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FDA clears software using AI to evaluate CT scans for stroke
Artificial Intelligence healthcare developer Viz.ai said this week it won approval from the FDA for its LVO Stroke platform designed to analyze computed tomography results and notify providers of potential strokes, touting it as the first such system to win FDA clearance. The company’s LVO Stroke platform is designed using deep learning and connects to a hospital CT scanner to alert stroke specialists that a suspected LVO stroke has been identified, with the ability to send radiological images directly to the physician’s phones. “Timely LVO stroke identification and transfer to a specialist hospital that ...
Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Software / IT vizai Source Type: news

Perflow Medical closes $12m round to support Stream Net thrombectomy device
Israel-based neurovascular device developer Perflow Medical said it closed a $12 million round of financing to help support its Stream dynamic neuro-thrombectomy net designed for treating acute ischemic stroke. Funding from the round will support the European commercialization of the company’s first product, the Stream Net device, and a 510(k) submission to the FDA in pursuit of US approval. Funds will also help support development of two new products based off the company’s Cerebral Net technology platform for aneurysm neck bridging and flow diversion procedures. The Stream Net device is designed to treat acut...
Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Neurological perflowmedical Source Type: news

BD sues Cytek over alleged stolen trade secrets
Becton Dickinson (NYSE:BDX) this week filed a suit against Cytek Biosciences, claiming the company stole trade secret information after hiring away a number of its former employees. The company claims that Cytek, which used to service its flow cytometers, began producing its own such devices based off knowledge it gained from former BD employees it hired. A total of 10 employees are named in the suit, which was filed in the U.S. District Court for the Northern District of California, including scientists, engineers and business people, according to court documents. “When they left BD to work for Cytek and therea...
Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Legal News bectondickinson cytekbiosciences Source Type: news

These trends have made medical device manufacturing what it is today
About 10 years ago, there were a number of notable trends and market forces which began to, once again, change how the medical device manufacturing sector brought its products to market. They’re still shaping the market we have today. Andrew Potter, Bonifacio Consulting Services, and Chris Delporte [Image from Unsplash]Perhaps the true measure of a forward-thinking industry is its ability to evolve to meet new market challenges, demands and opportunities. The medical device industry — and certainly the contract manufacturing sector that has grown over the last two decades into an integral part of medtech’...
Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Heather Thompson Tags: Business/Financial News Contract Manufacturing Outsourcing Bonifacio Consulting Services Source Type: news

Pacira shares fall after FDA committee rejects expanded use for Exparel pain drug
Shares in Pacira Pharmaceuticals (NSDQ:PCRX) fell nearly -16% today after a panel of experts convened by the FDA voted against an expanded use for Pacira’s injectable pain drug. The pharmaceutical company previously submitted an application seeking to use the local anesthetic as a regional pain-killer. Get the full story at our sister site, Drug Delivery Business News. The post Pacira shares fall after FDA committee rejects expanded use for Exparel pain drug appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Pain Management Pharmaceuticals Regulatory/Compliance Wall Street Beat Pacira Pharmaceuticals Source Type: news

Attivo Networks receives validation from BD for BOTsink cybersecurity solution
[Image courtesy of Blogtrepreneur on Flickr, per Creative Commons 2.0 license]Attivo Networks recently announced that it has received validation through a BD Product Security Partner Program for its BOTsink cybersecurity deception solution when used with BD devices. The company recently expanded its IOT portfolio and the BD collaboration will allow for improved detection capabilities against cyber threats that impact medical devices. The deception-based threat detection in the BOTsink features decoys and lures that misdirect potential attackers from production assets. Through the collaboration, BOTsink decoys will provide ...
Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Health Information Technology Attivo Networks BD Cybersecurity MedTech Source Type: news

