List of Devices Companies in Maryland - 32

Akrivita (formerly SeeTrue), a woman-owned company, specializing in microcapillary needles for precision microinjection. At AkriVita, we've developed the MultiPort Microcapillary Needle using advanced 3D printing and unique resin, ensuring precise and consistent needles. This innovative design eliminates recalibrations, reduces downtime and costs, and minimizes clogging. Our high-contrast needles offer consistent flow, improving the success rates of microinjection procedures. AkriVita provides biomedical scientists and healthcare practitioners with reliable tools that enhance outcomes, save time, and cut costs, enabling them to focus on advancing human health through discovery and innovation.

Amplexd is a patient-scientist led company, comprising pharmaceutical industry veterans and senior product developers blending the best of cutting-edge technology and patient-centric design to develop accessible, non-invasive treatments for HPV-induced cervical dysplasia.

Medical device design and development. First patented product under development is BondTrue, which standardizes surgical closure for better wound healing. Unlike other closure techniques, BondTrue knows where the incision was made so it can precisely realign the wound back together, reducing wound complications, saving time and costs.

BrainCool Inc is an innovative medical device company that develops, markets, and sellsleading medical cooling systems for indications and areas with significant medical benefitswithin the healthcare sector. The company focuses on two business segments, Brain Coolingand Pain Management.

Clear Guide Medical is a leader in next-gen medical imaging fusion and navigation technology. Our vision-based approach has been introduced in a family of clinical guidance products, including the CLEAR GUIDE SCENERGY for instrument guidance and SCENERGY FUSION for ultrasound and CT/MRI image fusion. Our products make minimally-invasive interventions like biopsies, ablations, pain injections, and peripheral nerve blocks efficient and cost-effective. The company is a privately-held spinout of the Johns Hopkins Medical Institutions and The Johns Hopkins University based in Baltimore, Maryland.

Introducing CLR, a simple solution for suction and irrigation through indwelling catheters such as chest tubes. The patented CLR Irrigator is an ergonomic suction/irrigator that empowers easy, one-handed lavage and evacuation of fluid collections such as hemothorax. Our unique CLR Port can stay attached to the indwelling catheter, allowing standard drainage as well as clean access for repeated/delayed lavage without breaking the drainage circuit. When it comes to thoracic irrigation, the solution is cl__r!

CoapTech is bringing a series of breakthrough medical devices to worldwide markets, leveraging a patented, disruptive platform technology called the Point-of-care Ultrasound Magnet Aligned (PUMA) System. The PUMA Platform will disrupt multiple medical procedures, reducing health care costs, and improving efficiency, safety, quality, patient experience, and access to services around the globe. Invented by Dr. Steven Tropello, a Johns Hopkins-trained critical care physician, the PUMA System enables diagnostic, interventional and therapeutic procedures in hollow organs. The system combines magnetic attraction for device placement guidance, and ubiquitous, low-cost, point-of-care ultrasound for visualization in hollow cavities. Our lead device, the PUMA-G, selected because of its low risk, clear FDA pathway, and strong commercial viability, is for the insertion of Gastrostomy (feeding) tubes. PUMA-G enables a point-of-care (i.e. bedside, as opposed to operating room) procedure for inserting gastrostomy tubes which can be quickly and easily performed by non-surgical providers. By eliminating specialty suites and specialist consultants, PUMA-G will save hospitals money and improve efficiency and safety for this common procedure. PUMA-G has been validated in human anatomy, and has a streamlined regulatory pathway based on FDA presubmission feedback.

