5 Wearable Technologies Conference exhibitors you should know
The 34th edition of the Wearable Technologies Conferenceseries is taking place today and tomorrow in San Francisco. Co-located with Semicon West, the Wearable Technologies Conference offers a number of panels to discuss wearables in healthcare and IoT, as well as conference exhibitors and networking opportunities. Here are five companies touting their latest wearable technologies at this year’s conference. Next>> (Source: Mass Device)
Source: Mass Device - July 9, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Diagnostics mHealth (Mobile Health) Pain Management Patient Monitoring Software / IT Accumold CareWear datwyler Multek Varta Source Type: news

UL to close up notified body shop ahead of Brexit
The U.K.’s pending secession from the European Union prompted UL International to start closing up shop as a notified body for medical device approvals. British voters in June 2016 approved withdrawing from the E.U. on a 51.9% to 48.1% vote. An initial Brexit deadline of March 29 was broken after Parliament voted three times to reject deals brokered with the E.U., raising the specter of a unilateral “no-deal” Brexit before the newest deadline of Oct. 31. Get the full story at our sister site, Medical Design & Outsourcing (Source: Mass Device)
Source: Mass Device - July 9, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Regulatory/Compliance Wall Street Beat UL International Source Type: news

DaVita, Fresenius slide on Trump threat to overhaul dialysis market
Shares of dialysis providers DaVita Healthcare (NYSE:DVA) and Fresenius (NYSE:FMS) took a hit today after a report surfaced that the Trump administration is readying an overhaul of the kidney treatment market. The president plans to issue an executive order tomorrow that would seek to incentivize kidney transplants and home hemodialysis in a bid to lower the federal government’s annual $100 billion kidney care tab, Politico reported, citing “two individuals with knowledge of the announcement.” The strategy involves new payment models from the U.S. Health & Human Services Dept. designed to move pa...
Source: Mass Device - July 9, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Dialysis Featured Wall Street Beat DaVita Inc. Dept. of Health & Human Services (HHS) Fresenius Source Type: news

Cutera snags Vyaire Medical ’ s Mowry for CEO | Personnel Moves, July 9, 2019
Cutera (NSDQ:CUTR) said today that it snagged Vyaire Medical CEO David Mowry to be its new CEO, effective immediately. The aesthetic device maker in January fired president & CEO James Reinstein after the company missed expectations for its 2018 top line, naming COO Jason Richey as interim chief executive. Mowry led Tornier to a $3.3 billion merger with Wright Medical in October 2015. After leaving the COO role at Wright the next year, he was tapped to lead Vyaire Medical, a rollup of four respiratory businesses BD acquired in the March 2015 deal for CareFusion. Initially a joint venture partner in Vyaire with pri...
Source: Mass Device - July 9, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Business/Financial News Camstent Cerner Corp. Cutera Inc. Dentsply Sirona Inari Medical Medline Industries Inc. Neuronetics Ocular Therapeutix Personnel Moves Pfizer Pure Bioscience Source Type: news

FDA approves ConTIPI Medical ’ s ProVate pelvic organ prolapse treatment
ConTIPI today announced FDA approval for its ProVate device. ProVate is designed to treat pelvic organ prolapse in women. It’s a disposable, non-invasive treatment option that supports lateral vaginal walls and mechanically prevents cervical/vault descent, according to the company. It blocks further descent of the anterior/posterior walls within its central piece and is available in six different sizes. “For many years we have been working to promote pelvic floor solutions and products that will help every woman conduct a normal life and fully control her medical condition,” founder and CEO Elan Ziv said ...
Source: Mass Device - July 9, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Food & Drug Administration (FDA) Women's Health ConTIPI Source Type: news

Fresenius invests in BioIntelliSense
Fresenius Medical Care (NYSE:FMS; ETR:FRE) today announced an investment in BioIntelliSense for an undisclosed amount. Denver-based BioIntelliSense is developing a medical-grade data services platform for continuous remote health monitoring, predictive analytics and algorithmic clinical insights. Through the agreement, Fresenius will use the advanced analytics and artificial intelligence to develop medical wearables for clinical pathways that allow clinicians to be alerted for early intervention of medical conditions. The company says the combination of the two technologies can help prevent complications and reduce un...
Source: Mass Device - July 9, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Diagnostics Dialysis Fresenius Fresenius Medical Care Source Type: news

