Therapeutic Focus
Transforming healthcare through clinical excellence and regulatory expertise in therapeutic focus.
Therapeutic Focus
- Cardiology: Bioexcel provides specialized services for medical devices related to cardiology, which include cardiovascular diagnostic equipment, cardiac implants, and interventional cardiology devices.
- Orthopaedics: Services encompass orthopaedic implants, prosthetics, and surgical instruments used in orthopaedic procedures.
- Diagnostics: Bioexcel serve the diagnostics market segment, focusing on diagnostic equipment and in vitro diagnostic (IVD) devices.
- Neurology: Services extend to medical devices used in the field of neurology, including neurosurgical instruments, neurostimulation devices, and diagnostic tools.
- Ophthalmology: Bioexcel work with devices for ophthalmology, such as intraocular lenses, ophthalmic diagnostic equipment, and laser eye surgery instruments.
- Dental: Dental devices, including dental implants, orthodontic equipment, and dental diagnostic tools, among the areas of expertise.
- Respiratory: Services include devices like respiratory therapy equipment, ventilators, and sleep apnea diagnostic tools.
- Gastroenterology: This segment encompass medical devices used in gastroenterology procedures and diagnostics, such as endoscopy equipment and gastrointestinal implants.
Therapeutic Focus with Case Studies
Bioexcel accelerates innovation in cardiovascular care with expert clinical trials and regulatory support for cardiac devices.
Case Study Examples:
Drug-Eluting Stent Trials:
Conducted a multi-center pivotal trial for a next-generation drug-eluting stent across 5 countries, achieving FDA and CE marking within 12 months.
Pacemaker Compliance:
Assisted a client in preparing the clinical evaluation report (CER) and conducting usability testing for a pacemaker, leading to MDR approval.
Cardiac Diagnostic Tool:Supported a startup in validating a cardiac MRI diagnostic software, helping secure regulatory approval and investor funding.
Bringing orthopedic solutions to market with proven expertise in trials and global regulatory pathways.
Case Study Examples:
Spinal Implant Validation:
Designed and executed clinical trials for a titanium-based spinal implant, demonstrating 99% success rate in restoring spinal alignment over 12 months.
Knee Implant Biocompatibility:
Conducted ISO 10993 biocompatibility testing and risk assessments for a polymer-based knee implant, ensuring global market access.
Trauma Fixation Device:
Supported the development and post-market surveillance of a novel bone fixation plate, enabling a smooth MDR submission process.
Empowering diagnostic innovators with clinical, regulatory, and validation services.
Case Study Examples:
HIV Diagnostic Kits:
Conducted analytical and clinical performance studies for HIV, HBsAg, and Syphilis IVD kits, enabling CDSCO and CE certification.
COVID-19 Testing Devices:
Managed the regulatory submission and ISO 13485 compliance process for a rapid antigen testing device, achieving approvals within 6 months.
Genetic Testing Tool:
Supported clinical trials for a next-generation sequencing (NGS) device, helping secure FDA premarket approval.
Leading clinical and regulatory efforts for cutting-edge neurological devices.
Case Study Examples:
Epilepsy Neurostimulator Trials:
Designed a pilot study for a neurostimulator aimed at reducing seizures, collecting real-world evidence to support a pivotal trial.
Brain Imaging Device Approval:
Facilitated CE marking for an advanced stroke monitoring system by managing technical file preparation and regulatory submissions.
Cognitive Assessment Tool:
Assisted a startup in developing and validating a cognitive impairment diagnostic software, enabling successful funding and clinical deployment.
Delivering safety and compliance solutions for respiratory device manufacturers.
Case Study Examples:
Ventilator FDA Clearance:
Conducted accelerated clinical trials for a portable ventilator and facilitated FDA 510(k) approval during the COVID-19 pandemic.
Sleep Apnea Device Validation:
Supported clinical validation of a smart CPAP device, enabling CE marking and global market entry.
Oxygen Therapy Systems:
Managed post-market surveillance for an oxygen concentrator, ensuring ongoing safety and compliance.
Helping innovators bring life-saving diabetes devices to market.
Case Study Examples:
Continuous Glucose Monitor (CGM):
Conducted a pivotal trial for a CGM device, supporting real-world data collection and FDA premarket approval.
Smart Insulin Pumps:
Provided regulatory strategy and MDR compliance support for an AI-powered insulin pump, ensuring safe and timely market launch.
Diabetic Foot Diagnostic Tool:
Assisted in clinical validation and MDR submission for a diabetic foot monitoring system to prevent complications.
