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
IDE applications for first-of-a-kind, Class II and III devices including:
- Non-refractory and refractory glaucoma implants
- Manual instruments to lower IOP in 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
- Synthetic, polymer urethral bulking agent for urinary incontinence
- Neurostimulation for stroke treatment, obesity, obstructive sleep apnea
- Synthetic, polymer urethral bulking agent for urinary incontinence
- 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
- Intrabronchial valves for COPD
- Intragastric balloons for weight loss
510(k) Premarket Notifications (selected, novel technology)
Successful 510(k) clearances, including:
- Collagen shields
- Diagnostic imaging and measurement tools including tonometers and biometers
- Diagnostic software
- Dry eye therapeutics
- Femtosecond lasers in cataract and refractive surgery
- Manual instruments to lower intraocular pressure (IOP) in glaucoma and for other indications
- 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
De Novo Petitions
Successful Class II De novo petitions, including:
- Smart contact lens
- Neurostimulation and light-based therapy for dry eye disease
HUD and HDE
Orphan device designations and approvals, including:
- Retinal prosthesis
- 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
GLOBAL ACCOMPLISHMENTS
PHARMACEUTICALS AND BIOLOGICS
Below are some of the many regulatory filings our team of consultants has partnered with clients to accomplish.
IND Applications
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- Ophthalmic PDT drug-device combination product for oncologic indication
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