Study: Abbott ’ s Nanostim leadless pacers solid at 3 years outside battery redesign issues
Abbott‘s (NYSE:ABT) Nanostim leadless pacemaker was found to be safe and effective after three years, outside of a battery-related malfunction that required a redesign, according to study data reported by Healio. Data came from the first-in-human Leadless study and was published in a research letter in the journal Circulation, according to the report. A single patient was reported to have experienced a complication caused by a battery malfunction, which culminated in a battery advisory that was sent to doctors and the redevelopment of battery components, Healio reports. A total of 33 patients were followed for u...
Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Abbott Source Type: news

Second Sight Medical enters Singapore market, touts 1st procedure in region
Second Sight Medical (NSDQ:EYES) said today it entered the Singapore market with its Argus II retinal prosthesis system through its regional exclusive distribution partner Mandarin Opto-Medic. The Sylmar, Calif.-based company said that its Argus II systems have been used in their first commercial procedure in the region, implanted last month in a 62-year-old patient with retinal degeneration at the Singapore National Eye Center by Dr. Edmund Wong and Dr. Laurence Lim with supervision from Dr. Emin Özmert. The Argus II induces visual perception in blind patients with retinitis pigmentosa by stimulating of the...
Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Optical/Ophthalmic Second Sight Source Type: news

Banyan Biomarkers wins 1st FDA nod for concussion blood test
Banyan Biomarkers this week won FDA clearance for its Banyan Brain Trauma Indicator blood test designed to evaluate concussions in adults, making it the first such test of its kind to get a pass from the federal watchdog. Approval for the device came through the the FDA’s breakthrough devices program and took only six months to review, according to a release from the agency. Patients with suspected mild traumatic brain injuries are normally examined using a neurological scale followed by a computed tomography scan to detect brain tissue damage or intracranial lesions that could require treatment, but often do not hav...
Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Diagnostics Food & Drug Administration (FDA) Neurological Regulatory/Compliance Banyan Biomarkers Source Type: news

FDA issues warning for Roche ’ s Accu-Chek diabetes management app
The FDA today issued a Class 2 device recall for Roche‘s (OTC:RHHBY) Accu-Chek connected diabetes management app. The company first notified the regulatory agency of the software bug in June last year. Roche reported that certain iOS and Andriod versions of the app had a program error in the Bolus Advisor feature – a calculator that helps the user determine insulin doses based on data from a glucose meter. Get the full story at our sister site, Drug Delivery Business News. The post FDA issues warning for Roche’s Accu-Chek diabetes management app appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Patient Monitoring Pharmaceuticals Recalls Wall Street Beat Roche Source Type: news

Tandem inks distribution deal in Scandinavia for insulin pumps
Tandem Diabetes Care (NSDQ:TNDM) has inked a distribution agreement with Rubin Medical to commercialize the medical device company’s t:slim X2 insulin pump, insulin cartridges and t:lock infusion sets in Sweden, Norway and Denmark. According to the terms of the deal, Rubin Medical is slated to perform all sales, marketing and customer training for Tandem’s devices. Get the full story at our sister site, Drug Delivery Business News. The post Tandem inks distribution deal in Scandinavia for insulin pumps appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Pharmaceuticals Wall Street Beat tandemdiabetes Source Type: news

With weeks left in flu season, the FDA is already working on next year ’s vaccine
Photo credit: USACE There are still weeks left in this year’s flu season, according to the FDA, but the agency is already planning on how to better protect the nation’s public health next year. An initial report from the Centers for Disease Control and Prevention concluded that this year’s flu vaccine sported a 36% efficacy rate. Although that’s better than some public health experts predicted, FDA chief Dr. Scott Gottlieb said in a statement that “there is still clearly significant room for improvement.” Get the full story at our sister site, Drug Delivery Business News. The p...
Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Pharmaceuticals Research & Development Wall Street Beat Centers for Disease Control & Prevention (CDC) National Institutes of Health (NIH) Source Type: news

NuVasive files alleged poaching, infringement suits against Alphatec
NuVasive Inc. (NSDQ:NUVA) has filed a suit against Alphatec (NSDQ:ATEC) claiming the company hired on executives, including former COO and prez Pat Miles, with knowledge of its XLIF lateral interbody fusion procedures in an attempt to recreate the technology for its own products. In its infringement suit, submitted this week to the U.S. District Court for the Southern District of California, San Diego-based NuVasive claims it created the XLIF method for fusing vertebral disks to reduce nerve damage and that Alphatec’s recently released devices, the Battalion lateral system, infringe on their products. ...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Legal News Patent Infringement Alphatec Nuvasive Source Type: news

