed by iData Research, over 13 million laparoscopic procedures are performed globally every year. Laparoscopy is a minimally invasive surgical procedure that allows a surgeon to access the inside of the abdomen and pelvis through small incisions, (5mm-15mm) eliminating the need for large incisions in the skin. Laparoscopy, also

LATEST!! Covid-19 Causes Major Impacts on Neurologic Disorders

LATEST!! Covid-19 Causes Major Impacts on Neurologic Disorders

The novel coronavirus (COVID-19; SARS-CoV-2) pandemic has affected millions worldwide. There are still many unknowns surrounding this virus yet one thing is for sure, in serious cases the virus causes devastating effect on the body – and not just on the lungs. “Neurology Online Journal“ has published a new study showing that the COVID-19 virus

World Spine Day 2020 – BACK ON TRACK

October 16th is the official World Spine Day, organized and coordinated by the World Federation of Chiropractors. This year’s theme is Back On Track, celebrating people being able to reactivate and revitalize their bodies by getting out and focusing on effective spine care. World Spine Day is celebrated to raise awareness around the prevention and

Dental Amalgam vs Composite Materials

Dental Amalgam Market Outlook For 2021

According to the latest market study by iData Research, the US dental amalgam market size was valued at over $89 million by 2020. Amalgam was the first filling material ever used in dentistry and is essentially an alloy of different metals, primarily mercury (~50%) and silver (~22-32%). Amalgam material was the predominant restorative material up

Top Dental Materials Companies in the US

Overview The American population is becoming more aware of the benefits of oral health as more information is provided. With more positives attributed to oral care, the overall dental market has seen an upward trend in more dental office visits for diagnostic and preventative procedures. However, this allowed identifying major threats to oral health and

Over 965,000 Angioplasties (PCIs) are Performed Each Year in the United States

According to the latest interventional cardiology procedural analysis by iData Research, over 965,000 angioplasties are performed each year in the United States. An angioplasty, also known as percutaneous coronary intervention (PCI), is a procedure that involves stent placement to open blocked or narrowing arteries. Interventional cardiology is primarily applied to the treatment of coronary artery

Dentsply Sirona’s imaging solution for exceptional patient experiences and greater practice success

Axeos™ – Dentsply Sirona’s Newest Imaging Solution

iData Research analysts have found that the continually expanding line of Orthophos devices has given Dentsply a broad range of devices to suit all a clinic’s needs, the Axeos is another addition to their already large suite of devices.   The large range of FoV’s allows for many different treatment areas, including specialized 3D imaging. The

Teleflex-Arrow-EZ-IO-300x265

Teleflex Announces Expanded Indications For Intraosseous Vascular Access System

Teleflex has announced its receival of 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the indications for the use of the Arrow® EZ-IO® Intraosseous Vascular Access System. This device is used to provide procedural guidance within the establishment of intraosseous vascular access, especially when intravenous access is difficult to obtain in

Market Share Shifts due to Smith+Nephew’s Acquisition of Integra LifeSciences

Radical Market Share Shifts due to Smith+Nephew’s Acquisition of Integra LifeSciences’ Extremity Orthopedics Division

Smith+Nephew (LSE:SN, NYSE:SNN) have announced that they have an agreement to acquire the Extremity Orthopedics business of Integra LifeSciences Holdings Corporation (NASDAQ:IART) for $240 million.  Smith+Nephew noted that the portfolio includes devices, implants and instruments designed for shoulder replacement and reconstruction of bones in the hand, wrist and elbow, as well as the foot and

CapsoCam Plus® is a pill sized capsule endoscopy system

FDA Allows At-Home Capsule Endoscopy Administration

Amidst the global COVID-19 pandemic, The FDA has granted enforcement discretion allowing CapsoVision the ability to launch at-home administration of CapsoCam Plus®. This device consists of a  video capsule system intended for further visualization of the small bowel mucosa in adults.  Gastrointestinal (GI) endoscopes are flexible visualization instruments that are inserted into the alimentary canal

COVID-19 Causes a Significant Drop in Interventional Cardiology Procedure Numbers

COVID-19 Causes Significant Drop in Interventional Cardiology Procedure Numbers

Interventional cardiology is a minimally-invasive technique that uses catheters to treat coronary arterial disease, which is one of the leading causes of death in the United States. These procedures allow the heart to continue functioning at its best moving almost 3,000 gallons of blood every day. Based on the European Heart Journal, cardiovascular disease (CVD)

Top 5 Insights From the Dental Materials Market in Europe

Top 5 Insights From the Dental Materials Market in Europe

According to the latest study by iData, the European Dental Materials market size is estimated to be at around €700 million in 2020. While the COVID19 pandemic had a major negative impact on the entire dental industry, the European market is expected to return to its pre-COVID numbers within the next two years and reach a

Investigational Intrepid™ Transcatheter Valve System

FDA Grants Medtronic Breakthrough Device Designation for Transcatheter Valve System

The FDA Breakthrough Devices Program enables manufacturers to streamline the market clearance/approval process for specific medical devices. Medtronic received the breakthrough device designation for its investigational Intrepid™ transcatheter tricuspid valve replacement (TTVR) system. The FDA has also approved an early feasibility study for the device. The new TTVR system will help treat tricuspid valve regurgitation,

Once swallowed, this capsule is designed to collect bacteria throughout the gut. A scientist unscrews the cap to retrieve the sample after the capsule has left the digestive system.

