Novocure launches pivotal ovarian cancer trial
Novocure (NSDQ:NVCR) said today that it kicked off a Phase 3 pivotal trial testing its Tumor Treating Fields therapy combined with paclitaxel in people with recurrent, platinum-resistant ovarian cancer.
The 540-patient trial has a primary endpoint of overall survival, with secondary endpoints that include progression-free survival, objective response rate, severity and frequency of adverse events and quality of life.
Get the full story at our sister site, Drug Delivery Business News.
The post Novocure launches pivotal ovarian cancer trial appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 22, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Featured Oncology Pharmaceuticals Wall Street Beat NovoCure Source Type: news
Hemodialysis device maker Phraxis raises $6m
Early stage medical device company Phraxis has raised approximately $5.6 million in a new round of equity and options financing, according to a recently posted SEC filing.
Phraxis is developing a novel treatment for patients who need vascular access for hemodialysis, according to the company’s website.
The St. Paul, Minn.-based company’s first product for commercialization is the InterGraft, a percutaneously delivered arteriovenous shunt intended to provide a unique, non-surgical approach for patients who need vascular access, according to the site.
Money in the round came from seven unnamed investors, with the first s...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Phraxis Inc. Source Type: news
Homeland Security details vulnerabilities in Medtronic ICD, CRT-Ds, CareLink devices
The U.S. Dept. of Homeland Security today released a medical advisory warning of exploits within a number of Medtronic (NYSE:MDT) implanted cardiac devices and associated equipment that could allow an attacker to affect the functionality of the devices or intercept transmitted sensitive data.
The vulnerability affects Fridley, Minn.-based Medtronic devices using its Conexus radio frequency telemetry protocol, according to the release, and requires only a low level of skill and adjacent access to exploit.
Successful exploitation could allow an outside actor to “interfere with, generate, modify, or intercept” the...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Software / IT Medtronic Source Type: news
IceCure Medical touts interventional radiology cryoablation study data
IceCure Medical yesterday released data from an interventional radiology study of its liquid-nitrogen-based cryoablation technology.
Results from the study were presented at the Annual European Association of Urology Congress in Barcelona, the Israel-based company said.
IceCure Medical’s ProSense cryoablation system uses liquid nitrogen technology for the treatment of benign and cancerous tumors through freezing, the company said.
“The ProSense system has already demonstrated excellent progress as a rapid, in-office solution for the treatment of breast tumors. This new data adds to our growing clinical evidenc...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials IceCure Medical Ltd. Source Type: news
FDA approves Otimizer Smart heart failure device from Impulse Dynamics
The FDA today said it approved the Optimizer Smart heart failure device developed by Impulse Dynamics under its breakthrough device designation.
The Stuttgart, Germany-based company’s device is designed to remodel the myocardium to increase the heart’s efficiency using “cardiac contractility modulation” – non-excitatory electrical pulses delivered to the heart muscle. An FDA advisory panel last December recommended approval for Optimizer Smart, voting voted 12-1 on safety, 11-2 on efficacy and 12-0, with a single abstention, that its benefits outweigh the risks. The system has had CE Mark approval in ...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Featured Food & Drug Administration (FDA) Regulatory/Compliance Impulse Dynamics Source Type: news
Semtech, Sonova ink hearing aid development deal
Sonova Holding AG (SIX:SOON) and semiconductor maker Semtech said today they jointly developed a new advanced radio system intended for use in Sonova’s hearing aids.
The new technology, an ultra-small integrated circuit, will serve as the main component in a new generation of hearing aids and enable support for multiple radio protocols in the 2.4GHz band, the companies said.
“This chip allows Sonova to move in a new direction with our hearing aids. The breakthrough radio technology and power management are the game changers for hearing aids. It allows them to support a number of applications that have previous...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Otolaryngology Ear, Nose & Throat Research & Development Sonova Holding AG Source Type: news
Appeals court declines full review of $254m Zimmer loss to Stryker
A federal appeals court declined a full review of its earlier decision to affirm a $248 million win for Stryker (NYSE:SYK) in its surgical tool patent case against Zimmer Biomet (NYSE:ZBH).
The U.S. Court of Appeals for the Federal Circuit last December upheld treble damages in the case, based on a U.S. Supreme Court decision in Halo Electronics v. Pulse Electronics that relaxed the standard for enhanced damage awards in patent infringement cases. Zimmer Biomet appealed that per curiam decision, asking for both a three-judge panel and the full Federal Circuit bench to re-evaluate the case. The court denied both petitions ...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Legal News Orthopedics Wall Street Beat Stryker Zimmer Biomet Source Type: news
Teleflex touts real-world UroLift study data
Teleflex (NYSE:TFX) today released results from real-world studies of its UroLift minimally invasive treatment for benign prostatic hyperplasia, touting its safety and effectiveness.
Data from the studies were presented at the 2019 European Association of Urology meeting in Barcelona, Spain.
The UroLift system uses tiny devices inserted into the urethra in a minimally invasive procedure to reopen the lower urinary tract by pushing aside tissue from the enlarged prostate, the Wayne, Penn.-based company said.
