Medtronic, Nutrino update iPro2 myLog app for CGM
Medtronic (NYSE:MDT) and Nutrino said today that they’re launching an update for the iPro2 myLog app, the FoodPrint Report, designed to give diabetes patients an understanding of the link between meals and blood glucose fluctuations. Powered by Nutrino’s artificial intelligence platform for assessing personal nutrition, FoodPrint patients photograph each meal or snack during a six-day evaluation of continuous glucose monitoring. Get the full story at our sister site, Drug Delivery Business News. The post Medtronic, Nutrino update iPro2 myLog app for CGM appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Diabetes Software / IT Medtronic Nutrino Source Type: news

Neural Analytics lands CE Mark for NeuralBot ultrasound guidance device
Neural Analytics said today that it won CE Mark approval in the European Union for its NeuralBot ultrasound guidance device for evaluating blood flow in the brain. Los Angeles-based Neural Analytics said that NeuralBot is designed to work with its already-CE Marked Lucid M1 transcranial doppler utrasound to provide non-invasive blood flow monitoring. “We are committed to advancing brain healthcare through transformative technology that empowers neurologists with the critical information needed to make clinical decisions and improve patient outcomes,” co-founder & CEO Leo Petrossian said in prepare...
Source: Mass Device - June 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Neurological Regulatory/Compliance Robotics Neural Analytics Source Type: news

Singapore HSA implements major medical device regulatory changes
By Stewart Eisenhart, Emergo Group Medical device market regulators in Singapore have begun enforcement of key regulatory changes affecting areas such as low-risk devices, telehealth products and quality system requirements starting June 1, 2018. 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 Singapore HSA implements major medical device regulatory changes appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 19, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

Elekta wins CE Mark for Unity high-field MR-linac
Elekta (STO:EKTA B) said today it won CE Mark approval in the European Union for its Elekta Unity magnetic resonance radiation therapy system. The Stockholm-based company touted that its Unity system allows clinicians to deliver radiation doses while simultaneously visualizing the tumor and surrounding tissue through MR imaging. The system also features integrated advanced tools that allow the operator to adapt treatment based on anatomical information. “Unity is a tremendous innovation in patient care, one that enables a scan-plan-treat approach to developing tailored regimens that should yield substantive clinical ...
Source: Mass Device - June 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Imaging Oncology Regulatory/Compliance Elekta Source Type: news

Ra Medical raises $60m
Ra Medical has raised approximately $60.2 million in a new round of financing, according to recently posted SEC filings. A total of seven unnamed investors participated in the Carlsbad, Calif.-based company’s option-based funding round, with the first sale noted on June 4, according to the filing. The company is not seeking any further funding in the financing round, has not yet publicly released details of the offering or commented on how it plans to spend funds raised. Earlier this month, Ra Medical reported raising approximately $18.3 million in a round of equity financing. The post Ra Medical raises $60...
Source: Mass Device - June 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Funding Roundup Wall Street Beat Ra Medical Source Type: news

Study finds nearly half of people with diabetes skip care due to costs
A newly-published report from UpWell Health found that nearly half of Americans with diabetes have skipped medical care at times because they couldn’t afford it. The 5,000-person survey showed that diabetes doesn’t just take a financial toll on people’s lives – it can impact their relationships, too; 37% of respondents reported that diabetes has harmed relationships with loved ones and co-workers. Get the full story at our sister site, Drug Delivery Business News. The post Study finds nearly half of people with diabetes skip care due to costs appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 18, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Pharmaceuticals American Diabetes Assn. Source Type: news

Paragonix Technologies aims to boost survival of donated lungs
Image courtesy of Paragonix Technologies Many lungs being transported for transplant arrive in such bad shape that they cannot be used. Paragonix Technologies, Inc. aims to change that with SherpaLung, a specialized cooler that keeps lungs properly inflated and at the right temperature to survive an airplane trip. Paragonix Technologies just landed support from the Lung Transplant Foundation to continue developing and commercialize SherpaLung, the latest in its series of specialized organ transport carriers. Braintree, MA-based Paragonix launched similar devices for hearts and kidneys within the past several months, a...
Source: Mass Device - June 18, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Business/Financial News News Well Transplants Lung Transplant Foundation Paragonix Technologies Source Type: news