CSSi LifeSciences™ Drug & Medical Device Commercialization & Medical Device CRO Our goal is to ensure a successful and expeditious pathway to commercialization for our clients’ drugs and medical devices by providing insight-driven analysis that saves time, development costs, and resources. We enable faster, more informed decision making to increase commercial success, while reducing the risk of late-stage failures and post-authorization action. Unparalleled Success from Discovery to Commercialization • Commercialized over 500 new drugs, biologics, medical devices, and in-vitro diagnostics • Over 250 medical device 510(k) Class 1-3 submissions with 100% success. • Extensive Orphan, “First in Class,” and “First In” Indication success. • Reduced time to approval by over 600 days. • Over 100 NDA, ANDA and BLA submissions, with 96% success. • Greater than 60 EMA CHMP Marketing Authorizations. • SmartStudyTM design and feasibility assessments enhanced study efficiency and success and reduced protocol amendments by over 50%. CSSi LifeSciences Medical Device CRO has experience navigating regulations in over 100 countries. Often companies struggle with the pathways for a medical device from design to commercialization because of the ambiguity and complexity of the process. Regulations and requirements change frequently and vary by notifying bodies, country, level of risk (i.e., Class 1-3), specific product claims, and intended use. Our diverse team has many years of medical device commercialization experience, with the knowledge that goes beyond published guidance, documents and initiatives. CSSi LifeSciences Medical Device CRO aims to impact the timeline of regulatory clearance and increase profitability.

DP Clinical, Inc. is a privately held Contract Research Organization (CRO) specializing in neurology/CNS (including spinal cord injury), oncology, ophthalmology, infectious disease/vaccines, and rare disease Phase I-IV clinical programs. DP Clinical provides a full complement of clinical trial services to pharmaceutical, biotech, and medical device companies including trial management, monitoring, data management, biostatistics, regulatory, safety monitoring and reporting, and medical writing. Since 1994, we have worked for clients of all sizes — small to large pharmaceutical and biotech companies, academic research institutions, and government sponsors. DP Clinical provides integrated trial solutions as well as specific service components based on sponsor need. Our comprehensive services include: • Project management • Clinical trial monitoring • Data management • Biostatistics • Pharmacovigilance and safety • Regulatory affairs • Quality assurance • Medical writing

We're building scalable low-cost, high-performance diagnostics for infectious disease in communities, starting with Tuberculosis. Our mission is to create large scale diagnostics that can be used to test large samples such as those from food, water, environments and air to prevent infectious disease outbreaks. For all 7 billion of us.

The Food and Drug Administration is an agency within the Department of Health and Human Services. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

Developer of oral, gut-targeted polymer therapeutics for the treatment of metabolic indications such as type 2 diabetes, and other chronic conditions. The company is developing a lead drug, which is orally administered, non-absorbed, gut-restricted duodenal exclusion therapy designed to replicate the metabolic effects of bariatric surgery with safety-advantages avoiding invasive complications of surgeries and procedures.

IZI Medical is a prominent medical device manufacturer and distributor, specializing in minimally invasive diagnostic and therapeutic solutions. Founded in 1991 by a neuroradiologist and a radiation oncologist, the company is headquartered in Baltimore, Maryland. In 2022, IZI became part of Halma plc, operating as a standalone entity within Halma’s Healthcare sector. The company is dedicated to enhancing patient care through physician-inspired innovations and aims to improve the quality of life for patients. IZI Medical offers a diverse portfolio of 44 medical devices across four key markets: image-guided surgery, interventional oncology, interventional neuro and spine, and radiation therapy. Their products include tools for instrument navigation, tumor localization, and treatment planning systems. With over 100 active patents, IZI Medical emphasizes innovation in minimally invasive procedures. The company serves more than 2,500 hospitals in the U.S. and distributes its products to physicians in 35 countries, focusing on improving clinical efficiency and patient outcomes.

JuneBrain is an early start-up company based in the Washington, DC area. Our mission is to develop a telehealth eye-scanning system that allows clinicians to monitor patients with eye and brain disease outside of the traditional clinical setting, leading to earlier detection of new disease and improved monitoring of treatment efficacy. Though our mission begins in the eye care community, our long-term goal is to extend the use of our device into the broader neurological disease population, thus creating a pathway towards more frequent, widely accessible monitoring of eye and brain health.

At kallisio, we're on a mission to revolutionize head & neck cancer care by safeguarding patients against the harmful effects of radiation therapy. Our 3D printed patient-specific immobilization devices provide unparalleled protection to Organs at Risk (OARs) while allowing radoncs to deliver the highest effective dose of radiation treatment. In collaboration with MDACC, we've pioneered a groundbreaking, scalable, billable, and custom-fit solution for precise patient immobilization and tongue deviation. Our innovation aims to mitigate long-term side effects, including mucositis, xerostomia, and dysphagia. Interested in joining our mission to protect patients from radiation-induced harm?

