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RxSight wins FDA nod for light-adjustable IOL
The FDA has cleared RxSight‘s implantable light adjustable intraocular lens and light delivery device. The company’s RxSight IOL is designed from a UV light reactive material meant to be treated by a specific Light Delivery Device, intended for use 17 to 21 days post-procedure. The lens is designed to be treated by 3-4 light treatments over 1 to 2 weeks in 40 to 150 second treatment periods, during which the patient must wear UV-protective glasses. “Until now, refractive errors that are common following cataract surgery could only be corrected with glasses, contact lenses or refractive surgery. This syste...
Source: Mass Device - November 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Optical/Ophthalmic Regulatory/Compliance rxsight Source Type: news

Chinese Xiaoyi AI-platform passes national medical licensing tests
A Chinese robotic and artificial intelligence platform has passed the country’s national medical licensing examination, according to a report from Futurism. The Xiaoyi robotic platform, developed by AI-company iFlytek, was originally designed to capture and analyze patient information. But the system was also able to pass the licensing test with a score of 456, 96 points higher than required, according to the report. Read the whole story on our sister site, The Robot Report The post Chinese Xiaoyi AI-platform passes national medical licensing tests appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Research & Development Robotics iflytek Source Type: news

NxStage shares dip on Q3 EPS miss
Shares in NxStage Medical (NSDQ:NXTM) have fallen slightly today after the medical device maker missed expectations on Wall Street with its third quarter earnings results. The Lawrence, Mass.-based company posted losses of $8.9 million, or 14¢ per share, on sales of $97.3 million for the 3 months ended September 30, seeing losses grow nearly 900% while sales grew a smaller 5.8% compared with the same period during the previous fiscal year, according to an SEC filing. Losses per share were well ahead of Wall Street analysts’ consensus, who expected to see the company break even. The company did not issue a r...
Source: Mass Device - November 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup NxStage Medical Inc. Source Type: news

Medicrea wins FDA nod for IB3D interbody devices
Medicrea (EPA:ALMED) said today it won FDA clearance for its IB3D portfolio of 3D-printed titanium interbody devices featuring its AdapTEK technology. The company’s AdapTEK technology is intended to allow surgeons to create interbody devices customized to individual specifications through in-house additive manufacturing techniques. Customization features include different ranges of footprints, lordotic angles, heights, lateral windows and endplate surface structure, Medicrea said. “With the FDA clearance of our 3D-printed Titanium interbodies, we are able to approach a large segment of the spine market, wh...
Source: Mass Device - November 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Spinal Medicrea Source Type: news

FDA wants to improve access to generic abuse-deterrent opioids: here ’s how
The FDA commissioner, Dr. Scott Gottlieb, has made the opioid crisis a priority in his time at the agency. Yesterday, the regulatory body issued guidance to help promote the development of generic opioids designed to prevent abuse. To date, the FDA has approved 10 of these products, called abuse-deterrent opioids. But, as Gottlieb noted in a statement, uptake by physicians has been slow. Get the full story at our sister site, Drug Delivery Business News. The post FDA wants to improve access to generic abuse-deterrent opioids: here’s how appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 22, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Pain Management Pharmaceuticals Regulatory/Compliance Wall Street Beat Endo Pharmaceuticals Source Type: news

CHF Solutions prices $18m offering
CHF Solutions (NSDQ:CHFS) said today that it prices an offering of Series F stock and warrants worth $18.0 million. Eden Prairie, Minn.-based CHF Solutions, formerly known as Sunshine Heart, said the Series F shares are convertible to common stock at $4.50 per share. The Series F shares also carry a one-year Series 1 warrant for 223 shares at $4.50 apiece and a seven-year Series 2 warrant for 223 shares also at $4.50 per share, the company said. The offering, which is slated to close Nov. 27, follows last month’s 1-for-20 reverse split that reduced the number of outstanding shares from approximate...
Source: Mass Device - November 22, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Wall Street Beat CHF Solutions Inc. Source Type: news