Foundation Medicine looks to expand oncology arsenal with precision drugs
Before she was Foundation Medicine‘s (NSDQ:FMI) chief business executive, Melanie Nallicheri was as an advisor to an ongoing project at the Cleveland Clinic, where she was witness to the power of personalized cancer treatment. Her team was caring for a patient with glioblastoma – an extremely aggressive form of brain cancer with a median survival time of 15 months. “The patient had resection and radiation and the question was: so now what?” she told Drug Delivery Business News. They turned to the patient’s molecular profile in search of answers, scouring over millions of pieces of data. T...
Source: Mass Device - June 18, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diagnostics Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Foundation Medicine Inc. Merck Source Type: news

DreaMed Diabetes wins FDA authorization to market insulin therapy management platform
DreaMed Diabetes said today that U.S. FDA has granted a de novo request for DreaMed Advisor Pro, its AI-based diabetes treatment decision support software. The news comes about four months after the Petah Tikva, Israel–based company won CE Mark clearance for the decision-support platform, which is meant to help healthcare professionals manage insulin therapy for people with Type I diabetes. Get the full story on our sister site Drug Delivery Business News. The post DreaMed Diabetes wins FDA authorization to market insulin therapy management platform appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 18, 2018 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News Diabetes Food & Drug Administration (FDA) Software / IT DreaMed Diabetes Source Type: news

Haemonetics closes $700m debt refi
Haemonetics (NYSE:HAE) said today that it closed the refinancing of some $700 million in debt as part of its restructuring plan. Last November the Braintree, Mass.-based blood management company unveiled plans to cut roughly 11% of its global workforce as it looked to pare $80 million from its annual cash burn by the end of fiscal 2020. Today the company said it took out a new, $700 million credit line and used it to pay of $254 million in senior unsecured term loans due next June. The credit line includes a $350 million senior unsecured term loan and a $350 million senior unsecured revolving credit lin...
Source: Mass Device - June 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Blood Management Funding Roundup Wall Street Beat Haemonetics Source Type: news

Boston Scientific wins third Mass. pelvic mesh trial
Boston Scientific (NYSE:BSX) last week won the third Massachusetts trial of a product liability lawsuit brought over two of its pelvic mesh products. Ana Martinez and her husband Jose sued Marlborough, Mass.-based Boston Scientific in August 2012 in the Bay State’s Middlesex County Superior Court. After a 16-day trial, the jury found June 15 that Boston was not negligent in the design of its Pinnacle and Obtryx pelvic mesh products and did not fail to warn patients of the risks associated with the meshes, according to court documents. The jury also found that the Pinnacle and Obtryx devices were not defecti...
Source: Mass Device - June 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Legal News Product Liability Women's Health Boston Scientific Pelvic Mesh Lawsuits Source Type: news

Johnson & Johnson Vision wins FDA nod for iDesign Lasik device
Johnson & Johnson (NYSE:JNJ) Vision said today that the FDA approved its iDesign Refractive Studio for planning Lasik eye procedures. iDesign uses a three-second scan to perform a wavefront analysis of how light travels inside the eye and maps the topography of the cornea to customize Lasik treatments for myopia, hyperopia, mixed astigmatism and presbyopic myopia, Santa Ana, Calif.-based J&J Vision said. “As a practicing ophthalmologist for more than 25 years, I know firsthand the importance of taking precise measurements and tailoring Lasik procedures for each patient,” medical & clinical affa...
Source: Mass Device - June 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Optical/Ophthalmic Regulatory/Compliance johnsonandjohnson Source Type: news

