Urology in California

Aulea Medical manufactures the Veloxion all-in-one system, a single-use, integrated platform for benign prostatic hyperplasia (BPH) treatment via transurethral resection of the prostate (TURP). The system combines fluid management, video imaging, and radiofrequency energy generation in a single console to streamline urology workflows. Key clinical innovations include automated intravesical pressure monitoring and control, motorized plasma cutting technology, multi-directional resection capability, and immediate tissue evacuation to maintain visualization. The Veloxion is designed to reduce BPH treatment time to approximately 20 minutes compared to standard TURP (60 minutes), enable same-day procedures in ambulatory surgery centers for prostate glands ranging 30–200g, and eliminate infection risk and cross-contamination through single-use endoscopic devices. The system requires minimal setup and teardown, reducing procedure time and cost of ownership. Aulea targets urology departments, ambulatory surgery centers, and specialty urology practices. The company emphasizes safety (pressure management to prevent bladder perforation, sterile single-use design), simplicity (plug-and-play console, automated fluid evacuation), and procedural efficiency. Manufacturing capabilities include single-use device fabrication and integrated RF energy generation systems.

Calyxo, Inc. is a medical device company specializing in minimally invasive urological surgery, with a focus on kidney stone management. The company manufactures the CVAC® System, an integrated ureteroscopic platform designed for complete stone clearance. The CVAC System combines multiple capabilities in a single device: laser lithotripsy, microjet irrigation, dynamic aspiration, and stone collection. The proprietary SURE Procedure (Steerable Ureteroscopic Renal Evacuation) is a treatment protocol performed exclusively with the CVAC System that uses laser lithotripsy, irrigation, and vacuum aspiration to achieve superior stone clearance outcomes. Clinical evidence from a randomized controlled trial demonstrates 97% stone clearance rates, superior to standard ureteroscopy. The company targets urology departments and ambulatory surgery centers performing endoscopic stone treatment. Calyxo positions the CVAC System as a game-changing innovation in kidney stone care, reducing procedural complexity by integrating multiple treatment modalities. The device appears to be FDA-cleared for clinical use (regulatory designation MAC00071.B referenced on homepage). The company is actively recruiting clinical staff and maintaining an active clinical development program with published outcome data.

Urocare Products, Inc. is a manufacturer of urological medical devices and drainage systems specializing in innovative urine collection and catheter care products. Founded in 1975, the company has developed a comprehensive line of urinary drainage solutions including reusable latex leg bags, disposable vinyl leg bags, and urinary drainage bottles. The company's flagship innovation is the patented Little Red Valve®, a self-cleaning anti-reflux valve designed to prevent urine backflow, reduce bladder distention risk, and minimize infection incidence associated with standard drainage products. Urocare manufactures these products as the sole provider of devices incorporating the Little Red Valve® technology. The company serves healthcare providers and patients in the United States and maintains international distribution. Products are designed with emphasis on durability, safety, and ease of use based on years of research, development, customer feedback, and engineering refinement. Urocare's offerings are recognized for practical clinical benefits in managing urinary incontinence and catheter-dependent patients, particularly in home care and long-term care settings.

Ningbo Wise Optomech Technology Corporation (trading as OTU Medical) designs and manufactures single-use digital flexible endoscopes and visualization systems for minimally invasive diagnostic and therapeutic procedures. The company's primary product line is the WiScope® Single-Use Digital Flexible Cystoscope (C311 Series), a disposable urological endoscope system designed for cystoscopy and urology procedures. OTU Medical serves multiple medical specialties including Urology, Gastroenterology, Pulmonology, Gynecology, and ENT (Otorhinolaryngology), indicating a platform approach to single-use endoscopic instrumentation across multiple clinical domains. The company manufactures image processors and visualization equipment to complement endoscopic instruments. Product lines are segmented by specialty (Urology, Gastroenterology, Pulmonology, Gynecology, ENT) with co-branding partnerships available. The company exhibits at major international medical conferences including AUA (American Urological Association) and EAU (European Association of Urology), indicating active engagement in the US and European urology markets. Manufacturing and technology capabilities center on digital single-use endoscope design, optics integration, and image processing systems. No specific FDA clearance status, ISO certification details, or manufacturing location details are available from the website content provided.