Facing pressure in diabetes, Novo Nordisk plans next big push – obesity
The world’s largest diabetes drug-maker, Novo Nordisk (NYSE:NVO), is reportedly looking to boost its efforts to treat obesity as the company’s well-established diabetes drugs face competition. At Novo Nordisk’s capital markets day yesterday, CEO Lars Fruergaard Jorgensen told investors that the company wants to rival surgery with their drugs as a solution for obesity. The drug-maker’s first target – semaglutide. Get the full story at our sister site, Drug Delivery Business News. The post Facing pressure in diabetes, Novo Nordisk plans next big push – obesity appeared first on M...
Source: Mass Device - November 22, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Diabetes Pharmaceuticals Wall Street Beat Novo Nordisk Source Type: news

Europe ’ s medtech alliance seeks prompt action on new med device rules
European medtech industry group MedTech Europe today said it is seeking “swift action” from national and European Union authorities after the implementation of new regulations, saying that additional resources need to be invested to make sure the regulations are successful. The medtech group published three separate position papers on the matter, calling attention to new in vitro medical device regulation and medical device regulations and what steps it believes need to be taken to make the regulations successful. In its first paper, the group suggests that additional resources will be needed to help implement ...
Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance MedTech Europe Source Type: news

Using digital pills, researchers find patients consume fewer opioids than expected
Clinicians at Brigham and Women’s Hospital published a paper in the December issue of Anesthesia & Analgesia showing that digital pills successfully monitored patients taking opioids following an injury. To track the participants’ opioid use, researchers used etectRx‘s ID-Cap system, which includes a capsule embedded with an ingestible sensor. Get the full story at our sister site, Drug Delivery Business News. The post Using digital pills, researchers find patients consume fewer opioids than expected appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Hospital Care Pain Management Pharmaceuticals Research & Development Brigham & Women's Hospital etectrx Source Type: news

Restasis buyers level antitrust lawsuit against Allergan
A proposed class of Restasis buyers filed an antitrust suit last week in a Texas federal court against Allergan (NYSE:AGN), according to reports from Law360. The suit accuses Allergan of blocking generics to its dry-eye drug using tactics like sham infringement suits and a controversial deal with a Native American tribe. Get the full story at our sister site, Drug Delivery Business News. The post Restasis buyers level antitrust lawsuit against Allergan appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Legal News Optical/Ophthalmic Patent Infringement Pharmaceuticals Wall Street Beat Allergan Source Type: news

Regenerative vessel stent dev Cardiovate raises $1m
Early stage medical device developer Cardiovate has closed a $1 million seed round to help support research and development for a scaffold the company claims can help regenerate vascular tissue, according to an Xconomy report. The Texas-based company, formed in 2012 by a student and two University of Texas in San Antonio, is developing the NeoVessel, designed to replace portion of clogged blood vessels and encourage new tissue regeneration, according to the report. Cardiovate hopes its product will replace other treatments, including synthetic stents and grafts, and claims that its graft also dissolves after encouraging ti...
Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Stent Grafts cardiovate Source Type: news

Fresenius Kabi to invest $100m in North Carolina manufacturing site
Fresenius (NYSE:FMS) business group Fresenius Kabi said today that it plans to invest more than $100 million over the next five years in a Wilson, N.C.-based manufacturing site. The company’s expansion project is designed to boost the facility’s capacity to produce generic medicines in pre-filled syringes, Fresenius reported. Get the full story at our sister site, Drug Delivery Business News. The post Fresenius Kabi to invest $100m in North Carolina manufacturing site appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Fresenius Source Type: news

Titan Medical increases offering to $18m
Titan Medical (TSX:TMD) said today it has increased the size of its previously announced offering to between $14.1 million (CDN $18 million) and $18 million (CDN $23 million), up from between $10.2 million (CDN $13 million) and $11.7 million (CDN $15 million). The Toronto-based company said it is looking to offer units at approximately 39¢ (CDN 50¢) each. Each unit in the offering is comprised of one common share of the company and the purchase warrant for an additional common share, exercisable at 47¢ (CDN 60¢) per share for a period of five years following the offering. Read the whole story at ou...
Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics titan medical Source Type: news

