Category: Biolase Technology Inc.
The FDA clears Biolase's WaterLase iPlus tissue laser in the U.S.
Biolase (NSDQ:BIOL) won 510(k) clearance from the FDA for its WaterLase iPlus, a laser used for soft-tissue orthopedic procedures.
The clearance opens up a $2.6 billion market opportunity for the WaterLase device, according to a company statement.
California medical device maker Biolase won FDA clearance to market its EPIC 10S soft tissue diode laser for more than 80 indications.
Dental devices maker Biolase (NSDQ:BIOL) touted FDA clearance for its EPIC 10S soft tissue diode laser, which the company can now market for more than 80 indications spanning 19 medical markets.
The FDA placed Class I risk status on Ad-Tech Medical Instrument Corp.'s recall of its Macro Micro Subdural Electrodes over concerns that the brain implants may cause injury to the brain.
MASSDEVICE ON CALL — Federal healthcare regulators gave Ad-Tech Medical Instrument Corp.'s wide-reaching brain implant recall Class I status, the highest-risk category for medical device recalls.
Late last year the Wisconsin-based medical device maker recalled its Macro Micro Subdural Electrodes over concerns that the implanted devices could cause damage to the brain.
Biolase wins a nod from the FDA to expand its soft-tissue laser to 19 different markets.
Biolase (NSDQ:BIOL) won FDA approval for the use of its 940nm Diolase 10 laser in a range of different markets. The federal watchdog agency also cleared 80 new procedures for the device.
The Irvine, Ca-based dental laser company said it can now sell into more than 20 new markets, including ear, nose and throat, arthroscopy, dermatology, plastic surgery and ophthalmology.
Dental devices maker Biolase gets some Wall Street love on positive cash flow expectations for Q4 2012.
Dental laser maker Biolase (NSDQ:BIOL) released a preliminary earnings report, expecting to positive cash flow for Q4 and the full year of 2012.
The optimistic outlook sent BIOL shares up 2.2% on the day to close at $2.77 from an open of $2.70 this morning.
Biolase Inc. lands 510(k) clearance for its EPIC 10 diode soft tissue laser to improve patient comfort.
California-based dental laser company Biolase (NSDQ:BIOL) touted FDA clearance and CE Mark approval for its EPIC 10 diode soft tissue laser to help dentists control the laser energy level and improve patient comfort.