Embolx Inc. is a medical device company specializing in advanced microcatheters for arterial embolization procedures. As a subsidiary of Edwards Lifesciences, the company develops innovative solutions for interventional oncology and related specialties, including treatments for cancerous tumors, benign prostatic hyperplasia (BPH), and uterine fibroids. The flagship product, Sniper® Balloon Occlusion Microcatheter, enables precise delivery of embolic agents with controlled blood flow pressure management. The latest generation, Sniper G3 (launched July 2025), offers improved efficiency and ease of use for healthcare providers. Embolx products are available in US and European markets and serve interventional radiologists and specialists performing minimally invasive embolization procedures.

Promaxo is a MedTech company specializing in compact, single-sided portable MRI systems and AI-driven technologies for interventional imaging and image-guided procedures. The company's flagship product is an office-based MRI platform that received FDA clearance in March 2021, enabling real-time MR-guided biopsies and cancer treatment in ambulatory settings without requiring dedicated MRI suites. Promaxo's system is designed for urologists and hospitals targeting prostate cancer diagnosis and treatment, featuring AI-driven tissue characterization with reported 77% cancer detection rates and 33% improvement in detecting clinically significant cancers versus standard of care. The system requires minimal facility upgrades and integrates seamlessly into existing clinical workflows, allowing concurrent clinic operations and interventional procedures. Founded in 2016 and backed by strategic investors including MicroPort and Zepp Health, Promaxo holds over 200 patents and is expanding applications to breast oncology and orthopedics. The company is led by CEO and Chairman Amit Vohra.

Eigen Health is a California-founded medical technology company (established 1975) specializing in advanced MRI-ultrasound fusion systems and minimally invasive focal therapies for prostate cancer diagnosis and treatment. The company operates in 36+ countries, serving academic institutions, hospitals, and clinical practices globally. The Artemis platform is their flagship 3D semi-robotic prostate biopsy system featuring real-time organ tracking and prospective needle navigation with switchable transrectal and transperineal modules. It performs rigid and elastic registration of multimodal imaging (MRI, PET-CT, PSMA PET-MRI) to real-time ultrasound. The TPO (Transperineal Operative) module is purpose-built for transperineal approaches with integrated ultrasound capabilities. ProFuse CAD is their advanced radiology software for computer-assisted detection, real-time mpMRI analysis, and MRI data preparation for fusion guidance. The Cryo product combines MRI/ultrasound fusion-guided biopsy with cryoablation for minimally invasive, often outpatient prostate cancer treatment. The company reports supporting clinical outcomes for over 3,000,000 patients worldwide and maintains multiple patents in fusion imaging and needle guidance technology. ISO 13485 certified, indicating compliance with medical device quality management standards. The company emphasizes long-term partnerships with distributors and clinical institutions for seamless technology integration into practice and research.

Accurate Surgical & Scientific Instruments Corp. (ASSI) is a leading manufacturer of precision surgical instruments for specialized surgical disciplines. With nearly four decades of industry experience, ASSI supplies a comprehensive range of expertly crafted instruments including bipolar and monopolar forceps, scissors, needle holders, retractors, microvascular clamps, and specialty tools for microsurgery, hand surgery, neurosurgery, plastic and reconstructive surgery, ophthalmology, ENT, urology, and vascular surgery. The company emphasizes precision engineering, quality materials (stainless steel, titanium, insulated variants), and customer service. Products span electrosurgical instruments, bone and soft tissue surgery tools, and specialized microsurgical equipment. ASSI operates manufacturing and distribution facilities on both US coasts with B2B direct sales to hospitals, surgical centers, and medical professionals.