Dexcom, Lilly ink deal to combine CGM into smart insulin delivery device
Dexcom (NSDQ:DXCM) said today that it inked a development deal with Eli Lilly (NYSE:LLY) to include its continuous glucose monitor in the insulin-maker’s connected delivery devices. The pair plans to start clinical trials by the end of this year, adding that they hope to position the combination of their technologies as a comprehensive solution for people with diabetes. Get the full story at our sister site, Drug Delivery Business News. The post Dexcom, Lilly ink deal to combine CGM into smart insulin delivery device appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Patient Monitoring Pharmaceuticals Wall Street Beat Dexcom Eli Lilly & Co. Source Type: news

FDA clears remote adjustments for Cochlear ’ s Nucleus implants
The FDA last week approved remote programming adjustments for Cochlear Ltd.‘s (ASX:COH) Nucleus cochlear implant, removing the need for a select group of users  to make repeat visits for in-person programming sessions. The newly-cleared remote programming feature is indicated for patients with 6 months of experience with their cochlear implant sound processors and who are comfortable with the programming process, according to an FDA release. Normally, such implants would require regular programming visits with an audiologist in which electronic settings that control how the implant stimulates nerves in the ear a...
Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Otolaryngology Ear, Nose & Throat Regulatory/Compliance Cochlear Ltd. Source Type: news

Globus sues Stryker, ex-engineer for trade secret theft
Globus Medical (NYSE:GMED) yesterday sued Stryker (NYSE:SYK) and a former Globus engineer, alleging that she took proprietary trade secrets with her when she took a new job at Stryker earlier this month. The lawsuit, filed in the U.S. District Court for New Jersey, alleges that Madeline Davis broke her non-compete and non-disclosure pacts with Globus when she took the job Nov. 1 at Stryker. Hire in 2015 as an associate project engineer and promoted to project engineer in January, Davis worked on the Forge corticocancellous spacer for cervical fusion, according to the complaint. The NCND agreements bar Davis ...
Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Legal News Orthopedics Globus Medical Stryker Source Type: news

Varian Medical opens new Brazilian manufacturing, training facilities
Varian Medical (NYSE:VAR) said today it opened a new regional facility in Jundiai, Brazil. The newly opened 50,600-square foot facilities include manufacturing and warehousing areas, a demonstration room and two training rooms featuring the Palo Alto, Calif.-based company’s Varian Trilogy linear accelerator platform. “We are excited that this facility is now open and demonstrates our long-standing commitment and partnership with the Brazilian Ministry of Health in the fight against cancer and increase the access to advanced radiotherapy treatment in the country and across Latin America. In the first y...
Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Varian Medical Systems Source Type: news

Aridis uses human antibodies to fight against “time bomb” of antibiotic resistance
Although antibodies have gained plenty of ground in recent years as vehicles for cancer therapies, Aridis Pharmaceuticals wants to use them as nature intended – to fight infection. “These are human monoclonal antibodies being investigated as anti-infectives to treat bacterial infections associated with pneumonia,” founder & CEO Vu Truong told Drug Delivery Business News, referring to the company’s projects that are in pivotal trials. “The fundamental reason is that this is exactly what the antibody is designed to do – that is, to fight infection,” he explained. G...
Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Hospital Care Pharmaceuticals Research & Development aridispharmaceuticals Source Type: news

UPDATE: Medtronic ’ s fiscal Q2 tops The Street
UPDATED November 21, 2017, with segment results, share prices Medtronic (NYSE:MDT) posted fiscal second-quarter numbers that beat both sales and earnings forecasts on Wall Street, after a better-than-expected recovery from Hurricane Maria. The Fridley, Minn.-based medical device giant reported profits of $2.02 billion, or $1.48 per share, on sales of $7.05 billion for the three months ended Oct. 27, for a bottom-line gain of 80.9% on a -4.0% sales decline compared with the same period last year. Adjusted to exclude one-time items, earnings per share were $1.06, 8¢ ahead of The Street, where analysts were looking for s...
Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat Medtronic Source Type: news