Teleflex said that it presented data from a real-world retrospective study of 30 men with
urinary retention treate...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Urology Teleflex Source Type: news
NE Ohio biomedical industry investments on the rise
Investment in the northeast Ohio biomedical sector totaled nearly $294 million in 2018 with 71 regional companies receiving funding, according to regional healthcare trade group BioEnterprise. Those figures make this region the third largest for total healthcare investment in the Midwest, following Minneapolis ($664 million) and Chicago ($551 million).
These were among the findings of BioEnterprise’s 2018 Midwest Healthcare Growth Capital Report, which tracks capital investments made in biomedical companies across 11 Midwestern states in three sectors — medical device; biotechnology and pharmaceuticals; and health IT/s...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Biotech Blog Business/Financial News Funding Roundup News Well Athersys Inc. BioEnterprise ViewRay Inc. Source Type: news
Appeals court reverses Organogenesis win in gender bias, retaliation lawsuit
A U.S. federal appeals court this week reversed a win for Organogenesis in an employment discrimination and retaliation lawsuit from former employees, according to recently released court documents.
The U.S Court of Appeals for the Ninth Circuit reversed and remanded the case filed by former employees Angela Gonzales, Linda Boyd and Brandee Colombo against Canton, Mass.-based Organogenesis.
In the case, which had previously been granted a summary judgement in Organogenesis’ favor, the employees levied one claim of retaliation and three claims of gender discrimination.
The appeals court said it believed that the district ...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Legal News Organogenesis Inc. Source Type: news
Abiomed ’ s stake in Shockwave is worth at least $58m
The $10 million Abiomed (NSDQ:ABMD) put into Shockwave Medical (NSDQ:SWAV) has paid off so far no matter how you slice it.
Shockwave raised nearly $97 million in an initial public offering earlier this month, inking a private-placement deal with Abiomed on the side for $10.0 million worth of SWAV shares at the $17-per-share IPO price. In a regulatory filing today, Santa Clara, Calif.-based Shockwave said Abiomed owns nearly 1.7 million shares, or a 6.0% stake.
With SWAV shares trading at $34.55 apiece today in mid-morning activity (up 4.8%), Danvers, Mass.-based Abiomed’s share would be worth roughly $58.7 million if...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Featured Wall Street Beat Abiomed Shockwave Medical Source Type: news
Neovasc claims win in German TMVR patent case against Edwards unit CardiAQ Valve
Neovasc (NSDQ:NVCN) today claimed a win in its patent infringement war with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve Technologies, saying a German appeals court dismissed a case there.
In June 2017 the District Court in Munich ruled that CardiAQ Valve contributed to the creation of Neovasc’s Tiara transcatheter mitral valve replacement, awarding”co-entitlement” rights to the patent in Europe. Both sides appealed that ruling, in the course of which CardiAQ withdrew its total ownership claim but asserted partial ownership, Vancouver-based Neovasc said today.
Munich’s Higher Regional Court dismiss...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Legal News Replacement Heart Valves Wall Street Beat CardiAQ Valve Technologies Edwards Lifesciences neovasc Source Type: news
Novo Nordisk seeks FDA nod for oral diabetes pill
Novo Nordisk (NYSE:NVO) said this week that it submitted applications to the FDA for its oral formulation of semaglutide, a once-daily glucagon-like peptide-1 receptor agonist therapy.
The company is hoping its pill will be approved as an adjunct to diet and exercise to improve blood sugar control in adults with Type 2 diabetes. Novo Nordisk also submitted for approval of an indication related to risk reduction of major adverse cardiovascular events.
Get the full story at our sister site, Drug Delivery Business News.
The post Novo Nordisk seeks FDA nod for oral diabetes pill appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Diabetes Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Novo Nordisk Source Type: news
Taking a more rigorous approach to investigating fatal medical errors in the U.S.
By Stewart Eisenhart, Emergo Group
On Friday, March 1, 2019, a Tesla automobile was involved in a fatal crash in Palm Beach, Florida. Considering the possibility that the vehicle crash occurred while the vehicle was in autopilot mode, the National Highway Traffic Safety Administration (NHTSA) and the National Transportation Safety Board (NTSB) initiated an investigation of the accident.
Get the full story here at the Emergo Group’s blog.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
The post Taking a more rigorous approach to inve...
Source: Mass Device - March 21, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news
Establishment Labs shares up on mixed-bag Q4, FY2018 earnings
Shares in breast implant maker Establishment Labs rose in after-hours trading today after the company posted fourth quarter and full year 2018 earnings that beat sales expectations but missed loss-per-share consensus on Wall Street.
The New York-based company posted losses of $10.5 million, or 52¢ per share, on sales of approximately $16.4 million for the three months ended December 31, seeing sales grow 38.8% while losses grew 47.4% compared with the same period during the previous year.
Losses per share were ahead of the 36¢ loss-per-share consensus on Wall Street where analysts expected to see sales of approximately ...
Source: Mass Device - March 20, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat Establishment Labs Source Type: news