Report: IBM Watson Health cuts back on hospital biz
The Watson Health operation at International Business Machine (NYSE:IBM) is reportedly cutting back on the portion of its business that sells to hospitals due to a softening market for value-based healthcare offerings. Managers for IBM Watson Health told workers last week that changes to the Affordable Care Act caused hospitals to spend less on managing outcomes-based contracts, a source who attended the June 13 meeting told Stat News. The meeting followed reports of widespread layoffs that the company later sought to downplay. Existing hospital contracts will be honored as resources shift to other areas, althoug...
Source: Mass Device - June 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Big Data Software / IT Wall Street Beat IBM Watson Health valuebasedhealthcare Source Type: news

AMG Int ’ l wins CE Mark for Archimedes bioresorbable biliatric stent
Q3 Medical Devices’ AMG International said today it won CE Mark approval in the European Union for its Archimedes biodegradable biliary and pancreatic stent. The Winsen, Germany-based company touts the Archimedes as the only fully biodegradable biliary and pancreatic stent cleared for use in obstructed biliary or pancreatic ducts globally. “The Archimedes biodegradable stent represents a major breakthrough in the treatment of obstructive biliary and pancreatic disorders, and also in the field of biodegradable and bioresorbable materials and their application in medical devices moving forward. This technology ha...
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Stents amginternational Source Type: news

InVivo prices $11m offering
InVivo Therapeutics (NSDQ:NVIV) has registered for a new offering of shares and warrants that could bring in approximately $11 million, according to an SEC filing. In the offering, the company will look to float approximately 1.5 million shares and 1.5 million Series A warrants at $7.40 per share. InVIvo Therapeutics has not yet announced the exercise price of the warrants, which will be exercisable upon issuance and will expire 20 years from the date they were issued, according to the SEC filing. The company will also offer pre-funded warrants to purchase excess shares in lieu of common shares for purchasers who woul...
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Funding Roundup Wall Street Beat InVivo Therapeutics Source Type: news

Verrica Pharmaceuticals prices $75m IPO to fund drug-device skin therapy
Verrica Pharmaceuticals said this week that it plans to offer 5 million shares priced between $14 to $16 apiece, setting its initial public offering at $75 million. The West Chester, PA-based company expects to use its newly-acquired funds to advance its lead product candidate: a drug-device combination product designed to administer a topical dermatological drug, cantharidin. Get the full story at our sister site, Drug Delivery Business News. The post Verrica Pharmaceuticals prices $75m IPO to fund drug-device skin therapy appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Funding Roundup Pharmaceuticals Wall Street Beat verricapharmaceuticals Source Type: news

FDA panel votes against BTG ’ s PneumRX Elevair
An FDA advisory committee panel yesterday voted against approving BTG‘s PneumRX’s Elevair endobronchial coil system intended for treating patients with severe emphysema. The panel voted 7 to 5 in favor of the device’s safety, but 8 to 3 that the benefits do not outweigh the risks, and 5 to 7 that the device was effective for use with patients in its proposed indications. The Elevair device is a nitinol endobronchial coil intended to be deployed bronchoscopically to reduce lung volume in patients with severe emphysema. The company submitted an application for premarket approval with the FDA, backed by clin...
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Respiratory BTG Source Type: news

FDA approves first generic sublingual film to treat opioid addiction
The FDA this week approved the first generic version of Indivior‘s (LON:INDV) billion-dollar opioid addiction treatment, Suboxone. The generic buprenorphine and naloxone sublingual film, sold by Dr. Reddy’s Laboratories (NYSE:RDY) and Mylan (NSDQ:MYL), is designed to suppress withdrawal symptoms that crop in people addicted to opioids, as well as block the neurochemical effects of opioids. Get the full story at our sister site, Drug Delivery Business News. The post FDA approves first generic sublingual film to treat opioid addiction appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pain Management Pharmaceuticals Regulatory/Compliance Wall Street Beat Dr. Reddy's Laboratories indivior Mylan Source Type: news