Medtronic ’ s fiscal Q2 tops The Street
Medtronic (NYSE:MDT) posted fiscal second-quarter numbers that beat both sales and earnings forecasts on Wall Street, after a better-than-expected recovery from Hurricane Maria. The Fridley, Minn.-based medical device giant reported profits of $2.02 billion, or $1.48 per share, on sales of $7.05 billion for the three months ended Oct. 27, for a bottom-line gain of 80.9% on a -4.0% sales decline compared with the same period last year. Adjusted to exclude one-time items, earnings per share were $1.06, 8¢ ahead of The Street, where analysts were looking for sales of $6.93 billion. “Our second-quarter financial res...
Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat Medtronic Source Type: news

The FAQs on encryption, FIPS 140 and medical devices
By Stewart Eisenhart, Emergo Group As cybersecurity vulnerabilities become a more urgent concern for the medical device industry, encryption requirements are emerging as a key tool to address medical device cybersecurity concerns. In the US, compliance with the FIPS 140-2 standard can help manufacturers of network-connected devices and software demonstrate encryption capabilities able to protect patient and user data. 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...
Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

GE Healthcare inks licensing deal with Israel-based DiA Imaging Analysis
GE Healthcare (NYSE:GE) has inked a multi-year, non-exclusive licensing and professional services deal with medical imaging analysis company DiA Imaging Analysis, according to a press release from the company. Through the deal, Israel-based DiA said it intends to develop its automated imaging analysis tech to work with GE’s ultrasound devices. “We are pleased to partner with DiA Imaging Analysis. GE Healthcare has a long history of bringing innovative solutions to our customers around the world. These tools would bring new capabilities to ultrasound at the point of care,” GE healthcare primary & ...
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging diaimaginganalysis GE Healthcare Source Type: news

NeuX, GoX Studio ink development deal for smart chronic pain stim
West Palm Beach, Fla.-based medtech firm NeuX Technologies said it inked a strategic alliance deal with GoX Studio looking to combine their technology platforms to improve treatments for chronic pain and musculoskeletal injuries. Through the deal, NeuX said it plans to combine its Interactive Neuromuscular Stimulation tech platform with GoX’s SmarWork platform to deliver improved diagnosing, treatment, measurement, monitoring and prevention for chronic pain and injuries, according to a press release. “Solutions for treating chronic pain and injuries often fail because they treat the symptoms. NeuX’s Inter...
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Pain Management goxstudio neuxtechnologies Source Type: news

Myomo readies $17m offering
Myomo said late last week it is looking to raise approximately $17.4 million in a new offering of shares and warrants to support its myoelectric braces and orthotics designed for individuals with neuromuscular disorders. In the offering the company plans to float approximately 1.5 million shares of common stock and warrants to purchase an additional 750,000 shares at an assumed combined offering price of $6.25 per share and 0.5 warrants. Read the whole story on our sister site, The Robot Report The post Myomo readies $17m offering appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Myomo Inc Source Type: news

Advanced Bionics wins FDA nod for HiFocus Slimj cochlear implant electrode
Advanced Bionics said late last week it won FDA approval for its HiFocus SlimJ electrode designed for use with the company’s HiRes Ultra cochlear implant. The Valencia, Calif.-based company touts the new electrode as featuring a thin, straight design for easier insertion during procedures and a slim profile to protect the delicate structures of the cochlea during insertion. “The HiFocus SlimJ electrode addresses the surgeon need for an alternate type of electrode whilst still offering full spectrum coverage and maintaining the performance potential of the individual. And surgeons have commented that it is easy ...
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Otolaryngology Ear, Nose & Throat Regulatory/Compliance Advanced Bionics LLC Source Type: news