Advancing dermatology innovations with regulatory and clinical expertise.
Case Study Examples:
Laser Treatment Device:
Conducted biocompatibility and risk analysis for a laser skin rejuvenation device, ensuring compliance with ISO 13485.
Wound Healing Systems:
Managed clinical studies for a wound care hydrogel device, resulting in successful CE marking.
Dermatoscopes:
Supported post-market surveillance for a skin cancer diagnostic dermatoscope, ensuring continued patient safety.
Delivering compliance solutions for gynecological and diagnostic devices.
Case Study Examples:
Breast Cancer Diagnostic Tools:
Conducted clinical trials and managed regulatory submissions for a non-invasive breast cancer screening device, enabling global distribution.
Fertility Monitoring Systems:
Assisted in usability testing and market approvals for a fertility tracker, meeting MDR requirements.
Contraceptive Devices:
Facilitated regulatory approval for a long-acting contraceptive implant, achieving CE marking.
Therapeutic Focus
At Bioexcel, we specialize in providing tailored solutions for manufacturers in diverse therapeutic areas, helping them navigate clinical trials, regulatory approvals, and compliance.
Cardiology
Advancing cardiovascular care with end-to-end support for stents, pacemakers, and diagnostic devices.
How Bioexcel Supports:
- Conducted pivotal clinical trials for a drug-eluting stent with over 1,000 patients across multiple sites.
- Assisted a manufacturer in obtaining CE marking for a pacemaker, reducing time to market by 20%.
- Supported regulatory submission for a cardiac diagnostic system in compliance with FDA and MDR guidelines.
Orthopedics
Bringing advanced orthopedic devices to market through trials and compliance support.
How Bioexcel Supports:
- Conducted biocompatibility testing for a titanium-based knee implant, ensuring ISO 10993 compliance.
- Managed clinical trials for a spinal fusion implant, focusing on safety and long-term performance.
- Secured FDA 510(k) clearance for a custom orthopedic prosthetic, meeting all regulatory requirements.
Diagnostics (IVDs)
Empowering innovation in diagnostic tools and IVDs for better healthcare outcomes.
How Bioexcel Supports:
- Conducted analytical and clinical performance studies for HIV, HBsAg, and Syphilis IVD kits, achieving regulatory approvals in India and Europe.
- Facilitated ISO 13485 certification for a COVID-19 diagnostic kit, ensuring global market access.
- Assisted in the development and validation of genetic testing devices for hereditary disease detection.
Neurology
Innovating neurological care with regulatory and clinical trial solutions.
How Bioexcel Supports:
- Designed and executed clinical trials for a neurostimulator targeting epilepsy treatment.
- Provided regulatory support for a brain imaging device to achieve CE marking under MDR.
- Helped a startup secure funding by preparing a clinical evaluation report (CER) for their cognitive assessment tool.
Respiratory Care
Innovating respiratory solutions with compliance and clinical trial support.
How Bioexcel Supports:
- Facilitated FDA 510(k) approval for a portable ventilator, enabling quick entry into the US market.
- Conducted post-market surveillance for an oxygen therapy device, ensuring continued compliance.
- Supported a client in developing and validating a nebulizer for pediatric use.
Diabetes Management
Enhancing patient care with cutting-edge diabetes devices.
How Bioexcel Supports:
- Conducted pivotal clinical trials for a continuous glucose monitor (CGM), gathering real-world data for regulatory submission.
- Provided technical documentation for a smart insulin pump in compliance with MDR requirements.
- Supported regulatory approval for a diabetic foot diagnostic tool in multiple regions.
Dermatology
Supporting dermatological innovations with compliance and research.
How Bioexcel Supports:
- Conducted biocompatibility studies for a wound healing device, ensuring ISO 10993 compliance.
- Assisted a client in achieving FDA approval for a laser-based skin treatment device.
- Managed post-market surveillance for a dermatoscope, ensuring safety and performance.
Women’s Health
Advancing healthcare solutions for women through innovative devices.
How Bioexcel Supports:
- Facilitated CE marking for a breast cancer diagnostic tool in compliance with MDR requirements.
- Conducted clinical trials for a fertility monitoring device, improving accuracy and usability.
- Supported post-market surveillance for a gynecological surgical instrument, ensuring ongoing safety.
Partner with Bioexcel to Bring Your Innovation to Life!
With expertise in clinical trials, regulatory compliance, and market approvals, Bioexcel is your trusted partner for success in the medical device industry.
