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 […]
9 early medical devices that will horrify or amaze you
The movie Frankenstein inspired eight-year-old Earl Bakken to consider how electricity could restore life and health to the human body. Bakken went on to invent the first external cardiac pacemaker and to co-found medtech giant Medtronic in 1949. Bakken’s fascination with the effects of electricity on the human body continued throughout his career, and he amassed a collection of […]
Astellas, Iota ink wireless implant pact
Iota Biosciences said last week that it has entered a research and development agreement with Astellas Pharma to explore new biosensing and treatment measures with wireless implantable medical devices. The deal will pair the companies up to design detailed specifications of the implantable devices and conduct preclinical studies for several diseases, according to a news release. […]
BioSig’s NeuroClear Technologies raises nearly $4m
BioSig Technologies (NSDQ:BSGM) said last week that its subsidiary, NeuroClear Technologies, raised nearly $4 million in an initial seed-funding round. NeuroClear said it intends to use the proceeds from the $3.7 million round to fund product development and initial pre-clinical studies, development of its intellectual property portfolio and for general corporate purposes. Founded in November 2018, […]
BioSig raises nearly $3.3 million for new, non-EP company
Cardiac arrhythmia-detection startup BioSig Technologies (NSDQ:BSGM) has raised $3.26 million for a subsidiary that is developing more applications for its electrogram-evaluation technology. The company attributed the funding round to 17 investors, according to a regulatory filing. It began the offering on August 5 with a goal of raising $3.6 million. BioSig formed NeuroClear Technologies in November […]
Study shows bioelectronic medicine reduces spasticity in stroke patients
A clinical trial of an investigational, non-invasive medical device has shown that trans-spinal direct-current stimulation and peripheral nerve direct-current stimulation significantly reduced upper-limb spasticity in participants who had experienced a stroke. The treatment involves passing a direct electrical current across the spinal cord with a skin-surface electrode, known as trans-spinal direct-current stimulation (tsDCS), and adding […]
BioSig lands $1M investment from Mayo Clinic
Cardiac arrhythmia-detection startup BioSig Technologies (NSDQ:BSGM) has received nearly $1 million in financing from the Mayo Clinic after working with the healthcare organization for two years. BioSig recently completed first-in-human studies at the Rochester, Minn.-based clinic aimed at validating the safety and efficacy of its Pure EP system during mapping and ablation procedures in a cardiac EP lab. Patient […]
Synchron’s thought-to-text tech starts clinical trial
Synchron said it has begun the first clinical trial for its neural interface technology designed to restore communication to people with severe paralysis. The trial will measure the safety of the company’s “thought-to-text” technology by assessing its Stentrode implant in combination with BrainOS software and the stability of high-fidelity signals from the brain to external communications […]
FDA issues ‘leap-frog’ guidance on brain/computer interfaces
FDA has issued draft guidance for developers of devices to help amputees and people with paralysis regain mobility or their sense of touch. FDA defines brain/computer interface (BCI) devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. The guidance proposes that non-clinical device testing can be used […]
Axonics Modulation touts results of sacral neuromodulation study
Axonics Modulation Technologies (NSDQ:AXNX) announced positive top-line results from a pivotal study of its novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction. The clinical study demonstrated that patients implanted with the Axonics r-SNM system experienced clinically meaningful and statistically significant improvements in urinary urgency incontinence (UUI) symptoms and quality of […]
Swedish patient receives ‘dexterous, sentient’ prosthetic hand
A Swedish woman with a hand amputation has become the first recipient of an osseo-neuromuscular implant to control a dexterous hand prosthesis, according to Chalmers University of Technology in Gothenburg, Sweden. Surgeons placed titanium implants in the two forearm bones (radius and ulna), and extended electrodes to nerves and muscle to extract signals to control a […]
