The FDA said last Friday it is recalling MicroPort Orthopedics ProFemur long cobalt chrome 8 degree Varus and Valgus modular neck implants over issues with the acute fractures. The federal watchdog labeled the recall as a Class I, the most serious type of recall issued by the FDA, which indicates “there is a reasonable probability that […]
Food & Drug Administration (FDA)
FDA warns St. Jude Medical on CardioMEMS plant in Atlanta
UPDATED Oct. 6 with comment from St. Jude Medical. St. Jude Medical (NYSE:STJ) last week revealed that the FDA sent it a warning letter after inspections at the Atlanta plant where it makes its CardioMEMS implantable heart monitor turned up problems with its corrective and preventive action plans. Little Canada, Minn.-based St. Jude said Oct. 2 […]
FDA approves Boston Scientific’s Synergy absorbable stent
UPDATED Oct. 14, 2015, with comment from Boston Scientific’s Dr. Craig Thompson. The FDA approved Boston Scientific‘s (NYSE:BSX) Synergy drug-eluting stent for treating coronary artery disease, sending BSX shares up today and making BSX the 1st U.S. entrant on the next front in the stent wars. The Marlborough, Mass.-based company said the Synergy device’s bioabsorbable polymer is designed to dissolve completely after delivering […]
ReVision Optics files final PMA module for Raindrop inlay
ReVision Optics said Monday it submitted the final module of its premarket approval application for its Raindrop near vision inlay. The Raindrop is a microscopic hydrogel inlay for treating presbyopia, which the Lake Forest, Calif.-based company said could reduce or eliminate the need for reading glasses. Data for the 4th and final module submitted came from […]
Intersect ENT files for expanded Propel PMA
Intersect ENT (NSDQ:XENT) said Tuesday it submitted a supplemental premarket approval application to the FDA to expand the indication on its Propel mini steroid releasing implant to cover frontal sinus surgeries. The new indication would allow the drug-device combo to be used in the frontal sinuses, located behind the eyebrows, the Menlo Park, Calif.-based company […]
EarLens wins FDA 510(k) for novel hearing aid
EarLens said Tuesday it won FDA 510(k) clearance for its laser diode-equipped direct vibration-based contact hearing device for use in adults with mild to severe sensorineural hearing impairment. The device is designed to directly contact the patient’s eardrum and use it as a speaker and act as an amplifier for a wide range of frequencies, […]
Medtronic wins expanded FDA PMA for Verify system
Medtronic (NYSE:MDT) said yesterday it won an expanded FDA premarket approval for its Verify system for testing patients for use with its Interstim bladder or bowel control sacral neuromodulation device during basic evaluations. The Verify allows patients with overactive bladder, non-obstructive urinary retention or bowel incontinence to test Interstim system for 3-7 days before making a long-term commitment, the Fridley, […]
Bayer wins PMA for Betaconnect electronic autoinjector
Bayer (ETR:BAYN) said Monday it won FDA premarket approval for its Betaconnect electronic autoinjector for treating relapsing-remitting multiple sclerosis patients on the drug Betaseron. The Betaconnect is the 1st and only electronic autoinjector if its kind to treat RRMS, Whippany, N.J.-based Bayer said. “Bayer has a long legacy of supporting and providing services for the RRMS […]
PAD: Intact Vascular wins IDE for Tack endo repair
Intact Vascular said today it won FDA Investigative Device Exemption for a clinical trial of its Tack endovascular system for patients with peripheral arterial disease undergoing percutaneous angioplasty. The Tack endovascular system is designed to repair dissections that occur as a complication of balloon angioplasty. The system allows operating physicians to repair dissections with only […]
Implanet wins expanded FDA 510(k) for Jazz band device
French orthopedic implant company Implanet said Wednesday it won expanded FDA 510(k) clearance for its Jazz spinal implant allowing it to be used with other posterior thoraco-lumbar fixation systems. The Jazz implant is intended to provide temporary stabilization as a bone anchor during bone fusions and to aid in the repair of bone fractures. The […]
FDA panel recommends limited use of Bayer’s Essure until more is known about safety
An FDA advisory panel yesterday recommended that the agency limit the use of Bayer‘s (ETR:BAYN) Essure female sterilization device until more is known about its safety, after thousands of women reported serious health issues they attribute to the nickel-titanium implant. Essure, the only approved permanent birth control device in the U.S., is a small metal coil that […]