Filtered By:
Source: Mass Device
Management: Marketing
This page shows you your search results in order of date.
Order by Relevance | Date
Total 15 results found since Jan 2013.
ReWalk Robotics raises $4m
ReWalk Robotics (NSDQ:RWLK) has raised approximately $4.3 million in a new round of financing, according to recently posted SEC filings.
In the offering, ReWalk Robotics sold warrants to purchase ordinary shares at a purchase price of approximately $5.20, according to the filing. Warrants offered in the round have an exercise price of $5.14 and are exercisable for 5.5 years from the date of issuance. Warrants were issued on April 5, ReWalk Robotics said.
Money in the round came from three unnamed investors, with the first date of sale noted as having occurred on April 3.
The company is looking to raise an additional appro...
Source: Mass Device - April 9, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics Wall Street Beat ReWalk Robotics Source Type: news
FDA goes after California stem cell doc for unapproved breast implant device
The FDA this week sent a warning letter to a Beverly Hills, Calif.-based surgeon for their marketing of an unapproved implantable device, dubbed the Pocket Protector, which the surgeon claims can prevent and treat capsular contracture, or scar tissue tightening, during breast implant procedures.
In its letter, the federal watchdog also accuses the surgeon, Dr. Mark Berman, of “significant deviations from the FDA’s quality system requirements and current good manufacturing practices,” including charges related to the sterility of implantable devices.
“This is not the first time the FDA has notified D...
Source: Mass Device - February 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Featured Food & Drug Administration (FDA) Stem Cells Source Type: news
Medtronic to pay $51m to settle Covidien, ev3 DoJ investigations
Medtronic (NYSE:MDT) said yesterday that it agreed to pay $50.9 million to settle a number of U.S. Dept. of Justice probes into marketing activities from companies it acquired, Covidien and ev3.
Medtronic said that its subsidiary ev3, acquired when the Fridley, Minn.-based medtech giant picked up Covidien in 2015, agreed to plead guilty to a misdemeanor charge related to its marketing of the Onyx Liquid Embolic System, pay $17.9 million and adopt new compliance and reporting terms for three years.
The charges relate to ev3’s marketing of the device for “unproven and potentially dangerous uses,” federal prose...
Source: Mass Device - December 5, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Legal News Medtronic Source Type: news
FDA approves Abbott ’ s HeartMate 3 as a destination therapy
Abbott (NYSE:ABT) said today it won FDA approval for its HeartMate 3 left ventricular assist device, now approved as a destination therapy for patients with advanced heart failure.
With the approval, the Chicago-based company said that the device can now be used in patients not eligible for a transplant as a life-long implant.
“We partner with physicians to holistically develop therapies that benefit patients and achieve better outcomes. The unique design of the HeartMate 3 LVAD—with its Full MagLev technology—takes an established innovation and improves upon it in meaningful ways to help people with advanced he...
Source: Mass Device - October 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Abbott Source Type: news
Dynatronics taps ex-NinePoint CEO von Jako as chief exec | Personnel Moves – July 11, 2018
Dynatronics said late last month it tapped former NinePoint Medical CEO Christopher von Jako as its new chief executive officer and board member, succeeding Kelvyn Cullimore Jr. who will stay on the company’s board of directors.
Prior to joining Dynatronics, von Jako acted as prez & CEO of NinePoint Medical. Before joining Nine Point, von Jako also served as prez & CEO of NeuroTherm, prez of ActiViews and held positions with medtech companies including Integra LifeSciences, Covidien and Medtronic.
“After thorough succession planning and a comprehensive search process, the board is pleased to have foun...
Source: Mass Device - July 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News AngioDynamics berkshiresterilemanufacturing Corindus Vascular Robotics Dynatronics Corp Guerbet integer MedPlast Medtronic Myomo Inc NinePoint Medical Inc. Pavmed viant Source Type: news
Cheetah Medical raises $12m
Cheetah Medical said today it raised $11.8 million in an expanded Series C funding round as it looks to grow its US footprint.
Financing was provided by existing investors including MVM Life Science Partners, Springfield Investment Management, Fletcher Spaght Ventures, HighCape Partners and Robert Basch Venture Capital, the Newton, Mass.-based company said.
Cheetah Medical provides noninvasive hemodynamic monitoring devices and systems, including its Cheetah Nicom and Starlin SV technologies, which operate around a proprietary algorithm designed to allow physicians to examine a patient’s full hemodynamic profile.
&#...
Source: Mass Device - September 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cheetah Medical Source Type: news
Ex-Invacare chief Mixon pulls the trigger on convertible shares
Invacare (NYSE:IVC) said yesterday that the former chairman & CEO who rescued the company from the doldrums in the 1980s, Malachi Mixon III, is pulling the trigger on the more than 700,000 convertible shares he controls.
The 1-for-1 exchange will take Invacare’s voting power from 40,155,366 votes to 33,820,158 votes, the Elyria, Ohio-based company said.
“The conversion will substantially diminish the significance of the company’s dual class voting structure, as after completion, the holders of the common shares will represent approximately 99.5% of the company’s total outstanding voting power,...
Source: Mass Device - June 1, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Wall Street Beat Invacare Rehabilitation Equipment Source Type: news
CytoSorbents touts Refresh trial study data
CytoSorbents (OTC:CTSO) today presented results from the Refresh trial of its CytoSorb blood purification technology, touting that the trial met its safety goals and that treatment reduced toxic inflammatory mediators during complex heart surgery.
