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Source: Mass Device
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Total 62 results found since Jan 2013.
Aspect Imaging raises $30m
MRI maker Aspect Imaging has raised $30 million in a new round of financing, according to VC & equity site Finsmes.
Funding from the round will go to support the development of its Embrace Neonatal MRI system and a newer, stroke-dedicated MRI system, the Israel-based company said.
Aspect Imaging did not release details on the investors in the round, according to the report.
The company, founded in 2003, has raised a total of $150 million, with $20 million coming from a round last year.
In April 2013, the FDA cleared Aspect Imaging’s compact M2 MRI system designed for in-place wrist imaging without a shielded room.
Th...
Source: Mass Device - April 18, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Imaging Aspect Imaging Source Type: news
Neural Analytics raises $10m
Updated to include new information from neural analytics.
Neural Analytics raised $10.1 million in a new round of equity and options financing, according to an SEC filing posted this week.
The Los Angeles-based company develops the Lucid M1, a portable all-in-one ultrasound system designed for rapid triaging and monitoring of patients with brain disorders.
Neural Analytic’s system is a battery operated medical grade tablet device which uses transcranial doppler to assess the brains blood vessels from outside the body. Analyses with the system can be performed in office and can help diagnose brain disorders and avoid mor...
Source: Mass Device - April 10, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Neurological Ultrasound Neural Analytics Source Type: news
Penumbra prices $99m offering
Penumbra (NYSE:PEN) said today that it priced a public offering worth nearly $99 million, not including an underwriter’s option worth nearly $15 million.
Alameda, Calif.-based Penumbra makes a line of instruments designed for neurovascular and peripheral vascular procedures, including stroke revascularization, embolization and thrombectomy.
The company said it plans to float 1.3 million shares at $76 apiece. The offering also includes a 30-day over-allotment option of some 195,000 shares that, if exercised in full, would bring the total raise to more than $113.6 million.
Penumbra said it plans to use the proceeds fo...
Source: Mass Device - March 17, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Catheters Funding Roundup Wall Street Beat Penumbra Inc. Peripheral Artery Disease Stroke Source Type: news
AliveCor raises $30m, launches Kardia Pro platform in U.S.
AliveCor said today that it landed $30 million in a series D funding round and that it released its artificial intelligence-enabled Kardia Pro platform in the U.S.
The company’s platform enables doctors to remotely monitor their patients for early signs of atrial fibrillation, a common cardiac arrhythmia.
“Heart disease is the No. 1 cause of death in the United States, claiming more lives than all forms of cancer combined. To manage heart disease and stroke risk, leading cardiologists want to see more than just ECGs from their patients,” CEO Vic Gundotra said in prepared remarks. “Kardia Pro tracks important meas...
Source: Mass Device - March 16, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Cardiovascular Funding Roundup Patient Monitoring Wall Street Beat AliveCor Source Type: news
Stealthy NeuroVasc Technologies raises $1m
Stealthy NeuroVasc Technologies said yesterday that it raised a $1 million funding round, taking it’s total raise since last year to nearly $2.5 million.
Laguna Hills, Calif.-based NeuroVasc is led by CEO Ev3 veteran Jianlu Ma, according to regulatory filings. According to the LinkedIn page of chairman Jeff Peters, the former Anulex Technologies CEO who’s also an Ev3 alum, NeuroVascular Technologies is developing an interventional neuroradiology technology to treat ischemic stroke.
The $1 million round included 3 unnamed investors, according to 1 of the filings. NeuroVascular Technologies reported raising $1...
Source: Mass Device - December 30, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Funding Roundup Neurological Vascular Wall Street Beat NeuroVasc Technologies Source Type: news
Neuravi raises $16.7m
Neuravi said today it raised $16.7 million (EU €15 million) in a new round of debt financing, with funds slated to support U.S. commercialization and portfolio expansion.
Money in the round came from healthcare alternative financing provider IPF Partners, the Galway, Ireland-based company said.
Funds raised in the round will be invested into the U.S. commercialization of its products and expanding its stroke treatment portfolio, Neuravi said.
“With the recent European launch of the EmboTrap II device and the excellent progress in enrolling our pivotal clinical trial, we are making significant headway in delivering...
Source: Mass Device - November 2, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Business/Financial News Vascular Neuravi Limited Source Type: news
Claret Medical files for FDA clearance for Sentinel cerebral protection device
Claret Medical said today that it filed an application with the FDA seeking 510(k) clearance for its Sentinel cerebral protection system designed for use during transcatheter aortic valve replacements.
The Santa Rosa, Calif.-based company’s Sentinel device is designed to capture and remove embolic debris dislodged during TAVR procedures, which can enter cerebral circulation and can potentially lead to strokes.
“Our contribution in building significant new science will help the rapidly growing TAVR field embrace the critical role of cerebral protection in all left heart and endovascular procedures. These studi...
Source: Mass Device - September 20, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Vascular Claret Medical Inc. Stroke Source Type: news
Silk Road Medical touts Medicare coverage decision for carotid procedures
Silk Road Medical said yesterday the Centers for Medicare and Medicaid Services granted coverage for transcarotid artery revascularization procedures, including those performed with the company’s Enroute transcarotid neuroprotection and stent system.