MacroLux Medical Technology Co., Ltd. is a China-based manufacturer focused on endoscopic diagnosis and treatment solutions. The company specializes in the design and development of single-use electronic endoscope products for minimally invasive procedures across multiple clinical specialties. Primary product lines include flexible ureteroscopes (CoralView U Series), airway management endoscopes, gynecological endoscopes, and ENT endoscopes. The CoralView U Series features advanced capabilities including digital imaging, adjustable bending with BendForce Enhancement Technology, and various French sizes (7.5Fr and others) optimized for different anatomical access. MacroLux serves global healthcare markets and participates in major international medical conferences including EAU, ESGE, and MEDICA, indicating significant market presence in Europe and beyond. The company has secured Series B+ venture funding from B Capital as of January 2025, supporting continued global expansion. Manufacturing and distribution are based in Shenzhen, China. While specific regulatory certifications (FDA, CE, ISO) are not explicitly mentioned in the fetched content, the participation in European medical conferences suggests alignment with relevant regulatory requirements. The company emphasizes innovation in minimally invasive urology and women's health endoscopy.

Caldera Medical is a U.S.-based medical device manufacturer headquartered in Westlake Village, California, specializing in minimally invasive surgical solutions for women's pelvic health. Founded in 2002, the company develops and markets innovative products for stress urinary incontinence (SUI), pelvic organ prolapse (POP), and hysteroscopic tissue removal. The company's product portfolio includes the Desara® Family for SUI treatment, the Vertessa® Family for POP repair, the Benesta Family for hysteroscopic procedures, and the Luminelle system launched in 2024 for advanced gynecological applications. Recognized as the fastest-growing women's health company for three consecutive years, Caldera Medical emphasizes surgeon collaboration, physician training, and clinical support. The company is committed to improving patient outcomes through durable, effective minimally invasive treatments while supporting a global humanitarian program aimed at reaching one million women with pelvic health education and treatment by 2027.

Boston Scientific Corporation is a global medical device manufacturer serving multiple clinical specialties including cardiology, urology, gastroenterology, interventional radiology, electrophysiology, neurology, pain management, vascular surgery, and structural heart disease. The company manufactures and distributes a broad portfolio of minimally invasive medical devices, including cardiac rhythm management systems, interventional cardiology devices, electrophysiology catheters and mapping systems, spinal cord stimulation systems for pain management, urological devices, endoscopy and visualization systems, defibrillators, and interventional oncology equipment. Boston Scientific operates a healthcare professional portal providing online training through EDUCARE, e-commerce ordering, reimbursement resources, and comprehensive customer support with specialty-specific representative contact networks. The organization serves hospitals, ambulatory surgery centers, and healthcare professionals across the United States through direct sales and support teams organized by medical specialty. Products undergo rigorous regulatory compliance (FDA 510(k), international certifications) and the company emphasizes quality assurance and product safety as core organizational values. Customer care is available via a dedicated U.S. customer service line, with extended business hours Monday–Friday.

RX Sleeve manufactures FDA Class II-listed penis sleeves and erectile dysfunction support devices. The company specializes in premium, skin-safe silicone wearable medical devices designed to address erectile dysfunction, post-surgical complications, and sexual health challenges. Products include customizable penis sleeves in multiple girth sizes (3.75" to 6.0"), the Grip™ patented harness system, and accessories including lubricants and sizing guides. Materials are medical-grade, hypoallergenic silicone available in natural skin tones. RX Sleeve offers custom fabrication services and serves patients with ED from various etiologies including prostate cancer, diabetes, medication side effects, Peyronie's disease, and age-related changes. The company provides doctor and therapist partnerships, supports FSA/HSA purchase eligibility, comprehensive 1-year warranty coverage, and discreet shipping. With over 20 years of operational history, the founder's background in surgical device design informs manufacturing standards. Customer support available M–F 9 AM–5 PM.

