NexStim wins Health Canada approval for NBS, NexSpeech
Nexstim said today that it won approval from Health Canada for its NBS system and NexSpeech devices. The Helsinki-based company’s NBS system and NexSpeech comprise a diagnostic device intended for the non-invasive localization of the brain areas that control motor and speech functions. The devices are used by neurosurgeons for surgical planning prior to brain tumor operations or in treating treatment-resistant epilepsy, Nexstim said. Both the NBS system and NexSpeech use navigated Transcranial Magnetic Stimulation to better allow for personalized, accurate and reproducible stimulation of specific areas of the brain,...
Source: Mass Device - March 29, 2019 Category: Medical Devices Authors: Fink Densford Tags: Neurological Regulatory/Compliance Nexstim Source Type: news

BioSig raises $9m
BioSig Technologies (OTCQB: BSGM) has raised $8.6 million in a new round of equity financing, according to a recently posed SEC filing. The Santa Monica, Calif.-based company is developing the Pure EP system, which is designed for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology procedures. The device is intended to reduce noise and artifacts to produce high-fidelity cardiac signals, which the company claims could increase the diagnostic values of the signals. BioSig is not loo...
Source: Mass Device - March 29, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat BioSig Technologies Source Type: news

Sterilization plant closures: Here ’s why you need to care
(Image by Jose Fontano on Unsplash) The recent shutdown of a Sterigenics medical device sterilization plant in Willowbrook, Ill. has affected medtech giants such as Becton Dickinson (NYSE:BDX), Boston Scientific (NYSE:BSX), Medtronic (NYSE:MDT), Smith & Nephew (NYSE:SNN) and Stryker (NYSE:SYK), according to an FDA list of devices processed at the sterilization plant. Medium-sized and smaller firms, including Teleflex Medical (NYSE:TFX), Arthrex and ArthroCare also had devices processed there. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, knives, stents and needles. W...
Source: Mass Device - March 29, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Cardiovascular Catheters Drug-Eluting Stents Featured Food & Drug Administration (FDA) Implants News Well Orthopedics Outsourcing Regulatory/Compliance Spinal Sterilization / Calibration Surgical Source Type: news

Tricuspid valve repair device maker Cro íValve raises $4m
Early stage tricuspid valve repair device developer CroíValve has raised approximately $3.6 million (EU €3.2 million) in an oversubscribed seed financing round, according to a report from the Irish Times. CroíValve is developing a novel percutaneous solution intended to treat tricuspid regurgitation that seals the central gap between the native valve leaflets to prevent regurgitation, according to the company’s website. The funding round was led by the business angel network HBAN and joined by Atlantic Bridge University Fund, Enterprise Ireland, Seán O’Sullivan’s SOSV and a total of 48 angel investors, according...
Source: Mass Device - March 29, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular croivalve Source Type: news

Endra Life Sciences touts preliminary TAEUS liver fat analysis study data
Endra Life Sciences today reported preliminary results from the first-in-man feasibility study of its Thermo Acoustic Enhanced Ultrasound System exploring its ability to measure and analyze liver fat. The TAEUS platform is designed to allow for the visualization of human tissue composition, function and temperature at a cheaper cost than computed tomography or magnetic resonance imaging and provided at the point-of-care, the Ann Arbor, Mich.-based company said. Preliminary data came from 25 subjects analyzed with the TAEUS platform as compared with quantitative MRI fat fraction measurements and other indicators including B...
Source: Mass Device - March 29, 2019 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Imaging endralifesciences Source Type: news

InspireMD pulls the trigger on another reverse stock split
InspireMD (NYSE:NSPR) said this week its stockholders approved a 1-for-50 reverse split of its stock, slated to take effect today. The reverse split comes only 13 months after its last 1-for-35 reverse split, which the Israel-based company initiated last February. Through the deal, each shareholder in the company will receive a single share of the company’s stock for every 50 they previously held, with any fractional shares rounded up to the nearest whole share, according to an SEC filing. InspireMD said that along with the reverse split, a proportionate adjustment will be made to the per share exercise price and nu...
Source: Mass Device - March 29, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Wall Street Beat InspireMD Source Type: news

LivaNova to settle majority of U.S. 3T Heater-Cooler cases
LivaNova (NSDQ:LIVN) said that it inked a deal to settle approximately 75% of litigations it faces in the U.S. related to its 3T Heater-Cooler device, which has been implicated in a number of unexpected severe patient infections, expecting to pay up to $225 million to settle the claims. In June 2016, the FDA warned patients and doctors about the risk of a type of bacterial infection posed by LivaNova’s 3T Heater-Cooler. Four months later, the U.S. Centers for Disease Control & Prevention warned of the risk of serious bacterial infection in open heart surgery patients using the 3T Heater-Cooler. A year later, ...
Source: Mass Device - March 29, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Legal News LivaNova Source Type: news

