AssurX

AssurX is a leader in cloud-based and on-premise enterprise quality management and regulatory compliance software for the life science, energy & utilities, manufacturing, as well as other highly regulated industries.

AssurX is a cloud-based quality management software designed for regulated industries such as manufacturing, life sciences, energy and utilities, medical devices, food and beverage, and high-tech manufacturing. The platform offers a comprehensive suite of features including audit management, corrective and preventive action (CAPA), compliance handling, change control, risk management, training management, customer quality management, and supplier quality management. AssurX's low-code platform enables easy customization, allowing businesses to adapt the software to their specific needs.

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About AssurX - Quality Management and Regulatory Compliance

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Enterprise Quality Management Software

Pushing the envelope in MedTech with emerging technologies

Next-gen Medical Devices

AssurX Appoints Vince Smith as Chief Revenue Officer

AssurX is a cloud-based quality management software designed for regulated industries such as manufacturing, life sciences, energy and utilities, medical devices, food and beverage, and high-tech manufacturing. The platform offers a comprehensive suite of features including audit management, corrective and preventive action (CAPA), compliance handling, change control, risk management, training management, customer quality management, and supplier quality management. AssurX's low-code platform enables easy customization, allowing businesses to adapt the software to their specific needs.
The software is designed to streamline quality and compliance processes, facilitating the transition from labor-intensive, paper-based processes to a streamlined electronic system. AssurX provides pre-configured workflows out-of-the-box, ensuring a smooth transition to digital quality management. With AssurX, organizations can benefit from easily searchable data, allowing for quick retrieval and efficient information management, saving valuable time.
AssurX boasts 21CFRPart11 compliance features for FDA computer system compliance, ensuring adherence to regulatory standards. The platform's comprehensive API enables extensive integration possibilities with other software solutions, eliminating data silos and promoting a unified system for maximum efficiency.

Convergent Dental, Inc. is a privately owned dental equipment and technology company. Its flagship product, Solea, is the only CO2 laser cleared by the FDA for all-tissue indications, delivering an anesthesia-free, blood-free, and suture-free experience for dentists and patients. Solea represents a breakthrough in dental laser technology, offering a distinct experience compared to traditional instruments or earlier laser treatments.
Solea is a novel 9.3-micron CO2 laser that nears the peak absorption of hydroxyapatite (enamel), enabling it to vaporize enamel with speed and precision. This unique wavelength, coupled with computer-controlled motors (galvos) that manipulate the beam thousands of times per second, allows dentists to perform procedures ranging from hard tissue to soft tissue with total control and efficiency.
A key feature of Solea is its variable-speed foot pedal, which lets dentists seamlessly transition from hard to soft tissue by adjusting the pressure applied. This intuitive design streamlines the learning curve for dentists accustomed to using a drill. Solea's three ergonomic handpieces – Contra-Angle, Straight, and Ultraguide – further enhance its versatility across various procedures.
Solea not only improves patient experiences but also offers practice benefits such as increased productivity, new patient flow, and efficiency gains. In October 2022, Convergent Dental received FDA clearance for Solea to aid in reducing mineral loss in dental enamel, protecting teeth against acid attack and caries development. This breakthrough application was commercially launched in November 2023 under the name Solea Protect.

Convergent Dental

Ossio is an orthopedic fixation technology company that has developed OSSIOfiber Intelligent Bone Regeneration Technology, a breakthrough implant material designed to securely fixate and fully integrate into the body's native anatomy without leaving any permanent hardware behind. This technology addresses the limitations of conventional metal and resorbable implants, combining unparalleled mechanical strength with natural bone healing.
Made from a proprietary mineral fiber matrix held together by a naturally degradable polymer, OSSIOfiber implants provide surgeons with a more biologically friendly way to restore patient stability and mobility. These implants are engineered to provide the strength required for functional fixation while allowing full integration into the native bone without adverse biological response.
Ossio's product portfolio includes compression screws, trimmable fixation nails, hammertoe fixation systems, suture anchors, and compression staples, all made with OSSIOfiber technology. These implants have received multiple FDA clearances since 2019, and the company has initiated commercialization of its products in the US. As of March 2022, over 6,000 implantations of OSSIOfiber products had been performed, demonstrating adoption of this innovative technology.
OSSIOfiber Intelligent Bone Regeneration Technology can address various surgical applications through the manufacturing of implant designs like nails, screws, staples, anchors, and plates. Ossio plans to pursue multiple applications in distal extremities, trauma, sports, reconstruction, pediatrics, and spine segments.
In February 2023, Ossio launched the world's first and only non-permanent compression staple made with OSSIOfiber technology, designed for predictable bone in-growth, regeneration, and replacement.