TransEnterix opens the doors to a competitive US surgical robotics market
The surgical robotics market in the US has finally become competitive. In October, the FDA granted clearance to only the second robotic surgical system to date – TransEnterix‘s (NYSE:TRXC) Senhance laparoscopic platform. The clearance was a huge milestone for the Morrisville, N.C.-based company and was quickly followed by yet another – almost exactly a month after receiving a nod from the federal watchdog, TransEnterix logged its 1st sale of the platform to the Orlando-based Florida hospital. Read the whole story on our sister site, The Robot Report The post TransEnterix opens the doors to a competit...
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics TransEnterix Source Type: news

Milestone Scientific plans launch for Botox injection device
Milestone Scientific (NYSE:MLSS) said today that it plans to launch a cosmetic injection instrument designed to deliver botulinum toxin. The company’s new drug delivery instrument is slated to include an integrated electronic record-keeping feature, as well as improved needle placement compared to its dental injection device. Get the full story at our sister site, Drug Delivery Business News. The post Milestone Scientific plans launch for Botox injection device appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Wall Street Beat milestonescientific Source Type: news

Cambridge Consultants prototypes miniaturized robot for cataract surgery
Cambridge Consultants showed off its prototype of a miniaturized robot designed for cataract surgery last week at its annual Innovation Day event. The system, Axsis, is one of the smallest known robots for surgical use, according to the firm, featuring instruments of just 1.8mm in diameter. Get the full story at our sister site, The Robot Report. The post Cambridge Consultants prototypes miniaturized robot for cataract surgery appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Optical/Ophthalmic Robotics Surgical Cambridge Consultants Source Type: news

Report: India eyes penalties for Johnson & Johnson over metal-on-metal hips
Johnson & Johnson (NYSE:JNJ) could reportedly be on the hook again for the metal-on-metal hip implants it pulled from the market in 2010, this time in India and for much less than it’s cost the company elsewhere. The world’s second-largest medical device maker has fielded numerous lawsuits about its ASR metal-on-metal hip replacement since it pulled the ASR XL Acetabular and ASR Hip Resurfacing systems from the market in August 2010, “due to the number of patients who required a second hip replacement procedure, called a revision surgery.” Three years later Johnson ...
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Legal News Metal-on-Metal johnsonandjohnson Source Type: news

Fresenius gets in on $3m Modulated Imaging Series A
Medtech imaging developer Modulated Imaging said today it closed a $2.9 million Series A financing round that was joined by dialysis giant Fresenius Medical Care‘s (NYSE:FMS; ETR:FRE) Ventures arm. The round was led by Grey Sky Venture Partners and joined by Mitsubishi UFJ Capital, Fresenius Medical Care Ventures and Hamamatsu Photonics’ Photonics Management Corporation, the Irvine, Calif.-based company said. “Hamamatsu Photonics has invested in Modulated Imaging once again due to its innovative work with photonics to improve human health. Modulated Imaging’s technology is very much in sync with Ham...
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging Fresenius modulatedimaging Source Type: news

LivaNova to deal CRM biz to MicroPort for $190m
LivaNova (NSDQ:LIVN) said today that it inked a deal to sell its cardiac rhythm management business to China’s MicroPort Scientific (HK:00853) for $190 million in cash. The companies, which are already partners in a CRM join venture in the People’s Republic, said the sale for LivaNova’s 900-worker CRM business is slated to close during the second quarter next year. LivaNova, formed by the $2.7 billion merger of Italy’s Sorin and Cyberonics in October 2015, said in September that it was putting the CRM business on the auction block. The business pulled in sales of $249 m...
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Wall Street Beat Cardiac Rhythm Management LivaNova MicroPort Scientific Source Type: news

Medtronic wins FDA nod for Azure remote monitoring equipped pacers
Medtronic (NYSE:MDT) said today it won FDA approval for its portfolio of Azure pacemakers with BlueSync patient monitoring technology. The clearances cover both the Azure XT MRI and Azure S MRI pacers including single chamber and dual chamber models, the Fridley, Minn.-based company said. The newly cleared pacers have estimated lifespans of 13.7 years for dual chamber pacers, which Medtronic estimates is 27% longer than the earlier-gen devices. The Azure portfolio of pacers feature the company’s Reactive ATP algorithm intended to slow the progression of atrial fibrillation and BlueSynch technology which allows f...
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Source Type: news