AxoSim touts results of nerve-on-a-chip study
A new study of AxoSim’s Nerve-on-a-Chip technology shows that the platform accurately provides key physiological readouts that could help speed the development of drugs to treat neurological disorders. The study also shows that Nerve-on-a-Chip technology is the first all-human in vitro model that can measure critical factors that were formerly only available using live animal models. These include robust axonal outgrowth, myelination of human stem cell-derived neurons by primary human Schwann cells, and evaluation of nerve conduction velocity, according to the New Orleans-based company. Get the full story o...
Source: Mass Device - July 9, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Featured Neurological Research & Development Stem Cells axosim Source Type: news

Clearside Biomedical licenses microinjector to Aura Biosciences
Clearside Biomedical (NSDQ:CLSD) said today that it licensed its microinjector technology to Aura Biosciences for use with Aura drug candidates in treating ocular cancers. Alpharetta, Ga.-based Clearside’s Suprachoroidal Space Microinjector is designed to deliver therapeutics into the suprachoroidal space between the sclera and choroid of the eye. Aura, based in Cambridge, Mass., is developing viral nanoparticle conjugates designed to seek out and eliminate cancer cells. Get the full story at our sister site, Drug Delivery Business News (Source: Mass Device)
Source: Mass Device - July 9, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Drug-Device Combinations Optical/Ophthalmic Research & Development Aura Biosciences Clearside Biomedical Source Type: news

Australia regulators publish guidance on recognized QMS standards
By Kate Jablonski, Emergo Group The Australia Therapeutic Goods Administration (TGA) published guidance on its recent update to Medical Device Standards Order (MDSO), Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019, on June 19. 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. (Source: Mass Device)
Source: Mass Device - July 9, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

Japan approves iSchemaView ’ s Rapid stroke imaging device
iSchemaView today announced that it received registration approval in Japan for its Rapid imaging platform. The company received registration approval through the Japanese Pharmaceutical Affairs Law and through a third party review by the Japanese Assn. for the Advancement of Medical Equipment for the Rapid imaging platform. Rapid is designed to give physicians a fast, fully automated and easy-to-interpret imaging system that can help doctors make clinical decisions about stroke. “Stroke remains the fourth most common cause of death in Japan, and as the population ages, stroke is likely to become an increasing health...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Hospital Care Imaging ischemaview Source Type: news

Inspire Medical scores reimbursement win from UnitedHealth
Inspire Medical Systems (NYSE:INSP) logged another reimbursement win, this time with the nation’s largest private insurer, UnitedHealth. Minneapolis-based Inspire makes an eponymous device designed to treat obstructive sleep apnea using hypoglossal nerve stimulation. UnitedHealth has about 41 million lives under coverage, Inspire said. “We are very pleased to receive this positive coverage decision from UnitedHealthcare. As health plans continue to update their coverage policies to include Inspire therapy, an increasing number of patients and physicians will have access to our innovative therapy,” preside...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Neuromodulation/Neurostimulation Respiratory Wall Street Beat Inspire Medical Systems Inc. Reimbursement UnitedHealth Group Source Type: news

Strata Skin Sciences inks Korea distribution deal
Strata Skin Sciences (NSDQ:SSKN) today announced a new Korean direct distribution deal with Kosmo Meditech for direct capital sales and direct recurring revenue sales in Korea. Kosmo Meditech has worked with Strata Skin Sciences for more than 13 years. The deal with help strengthen Strata’s Xtrac excimer laser value proposition in Korea and expand its installed base of over 250 devices in the country, according to the company. “We have been a proud partner in the Xtrac business in Korea for over 13 years and are very happy to be the first international launch partner of Strata’s recurring business mo...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Distribution Kosmo Meditech Strata Skin Sciences Source Type: news