Ossio

Casana is a healthcare technology company that has developed the Heart Seat, an innovative toilet seat that enables effortless, integrated, and consistent in-home health monitoring. The Heart Seat is a replacement for a standard toilet seat and is designed to measure key clinical parameters such as heart rate, blood oxygen saturation (SpO2), and blood pressure.
In May 2023, Casana received FDA clearance for the Heart Seat to measure heart rate and SpO2 in adults aged 22 years and older, weighing between 90 to 350 pounds. The company plans to file for additional indications, including systolic and diastolic blood pressure, with the goal of launching the product in the market by the end of 2023.
The Heart Seat is equipped with sensors that passively capture health data whenever the seat is used, eliminating the need for user compliance or behavior changes. The data is automatically uploaded to the Casana Cloud, where it can be viewed by healthcare providers, enabling them to monitor patients' health trends and respond to changes in near real-time.
Casana's technology allows for the effortless collection of consistent and reliable data, assisting medical teams in monitoring chronic conditions beyond the hospital or physician's office. The company aims to unlock a new category in healthcare technologies that enables seamless, integrated, and continuous in-home health monitoring.
In January 2022, Casana was acquired by an undisclosed entity, further accelerating the commercialization of the Heart Seat.

Casana

Neurent Medical is a company pioneering innovative non-surgical interventions to treat chronic inflammatory sinonasal diseases, particularly chronic rhinitis. The company's flagship product is the NEUROMARK System, a device that received US Food and Drug Administration (FDA) 510(k) clearance in October 2021.
The NEUROMARK System is designed to gently apply controlled low-power radio frequency (RF) energy to target regions of the nasal cavity, disrupting the parasympathetic nerve signals that can trigger an inflammatory response. This alleviates chronic rhinitis symptoms such as persistent congestion, rhinorrhea (runny nose), swelling of the mucosal membrane, sneezing, and nasal itching. The system's unique flexible leaflet design and proprietary smart algorithms enable precise neurolysis (disruption) of the posterior nasal nerves (PNN) and accessory pathways, accommodating a range of patient anatomies while maintaining mucosal and vascular integrity.
Neurent Medical announced the limited market release of the NEUROMARK System in the US in February 2023, following the establishment of a new Category I Current Procedural Terminology (CPT) code by the American Medical Association (AMA) for PNN procedures, effective January 2024. The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) also endorsed the PNN procedure in 2023.

Neurent Medical

Genetesis is a medical imaging company specializing in biomagnetic cardiac imaging solutions. It has developed CardioFlux, a flagship magnetocardiography (MCG) system that non-invasively identifies myocardial ischemia, a condition where blood flow to the heart muscle is reduced. The technology measures the magnetic fields generated by the heart's electrical activity to detect ischemia within minutes, without using pharmaceuticals or radiation. CardioFlux MCG is designed to provide advanced imaging while prioritizing patient comfort.
The company's solutions target the diagnosis of coronary microvascular disease (CMD), a condition that has been challenging to identify due to a lack of effective functional diagnostics. By offering an accurate and rapid test for CMD, Genetesis aims to address an unmet clinical need and enable timely management of the condition.
In April 2023, the US Food and Drug Administration (FDA) granted CardioFlux MCG Breakthrough Device designation for the non-invasive diagnosis of myocardial ischemia in patients suspected of having CMD.
Genetesis was founded in 2013 and is headquartered in Mason, Ohio. The company has received over USD 40 million in funding to date, including a USD 17.5 million Series C round in October 2022. In April 2020, TDK Ventures, the corporate venture capital arm of TDK Corporation, invested in Genetesis, providing access to TDK's expertise in areas like biomagnetic sensors and magnetic noise suppression.

Genetesis

Companies that develop diagnostic devices used in a hospital setting to identify a disease, condition, or injury, such as imaging systems and endoscopes

Companies that develop implantable medical devices designed to be surgically placed inside the human body, either temporarily or permanently, including devices such as pacemakers, artificial joints, stents, and cochlear implants

Companies that develop non-surgical devices that are used in a procedure or intervention to cure or relieve a patient from an illness or disease such as laser treatments, dental equipment, and wound care management

Companies that develop monitoring devices that are used in a hospital setting to measure patient vital signs and ensure patient well-being post-treatment, such as cardiac and respiratory monitoring systems

Providers of software that enhances the functionality of medical device hardware (diagnosis, treatment, and monitoring)

Companies that develop surgical devices involving invasive interventions (cutting into a patient's body tissues) to treat, cure, or relieve a patient of an illness or disease

Companies that develop devices to administer pharmaceutical substances into a patient's body, ensuring controlled release or targeted delivery, specifically for use in clinical settings to treat or manage medical conditions effectively

Providers of software that helps manage risks, ensure quality, and streamline audit processes during medical device development

IoT connects devices to EHR systems for precise patient diagnosis and treatment support

Devices are linked to software platforms that use digital technologies such as AI/ML and VR

Startups leverage AI/ML and deep learning to support patient diagnosis and early detection

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