Jiangsu Conod Medical Devices Co., Ltd. is a Chinese medical device manufacturer and supplier with approximately 20 years of export experience serving over 50 countries across the Americas, European Union, Japan, and developing markets in Asia, Africa, and Latin America. The company manufactures and distributes a broad portfolio of single-use medical consumables and devices across eight primary product categories: urology (catheters, drainage bags, catheterization trays, leg bags, urine meters), personal protective equipment (medical masks, surgical masks, face shields, isolation gowns, examination gloves), wound drainage systems (suction accessories, drainage devices, sputum suction kits), anesthesia and breathing supplies (anesthetic masks, aerosol trays), enteral feeding systems (feeding sets, feeding pumps), household emergency kits, nonwoven fabric materials, and specialty products (enema systems, fecal management collectors). The company operates vertically integrated capabilities including precision mold design and development, in-house injection molding (27 molding machines), third-party sterilization services (ETO sterilization with ISO 11135-2014 and ISO 13485-2016 certifications, FDA and Japanese FMA registration), and independent testing and detection center services. Conod holds Chinese medical device registration certificates and serves domestic and international hospital systems, clinical facilities, and distribution partners. The company emphasizes quality control, advanced manufacturing equipment, and customized product solutions aligned with international regulatory standards.

International Medical Devices, Inc. (IMD) is a Beverly Hills-based medical device company established in 2013, specializing in cosmetic penile implant technology. The company develops and commercializes Himplant®, the first and only FDA-cleared cosmetic penile implant on the market, backed by over two decades of clinical research and four separate FDA 510(k) clearances since 2004. Himplant® is available in five sizes for anatomical customization and is designed for outpatient surgical procedures with established clinical protocols. IMD operates across multiple continents, including the United States, Colombia, Mexico, and Middle Eastern countries (UAE, Saudi Arabia, Qatar, Jordan, Turkey), with an extensive international patent portfolio. The company actively recruits distribution partners and maintains a trained surgeon network for procedure delivery. IMD serves three primary market segments: distribution partners seeking territorial expansion, surgeons and clinicians requiring training and clinical protocol support, and patients seeking the procedure. The company holds multiple FDA 510(k) clearances and maintains regulatory compliance across its operating regions. IMD provides comprehensive clinical data, product specifications, and partnership support through its corporate headquarters and online platforms.

Fellow Health Inc. is a CLIA-certified diagnostic laboratory specializing in mail-in semen analysis and reproductive health testing. The company provides clinical-grade semen analysis, vasectomy post-procedure testing, and sperm cryopreservation services to over 3,000 clinics, including urology and reproductive endocrinology practices. Fellow's proprietary testing methodology has been peer-reviewed and validated to deliver clinically accurate results comparable to fresh samples analyzed within one hour, with turnaround times under 2 business days from specimen receipt. The service addresses compliance barriers in post-vasectomy semen analysis testing, achieving 86% compliance rates—significantly higher than industry standards—by offering patients a convenient, privacy-preserving home-based collection option. Fellow operates a CLIA-certified (#05D2177822) and COLA-accredited (#31245) laboratory and has processed over 225,000 samples. The company conducts peer-reviewed research into male reproductive health factors and seminal fluid diagnostics, publishing in journals including Fertility and Sterility and Journal of Urology. Markets served include high-volume vasectomy providers, urologists, reproductive endocrinologists, and OB/GYNs. The testing platform is designed to reduce clinic call volume related to results communication and improve patient satisfaction (93% reported satisfaction).

Medical Electronic Systems (MES) is a global leader in semen analysis and sperm quality testing solutions. The company manufactures automated Sperm Quality Analyzers (SQA), laboratory validation kits, and consumer-direct fertility testing products. MES serves fertility clinics, reference laboratories, clinical laboratories, mail-in diagnostic programs, and at-home testing markets across the United States and internationally. The product portfolio includes the SQA-Vision and SQA-iOw automated analyzers for clinical laboratory use; QwikCheck validation and SQA supply kits for quality control and calibration; the YO Home Sperm Test for direct-to-consumer at-home semen analysis; and MaleMan lab services for comprehensive semen evaluation. All analyzers are CE-marked and FDA-cleared. The company maintains direct customer support, calibration and validation services, and international distribution capabilities. MES systems are deployed across fertility centers, major health systems (Kaiser Permanente, Sutter Health, UCHealth, NYC Health + Hospitals), reference laboratories (Labcorp, Quest Diagnostics), military installations (US Air Force, US Navy, US Army), and international institutions in France, Germany, Belgium, Canada, and Australia. The company emphasizes reliability, ease of use, reduced turnaround time, standardized reporting, and decreased manual labor requirements for clinical semen analysis workflows.

