Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
- Sonitus wins European approval for teeth-based hearing aid
Sonitus Medical Inc. received CE Mark approval for its SoundBite Hearing System. The company received its EC Certificate, which indicates Full Quality Assurance System Approval. This is the first European regulatory certification for the company and the product. The SoundBite hearing system is the world’s first and only non-surgical and removable hearing solution designed to imperceptibly transmit sound via the teeth to help people who are essentially deaf in one ear regain their spatial hearing ability. It employs a principle called bone conduction to deliver sound to the inner ear.
- Teleflex wins FDA clearance for Arrow NextStep antegrade catheter for chronic hemodialysis
Teleflex Inc. (NYSE:TFX) announced that its Arrow NextStep Antegrade Chronic Hemodialysis Catheter received market clearance from the Food & Drug Administration. The NextStep Antegrade Chronic Hemodialysis Catheter is designed to attain long-term vascular access for hemodialysis and apheresis. It is indicated for use in adult patients. Teleflex expects to launch the product in the United States later this year.
- Elana lands FDA approval for neurosurgery kit
Utrecht, Netherlands-based Elana won FDA approval for a surgical kit that allows neurosurgeons to reroute blood flow around an aneurysm or a tumor in the brains of patients at greater risk of stroke during standard bypass surgery. The ELANA (Excimer Laser Assisted Non-Occlusive Anastamosis) Surgical Kit allows neurosurgeons to create a bypass without shutting off the blood flow. It consists of a small platinum ring and a hand piece connected to a surgical laser and suction tubing. Standard bypass surgery in the brain requires clipping the artery to halt blood flow during the procedure.
- Tenex wins FDA clearance for TX1 tissue removal device
Tenex Health won FDA 510(k) clearance for the TX1 Tissue Removal System. This portable, self-contained system offers precise soft tissue removal for tendons and other soft tissues with intended use in the elbow, knee, ankle, foot, and shoulder. Each year, over 8 million people in the United States suffer from tendon injuries with associated chronic pain and loss of function. Physicians can now utilize the TX1 Tissue Removal System in the FAST procedure — Focused Aspiration of Soft Tissue — for removal of degenerated tissue and restoration of natural tendon and soft tissue function for their patients.
- Nexera receives simultaneous FDA 510(k) and NIOSH clearance for SpectraShield antibacterial respirator mask
Nexera Medical Inc. announced that it received FDA 510K and NIOSH clearance to commercially market their SpectraShieldTM Antibacterial N95 Respirator Mask. Nexera, a leading developer in microbial fighting textile based healthcare products introduced this new antibacterial respirator mask technology. Considered the model for the next generation respirator mask, the SpectraShieldTM respirator mask is equivalent to a N95 (NIOSH rating), or a FFP3 (E.U. criteria) respirator mask. The SpectraShieldTM mask begins to kill certain strains of bacteria immediately on contact, and is available in both adult and children’s sizes. This revolutionary next generation mask is designed to give the general public, health officials, first responders, and care givers the best available protection against infectious diseases.
- BIOTRONIK AlCath Flux eXtra Gold Is launched in Europe
BIOTRONIK SE Co. & KG, a leading manufacturer of cardiac devices, announced that its innovative new ablation catheter, AlCath Flux eXtra Gold, is now available throughout Europe after receiving CE mark and successfully completing the premarket evaluation in Germany, Italy, Switzerland and several other European countries. The unique features of the AlCath Flux eXtra Gold facilitate optimal irrigation. Building on the superior thermal properties of gold, the catheter tip’s innovative X-shaped configuration of the 12 irrigation channels further increases the cooling effect by more than 33 percent compared to the preceding model. Proximal cooling specifically addresses the transition from tip to shaft to prevent charring during the procedure.
- MyoPowers lands ISO 13485:2003 certification and positive statement on clinical investigation plan
MyoPowers Medical Technologies SA, a Swiss medical device startup company which develops and manufactures artificial muscles to treat sphincter dysfunction and incontinences, announced that it received the International Organization for Standardization (ISO) 13485:2003 certificate for the "design, development, production, manufacture and distribution of active implantable medical devices for the treatment of incontinence." The company is currently developing an artificial urinary sphincter to treat severe urinary incontinence in both males and females.
- Excelsior Medical receives FDA clearance for SwabFlush
Excelsior Medical Corp. announced that it received FDA 510(k) clearance for SwabFlush, its latest product for the vascular access and infection control markets. SwabFlush is the only IV catheter flush syringe that provides a disinfection cap for needleless IV connectors, built into the plunger of the syringe. The all-in-one combination of SwabCap and Excelsior’s ZR pre-filled flush syringe promotes compliance with required protocols for both catheter flushing and disinfection of IV connectors.
- Breathe Technologies wins FDA clearance for home use of portable ventilator
Breathe Technologies Inc., a manufacturer of technology solutions for people with respiratory conditions, including chronic obstructive pulmonary disease (COPD), announced that it received FDA clearance for use of the Breathe Technologies BT-V2S ventilator in the home setting. The one-pound portable device provides ventilation assistance to aid select adult patients who suffer from respiratory insufficiency.