SpeechVive announced today that it raised more than $1.5 million upon the completion of a convertible note as it looks to begin scaling its business. The West Lafayette, Ind.-based, Purdue University-affiliated medical device company develops treatments for speech conditions in people who suffer from chronic neurological diseases, such as Parkinson’s disease. SpeechVive’s device fits behind […]
Otolaryngology/Ear, Nose & Throat (ENT)
FDA approves Cochlear sound processor
Cochlear Ltd. (ASX:COH) announced today that it received FDA approval for three new products in its suite of implantable hearing technology. Lone Tree, Colo.-based Cochlear won approval for its Nucleus Kanso 2 sound processor, Nucleus 7 sound processor for Nucleus 22 implant recipients and Custom Sound Pro fitting software, according to a news release. Cochlear touts […]
Smith & Nephew expects 29% sales dip in Q2
Smith & Nephew (NYSE:SNN) said today it expects second-quarter revenues to dip by 29% due to the coronavirus pandemic, although results gradually improved as time went on. Sales were hardest hit in the company’s orthopedic reconstruction, sports medicine and ENT businesses due to the pandemic-related lockdown and pause in elective surgeries. The company’s advanced wound management […]
Why FDA put the pedal to the metal for radar and hummingbirds and why medtech needs Google
In this week’s episode of DeviceTalks Weekly, co-hosts Chris Newmarker and Tom Salemi dig into the recent successes by startups Circadia Health and Preceptis Medical, which both saw expedited approval from the FDA due to the pandemic. Circadia Health earned a spot on this year’s “20 medical device startups you need to know” list. Circadia […]
FDA clears Preceptis Medical’s in-office ear tube placement for kids
Preceptis Medical today announced FDA clearance that allows placement of its Hummingbird tympanostomy tube system in an ENT surgeon’s office. Officials at Maple Grove, Minn.–based Preceptis say the Hummingbird system significantly reduces trauma and procedure time for ear tube placement in young children. Kids receiving the ear tubes don’t need general anesthesia, and they don’t […]
3NT Medical lands FDA clearance for Colibri endoscopy system
3NT Medical announced that it received FDA 510(k) clearance for its Colibri micro ENT single-use endoscope used for otology. In a news release, the Short Hills, N.J.-based company touted the Colibri scope as the world’s first single-use endoscope specifically designed for otology. It features a lightweight, ergonomic handpiece, a 2.2mm diameter tip and a built-in […]
Smith & Nephew launches Tula ear tube system
Smith & Nephew (NYSE:SNN) announced today that it launched its Tula system for the placement of tympanostomy tubes (ear tubes). London-based Smith & Nephew’s Tula system is an in-office option that allows surgeons to place ear tubes in an awake child without the need for general anesthesia. Physicians using the Tula system numb the eardrum with […]
CMS recommends postponing most elective procedures
The Centers for Medicare and Medicaid Services (CMS) released guidance late yesterday asking healthcare providers to postpone adult elective surgeries and procedures, including dental procedures, until further notice. The move is an attempt to preserve the supply of ventilators and personal protective equipment such as masks and gowns while protecting patients and staff from exposure […]
Cochlear loses appeal over $268m in patent damages
The U.S. Court of Appeals for the Federal Circuit upheld a U.S. District Court decision that awarded $268 million in damages from Cochlear Ltd. (ASX:COH) to two competitors in a patent dispute. Yesterday’s ruling comes after several years of legal battles over the patents for hearing implants, and likely won’t be the end, as Cochlear is […]
OtoNexus raises $9.8m
OtoNexus Medical Technologies filed an amendment to its SEC Form D last week to confirm the sale of nearly $10 million in an equity offering. The Seattle-based ultrasound technology maker sold approximately $9.77 million of an $18.2 million offering, leaving just over $8.4 million remaining to be sold, according to the filing. OtoNexus made the […]
Neuromod Devices appoints Elsaesser as CCO
Non-invasive neuromodulation technology developer Neuromod Devices announced today that it is appointing Florian Elsaesser as its new chief commercial officer. Elsaesser is a 12-year veteran in the space, having worked extensively in the hearing aid industry, according to a news release. He previously held executive positions at Sivantos and Siemens (NYSE:SI) Audiology. Dublin-based Neuromod Devices said […]