Orexo nabs regulatory win for fast-dissolving opioid dependence therapy
Orexo (STO:ORX) said today that the European Medicines Agency granted marketing authorization for its Zubsolv rapidly-disintegrating treatment for opioid dependence. The buprenorphine and naloxone sublingual tablet is the first to be approved in Europe with six different strengths, according to the Sweden-based company. Get the full story at our sister site, Drug Delivery Business News. The post Orexo nabs regulatory win for fast-dissolving opioid dependence therapy appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Pharmaceuticals Regulatory/Compliance Wall Street Beat Orexo AB Source Type: news

FDA approves Kaleo ’ s allergy auto-injector designed for infants
The FDA has approved Kaleo‘s Auvi-Q epinephrine auto-injector designed to treat life-threatening allergic reactions in infants and small children, according to the privately-held biopharma company. The device, which Kaleo touts as the first of its kind, was given priority review by the FDA. Get the full story at our sister site, Drug Delivery Business News. The post FDA approves Kaleo’s allergy auto-injector designed for infants appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pediatrics Pharmaceuticals Regulatory/Compliance Respiratory Kaleo Inc Source Type: news

After FDA nod, Flexion launches osteoarthritis injection
Flexion Therapeutics (NSDQ:FLXN) today launched its Zilretta therapy designed to help patients manage pain associated with osteoarthritis of the knee. The Burlington, Mass.-based company’s extended-release intra-articular injection combines a commonly administered, short-acting corticosteroid with a polylactic-co-glycolic acid matrix using Flexion’s microsphere technology. Get the full story at our sister site, Drug Delivery Business News. The post After FDA nod, Flexion launches osteoarthritis injection appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Orthopedics Pain Management Pharmaceuticals Wall Street Beat Flexion Therapeutics Source Type: news

FDA releases framework guidelines for regenerative med development
The FDA this week laid out guidelines for a new framework it’s implementing for the development and oversight of regenerative medicine products including novel cellular therapies. The framework is laid out through four guidance documents which build on the FDA’s existing regulatory approach and describe more clearly which products are regulated as drugs, devices and biological products, according to a new FDA release. The documents include new science-based processes for ensuring the safety and effectiveness of such products and a risk-based framework for how it plans to enforce actions against potentially harm...
Source: Mass Device - November 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regenerative Medicine Regulatory/Compliance Source Type: news

Amgen launches Enbrel Mini single-dose cartridges with reusable auto-injector
Amgen (NSDQ:AMGN) announced today the U.S. launch of its Enbrel Mini single-dose prefilled cartridges delivered using its reusable AutoTouch auto-injector. The drug-device combination was designed with a needle that stays hidden during injection and a sensor to detect placement on the skin. Get the full story at our sister site, Drug Delivery Business News. The post Amgen launches Enbrel Mini single-dose cartridges with reusable auto-injector appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 17, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Orthopedics Pharmaceuticals Wall Street Beat Amgen Source Type: news

Belluscura plans IPO to commercialize licensed Stryker IP
Medical device group Belluscura is planning a U.K.-based IPO that could be worth up to $13.2 million after it picked up the rights to make and sell certain Stryker (NYSE:SYK) devices, according to a filing from the company. The company was created by Tekcapital in 2015 to pick up and commercialize rights to medical devices. So far, the company has acquired licenses to manufacture and sell four medical device product lines from Stryker, including the Snap II, Passport, Slyde and Wire Caddy devices, according to the filing. Earlier this week, Belluscura said it picked up the rights to manufacture and sell Styrker’...
Source: Mass Device - November 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Initial Public Offering (IPO) belluscura Source Type: news