First U.S. patient treated with Cook Medical endovascular aortic dissection system
Cook Medical’s Zenith endovascular dissection system consists of two stents to treat a tear within the aorta. (Image from Cook Medical) Cook Medical has launched its Zenith dissection endovascular system, recently approved by the FDA. The first patient was treated with the system at Cooper University Health Care in Camden, N.J., Cook Medical announced yesterday. The Zenith system was designed to provide physicians with a less-invasive alternative to open surgery for repair of Type B dissections of the descending thoracic aorta. Zenith consists of a proximal stent-graft component and a distal bare-stent component. Ge...
Source: Mass Device - March 29, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Cardiovascular Implants News Well Stent Grafts Stents Cook Medical cooperuniversityhealthcare Source Type: news

AngioDynamics wins expanded FDA clearance for OARtrac radiation dose monitor
AngioDynamics (NSDQ:ANGO) said late yesterday that it won expanded FDA 510(k) clearance for its OARtrac radiation dose monitoring system. With the new clearance, the Latham, N.Y.-based company’s OARtrac system is cleared for use with patient-specific, pre-calibrated Plastic Scintillating Detector sensors used during cancer treatments to monitor photon and electron radiation therapy as an adjunct to treatment planning. AngioDynamics’ OARtrac system is designed to enable the measurement and validation of targeted radiation doses to improve accuracy and allow for more informed dosing. “This expanded clearan...
Source: Mass Device - March 29, 2019 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Radiosurgery/Radiation therapy Regulatory/Compliance AngioDynamics Source Type: news

ECRI Institute to open international medtech testing lab in Malaysia
ECRI Institute said it is launching its first medical device evaluation laboratory outside the United States. The ECRI International Research Centre in Selangor, Malaysia will evaluate medical devices used across all care settings in Europe and Asia to help medical professionals make informed decisions that improve patient safety, according to the nonprofit, independent organization. It is scheduled to open April 11. Get the full story on our sister site, Medical Design & Outsourcing. The post ECRI Institute to open international medtech testing lab in Malaysia appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 29, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Materials Testing News Well Research & Development ECRI Institute Source Type: news

Align Tech, ClearCorrect parent co Straumann bury the hatchet, ink distro deal
Align Technology (NSDQ:ALGN) said today that it inked a deal with competitor ClearCorrect parent company Straumann Holding to settle all outstanding patent disputes between the companies. The deal includes a $35 million payment from Switzerland-based Straumann, as well as a 5-year global distribution deal through which Straumann will distribute 5,000 of San Jose, Calif.-based Align Tech’s iTero Element scanners. The scanners will be integrated into the Straumann/Dental Wings Cares/DWOS workflow, Align Tech said in an SEC filing. Both companies agreed to dismiss all existing patent disputes between them in both the...
Source: Mass Device - March 29, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Dental Featured Legal News Patent Infringement aligntechnology Straumann Holdings AG Source Type: news

Bayer loses bid to toss some claims in Essure class action suit
A federal judge in Philadelphia will allow six women who are suing Bayer (ETR:BAYN) over its Essure sterilization implant to proceed with their personal injury claims and three others to pursue their breach-of-warranty claims. One woman who became pregnant following implantation with Essure will be able to pursue her claim that Bayer fraudulently concealed the risk of pregnancy, the judge ruled. Bayer had filed a motion for partial summary judgment on all 12 plaintiffs’ claims in the class action suit, citing statutes of limitations. Judge John Padova of the Eastern District of Pennsylvania granted Bayer’s moti...
Source: Mass Device - March 28, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Featured Gynecological Implants Legal News News Well Women's Health Bayer Source Type: news

Wound Management Tech shareholders approve 1-for-100 reverse split, name change to Sanara Medtech
Wound Management Technologies (OTC:WNDM) said this week that its shareholders approved a 1-for-100 reverse split of its stock and a name change to Sanara MedTech. The Fort Worth, Texas-based company said that through the split, each shareholder of the company will receive a single share of common stock for every 100 shares they previously held, with a cash payment provided for fractions of shares dependent upon market price of the stock the day before it becomes effective. Wound Management Tech said that upon completion of the reverse stock split, the total authorized capital stock of the company will be reduced to 20 mi...
Source: Mass Device - March 28, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat Wound Management Technologies Source Type: news

Guided Therapeutics pulls trigger on 1-for-800 reverse stock split
Guided Therapeutics (OTC:GTHP) said today that it pulled the trigger on a 1 for 800 reverse split of its stock, effective March 29. The Norcross, Ga.-based company said that its shareholders approved the reverse split last October. Through the deal, each shareholder of Guided Therapeutics will receive a single share of the company’s common stock for each 800 they previously held. Guided Therapeutics said it also cleared out variable rate convertible loans with three lenders and reached preliminary agreements with two other lenders to exchange variable rate convertible notes for cash and fixed rate equity once ̶...
Source: Mass Device - March 28, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat Guided Therapeutics Inc. Source Type: news

Biolinq adds $5m to Series A
Biosensor developer Biolinq said today it raised $4.8 million as an extension of its Series A financing round. The San Diego-based company said that the investment in its expanded, oversubscribed Series A round was led by the JDRF T1D Fund, Aphelion Capital and LifeSci Venture Partners. With the additional funding, Biolinq said it has raised a total of $15 million in the Series A round. Read the whole story on our sister site, Drug Delivery Business News The post Biolinq adds $5m to Series A appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 28, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Diabetes Wall Street Beat biolinq Source Type: news