Convergent Laser Technologies is a leading manufacturer of medical laser systems and fiber-optic devices for clinical applications. The company specializes in urology, including laser lithotripsy and benign prostatic hyperplasia (BPH) treatment, leveraging proprietary fiber delivery technology to achieve reliable, controlled, and precise power delivery for physician-selected techniques. Key product lines include the Optica XT (stone dusting and soft tissue applications), T-1470 ProTouch and LiteTouch (prostate treatment), and Odyssey 30 systems. Convergent also offers remanufactured fiber solutions designed to reduce procedural costs and environmental impact. Based in Alameda, California, the company serves hospitals and surgical centers with clinical training and field support.

Bentec Medical OpCo, LLC is a medical-grade silicone fabrication and contract manufacturing specialist founded in 1994 and currently headquartered in Woodland, California. The company operates in two primary segments: (1) OEM contract manufacturing services providing silicone component fabrication, assembly, sterilization, packaging, design consultation, and regulatory support for medical device partners; and (2) proprietary FDA and CE-approved silicone medical devices distributed under the Bentec Medical brand. The company specializes in advanced silicone fabrication capabilities including micro-molding, multi-lumen extrusions, hybrid calendered sheeting, dip coating, and knife coating. Manufacturing expertise encompasses tight-tolerance components, complex multi-process assemblies, and material compounding. Bentec serves OEM customers and direct end-users across oncology, cardiology, urology, pediatrics, bariatric, general and cosmetic surgery, ENT, and interventional radiology specialties. Quality and regulatory credentials include FDA registration, ISO 13485:2016 certification, and ISO 14644 Class 7 cleanroom certification. The company maintains a track record of 100% monthly supplier scorecards from Fortune 500 OEM customers. Manufacturing capabilities combine proprietary techniques with fully validated processes and stringent environmental controls. Bentec was acquired by Hermitage/Greyrock in 2016, which implemented institutional ownership standards, enhanced engineering and quality management systems, and expanded production capacity and fabrication technology.

Avatar Medical USA Inc develops FDA-cleared and CE-marked 3D medical imaging visualization software that transforms DICOM medical images into interactive 3D patient avatars for clinical consultation, surgical planning, and medical education. The platform is hardware-agnostic and integrates with existing PACS systems without preprocessing requirements. It enables real-time 3D visualization suitable for multiple surgical specialties including neurosurgery, oncology, ENT, oral maxillofacial surgery, cardiovascular and vascular surgery, and urology. The software supports intraoperative guidance, multidisciplinary team collaboration, and patient engagement during pre- and post-operative consultations. Avatar Medical also offers Eonis Vision, a consultation-focused product, and Avatar Medical Academy for medical education. The platform supports extended reality (XR) interaction for immersive visualization. Clinical applications span from patient communication and informed consent to detailed surgical planning and training environments. The company serves major teaching hospitals and medical centers across North America and Europe, including Assistance Publique-Hôpitaux de Paris, Sorbonne University, and University of Miami.

ENDOSEMIO Co., Ltd. is a Taiwan-based medical device company specializing in miniaturized endoscopic imaging technology and single-use (disposable) endoscopes. The company focuses on high-resolution, ultra-compact endoscopic systems with tube diameters under 2.2 mm, enabling insertion into neonatal airways and other delicate anatomical spaces. Product offerings include single-use flexible ureteroscopes, neonatal/pediatric bronchoscope imaging kits, wireless endoscope-imaging tracheostomy kits, high-resolution digital otoscope sets, and veterinary imaging solutions. Core technical capabilities include high-definition micro CMOS imaging sensors, color calibration technology, and silicone endoscope tubing. The modular platform design allows accessory customization for different clinical specialties (ENT, urology, pediatrics, neonatology) and veterinary applications. Recent developments include AI-powered ENT endoscopy systems with enhanced mucosal and vascular pattern recognition for early lesion detection. Single-use design eliminates reprocessing labor, reduces cross-infection risk, and improves operating room turnover efficiency. Products are marketed globally at major trade shows (MEDICA, Healthcare Taiwan). The company emphasizes clinical collaboration and user-centered design developed in partnership with healthcare practitioners.