New Cost-effective Microcapsule Used for Endoscopies

Gastrointestinal testing and surveying methods, such as endoscopies and colonoscopies, are often very invasive and are limited in how much of the small intestine they can reach. Thus, there is a need to develop devices or techniques that can both increase the visibility of the gastrointestinal tract and decrease invasiveness while preserving functionality. Pill-shaped forms

B. Braun Gains FDA Clearance for SpaceStation MRI

B. Braun Gains FDA Clearance for SpaceStation MRI

B. Braun has received FDA 510(k) clearance for its MRI system SpaceStation MRI. Based out of Germany, B. Braun is a leader of infusion therapy and medical imaging devices, as well as a variety of other medical devices. This new imaging technology differs from other MRI systems as it can be used with the Space

Fitbit Used to Track COVID-19 Symptoms Remotely

Fitbit Used for Early Detection of COVID-19 Symptoms

Currently, the demand for healthcare workers and facilities is extraordinarily high in areas heavily affected by COVID-19. The demand for patient monitoring devices is also high. One of the biggest challenges in reducing the spread of the virus is contact tracing, which is made difficult through a high demand for health personnel, and because of

New Diabetes Test Using Smartphone and Deep Learning

New Diabetes Test Using Smartphone and Deep Learning

Researchers at UCSF have developed a method to help detect diabetes using a smartphone. They have developed a deep-learning technology that can be combined with a mobile app to offer a low-cost method of detecting diabetes. Instant Heart Rate Measurement The Azumio Instant Heart Rate app was recently used as part of the Health eHeart

Top Product Releases to Follow in the Video Endoscopy Market

According to the latest study by iData Research, the US Video Endoscopy Equipment market was valued at $972 million by 2020. The US market has been growing consistently over the past few years due to the growing popularity of minimally invasive surgery (MIS). Additionally, the market was primarily driven by the replacement of older and

Fujifilm Partners with Caresyntax to Provide New Operating Room and Interventional Integration Platform

Fujifilm Partners with Caresyntax to Provide New Operating Room and Interventional Integration Platform

Fujifilm Medical Systems has announced they will partner with Caresyntax to develop Fujifilm Systems Integration. Caresyntax, a major developer in automation in surgical equipment and procedures, will be supplying their innovative automation intelligence to help create this Systems Integration. The COVID-19 pandemic has led to an increased need for streamlined surgical procedures and other hospital

COVID-19’s Effect on the Immune System During Pregnancy

COVID-19’s Effect on the Immune System During Pregnancy

Much like during the initial outbreaks of other coronaviruses, there is little certainty regarding the exact effects of COVID-19, especially long-term. However, data about its effects on pregnant women is starting to accumulate and provide preliminary information and precautions. Both the acute and immediate effects of COVID-19 on the mother and child must be considered,

US Pelvic Floor Repair Market Value by Segment, 2016-2026

Astonishing 26.9% Decline of Pelvic Floor Repair Market due to FDA Recalls

According to the recent market study by iData Research, the total Pelvic Floor Repair market in the U.S. will consequently decline at a -26.9% cumulative growth rate between the years of 2019-2026. The sharp decline is a result of FDA recalls for all transvaginal mesh devices along with a poor reputation of the sacrocolpopexy surgery.  Pelvic organ prolapse

Engage Surgical Granted FDA Approval for Cementless Engage Partial Knee System

Engage Surgical has gained FDA approval for its Engage Partial Knee system, making it the only cementless partial knee system approved for use in the U.S. It uses Engage’s innovative Anchor technology to provide stability at the tibial surface, and increased compression compared to other techniques. The Engage Partial Knee system is also combined with

Top 6 surprising developments in the U.S. Sports Medicine Device market

Top 6 Surprising Developments in the U.S. Sports Medicine Device Market

According to the latest study by iData Research, the U.S. sports medicine market was valued at $1.7 billion by 2020. The total market is highly limited by the relatively stable incidence rate of tendon and ligament injuries, which varies greatly among different anatomies and different population groups. In spite of this trend, the level of

anika announces six new fda approved sports medicine products

Anika Releasing Six New FDA-Approved Sports Medicine Products in 2020

Anika, an orthopedic device manufacturer based out of Bedford, Massachusetts, has announced the release of six new sports medicine products in 2020. This marks the first time Anika has released new products since acquiring Parcus Medical and Arthrosurface earlier in the year. All six of these products have received FDA approval. They are mainly focused

Philips Launches Two Portable Biomedical Products In US

Philips Launches Two Portable Biomedical Products In US

Philips has announced the launch of two portable biomedical products, after obtaining FDA approval for them: the Tempus ALS and Tempus Pro. Both of the devices are designed for use with Philips’ Intellispace Corsium software. This web-based platform is used to record and upload data real-time, and it can be used for communication. This adds

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