CVRx announced today that it observed positive six-month results from its BeAT-HF trial for the Barostim Neo device for improving symptoms of heart failure. Barostim Neo uses patented technology to send electrical pulses to baroreceptors in the wall of the carotid artery in an effort to restore balance to the automatic nervous system and improve […]
Masimo announces drug-free opioid-withdrawal device
Masimo (NSDQ:MASI) announced that it received FDA de novo classification for its Bridge neuromodulation-based opioid withdrawal device. Bridge uses neuromodulation to aid in reducing the symptoms associated with opioid withdrawal. Irvine, Calif.-based Masimo touts it as the first evidence-based, drug-free, non-surgical device of its kind. The wearable, single-patient-use, percutaneous neurostimulator fits behind the ear and applies […]
CEO Ryan explains how Cala Health is building bioelectronic medicine business
In this week’s episode of DeviceTalks Weekly, Tom Salemi, editorial director of DeviceTalks events and content, visits with Renee Ryan, the CEO of neuromodulation startup Cala Health. Ryan came to Cala from the venerable medtech investor Johnson & Johnson Development Corp., where she made over 15 investments helping to create companies including Auris Surgical, Cala […]
Medtronic recall of DBS placement software is Class I
FDA said today that a Medtronic (NYSE:MDT) recall of software used to help place deep brain stimulation systems is Class I, the agency’s most serious level. The company in August 2019 recalled the auto-registration feature of its StealthStation DBS software due to inaccuracies caused by minor patient movements during the auto-registration process when used with NexFrame […]
Pulse plans to seek $30m from investors
Pulse Biosciences (NSDQ:PLSE) announced it has filed a registration statement to raise approximately $30 million from existing shareholders. The rights offering will be made through the distribution of non-transferable subscription rights to purchase shares of the Hayward, Calif-based company’s common stock. The final price has not been set. Pulse Biosciences said it will use the proceeds […]
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 […]
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 […]