At kallisio, we're on a mission to revolutionize head & neck cancer care by safeguarding patients against the harmful effects of radiation therapy. Our 3D printed patient-specific immobilization devices provide unparalleled protection to Organs at Risk (OARs) while allowing radoncs to deliver the highest effective dose of radiation treatment. In collaboration with MDACC, we've pioneered a groundbreaking, scalable, billable, and custom-fit solution for precise patient immobilization and tongue deviation. Our innovation aims to mitigate long-term side effects, including mucositis, xerostomia, and dysphagia. Interested in joining our mission to protect patients from radiation-induced harm?

Founded in 1998, Key Tech (www.keytechinc.com) is a high-tech product design and prototyping company located in Baltimore, Maryland. Our clients value our ability to create first-of-a-kind applications and solve challenging technical problems. A diverse mixture of electrical, mechanical, and computer engineers, as well as industrial designers and physicists, we specialize in transforming complex technologies into simple, intuitive solutions. Services Include: Product de-risking, Prototype and Full Scope Development, Industrial Design, Technology Development, Expertise on Demand, and solving the seemingly unsolvable.

For 45+ years, LKC Technologies has been making functional eye testing simple and practical for busy clinicians. The handheld, portable RETeval® ERG/VEP device aids in the diagnosis and management of ischemic conditions such as diabetic retinopathy, optic nerve conditions, and other retinal dystrophies by providing objective results without corneal contact.

𝘐𝘮𝘱𝘳𝘰𝘷𝘪𝘯𝘨 𝘏𝘦𝘢𝘭𝘵𝘩 𝘛𝘩𝘳𝘰𝘶𝘨𝘩 𝘐𝘯𝘯𝘰𝘷𝘢𝘵𝘪𝘷𝘦 𝘋𝘪𝘢𝘨𝘯𝘰𝘴𝘵𝘪𝘤𝘴. MaximBio's comprehensive in-house capabilities provide you a world-class experience and confidence in our ability to keep costs down and deliver your products in time. At MaximBio, our team of dedicated professionals with over 25 years of expertise work to create a custom-fit, full service program in state-of-the-art facilities to meet all your needs and specifications: • FDA cGMP Registered for manufacture and distribution of medical devices • Compliant with 21 CFR Part 820 for medical devices • ISO 13485:2016 Certified for manufacturing and packaging of medical devices

Noxilizer, Inc. provides ultra-low temperature (10°C to 30°C) nitrogen dioxide sterilization technology that offers many benefits over traditional sterilization methods. Noxilizer sells sterilization equipment to pharmaceutical, biotech and medical device manufacturers and also offers contract sterilization services at its Baltimore, MD facilities. Noxilizer’s expert microbiology and material compatibility team is ready to partner to solve sterilization challenges through every phase of the process. To learn more about Noxilizer’s contract sterilization services or sterilization equipment please email info@noxilizer.com or visit www.noxilizer.com

Nuo Therapeutics, Inc. is a biomedical company that develops and commercializes individualized wound care therapies that harness a patient’s innate regenerative ability to stimulate wound healing. The Company’s flagship product, Aurix is a biodynamic hematogel derived from the patient’s own platelets and plasma, which is used at the point-of-care to jumpstart the natural healing process in a broad range of chronic wounds, including diabetic foot ulcers, venous leg ulcers and pressure injuries.

Otomagnetics is a medical device manufacturer that designs and commercializes magnetic injection system for the delivery of drugs to the inner ear.

RenOVAte Biosciences Inc (RBI) is a Delaware Incorporated, Maryland based animal biotechnology company founded in December 2016. RBI is in the business of performing sophisticated and precision genome editing and genetic engineering in livestock species, to address critical priorities of animal and human health.

Restorative Therapies is a medical devices company that provides revolutionary Functional Electrical Stimulation devices and therapies to help patients achieve their full potential.