Markets slide on Trump ’ s China tariffs
Stock markets the world over slipped today after the Trump Administration pulled the trigger on $50 billion in tariffs against China, including medical devices made in the People’s Republic that could put a $5 billion hit on the U.S. medtech industry. The new tariffs impose an extra 25% duty on Chinese imports with “industrially significant” technologies, according to the office of U.S. Trade Representative Robert Lighthizer, which claimed that an “exhaustive” investigation found that “China’s acts, policies and practices related to technology transfer, intellectual property, and i...
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Wall Street Beat tariffs Source Type: news

Appeals court slashes $50m from J & J stapler suit damages
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon had approximately $50 million slashed from punitive damages it owes in a product liability suit over its PPH 03 hemorrhoid stapler, according to recently released court documents. In December 2015, a California state jury awarded the plaintiff in the case, Florence Kuhlmann, $70 million in punitive damages on top of an initial $9.8 million in compensatory damages. This week, the Court of Appeals for the State of California’s First Appellate District, Division Five, cut the punitive damages down to $19.6 million, or two times the compensatory damages it owe...
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Product Liability Surgical Ethicon johnsonandjohnson Source Type: news

Neuronetics adds up-to $12m over-allotment option to pending IPO
Neuronetics this week added an underwriter’s option to its initial public offering, which could bring in between $10.5 million and $12 million if fully exercised, and gave a rough price range for the offering. The Malvern, Penn.-based company said it is filing for the public offering to expand its commercialization efforts for the NeuroStar transcranial magnetic stimulation device for treating depression. Neuronetics now plans to offer a total of 5 million shares up front, expecting them to be priced between $14 and $16 per share, which would bring the total for the IPO to between $70 million and $80 million. Th...
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Initial Public Offering (IPO) Neurological Wall Street Beat Neuronetics Source Type: news

Newly formed pVAD dev Supira Medical raises $16m
Medtech incubator Shifamed said this week that its newly formed portfolio company Supira Medical has raised $15.5 million in a new round of financing. The round was led by The Capital Partnership and joined by Cormorant Asset Management and Shifamed Angels, the Campbell, Calif.-based incubator said. The round officially closed on April 25. Supira Medical is developing a next-generation percutaneous ventricular assist device intended for use in high-risk patients undergoing interventional procedures, and is being run by Jean Orth in Shifamed’s Silicon Valley facilities. “I am delighted Jean will lead the Supira ...
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Shifamed supiramedical Source Type: news

HealthPrize takes aim at medication nonadherence with habit-forming tech
At HealthPrize Technologies, chief executive Tom Kottler is tackling a problem that many in the pharmaceutical industry are trying to solve: What stops people from taking their medications and how can the industry boost medication adherence rates? In order to encourage patient compliance, Kottler told Drug Delivery Business News that he’s taking a different approach than his competitors. Instead of trying to change a person’s behavior, the team at HealthPrize wants to help people form better habits. “I don’t believe that you can change a person’s behavior,” Kottler said. &ldquo...
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals healthprizetechnologies Source Type: news

Philips acquires Remote Diagnostic Technologies
Royal Philips (NYSE:PHG) said today it acquired U.K.-based Remote Diagnostic Technologies for an undisclosed amount. Remote Diagnostic Technologies develops cardiac therapy, data management and monitoring solutions for the pre-hospital market, and has a portfolio of connected emergency care solutions that Amsterdam-based Philips said will complement its therapeutic care biz. “We are committed to investing in and expanding our resuscitation and emergency care offering, and with the acquisition of RDT we can boost our capabilities and portfolio in this vital area of healthcare. With its focus on the pre-hospi...
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Patient Monitoring royalphilips Source Type: news

Insys Therapeutics reports positive preliminary data for allergy nasal spray
Shares in Insys Therapeutics (NSDQ:INSY) jumped yesterday after the company reported positive data for its investigational epinephrine nasal spray designed as a needle-free treatment for anaphylaxis. In a 60-person pharmacokinetics study, early data show that the company’s intranasal formulation of epinephrine boasted similar bioavailability to epinephrine delivered via Mylan’s EpiPen auto-injector. Get the full story at our sister site, Drug Delivery Business News. The post Insys Therapeutics reports positive preliminary data for allergy nasal spray appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Pharmaceuticals Wall Street Beat Insys Therapeutics Inc. Source Type: news