Smith & Nephew touts results from Allevyn Life adhesive dressing hip fracture trial
Smith & Nephew (NYSE:SNN) today released the results from a trial of its Allevyn Life multi-layer silicone adhesive foam dressing, touting that its addition to standard care protocols reduces the onset of pressure ulcers by 71% in elderly patients being treated for hip fracture. The trial was published in the International Wound Journal, the London-based company said. “Hip fractures in the elderly are a serious problem due to the high rate of mortality and complications such as pressure ulcers, which occur mainly in the sacral area. Preventive measures play an important role in increasing quality of care, re...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Orthopedics Wound Care Smith & Nephew Source Type: news

Stryker wins expanded FDA indications for Trevo thrombectomy device
Stryker (NYSE:SYK) said today it won expanded FDA indications for its Trevo thrombectomy device, now cleared as a front-line treatment for acute ischemic stroke patients for up to 24 hours from symptom onset. The expanded indication lifts the previously cleared treatment window by 18 hours, according to the Kalamazoo, Mich.-based company. “The 24-hour indication opens the treatment window to patients whose stroke would previously have progressed until all the brain tissue surrounding the affected arteries was dead, leaving them with a life of significant disabilities. These patients now have a much better chance...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Food & Drug Administration (FDA) Regulatory/Compliance Vascular Stryker Source Type: news

Zimmer Biomet, Plaintiffs look to settle roughly 300 NexGen knee cases
Zimmer Biomet (NYSE:ZBH) has reportedly reached a settlement with plaintiffs in a case over allegedly defective NexGen knee implants, according to court documents filed this week. The Warsaw, Ind.-based company and individuals involved in the multidistrict litigation told US District Judge Rebecca Pallmeyer this week that they’ve “reached a confidential settlement in principle that will potentially resolve the entirety of cases,” according to the documents. The settlement could cover approximately 300 cases involved in the litigation as well as a number of cases in state courts that were pending, acc...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Legal News Orthopedics zimmerbiomet Source Type: news

Tandem Diabetes touts pivotal study of insulin pump with low glucose suspend feature
Tandem Diabetes Care (NSDQ:TNDM) touted data today from a pivotal study of its t:slim X2 insulin pump, which features a predictive low glucose suspend feature called Basal-IQ. The study showed that the system reduced time spent in hypoglycemia by 31% compared to just sensor-augmented pump therapy, according to Tandem. Get the full story at our sister site, Drug Delivery Business News. The post Tandem Diabetes touts pivotal study of insulin pump with low glucose suspend feature appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Pharmaceuticals Wall Street Beat tandemdiabetes Source Type: news

Icon reports more expectation-beating results
Medtech, pharma and biotech development outsourcer Icon continues to beat the Street when it comes to its results. Dublin, Ireland–based Icon (Nasdaq:ICLR) said today that it earned $78.5 million, or $1.43 per share, off $455.1 million in sales for the fourth quarter ended Dec. 31, 2017 – up from $74.3 million, or $1.33 per share, in profits off $435.1 million in revenue for the same quarter a year before. Analysts on average had expected fourth-quarter profits of $1.42 per share off $454.6 million in revenue, according to Yahoo Finance. Get the full story on our sister site Medical Design & Outsourcin...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News News Well Outsourcing Wall Street Beat ICON plc Source Type: news

Acelity to layoff 68 San Antonio employees
Wound care company Acelity is set to lay off 68 employees in San Antonio, Texas, according to a report from the San Antonio Express-News. The employees are slated to be released from their positions on May 8, according to a Workforce Adjustment and Retraining Notification Act notice from the Texas Workforce Commission posted this week. “While decisions that affect our valued employees are extremely difficult, health care is rapidly changing and we are taking steps to evolve and grow Acelity to meet both the demands of the marketplace and our customers. We have made some changes to our IT organization that will give u...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wound Care Acelity Source Type: news