Agiliti snags Zetta Medical
Healthcare technology management firm Agiliti said it acquired Zetta Medical Technologies for an undisclosed amount. Lake Zurich, Ill.-based Zetta offers engineering services, parts and pre-owned medical imaging equipment via a network of OEM trained-engineers, according to Minneapolis-based Agiliti, formerly known as Universal Hospital Services. “Zetta’s specialized capabilities and technical expertise are an ideal complement to our expanding platform of clinical engineering services,” CEO Tom Leonard said in prepared remarks. “This acquisition builds upon our outsourced and supplemental biomedical...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Imaging Mergers & Acquisitions Wall Street Beat Agiliti Zetta Source Type: news

Medeon invests in ortho, urologic companies
Medeon Biodesign (TPEx:6499)  said today that it recently led and closed investments in an orthopedics startup and a company whose device was designed to treat benign prostatic hyperplasia (BPH). Panther Orthopedics is a Silicon Valley startup working on fixation solutions for orthopedic extremity applications. Prodeon is a Taiwan-based company offering a simple, office-based treatment option for BPH patients who are seeking immediate relief from lower urinary tract symptoms (LUTS). Panther Orthopedics’ FDA- 510(k) cleared Puma System is designed to treat orthopedic injuries with the benefits of screws and flexi...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Funding Roundup News Well Orthopedics Urology Wall Street Beat Medeon Biodesign pantherorthopedics Prodeon Source Type: news

FDA clears Biotronik ’ s third-gen injectable cardiac monitor
Biotronik said today that it won 510(k) clearance from the FDA for its Biomonitor III injectable cardiac monitor. Oswego Lake, Ore.-based Biotronik said the Biomonitor III is 60% smaller than its predecessor and offers increased signal quality and a patient app that reports system diagnostics. The device is approved as MR-conditional for both 1.5T and 3.0T scans. “Receiving FDA clearance on Biomonitor III further demonstrates Biotronik’s continued dedication to designing innovative technology solutions that improve patient lives,” president Ryan Walters said in prepared remarks. “This device ma...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Food & Drug Administration (FDA) Patient Monitoring Regulatory/Compliance Biotronik Source Type: news

Intuitive Surgical recalls staple lots on manufacturing variation
Intuitive Surgical (NSDQ:ISRG) is recalling 23 lots of staples used with its da Vinci Xi robot-assisted surgery device after internal testing turned up a manufacturing “variation” that could cause an incomplete staple line. The Sunnyvale, Calif.-based company said the problem with some of its da Vinci Xi SureForm 60 Black and Green Reloads has a low likelihood of occurring. The variation could result in the reloads failing to deploy three adjacent staples, causing a “minor delay” to reinforce the staple line, the company said. The risk depends on the type of procedure involved, Intuitive s...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Recalls Regulatory/Compliance Robotics Intuitive Surgical Source Type: news

Valeritas touts study results
Valeritas (NSDQ:VLRX) today announced the results of a study that showed patients using its V-Go wearable insulin delivery device needed less insulin, had lower A1c levels and reduced diabetes-related medication cost compared with patients using multiple daily injection (MDI) therapy. The retrospective study by the Bridgewater, N.J.-based company used information from the HealthCore Integrated Research Database (HIRD). Get the full story on our sister site, Drug Delivery Business. (Source: Mass Device)
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Diabetes Drug-Device Combinations Featured News Well Wall Street Beat Valeritas Source Type: news

Medtronic touts stroke data from HeartWare HVAD thoracotomy study
Medtronic (NYSE:MDT) today touted stroke data from the Lateral trial of its HeartWare HVAD left ventricular assist device involving implantation via thoracotomy instead of open surgery. With a thoracotomy implantation, surgeons insert the pump via a small, lateral incision between the left ribs and make a second small incision to accommodate the pump’s outflow graft. Fridley, Minn.-based Medtronic said Lateral results presented at the annual meeting of the American Society for Artificial Internal Organs showed that 95% of thoractomy patients were free from disabling stroke at two years. Adverse events were more ...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Assist Devices Cardiovascular Clinical Trials Featured Medtronic Source Type: news

How one medtech company is working on solving the data dilemma
(Image by Rishi Deep on Unsplash) The electronic medical record was designed to better track patient care, but it has had unintended consequences. Physicians are bombarded with digital patient information all day long, reducing their patient eye-to-eye interactions and adding hours to their workday. A 2016 American Medical Association study found that physicians spent about two hours on electronic health record and other desk work per day for every hour that they provide direct clinical face-time to patients. Outside office hours, physicians spend another one to two hours of personal time each night doing additional comput...
Source: Mass Device - July 5, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Electronic Medical Records Endoscopic / Arthroscopic Featured Health Information Technology Implants News Well Patient Monitoring Research & Development Software / IT American Medical Association Boston Source Type: news