Cardinal Health deals majority stake in NaviHealth to PE shop CD & R
Cardinal Health (NYSE:CAH) said this week it divested itself of its majority stake in NaviHealth to private equity firm Clayton, Dubilier & Rice, with Cardinal Health retaining the call right to reacquire the business. NaviHealth provides post-acute car programs to hospital systems, health planst, physician groups and healthcare providers as part of value-based care programs, Cardinal Health said. Through the deal, CD&R will obtain a 55% ownership stake in NaviHealth, while Dublin, Ohio-based Cardinal Health will retain an approximate 45% stake in the post-acute care focused business. “This new investmen...
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Cardinal Health Source Type: news

Titan Medical shareholders approve 30-1 reverse split
Titan Medical (TSX:TMD;OTC:TITFX) shareholders this week approved a reverse stock split that could see the company exchange a single share for as many as 30. The robot-assisted surgery company, which lists its shares on the OTC exchange in the U.S. and on the Toronto Stock Exchange, said earlier this month that the reverse split is slated to go into effect June 19 when the markets open. Titan also wants to move its U.S. listing to the NASDAQ exchange; the reverse split is aimed at meeting the exchange’s listing requirements. Today Titan said some 88.1% of the more than 297 million shares voted at the meeting app...
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Robotics Wall Street Beat Titan Medical Inc. Source Type: news

Over-allotment takes Hancock Jaffe IPO to nearly $9m
The underwriter of an initial public offering by Hancock Jaffe Laboratories (NSDQ:HJLI) this week exercised in full its over-allotment option, taking the gross proceeds from the flotation to nearly $9 million. The IPO, which priced on the last day of May, initially brought in $7.5 million for Irvine, Calif.-based Hancock Jaffe, which makes bioprosthetic implants designed to treat chronic deep vein insufficiency, heart valve conditions and coronary artery bypass grafts. The shares trade on the NASDAQ exchange under the symbol “HJLI.” Network 1 Financial Securities, the offering’s managi...
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Initial Public Offering (IPO) Vascular Wall Street Beat hancockjaffelabs Source Type: news

Medtronic wins FDA nod for new lengths of drug-coated balloon
Medtronic (NYSE:MDT) said today that it won FDA approval for 200mm and 250mm lengths of its In.Pact Admiral drug-coated balloon. The newly-approved lengths are designed to treat patients with longer, more complex superficial femoral artery lesions, according to the medtech giant. Get the full story at our sister site, Drug Delivery Business News. The post Medtronic wins FDA nod for new lengths of drug-coated balloon appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Vascular Wall Street Beat Medtronic Source Type: news

7 medtech stories we missed this week: June 15, 2018
[Image from unsplash.com]From Cytosorbents opening a new U.S. manufacturing facility to DyAnsys received FDA clearance for a wearable to treat opioid withdrawals, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Cytosorbents opens new U.S. manufacturing facility CytoSorbents announced in a June 12 press release that it has opened a new manufacturing facility in Monmouth Junction, N.J. with the company’s ISO 13485:2003 certification. The new facility is expected to quadruple production capacity and will accelerate margin expansion and drive operating profitability. Cy...
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Contract Manufacturing Diagnostics Food & Drug Administration (FDA) Hospital Care Implants mHealth (Mobile Health) Neuromodulation/Neurostimulation Orthopedics Regulatory/Compliance Spinal Surgical Centinel Spine LLC CytoS Source Type: news

Sirtex accepts CDH acquisition offer, moves away from Varian
In the ongoing back-and-forth to acquire Sirtex Medical (ASX:SRX), it seems that Varian Medical‘s (NYSE:VAR) $1.2 billion bid just wasn’t enough. Varian said today that it heard from Sirtex that the company’s board couldn’t turn down the $1.41 billion unsolicited offer from China’s CDH Investments. The bid from CDH Investments came in at a 20% premium on Varian’s A$28-per-share offer, prompting Sirtex to reconsider a merger that already had approval from U.S. antitrust authorities and the German Federal Cartel Office. Get the full story at our sister site, Drug Delive...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Mergers & Acquisitions Oncology Wall Street Beat CDH Investments Sirtex Medical Varian Medical Systems Source Type: news