Medtronic looks to expand MiniMed 670G into pediatric diabetes
Medtronic (NYSE:MDT) touted data today from an at-home pediatric study of its MiniMed 670G hybrid closed-loop diabetes management system. The company’s study included 105 kids, ages 7 to 13, and found that patients spent more time in the target blood glucose range, had less glycemic variability and experienced less hypo- and hyperglycemia compared to baseline data. Data from the pediatric study was included as part of an application to the FDA, as Medtronic looks to expand MiniMed’s indication to include children between the ages of 7 and 13. Get the full story at our sister site, Drug Delivery Business Ne...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Diabetes Drug-Device Combinations Pediatrics Pharmaceuticals Regulatory/Compliance Wall Street Beat Medtronic Source Type: news

Acorda posts Q4 revenue beat, but misses EPS estimates
Shares in Acorda Therapeutics (NSDQ:ACOR) fell today after the biotech company met sales expectations on Wall Street with its fourth-quarter results, but missed EPS estimates. The Ardsley, N.Y.-based company posted a net loss of -$171 million on sales of $188.4 million for the 3 months ended Dec.31, for sales growth of 34% compared with the same period last year. In explaining the company’s quarterly loss, Acorda cited a $234 million charge associated with the termination of one of its Parkinson’s therapy programs and a $24 million charge linked with a clinical trial that failed to meet key endpo...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations MassDevice Earnings Roundup Pharmaceuticals Wall Street Beat Acorda Therapeutics Source Type: news

BD closes $100m biopsy assets divestiture to Merit Medical
Becton Dickinson (NYSE:BDX) said today it closed the divestiture of its soft tissue core needle biopsy line and Aspira product line to Merit Medical (NSDQ:MMSI) for $100 million. Assets in the sale include the Achieve programmable automatic biopsy system, Temno biopsy system, Tru-Cut biopsy needles and the Aspira pleural effusion drainage kits and peritoneal drainage systems, Merit Medical said. South Jordan, Utah-based Merit Medical said the newly acquired products will be sold by both its direct sales force and distribution partners. The company added that it expects the acquisition to be accretive to both...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions bectondickinson Merit Medical Systems Inc. Source Type: news

Exactech closes $737m go-private sale to TPG Capital
Exactech (NSDQ:EXAC) late yesterday announced the closing of its $737 million go-private sale to TPG Capital, with TPG acquiring all issued and outstanding stock of the company. TPG paid approximately $49.25 per share for each share of the Gainesville, Fla.-based company, up from an initial $42 per share offer it made to the company in October. The deal includes provisions that would see founders Dr. Bill Petty, Betty Petty and CEO David Petty exchange their collective 18.8% stake for shares in the private version of Exactech at the same $49.25 rate, the company said. Exactech’s founders, CEO and ...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Wall Street Beat Exactech Inc. Source Type: news

Edwards Lifesciences wins CE Mark for Centera TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its self-expanding transcatheter Centera aortic heart valve, with indications for treating symptomatic aortic stenosis patients at high risk of open-heart surgery. The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which the valve is pre-attached to the mechanism for quick preparation, the Irvine, Calif.-based company said. “With the Edwards Centera valve, European clinicians and their patients may now benefit from a self-ex...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news

After 20 years, Paratek ’s broad-spectrum antibiotic is headed to the FDA
More than two decades after it was first synthesized in a lab, omadacycline is finally being reviewed by the FDA for its potential as a broad-spectrum antibiotic. It’s a long-awaited milestone for Dr. Evan Loh, who serves as president, COO and CMO of Paratek Pharmaceuticals (NSDQ:PRTK), the company developing and commercializing omadacycline. It’s also emblematic of why so many pharmaceutical companies have pivoted away from the antibiotic space. “Most antibiotics do not become profitable until the third year after their launch,” Loh told Drug Delivery Business News. “From a big...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Hospital Care Pharmaceuticals Wall Street Beat Biogen paratekpharmaceuticals Source Type: news