Data was presented at the American Association for Thoracic Surgery’s centennial conference in Boston this week.
The Monmouth Junction, N.J.-based company’s CytoSorb is an extracorporeal cytokine filter, made up of biocompatible, porous polymer beads that use pore capture and surface adsorption to remove toxic substances from the blood and other bodily fluids.
The pr...
Source: Mass Device - May 5, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Clinical Trials CytoSorbents Corp. Source Type: news
Keystone Heart, Venus Medtech ink Asian TAVR stroke partnership deal
Keystone Heart and Chinese heart valve maker Venus Medtech said today they inked a partnership deal covering China and other Asian markets.
Through the deal, the companies will provide Venus Medtech’s transcatheter aortic valve replacement system along with Keystone’s TriGuard cerebral embolic protection device.
TriGuard is a cerebral embolic protection device designed to reduce the amount of embolic material entering blood circulation to the brain during TAVR procedures, by allowing blood to pass through while catching potentially dangerous embolic debris.
“Providing brain protection for every TAVR pat...
Source: Mass Device - March 2, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiovascular Catheters Replacement Heart Valves Keystone Heart Venus Medtech Source Type: news
4 Key Insights When Raising Money for Your Medtech Startup: Interview with Bruce Shook, CEO of Intact Vascular
Welcome to the Medsider interview series, a regular feature at MassDevice. All interviews are conducted by Scott Nelson, Founder of Medsider and Group Director for WCG. We hope you enjoy them!
Bruce Shook joined Intact Vascular in 2014 as President and CEO. A highly-experienced, medical device executive with more than 30 years of industry experience, Bruce was previously Co-founder, Director, President, and CEO of Neuronetics, which is a privately held medical device company that markets a non-invasive brain stimulation technology for the treatment of depression.
Previously, Shook was Co-founder, Director, President, an...
Source: Mass Device - February 27, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Blog medsider Source Type: news
7 medtech stories we missed this week: Feb. 24, 2017
[Photo from unsplash.com]Several companies made distribution deals this week, while others received approval for their products. Here are 7 medtech stories we missed this week but were still worth mentioning.
1. Israel OKs E-Qure’s BST device for chronic wounds
E-Qure Corp. announced this week that it received marketing approval for its Bio-electrical Signal Therapy Device (BST Device) from the Israeli Ministry of Health, according to a Feb. 24 news release. BST is an electrotherapeutic method for treating chronic wounds. E-Qure will begin marketing its device in Israel by activating a signed distribution agreement with...
Source: Mass Device - February 24, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Electronic Medical Records Imaging Mergers & Acquisitions mHealth (Mobile Health) Regulatory/Clearance Align Technology Clarius Mobile Health Corin Group E-Qure Henry Schein Medical Nexstim Skyline Medical 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
Brainlab invests nearly $8m into Jan Medical
Jan Medical said today it obtained $7.5 million in Series C funding from partner Brainlab Inc, with funds slated to aid in completion of a clinical trial and filing for de novo clearance with the FDA and CE Mark approval in the European Union for its BrainPulse tool.
Mountain View, Calif.-based Jan Medical’s BrainPulse device is designed to non-invasively capture novel physiological signals through a patient’s cardiac output, used to measure vascular and brain tissue conditions, the company said. The data can be used as an ‘aid to diagnoses’ for multiple indications, including concussion and stro...
Source: Mass Device - January 25, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiovascular Diagnostics Regulatory/Compliance Brainlab Jan Medical Source Type: news
InspireMD CEO Milinazzo, CTO Bar to bow out | Personnel Moves
InspireMD (OTC:NSPR) said today that it’s looking for a replacement for CEO Alan Milinazzo as it looks to drill down on the largest markets for its CGuard and MGuard stents, which are designed to help prevent blood clots that can cause stroke.
Milinazzo agreed to stay on until either a replacement is found or June 30, whichever comes 1st. The new CEO will be hired to grow sales in Europe and improve the balance sheet, InspireMD said.
The Boston-based company said also said it tapped as vice chairman biotech legend Isaac Blech, the founder of Celgene (NSDQ:CELG), ICOS Corp., Pathogenesis, Nova Pharmaceutical and Gene...
Source: Mass Device - January 22, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Business/Financial News HemaFlo Therapeutics InspireMD Intuitive Surgical Inc. IsoRay RefleXion Medical Reva Medical Inc. Source Type: news
McGuire to take reins at Second Sight, Greenberg heads board | Personnel Moves
Second Sight Medical‘s (NSDQ:EYES) newly appointed CEO Will McGuire is set to take the reins starting August 18, the company said.
Announced in June, former CEO Dr. Robert Greenberg will become chairman of the board at Second Sight, replacing Alfred Mann who will become chairman emeritus, according to the Sylmar, Calif.-based ‘bionic eye’-developing company.
“Will brings an immense depth of experience in the life sciences industry that will advance Second Sight’s commercialization of the Argus II retinal prosthesis. After a thorough search process, management and the board of directors are con...
Source: Mass Device - August 13, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Invuity Monteris Medical Personnel Moves Second Sight Medical Products Inc. Volcano Corp. Source Type: news