Preceptis Medical closes Series B
Preceptis Medical said yesterday it closed a Series B round of financing to help support its Hummingbird tympanostomy tube system designed for pediatric ear tube placement procedures. The Plymouth, Minn.-based company’s Hummingbrid TTS tympanostomy tube system is designed to reduce pain for pediatric patients undergoing ear tube procedures, allowing moderate, conscious sedation with no need for general anesthesia. Preceptis said the Series B financing round was led by Montesy Helen Limited, and will support the expansion of the company’s commercial infrastructure, the completion of an office study and for ...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Funding Roundup Otolaryngology Ear, Nose & Throat Preceptis Medical Source Type: news

Avinger launches post-market study comparing OCT to IVUS in PAD treatments
Avinger (NSDQ:AVGR) said today it launched a post-market study comparing optical coherence tomography to intravascular ultrasound as used during interventions in the peripheral arteries. The Redwood City, Calif.-based company’s Lumivascular tech, including its Pantheris image-guided atherectomy device and Ocelot image-guided chronic total occlusion crossing catheters, use OCT for real-time intravascular imaging during interventions to treat peripheral artery disease. “As a regular user of diagnostic IVUS to plan treatment and assess results after the delivery of therapy, I have found that having an intrava...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Imaging Vascular Avinger Source Type: news

FDA rejects Mylan ’ s Advair generic in win for GSK
Shares in Mylan (NSDQ:MYL) dropped -5% yesterday after the pharmaceutical company revealed that it received the dreaded ‘complete response letter’ from the FDA, denying its application for a generic version of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug. Canonsburg, PA-based Mylan noted that the CRL was due to “minor deficiencies” identified in its application and that it expects to wait until it receives the full notice on June 27 to determine how the rejection will impact its 2018 financial outlook. Get the full story at our sister site, Drug Delivery Business ...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Respiratory Wall Street Beat GlaxoSmithKline plc Mylan Novartis Source Type: news

TheraNova, UCSF Surgical Innovations ink collab accelerator deal
Medical device innovation firm TheraNova said this week it is partnering with incubator-accelerator UCSF Surgical Innovations to help co-develop device tech intended to address unmet patient needs. The partnership will establish collaboration between both sites, allowing parties to utilize UCSF’s intellectual and clinical environment and TheraNova’s product development capabilities and knowledge, the San Francisco-based companies said. “As industry director of the UC Berkeley-UCSF Master of Translational Medicine program I have been impressed with the caliber of both the students and the faculty. With thi...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Research & Development Source Type: news

5 things medtech manufacturing executives learned from their dads
Sometimes working for your dad seems like destiny, but taking over the family business wasn’t always the plan. There are many second- and third-generation medtech manufacturers run by executives following in their dads’ footsteps. Here’s what they learned.  [Image from unsplash.com]Eric Crainich, president and owner of Design Standards (Charlestown, N.H.), was told from a young age that it was essentially his destiny to take over the company his father founded in Connecticut in 1971. “Nothing would make him prouder or happier, and in the back of my mind, I knew that’s where I would land,&...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Contract Manufacturing Acme Monaco Design Standards MedTech Oscor Source Type: news

LivaNova wins FDA nod for Memo 4D mitral annuloplasty ring
LivaNova (NSDQ:LIVN) said today it won FDA 510(k) clearance for its Memo 4D semi-rigid mitral annuloplasty ring, and said that the device has been used in its first commercial procedure. The Memo 4D mitral annuloplasty ring is a next-generation device designed for treating patients with mitral regurgitation, and is available in sizes from 24 mm to 42 mm, the London-based company said. “Memo 4D simplifies and standardizes degenerative complex mitral valve repair, facilitates minimally invasive surgical approaches and preserves the mobility of the mitral valve leaflets. The new larger sizes allow us to treat more ...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance LivaNova Source Type: news

