Intersect ENT (NSDQ:XENT) shares dipped today on fourth-quarter losses that topped the consensus forecast. The Menlo Park, Calif.-based ear, nose and throat condition treatment developer posted losses of -$7.96 million, or -25¢ per share, on sales of $31.75 million for the three months ended Dec. 31, 2019, for a nearly $3 million bottom-line slide on a […]
PhotoniCare wins FDA nod for imaging tech to spot ear infections
PhotoniCare announced today that it won FDA 510(k) clearance for its TOMi Scope for non-invasive imaging of the middle ear to spot ear infections and more. The TOMi Scope is designed to determine the presence or absence of fluid in the middle ear, as well as to characterize the fluid type, by using optical coherence […]
Flexicare recalls fiber optic laryngoscope blades and handles
Flexicare Medical today issued a recall for its BritePro Solo and BriteBlade Pro single-use fiber optic laryngoscope blades and handles due to a risk of choking. According to a medical device alert pertaining to England, Scotland, Wales and Northern Ireland, the BritePro Solo and BriteBlade Pro contain loose bearings and a retaining ring that may […]
FDA clears Cochlear piezoelectric hearing implant
The FDA has cleared a second-generation pioezoelectric bone-conduction hearing implant from Cochlear (ASX:COH), the company announced today. The Osia 2 system is an active osseointegrated, steady-state implant (OSI) that uses digital piezoelectric stimulation to bypass damaged areas of the natural hearing system to send sound vibrations directly to the inner ear. It is designed to […]
3DBio Therapeutics wins FDA rare pediatric disease designation for outer ear reconstruction
3DBio Therapeutics announced today that the FDA granted it rare pediatric disease designation for the AuriNovo outer ear reconstruction system for patients with microtia. According to the New York–based company, there are currently no other established treatments for microtia that allow a patient to regain an auricle comprising living tissue aside from limited rib grafts […]
Tusker Medical’s pediatric ear tubes land breakthrough device designation
The FDA has given breakthrough device approval to a system to deliver tympanostomy tubes to young children with recurrent ear infections, in a physician’s office and under local anesthesia. Tusker Medical’s Tubes Under Local Anesthesia (Tula) system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices needed for the delivery of the […]
Intersect ENT’s Ascend study misses endpoint
Intersect ENT (NSDQ:XENT) shares plunged today after the company said it failed to meet the primary endpoint in a study of its Ascend investigational drug-coated sinus balloon. The 70-person, randomized, double-blind trial was designed to compared treatment with Intersect ENT’s DCB when randomized against an uncoated balloon control. The study missed the primary endpoint, frontal sinus […]
Frequency Therapeutics prices $84m IPO
Frequency Therapeutics said yesterday that it priced its initial public offering at roughly $84 million. The 6-million-share offering priced at $14 per share and includes a 30-day underwriters option on another 900,000 shares that’s worth $12.6 million, the Woburn, Mass.-based company said. Get the full story at our sister site, Drug Delivery Business News.
Forward Science buys EarAid smart earplugs from Dental Innovations
Forward Science said yesterday that it acquired exclusive rights to earpieces from Dental Innovations for smart earplug technology for dental health providers. The Dental Innovations device, which Forward Science will rebrand as EarAid, is designed to protect dental professionals who are exposed to damaging noise from high-speed handpieces, high-volume suction, ultrasonic instruments, model trimmers and […]
U.S. exempts more Chinese medtech products from tariffs
The U.S. has exempted another 18 medical devices or device components from the 25% tariffs imposed on Chinese goods by the Trump administration. The new list includes ultrasound, X-ray, MRI and infusion equipment. The Office of the U.S. Trade Representative (USTR) said the new exclusions are retroactive to August 23, 2018, when additional tariffs went […]
Apple announces medical studies using new Research app
Apple (NSDQ:AAPL) said yesterday that it is launching medical studies into women’s health, hearing, and heart function and movement with its new Research app. The Cupertino, Calif.-based company said the app will show how medical research is conducted and allow participants to contribute to potential medical discoveries. The Research app will be available as a free […]
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