Fresenius to expand kidney research
Fresenius Medical Care (NYSE:FMS; ETR:FRE) said this week that it is expanding its clinical research activities. Frenova Renal Research, previously a Fresenius Medical Care North America subsidiary, will now offer its services worldwide and will be integrated into a new global medical office headed by chief medical officer Dr. Frank Maddux. Frenova offers services for the clinical development of medicines and medical products in the field of kidney research. This offering, previously limited to North America, will now be linked with the corresponding services of Fresenius Medical Care’s Europe, Middle East and Africa...
Source: Mass Device - July 5, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Business/Financial News Dialysis News Well Research & Development Frenova Fresenius Medical Care Source Type: news

Sonendo raises another $17m for acoustic-based root canal treatment tech
Sonendo has brought in $17 million — its latest multimillion-dollar money raise as it expands marketing of its GentleWave system that uses acoustic energies to better clear out a tooth’s root canal system. The roughly $17 million matches the full amount that Laguna Hills, Calif.–based Sonendo was seeking to raise, according to a Form D the company filed with the U.S. Securities and Exchange Commission on July 1. The news comes about three months after Sonendo announced the Canada launch of GentleWave, with CEO Bjarne Bergheim touting increased demand for the procedure. GentleWave uses a combination of pro...
Source: Mass Device - July 5, 2019 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News Dental Featured Funding Roundup Sonendo Source Type: news

Advent Access wins CE Mark for dialysis device
The av-Guardian vascular access system designed for hemodialysis patients. (Image from Advent Access) Singapore-based vascular access device company Advent Access said it has received the CE Mark for its av-Guardian technology designed to create vascular access for dialysis patients. The device-guided needling platform features the company’s “guardian guide-door” technology for accessing arteriovenous fistulas, which it claims can reduce wear and tear on the dialysis patient’s veins. The technology may be used in a dialysis center or at home, regardless of the types of dialysis machine being used, a...
Source: Mass Device - July 5, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Dialysis Featured News Well Regulatory/Compliance Advent Access CE Mark Source Type: news

Activ Surgical raises $13m
Activ Surgical has raised nearly $13 million as the company continues development of its Smart Tissue Autonomous Robot (STAR). The Boston-based company has been seeking nearly $19 million in the money-raise, according to a Form D filed with the U.S. Securities and Exchange Commission on July 1. Founded in 2017, Activ’s initial technology is STAR. Developed out of Children’s National Medical Center in Washington, D.C., the robot uses near-infrared fluorescent (NIRF) markers to provide a biocompatible, near-infrared 3D tracking system. The result, according to the robot’s developers, is accurate 3D tra...
Source: Mass Device - July 5, 2019 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News Imaging News Well Robotics Surgical Activ Surgical Source Type: news

Senators question proposed device approval changes
U.S. Senators Patti Murray (left) and Elizabeth Warren U.S. Senators Patti Murray (D-Wash.) and Elizabeth Warren (D-Mass.) are challenging an FDA budget proposal that would ease the approval process for certain medical devices. In a June 24 letter to Acting Commissioner Dr. Ned Sharpless and Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health, Murray and Warren target the “progressive approval for devices” program included in the agency’s fiscal year 2020 budget that would expand the conditional approval pathway for animal drugs to human medical products. Former FDA Commissioner...
Source: Mass Device - July 5, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Featured Food & Drug Administration (FDA) News Well Regulatory/Compliance U.S. Senate Source Type: news

Digirad board approves deal to acquire ATRM Holdings
Digirad Corp. (NSDQ:DRAD) said this week that its board of directors approved a deal to buy ATRM Holdings as a “kick-off” transaction to convert Digirad to a diversified holding company. As part of the acquisition, Digirad plans to create Series A non-convertible, cumulative, perpetual preferred stock with a stated value of $10 apiece. ATRM shareholders are slated to receive consideration consisting of 0.03 shares of Digirad Series A preferred stock for every ATRM common share. Also, each Series B preferred stock of ATRM will be exchanged for 2.5 shares of Digirad’s Series A preferred stock, accordin...
Source: Mass Device - July 5, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Mergers & Acquisitions Wall Street Beat Digirad Corp. Source Type: news