DreaMed Diabetes wins CE Mark for insulin therapy management platform
DreaMed Diabetes has won CE Mark clearance for its Advisor Pro decision-support platform, designed to help healthcare professionals manage insulin therapy for their Type I diabetes patients. The company’s cloud-based platform provides personalized insulin treatment plans by combining data from insulin pumps and continuous glucose monitors. Using machine learning techniques, the system analyzes all of the data it collects from connected devices to come up with an optimized insulin dosing treatment plan. Get the full story at our sister site, Drug Delivery Business News. The post DreaMed Diabetes wins CE Mark for ...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Pharmaceuticals Regulatory/Compliance DreaMed Diabetes Glooko Source Type: news

LivaNova to buy TandemLife in deal worth up to $250m
LivaNova (NSDQ:LIVN) said today it inked a deal to acquire cardiopulmonary temporary support sollutions dev TandemLife in a deal worth up to $250 million. LivaNova said it will pay up to $250 million for TandemLife, with a total of $200 million in upfront costs and up to $50 million in contingent considerations based on regulatory milestones. London-based LivaNova said the buy is expected to be moderately accretive this year, with an expected closure date in the first half of this year. “The TandemLife systems allow hospitals to offer a comprehensive platform, which controls costs without sacrificing qualit...
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Mergers & Acquisitions LivaNova Source Type: news

Motus GI downsizes IPO to $18m
Motus GI today priced its upcoming initial public offering, dropping the range from a midpoint of $26 million to a total of $18 million. In the offering, the Fort Lauderdale, Fla.-based company said it will offer 3.5 million shares of common stock at $5 per share, with its shares slated to begin trading on Nasdaq today under the ticker symbol “MOTS”. Motus GI originally hoped to raise $28.8 million in the IPO when it announced it in early January. When the company set its terms for the offering, it had a midpoint of nearly $26 million. The company developed and produces the Pure-Vu cleaning system which is...
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Initial Public Offering (IPO) MOTUS GI Source Type: news

Stryker nears closure of Vexim takeover, passes 95% ownership
Stryker (NYSE:SYK) said today it has acquired approximately 95.5% of the share capital of French spinal implant maker Vexim, and that it plans to acquire the remaining shares soon. The Kalamazoo, Mich.-based company said that it has since crossed the 95% threshold and that it intends to file a proposed public buy-out offer and a squeeze-out for the remaining shares in accordance with French tender offer laws and regulations. Stryker is looking to pick up the remaining shares at approximately $24.88 (EU €20) per share through its buy-out offer, and said that both the buy-out offer and squeeze-out ar...
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Spinal Stryker Source Type: news

Pieris Pharmaceuticals prices $44m public offering
Pieris Pharmaceuticals (NSDQ:PIRS) today priced an underwritten public offering of 5.5 million shares of its common stock at $8.00 per share. The company said it expects to generate $44 million from the offering, which it will use to fund the pre-clinical and clinical development of its pipeline. Get the full story at our sister site, Drug Delivery Business News. The post Pieris Pharmaceuticals prices $44m public offering appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Funding Roundup Pharmaceuticals Wall Street Beat pierispharmaceuticals Source Type: news

HeartFlow closes $240m Series E
HeartFlow said today it closed a $240 million Series E round of financing, with funds slated to support commercial expansion and studies of its HeartFlow FFRct analysis system. Redwood City, Calif.-based HeartFlow’s FFRct technology works by taking the data from a standard CT scan and applying algorithms that result in a color-coded 3D “map” detailing the changes in flow across coronary lesions. Financing in the round included investments from Wellington Management, Baillie Gifford & Company and existing investors, the company said. “We are delighted to be investing in HeartFlow on beh...
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Funding Roundup HeartFlow Source Type: news