Here ’ s what the FDA is doing about IV fluid shortages following hurricanes Maria, Irma
Nine weeks after hurricanes Maria and Irma brought devastation to Puerto Rico, FDA commissioner Dr. Scott Gottlieb says hospitals across the U.S. are reporting shortages of IV fluids – medical products that are often sourced from Puerto Rico. Hospitals are specifically noting that 0.9% injection bags of saline, used to inject drugs intravenously, are of short supply. Gottlieb said in a prepared statement that despite the agency’s best efforts, the damage to Puerto Rico’s infrastructure has “greatly exacerbated this supply issue.” Get the full story at our sister site, Drug Delivery Business Ne...
Source: Mass Device - November 17, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Wall Street Beat Baxter Source Type: news

House committee urges HHS to improve med device cybersecurity
The US House Energy and Commerce committee is looking to the Department of Health and Human Services to shore up medical device cybersecurity, according to a report from The Hill. Committee Chair Greg Walden (R-Ore.) sent a letter to the HHS asking it to require device makers to provide a listed bill of materials, including third-party software components, used in each of its products, according to the report. “Stakeholders do not know, and often have no way of knowing, exactly what software or hardware exist within the technologies on which they rely to provide vital medical care. This lack of visibility directly af...
Source: Mass Device - November 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Software / IT Cybersecurity Dept. of Health & Human Services (HHS) Source Type: news

Align Technology expands iTero distro, integration deal with Glidewell
Align Technology (NSDQ:ALGN) said today it expanded a distribution deal with Glidewell Dental to distribute Align’s iTero Element intraoral scanning system in North America. Through the deal, San Jose, Calif.-based Align’s said its iTero Element scanner will feature Glidewell’s fastdesign.io software which serves to auto-design restorations for clinician approval and to communicate with a lab’s digital design technicians as needed. “This is an exciting opportunity to join together to deliver a restorative work flow driven by digital precision and enabling the growth of digital dentistry. ...
Source: Mass Device - November 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Dental Distribution aligntechnology Source Type: news

JDRF touts win after Anthem decides to cover artificial pancreas systems
JDRF said today it successfully persuaded Anthem to cover artificial pancreas systems, after meeting the health insurer as part of is Coverage2Control campaign. America’s 25 largest health insurers now cover Medtronic‘s (NYSE:MDT) MiniMed system, according to the organization. Get the full story at our sister site, Drug Delivery Business News. The post JDRF touts win after Anthem decides to cover artificial pancreas systems appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 17, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Pharmaceuticals Wall Street Beat Anthem Inc. Juvenile Diabetes Research Foundation (JDRF) Medtronic Source Type: news

7 medtech stories we missed this week: Nov. 17, 2017
[Image from unsplash.com]From Skyline Medical’s joint venture to Lensar receiving FDA clearance and CE Mark, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Skyline Medical launches JV deal with Helomics Skyline Medical announced in a Nov. 15 press release that it has signed a joint venture agreement with Helomics. The agreement comes after a strategic collaboration between the companies that allows Skyline to reach more markets. The joint venture leverages the Helomics D-Chip platform to develop and market new approaches for personalized cancer diagnostics and care. 2.&...
Source: Mass Device - November 17, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Diagnostics Food & Drug Administration (FDA) mHealth (Mobile Health) Neurological Neuromodulation/Neurostimulation Regenerative Medicine Regulatory/Compliance Research & Development Helomics InnerScope iReliev LensAR Inc. Source Type: news

Staar Surgical plans pivotal of Visian EVO ICL presbyopia optic for Q1 2018
Staar Surgical (NSDQ:STAA) this week reported results from the feasibility clinical study of its Evo+ Visian ICL with aspheric optics designed to reduce presbyopia, and that based on the results it plans to launch a pivotal clinical study of the device during the 1st quarter next year. The Monrovia, Calif.-based company’s EVO+ Visian ICL is designed to be surgically implanted and operate with the patient’s eye to correct vision. The lens is designed to be positioned inside the eye between the iris and natural lens where it stays indefinitely. Staar Surgical said that it presented results from 24 patients i...
Source: Mass Device - November 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Optical/Ophthalmic STAAR Surgical Co Source Type: news

