Accomplishments
Our accomplishments are the product of collaborations with clients as we identify an optimal and individualized pathway
GLOBAL ACCOMPLISHMENTS
Below are some of the many regulatory filings our consultants have partnered with clients to accomplish.
IDE Applications
Approved IDE study applications for Class II and III devices, some of which are first-of-a-kind, including:
- Non-refractory and refractory glaucoma implants
- Manual instruments to lower IOP in the treatment of glaucoma
- Lasers for the treatment of glaucoma
- Radiation therapy for age-related macular degeneration
- Corneal refractive procedures (lasers, inlays, and implants for ametropia, presbyopia, etc.)
- Femtosecond lasers in refractive surgery
- Ophthalmic viscoelastics (sodium hyaluronate, HPMPC)
- Implants to address corneal blindness
- Intracanalicular plugs
- Intraocular lenses (premium and non-premium)/telescopes
- Synthetic, polymer urethral bulking agent for urinary incontinence
- Intrabronchial valves for COPD
- Neurostimulation for stroke treatment, obesity, obstructive sleep apnea
- Synthetic, polymer urethral bulking agent for treatment of GERD
- Neurointerventional devices (coils, intracranial stents, polymers for embolization, clot retrieval devices) for arteriovenous malformations, aneurysm, stroke, and stroke prevention
- Intravascular anastomosis device for refractory hypertension and COPD
- Intravascular catheter-based system for acute ischemic stroke prevention
- Adhesion-barrier device for use in laparoscopic surgery
- Temperature regulation system for neuro-intensive care unit patients
- Cardiac resuscitation device
- Breast biopsy devices
- Intragastric balloons for weight loss
510(k) Premarket Notifications (selected, novel technology)
Successful 510(k) clearances, including:
- Advanced laser technology for the treatment of glaucoma
- Dry eye therapeutics including eyelid heating and intracanalicular plugs
- Neuromuscular electrical stimulation (NMES)
- Amblyopia digital therapeutic device
- Vitrectomy instruments
- Synthetic patch graft for scleral reinforcement/glaucoma implants
- Collagen shields
- Diagnostic imaging and measurement tools including tonometers and biometers
- Diagnostic/monitoring software (home use and clinical use)
- Femtosecond lasers in cataract and refractive surgery
- Ophthalmic lasers for other applications (glaucoma, retina, etc.)
- Photocoagulation lasers
- Refractory glaucoma implants
- Subretinal and suprachoroidal therapeutic delivery
- Temperature regulation system for neurointensive care units
- Atherectomy devices for cardiointerventional application
- Aneurysm coils with novel configuration and polymer coating
- Coil/clot removal device for intracerebral application
- Manual instruments to lower intraocular pressure (IOP) in glaucoma and for other indications
De Novo Petitions
Successful Class II De novo petitions, including:
- Smart contact lens
- Tear neurostimulator
- Neurostimulation and light-based therapy for dry eye disease
- Amblyopia digital therapeutic device
HUD/HDE and Breakthrough Designations
Orphan device designations and approvals, including:
- Retinal prosthesis
- Artificial lens capsule
- Corneal therapeutic devices
- Intraocular lenses
- Intracerebral stent for stroke prevention
- Intrabronchial valves for pulmonary indication
Premarket Approval Applications
Successful PMA approvals, many of which are first-of-a-kind, including:
- Corneal refractive procedures (lasers and implants for ametropia, presbyopia, etc.)
- Implants for non-refractory glaucoma
- Intraocular refractive and therapeutic implants [phakic and aphakic intraocular lenses (premium and conventional), adjustable IOL’s, implantable telescope, capsular tension ring, silicone oil, viscoelastic devices, etc.]
- Diagnostic imaging systems (breast, pulmonary, etc.)
- Implants for management of gastroesophageal reflux disease (GERD)
- Implantable polymer for bulking of the urethral sphincter in female stress urinary incontinence
- Renal stents
- Transcatheter aortic valve replacements
- Atherectomy devices for cardiointerventional application