Sanofi touts real-world data for Toujeo insulin glargine injection
Sanofi (NYSE:SNY) touted data today from its 10,000-patient Lightning study, which evaluated electronic medical records of adults with Type II diabetes to study its long-acting insulin glargine injection, Toujeo. The company found that Toujeo significantly lowered patients’ risk of experiencing severe low blood sugar compared to other long-acting insulin, like its own Lantus product. Get the full story at our sister site, Drug Delivery Business News. The post Sanofi touts real-world data for Toujeo insulin glargine injection appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Pharmaceuticals Wall Street Beat Sanofi-Aventis Source Type: news

Avinger prices $18m Series B
Avinger (NSDQ:AVGR) today priced an offering of Series B convertible preferred stock looking to raise a total of $18 million. In conjunction with the offering’s closing, the Redwood City, Calif.-based company said that lenders under its term loan agreement have agreed to convert $38 million of debt into the company’s Series A convertible preferred stock. Series B preferred stock issued in the offering is convertible into common stock at a price of $2 per share, and each share of Series B preferred stock will be accompanied by a Series 1 warrant to purchase 500 additional shares at an exercise price of...
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Avinger Source Type: news

Cardiovascular Systems launches Diamondback 360 EL in the US, touts 1st patients treated
Cardiovascular Systems (NSDQ:CSII) said today it launched its FDA-cleared extended length Diamondback 360 peripheral orbital atherectomy device in the US and that the first commercial patients have been treated with the device. The first procedures were performed at the Detroit Medical Center Heart Hospital by Dr. Mahir Elder and at the Arkansas Heart Hospital by Dr. Ian Cawich and Dr. Vasili Lendel, the St. Paul, Minn.-based company said. “From a physician’s perspective, radial access is a viable alternative that allows us to minimize bleeding and avoid commonly diseased femoral arteries. Additionall...
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Vascular Cardiovascular Systems Inc. Source Type: news

Nektar lands record $3.6B deal with Bristol-Myers Squibb for cancer immunotherapy
Bristol-Myers Squibb (NYSE:BMY) could fork over as much as $3.63 billion for the rights to Nektar Therapeutics‘ (NSDQ:NKTR) cancer immunotherapy drug, according to a deal announced today by the two companies. Nektar’s NKTR-214, which is still in development, is designed to boost the number of cancer-killing T-cells around the tumor’s micro-environment. Bristol-Myers Squibb plans to pair the investigational therapy with its own cancer drug, Opdivo, across more than 20 indications in nine tumor types. Get the full story at our sister site, Drug Delivery Business News. The post Nektar lands record ...
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Oncology Pharmaceuticals Research & Development Wall Street Beat Bristol-Myers Squibb Co. nektartherapeutics Source Type: news

Mazor Robotics shares down despite Street-beating Q4, FY2017 earnings
Shares in Mazor Robotics (NSDQ:MZOR) have fallen slightly today despite the surgical robotics platform maker topping expectations on Wall Street with its fourth quarter and full fiscal year 2017 earnings. The Israel-based company posted profits of $437,000, or 1¢ per share, on sales of $19.1 million for the three months ended December 31, seeing a 110.2% swing from the red on the bottom-line while sales grew 36.4% when compared to the same period last year. Adjusted to exclude one-time items, earnings per share were 3¢, well ahead of the negative 15¢ per share consensus on Wall Street, where analysts we...
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat mazorrobotics Source Type: news

This smartphone case monitors blood glucose on the go
[Image from David Baillot/UC San Diego Jacobs School of Engineering]University of California San Diego engineers have created a smartphone case that, when paired with an app, can make it easier for people with diabetes to track and record blood glucose levels on the go. “Integrating blood glucose sensing into a smartphone would eliminate the need for patients to carry a separate device,” Patrick Mercier, professor of electrical and computer engineering at UC San Diego, said in a press release. “An added benefit is the ability to autonomously store, process and send blood glucose readings from the phone to...
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Diabetes Diagnostics mHealth (Mobile Health) blood glucose monitoring MedTech University of California at San Diego Source Type: news