Neovasc raises $65m to cover damages in CardiAQ case
Neovasc (NSDQ:NVCN) said today it closed an offering of approximately $37.5 million and a private placement of approximately $27.8 million to cover the roughly $42 million balance of damages and interest in a litigation with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve. In its offering, Neovasc offered approximately 6.6 million Series A units and 19.1 million Series B units at a price of $1.46 per unit. In a separate private placement, the Vancouver-based company sold approximately $32.8 million aggregate principal amount of senior secured convertible notes and Series E warrants, bringin...
Source: Mass Device - November 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News CardiAQ Valve Technologies Edwards Lifesciences Neovasc Inc. Source Type: news

Implandata Ophthalmic touts 1st-in-human use of next-gen Eyemate IOP sensor
Implandata Ophthalmic Products today touted the first-in-human use of its next-gen Eyemate micro-sensor implant designed to monitor intraocular pressure. The Eyemate microsensor is designed for the continuous monitoring of intraocular pressure and can be checked remotely, removing the need for a patient to visit a doctor’s office for measurements, the Hannover, Germany-based company said. “This opens up the path to proceed forward towards design finalization, expanded clinical validation and regulatory approval. Eventually this will further increase the use of the Eyemate system,” CEO Max Ostermeier ...
Source: Mass Device - November 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Optical/Ophthalmic Implandata Ophthalmic Products Source Type: news

J & J ’ s DePuy Ortho faces $247m ruling in Pinnacle bellwether trial
A Dallas federal jury this week ruled that Johnson & Johnson (NYSE:JNJ) and its DePuy Orthopaedics must pay $247 million to six patients claiming to be injured by its Pinnacle metal-on-metal hip implants, according to a Reuters report. The jury ruled that the controversial metal-on-metal hip implants were defectively designed and that patients did not receive appropriate warning about the risks associated with them, according to the report. The six plaintiffs and patients in the case claim that after implantation, the devices led to injuries including tissue death, bone erosion and other negative health effects, a...
Source: Mass Device - November 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Legal News Orthopedics depuysynthes johnsonandjohnson Source Type: news

iVeena finishes pilot trial of sustained-release implant
iVeena Delivery Systems said earlier this month that it finished a pilot trial for its IVMED-10 bioerodible implant designed to treat pain and inflammation after cataract surgery. Placed during cataract surgery, the sustained-release implant delivers dexamethasone for two weeks from the lens capsule. Get the full story at our sister site, Drug Delivery Business News. The post iVeena finishes pilot trial of sustained-release implant appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 17, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Optical/Ophthalmic Pain Management Pharmaceuticals Surgical iveenadeliverysystems Source Type: news

Researchers reverse diabetes in mice by infusing them with blood stem cells
Researchers at Boston Children’s Hospital successfully reversed Type I diabetes in a mouse model using blood stem cells, according to a study published this week in Science Translational Medicine. The researchers used cells that were pre-treated to make more of a protein, PD-L1, which is deficient in mice and people with Type I diabetes. “There’s really a reshaping of the immune system when you inject these cells,” senior investigator Dr. Paolo Fiorina said in prepared remarks. Get the full story at our sister site, Drug Delivery Business News. The post Researchers reverse d...
Source: Mass Device - November 17, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Pharmaceuticals Regenerative Medicine Research & Development Stem Cells Boston Children's Hospital Source Type: news

G Medical Innovaions raises $10m to support Prizma medical smartphone case
Mobile health dev G Medical Innovations said today it raised $10.3 million (AUSD $13.5 million) to support commercialization of its Prizma medical smartphone accessory and case. The Australian company said the round was “substantially oversubscribed,” with funds raised through the sale of 31.4 million shares at 33¢ (AUSD 43¢) per share. G Medical’s Prizma medical smartphone case is designed to allow users to use their smartphone as a mobile medical monitor to measure a wide range of vital signs and record the data into a cloud-based storage solution. Data collected from the Prizma can then be sh...
Source: Mass Device - November 16, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Diagnostics mHealth (Mobile Health) gmedicalinnovations Source Type: news