Mindstrong Health raises $15m in Series B
Neurological-focused device start-up Mindstrong Health said today it raised $15 million in a Series B round of financing to support its neuropsychiatric treatment and diagnosis platform. Funds from the round will be used to help scale Mindstrong’s business and advance commercial deployments with its partners across a number of healthcare verticals, the Palo Alto, Calif.-based company said. “Mindstrong continues to show great progress in deploying solutions that improve behavioral healthcare by enabling providers to detect deterioration and deliver effective care early. We expect this to improve access and ...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Funding Roundup mindstronghealth Source Type: news

Venus Medtech launches Venus pulmonary valve implant
Chinese heart valve maker Venus Medtech said today it launched its Venus P-Valve self-expanding pulmonary valve implant in Canada, touting that the first procedures with the valve have been performed in the region. The Venus P-Valve was designed for percutaneous use in native right ventricular outflow tracts, the Hangzhou-baesd company said, and is intended for patients who wish to avoid sternotomy and cardiopulmonary bypasses associated with traditional valve replacement surgeries. The first procedures were performed on two patients who had previously been treated with surgical patch correction for tetralogy of ...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Replacement Heart Valves Venus Medtech Source Type: news

Mevion Medical closes $150m funding round
Mevion Medical Systems said today it closed a $150 million financing round with funds slated to support the company’s proton therapy devices and to expand manufacturing. The round was led by YuanMing Capital and joined by Henan Maisheng Medical Technology and existing investors including HOPU Investments and China Everbright Limited, the Littleton, Mass.-based company said. Mevion said that funding would be used to support its proton therapy business and to expand the company’s manufacturing capabilities to meet an increased interest in its Hyperscan systems. Funding will also support the company’s expans...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Funding Roundup Wall Street Beat Mevion Medical Systems Source Type: news

K2M readies $65 million senior note offering
K2M (NSDQ:KTWO) said this week it looks to raise $65 million through an offering of convertible senior notes due 2025. The Leesburg, Va.-based company said it also expects to grant initial note buyers an option to purchase an additional $10 million worth of the notes during a 13-day period beginning the first day it issues the notes. Notes offered in the round will mature on June 30, 2025, unless converted, redeemed or repurchased earlier than that date, K2M said. Net proceeds from the offering will be used to repay approximately $18 million in borrowings under the company’s revolving credit facility, while...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat K2M Source Type: news

FDA panel backs Cardinal Health ’ s Incraft stent graft
Cardinal Health (NYSE:CAH) said this week that the FDA Circulatory System Devices Panel of its Medical Devices Advisory Committee issued a favorable recommendation on the premarket approval application for the company’s Incraft abdominal aortic aneurysm stent graft system. The panel voted 11 to 4 in favor of the Incraft system, which is designed as an advanced endovascular aneurysm system for treating infrarenal abdominal aortic aneurysms, the Dublin, Ohio-based company said. The Incraft AAA system differs from other EVAR systems as it is intended to treat a wider range of patients, as many EVAR devices are limi...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Stent Grafts Vascular Cardinal Health Source Type: news

Report: Apple files patent for blood pressure monitor
Apple (NSDQ:AAPL) has submitted a patent application for a wearable blood pressure monitoring cuff, according to a recent report from The Verge. The application, submitted two years ago, shows a wearable cuff equipped with sensors intended to measure blood pressure, according to the report. The device could come in a similar package to the current Apple Watches on the market, as the patent application mentions a possible touchscreen face and Bluetooth connectivity, The Verge reports. The tech in the patent is similar to other blood pressure monitoring devices, according to the report, but given Apple’s cont...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Diagnostics Apple Source Type: news