The TCAR procedures are now eligible for coverage for patients who are treated with FDA-approved proximal embolic protection devices and approved carotid artery stent systems indicated for transcarotid procedures. The devices are also required to be entered into the national TCAR Surveillance Project, Sunnyvale, Calif.-based Silk Road Medical said.
The company said it...
Source: Mass Device - September 16, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Stents Vascular Centers for Medicare and Medicaid Services (CMS) Silk Road Medical Inc. Source Type: news
Neural Analytics lands $3M NIH grant
Neural Analytics landed a $3 million grant from the National Institutes of Health for the diagnostic and monitoring technology it’s developing for traumatic brain injury and stroke, the company reported. The NIH’s Small Business Innovation Research program funded the grant.
Los Angeles-based Neural Analytics, founded in 2013, develops technology to measure and track brain health, particularly traumatic brain injury, acute ischemic stroke, and dementia. The company is working on a portable ultrasound headset for athletes at risk of concussion.
With the NIH funding, they hope to create a portable device for 1st responder...
Source: Mass Device - September 14, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diagnostics Funding Roundup Neurological National Institutes of Health (NIH) Neural Analytics Source Type: news
InVivo Therapeutics adds another clinical site
InVivo Therapeutics (NSDQ:NVIV) said today that it added another site to the clinical trial of its neurospinal scaffold, taking the total number of participating sites to 22.
That includes the 1st Canadian site, added last week after Health Canada OK’d the trial.
The latest site to join the Inspire study is the Ben Taub Hospital at the Texas Medical Center in Houston, InVivo said. Its device is a bioresorbable scaffold designed to encourage nerve regeneration after traumatic spinal cord injuries.
“I’m thrilled to bring the Inspire study to the Ben Taub Hospital,” principal site investigator Dr. ...
Source: Mass Device - July 18, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Neurological InVivo Therapeutics Corp. Source Type: news
Health Canada OKs trial for InVivo Therapeutics spine scaffold
UPDATED July 14, 2016, with news of 1st Canadian trial site.
Just a day after the FDA approved the expansion of the Inspire study of its neuro-spinal scaffold, InVivo Therapeutics (NSDQ:NVIV) said Health Canada granted investigational testing authorization for the study. Today the company said the Toronto Western Hospital’s Research Ethics Board approved its participation in the trial.
“The Canadian scientific and medical community recognizes spinal cord injury as a significant unmet medical need and has been at the forefront of researching potential therapies for years,” chairman & CEO Mark Perrin...
Source: Mass Device - July 14, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Regulatory/Compliance Spinal InVivo Therapeutics Corp. Source Type: news
FDA OKs expansion of InVivo Therapeutics spinal scaffold study
InVivo Therapeutics (NSDQ:NVIV) said today that the FDA cleared an expansion of its Inspire study of its neuro-spinal scaffold, now set to enroll up to 20 patients, and announced the 9th and 10th implantation in the trial, though the 10th patient died of an unrelated stroke.
The Cambridge, Mass.-based company’s neuro-spinal scaffold is surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.
The federal watchdog cleared the company to expand the trial for up to 20 evaluable patients. The decision came based off the review of 6-month safety data from the trial, InViv...
Source: Mass Device - July 12, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Spinal InVivo Therapeutics Corp. Source Type: news
InspireMD closes $15m offering
InspireMD (NYSE:NSPR) said yesterday that it raised $14.6 million in a “best efforts” stock offering it plans to use to boost sales of its anti-stroke devices.
Boston-based InspireMD said the offering consisted of 442,424 shares of Series B stock convertible into 100 shares of common stock at 33¢ per share, with a 5-year cumulative dividend rate of 15% a year.
The offering also included warrants for more than 44.2 million shares of common stock at an exercise price of 20¢ per share, the company said.
The Series B stock and warrants went for $33 per share, leading to gross proceeds of roughly $14.6 mil...
Source: Mass Device - July 8, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Funding Roundup Neurological Wall Street Beat InspireMD Source Type: news
Nico touts studies using BrainPath to treat hemorrhagic stroke
Nico Corp today released data from 2 recently published studies which utilized its BrainPath Approach to treat hemorrhagic stroke, touting a 95% clot reduction and no mortalities associated with the device.
The BrainPath system uses a shunt and specially designed instrumentation to give surgeons access to the subcortical section of the brain. The device won 510(k) clearance from the FDA last June for treating primary and secondary brain tumors, vascular abnormalities, intraventricular tumors or cysts.
Data from the studies was published in the journals Neurosurgery and Operative Neurosurgery, the Indianapolis-based c...
Source: Mass Device - June 29, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Neurological Surgical Nico Corp. Source Type: news
Helius touts 6-patient study of advanced MS cases
Helius Medical Technologies this week released the result of a 6-patient pilot study of its PoNS therapy used to treat the advanced symptoms of multiple sclerosis, touting improvements in physical, cognitive and quality of life parameters.
Data from the study was presented at the 2016 Annual Meeting of the Consortium of Multiple Sclerosis Centers this month, the Newtown, Penn.-based company said.
“Those with greater functional ability at the beginning of the study (EDSS 6.5-7.0) made the most significant gains but all subjects could be qualified as improved. The intervention shows promise to prolong functional ambula...
Source: Mass Device - June 24, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Neuromodulation/Neurostimulation Helius Medical Technologies Source Type: news