Senseonics, Inc. is a medical device startup company in Germantown, Maryland, USA (near Washington, DC) developing transformative glucose monitoring products that are intended to enable people with diabetes to confidently live their lives with ease. Utilizing breakthrough fluorescence sensing technology, the Senseonics continuous glucose monitoring ("CGM"​) system is being designed to be the first fully implantable CGM that is highly accurate and stable throughout its long sensor life. The system consists of a very small sensor implanted under the skin, an external transmitter, and a mobile medical application, which allows for discreet, easy access to real-time glucose measurements without the need for a dedicated receiver.

Sonavex, Inc. is a Baltimore-based medical device company originally spun out of Johns Hopkins focused on Empowered Patient Care. The company has developed a portfolio of novel ultrasound solutions that empower patient care by delivering critical visual and quantitative data to improve outcomes and reduce costs. EchoMark is a bioresorbable and highly echogenic (visible under ultrasound) implant used to mark at-risk blood vessels such that the site can be easily assessed for future complications. EchoSure is a deep-learning enabled 3D automated ultrasound device designed to be used by healthcare providers without ultrasound training to assess blood flow and morphology of vessels marked by the implanted EchoMark device. For more information, please visit http://www.sonavex.com

Sonogen Medical is a medical devices company developing next generation ultrasonic bone fracture healing technology, based on highly innovative applications of low-intensity pulsed ultrasound (LIPUS).

Sotelix Endoscopy is a privately held medical device startup focused on developing groundbreaking therapeutic endoscopy devices for minimally invasive treatments in the gastrointestinal tract. Sotelix Endoscopy is based in Baltimore, MD.

Texcell is a dedicated partner for biotechnology and pharmaceutical companies since more than 2 decades. Thanks to an unique combination of expertise in Virology and Immunology, we can provide a full support to your product development from the proof of concept to clinical studies and GMP manufacturing. Our state-of the Art facilities are located in France, Germany and in the US where we use most recent technologies to efficiently perform a wide range of assays What do we provide ? A specialized analytical lab for your preclinical and clinical studies, including: - Cell based assays/potency assays during development - Immunogenicity, TK/PK, ADA and neutralizing Antibody Testing - Immunotoxicology studies - Sample pre analytics: serum/plasma isolation, PBMC isolation & storage - Biobanking - Read-outs: ELISA, ECLIA, Flow cytometry, ELISpot, HAI, proliferation... Texcell Viral Safety lab: Expertise in biosafety of biological and pharmaceutical products. - Virus/TSE Validation - Viral Clearance study - 25 model viruses available - spiking in L2 and L3 labs... - Viral safety testing - a complete range of tests (NGS, in vitro, in vivo, TEM, Q-PCR…) to characterize cell banks and ensure microbiological safety (viruses, mycoplasma, etc…). - Cell and Gene therapy (ATMPs) and Biodistribution/biodissemination - experience with adenovirus, retrovirus, lentivirus... - Virucidal Norm and cleaning validation - Standard Toxicology and Medical Device Biocompatibility studies (ISO 10993) Texcell GMP cell bank facility: Expertise in handling and growing more than one hundred mammalian cell lines. - Production of RCB, MCB and WCB in GMP - Modern class B and class C cell culture room - Dedicated class B room to fill automatically cells in vials - Culture of adherent and suspension cell line with single use disposable - Viral safety control of cell banks performed directly in-house For more information visit www.texcell.com.

Developed a computational platform that converts recombinant proteins intomaterial-binding variants that can be used to coat implants, devices, and injectable carriers.

United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions. We currently have five approved products on the market, and a long-term mission of providing an unlimited supply of transplantable organs for those who need them! Our employees can be found collaborating across the United States, Europe and Asia. As a group, we are relentless in our pursuit of “medicines for life” and continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers, and other orphan diseases.

Xcision Medical Systems, LLC is a medical technology company that has developed the GammaPod, an advanced stereotactic radiotherapy system with the potential to significantly improve the convenience and quality of life for patients with early-stage breast cancer. The company's technology is designed to extend the benefits of radiation oncology to more patients and enable precision noninvasive treatments that allow patients to return to living fuller lives more quickly with less discomfort after receiving a cancer diagnosis. The system has been developed based on a patent licensed from the University of Maryland School of Medicine.