Tandem closes $69m underwritten public offering
Tandem Diabetes Care (NSDQ:TNDM) has closed its previously-announced underwritten public offering of 30 million shares of common stock at $2.00 apiece. The San Diego, Calif.-based company reeled in $69 million from the offering, after underwriters exercised an option to buy 4.5 million additional shares of Tandem’s common stock. Get the full story at our sister site, Drug Delivery Business News. The post Tandem closes $69m underwritten public offering appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Funding Roundup Pharmaceuticals Wall Street Beat tandemdiabetes Source Type: news

Abiomed wins expanded Impella FDA nod for elective, urgent high-risk PCI
Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval for its Impella 2.5 and Impella CP heart pumps, now cleared for use during elective and urgent high risk percutaneous coronary intervention procedures. With the expansion, the Impella heart pump is cleared for use with patients with severe coronary artery disease, complex anatomy and a number of co-morbidities with or without depressed ejection fractions, the Danvers, Mass.-based company said. “This expanded FDA approval with moderately reduced ejection fraction validates our real-world experience using hemodynamic support in patients turned d...
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Catheters Food & Drug Administration (FDA) Regulatory/Compliance Abiomed Source Type: news

Titan Medical touts hitting all milestones in 2017 financial results
Titan Medical (TSX:TMD) Titan Medical late yesterday released its full year 2017 financial results, touting that it met all its milestones during the year and that its Sport system was used in the first single-port procedures. The Toronto-based company reported research and development expenses of $12.9 million for the year, down from $22.6 million the company spent the previous year, with reported losses of approximately $33.6 million for the year, up from $23.3 million it reported in 2016. “I joined Titan Medical in January 2017 and based on our achievements this past year, I am more confident than ever in our...
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics Surgical titanmedical Source Type: news

GSK seeks expanded label for Trelegy Ellipta inhaler in EU
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data to the European Medicines Agency in the hopes of expanding the label for its once-daily, triple combination inhaler, Trelegy Ellipta. The drug-device combo was approved in Europe in November last year as a maintenance treatment for adult patients with moderate to severe chronic obstructive pulmonary disease who are not adequately treated by a inhaled corticosteroid combined with a long-acting beta-adrenergic agonist. GSK and Innoviva hope that data from its Impact trial will support the product’s use in a broader populati...
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Pharmaceuticals Respiratory Wall Street Beat GlaxoSmithKline plc Innoviva Source Type: news

TransEnterix files expanded 510(k) application for Senhance robotic platform
TransEnterix (NYSE:TRXC) said today it filed an FDA 510(k) submission looking to expand the indications for its Senhance robotic surgical platform to include laparoscopic inguinal hernia and laparoscopic cholecystectomy surgeries. The Research Triangle Park, N.C.-based company said that with the additional indications, its Senhance system would be cleared for use in the most common abdominal surgeries in the US in general surgery, gynecology and colorectal surgery. TransEnterix said it is hopeful to receive approval for the expanded indications by the mid-year. “We have performed more than 150 Senhance surg...
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Robotics Surgical TransEnterix Source Type: news

Glooko wins FDA nod for mobile insulin dosing system
The FDA has approved Glooko‘s mobile insulin dosing system, which is designed to titrate long-acting insulin for people with Type II diabetes. The company’s system accesses blood glucose data directly from the user’s glucose meter so that the user doesn’t have to manually enter their fasting glucose values. Then, it analyzes those levels to recommend insulin dose adjustments based on a healthcare provider’s treatment plan and published clinical guidelines. Get the full story at our sister site, Drug Delivery Business News. The post Glooko wins FDA nod for mobile insulin dosing system appe...
Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Glooko Source Type: news

Exactech shareholders approve $733m go-private sale to TPG Capital
Exactech (NSDQ:EXAC) said today its shareholders voted to approve its $733 million go-private sale to TPG Capital. TPG will pay approximately $49.25 per share for each share of the Gainesville, Fla.-based company, up from an initial $42 per share offer it made to the company in October. A total of 94.5% of shareholders voted in favor of the merger, representing approximately 73.7% of outstanding common shares, according to a press release from the company. The deal includes provisions that would see founders Dr. Bill Petty, Betty Petty and CEO David Petty exchange their collective 18.8% stake for shares in the pr...
Source: Mass Device - February 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Exactech Inc. Source Type: news