Pulmatrix touts Ph1 data for inhaled COPD therapy
Pulmatrix (NSDQ:PULM) touted data today from a dose-ranging Phase I trial of its once-daily inhaled therapy designed for people with chronic obstructive pulmonary disease. The company’s product is a reformulation of tiotropium bromide, the active component in Boehringer Ingelheim’s blockbuster drug, Spiriva. Get the full story at our sister site, Drug Delivery Business News. The post Pulmatrix touts Ph1 data for inhaled COPD therapy appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 13, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Pharmaceuticals Respiratory Wall Street Beat Pulmatrix Inc. Source Type: news

Natus Medical faces proxy battle with Voce Capital
Natus Medical (Nasdaq: BABY) is facing a proxy battle with investment firm Voce Capital which is urging shareholders to oust chairman Robert Gunst. The Pleasanton, Calif.-based company referenced a recent report from Glass Lewis & Co. regarding its most recent annual meeting, which stated that Voce “has not presented a detailed operating plan for the company, nor has it offered specific suggestions to improve the company’s financial or operating performance.” Natus agreed with the rejection of Voce’s proposal and added that it believed its shareholders should vote for its existing nomi...
Source: Mass Device - June 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat Natus Medical Inc. Source Type: news

FDA to review Sunovion ’s apomorphine sublingual film for Parkinson’s disease
Sunovion Pharmaceuticals said today that the FDA accepted its new drug application for a sublingual film designed to treat motor fluctuations in people living with Parkinson’s disease. The U.S. regulatory agency is slated to make a decision regarding Sunovion’s application by January 29. Get the full story at our sister site, Drug Delivery Business News. The post FDA to review Sunovion’s apomorphine sublingual film for Parkinson’s disease appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 13, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Neurological Pharmaceuticals Sunovion Pharmaceuticals Source Type: news

Ra Medical raises $18m
Ra Medical has raised $18.3 million in a new round of equity financing, according to a recently posted SEC filing. Money in the round came from 49 unnamed investors, according to the filing, with the first sale recorded last September. The Carlsbad, Calif.-based company is still seeking an additional $718,000 in the offering, according to the SEC filing, and has not officially stated how it plans to spend funds raised in the round. In late April, Ra Medical said it named former AltheaDx CFO Andrew Jackson as its new chief financial officer. The post Ra Medical raises $18m appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat Ra Medical Source Type: news

Wright Medical wins FDA PMA for Augment injectable bone graft
Wright Medical (NSDQ:WMGI) said today it won FDA premarket approval for its Augment injectable bone graft. The bone graft won clearance for the same indications as the Amsterdam-based company’s non-injectable Augment bone graft. The newly cleared Augment Injectable consists of both recombinant human platelet derived growth factor and a blend of Type I collagen and beta tri-calcium phosphate, the company said. “In Canada, my colleagues and I have been using Augment Injectable since 2011 based upon its ideal handling characteristics and impressive clinical results.  FDA approval of Augmen...
Source: Mass Device - June 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Orthopedics Pre-Market Approval (PMA) Regulatory/Compliance wrightmedical Source Type: news

Here ’s how FDA officials think you can legally promote off-label device, drug uses
The FDA has issued final guidance clarifying what it considers permissible off-label information for devicemakers and drug companies to convey to potential customers. A pair of guidance documents outlines how medtech and pharmaceutical companies can explain to payors and hospitals how their products can affect outcomes and potentially save money, beyond what the products’ indication with the agency says. They might include data from post-market studies and surveillance of a product’s approved uses, or additional information from the pre-market studies, FDA Commissioner Scott Gottlieb said in a st...
Source: Mass Device - June 13, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

Medtronic warns on external pacemaker issues
Medtronic (NYSE:MDT) has released an urgent field safety notice warning of issues with a subset of its model 53401 single chamber external pacemakers in which the device may experience an unexpected power on reset. The Fridley, Minn.-based company said that the issue is due to an initial version of the firmware for the device which allowed for an unused, unterminated digital input/output pin to act as an input. The unterminated pin was found to act as an antenna to detect external electrical signals, despite the device expecting it to be silent, according to the notice. Upon detecting an electrical signal, the firmwar...
Source: Mass Device - June 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Medtronic Source Type: news