MD & M West: 10 technologies you should know
MD&M West is one of the largest medical device manufacturing events in the world, so it’s easy to get lost on the show floor. Even if you were in Anaheim, Calif., for the event last week, you may have missed a lot. From a new robotics insights display from Rethink Robotics to a disinfectant-resistant plastic from Eastman to Guill’s extrusion tool with single-point concentricity adjustment, here are 10 things you may have missed at MD&M West. Next>> Senior editor Heather Thompson contributed with the final two slideshow items. The post MD&M West: 10 technologies you should know appeared first o...
Source: Mass Device - February 13, 2018 Category: Medical Devices Authors: Chris Newmarker Tags: Contract Manufacturing eastman flexcon guilltool junkosha kiniticsautomation MasterControl Maxon Motor MD&M West microcare rethinkrobotics teconnectivity Source Type: news

RenovaCare strikes back at shortseller Streetsweeper
RenovaCare late yesterday issued a response to shortseller Streetsweeper after the group released a scathing review of the company that was skeptical of it’s ability to hold its market valuation. The Gainesville, Fla.-based company strongly rejected the firm’s assessment, saying that Streetsweeper is known for spreading “short and distort” commentaries on companies it targets for short selling. “We will not be distracted by the irresponsible and nefarious actions of these short sellers and a handful of internet posters. We have an obligation to expose those who prey on our shareholders fo...
Source: Mass Device - February 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wound Care RenovaCare Source Type: news

Report: Amazon gearing up for entry into medical supplies biz
Amazon (NSDQ:AMZN) is looking to up the ante in its medical supplies business and turn the unit into a major supplier to US hospitals and clinics, according to a Wall Street Journal report. The online mega retailer has initiated a trial of a new system testing to see if it can use its Amazon Business site to supply healthcare products to a large midwestern hospital and its approximately 150 outpatient facilities, according to the report. The system is customized to the hospital’s catalog of supplies and allows employees to compare prices on the Amazon Business marketplace to those it negotiates with through dist...
Source: Mass Device - February 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Distribution Hospital Care Amazon Source Type: news

Acessa Health touts Medicaid win
Acessa Health said today that 32 state Medicaid programs now provide access to the company’s Acessa procedure designed to treat uterine fibroids using radiofrequency ablation. The Acessa procedure, utilizing the Acessa system, is designed as a uterine sparing alternative to hysterectomy. The procedure can treat most sizes and locations of fibroids, including those in the uterine walls, and requires no suturing or cutting of the uterine tissue, the company said. The decision from the state-run Medicaid programs adds an additional 20 million women who are eligible to receive treatment with the Acessa system, bring...
Source: Mass Device - February 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Women's Health acessahealth Source Type: news

Sandoz wins FDA nod for generic, injectable MS drug
Sandoz said today that the FDA has approved its Glatopa glatiramer acetate injection as a generic version of Copaxone to treat relapsing forms of multiple sclerosis. The therapy, which is given three days per week, is administered using the Glatopaject injection device. Get the full story at our sister site, Drug Delivery Business News. The post Sandoz wins FDA nod for generic, injectable MS drug appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 13, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Novartis sandoz Source Type: news

Orthofix launches RCStim rotator cuff repair trial
Orthofix (NSDQ:OFIX) said today it launched a study looking to evaluate the use of pulsed electromagnetic field technology with the company’s RCStim device as adjunctive treatment to the surgical repair of rotator cuff tears. The 538-patient study, which has begun enrollment, will evaluate the safety and effectiveness of PEMF technology designed to promote bone growth and whether it can reduce the rate of repaired tendons being subsequently torn, as well as overall improvement in patient outcomes. “Arthroscopic repair of rotator cuff tears can improve pain and functional use of the shoulder but a continuin...
Source: Mass Device - February 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Orthopedics Orthofix Source Type: news