Glaukos touts 5-year study of glaucoma stents
This study shows that not only are Glaukos’ iStents as effective as once-daily topical travoprost in controlling IOP, but they also succeed at maintaining IOP reductions over the long-term with fewer additional medications.” Three-year outcomes of this study were published in 2016 in Ophthalmology and Therapy. The most recent article detailing five-year outcomes may be accessed online here. “This latest publication represents the first-ever five-year, protocol-driven, randomized evaluation of standalone iStent implantation in newly diagnosed glaucoma patients,” said Glaukos prez & CEO Thomas Bur...
Source: Mass Device - April 15, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Clinical Trials Featured Implants News Well Optical/Ophthalmic Vision Glaukos Ivantis Source Type: news

More device shortages pegged to sterilization plant shutdown
Cardinal Health’s Accu-Trace intrauterine pressure catheter (Image from Cardinal Health) More medtech companies are experiencing shortages of medical devices due to the sudden closure in February of a Sterigenics sterilization plant. Officials from Cardinal Health (NYSE:CAH), and Guerbet (EPA:GBT) have written letters to customers indicating that certain devices are already in short supply or may experience shortages, Medical Device & Outsourcing has learned. The letter from Cardinal Health (Dublin, Ohio) said that the company expects a shortage of its Kendall Accu-Trace intrauterine pressure ...
Source: Mass Device - April 15, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Business/Financial News Catheters Featured Food & Drug Administration (FDA) Imaging News Well Respiratory Sterilization / Calibration Surgical Women's Health Cardinal Health Guerbet Medtronic Smiths Medical Sterigenics Internat Source Type: news

Penumbra VR device wins FDA clearance
Penumbra recently announced that it has received FDA 510(k) clearance for its Real Immersive virtual reality system. The Real Immersive System is an immersive virtual reality and display system that tracks upper extremity rehabilitation exercises for adults who have symptoms related to acute pain, cerebral palsy, stroke, orthopedic or neurodegenerative diseases. The exercise routines with the Real Immersive System are designed to be done in a seated position in a clinical environment, according to Penumbra. The system features a clinician tablet, head-mounted display component, small sensors, large sensor, sensor char...
Source: Mass Device - April 15, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Regulatory/Compliance Penumbra Inc. Source Type: news

Corindus touts first Japanese CorPath GRX procedures
Corindus Vascular Robotics (NYSE:CVRS) said today that the first Japanese procedures using its CorPath GRX robot-assisted device took place as part of a post-market surveillance study. Waltham, Mass.-based Corindus, which last June won clearance from Japan’s Pharmaceutical & Medical Device Agency for CorPath GRX, inked a distribution deal for Japan in February 2017 that included a $2 million advance and provision for 12 of the devices; the system used in the initial cases there was the first placement of that deal and followed A1 technical fee reimbursement approval last month, Corindus said today. CorPath G...
Source: Mass Device - April 15, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Robotics Stents Corindus Vascular Robotics Source Type: news

FDA approves Intact Vascular ’ s Tack dissection repair device
The FDA last week granted pre-market approval to the Tack endovascular repair device developed by Intact Vascular. The Wayne, Pa.-based company’s Tack system is designed to repair dissection complications during balloon angioplasty for peripheral artery disease. Intact said the federal safety watchdog based the April 11 PMA decision on the results of a pivotal, 213-patient single-arm trial that met both its safety and efficacy endpoints. The Tack device won CE Mark approval in the European Union in January 2017. The Toba II study‘s rate of freedom from clinically-driven target lesion revascularization, amputati...
Source: Mass Device - April 15, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Vascular Wall Street Beat Intact Vascular peripheral Source Type: news

FDA clears Gelesis weight-loss hydrogel pill Plenity
  [Image from Gelesis]Gelesis (Boston) recently announced that it has received FDA clearance for its Plenity weight management prescription drug. The drug is a weight management aid for adults who have a body mass index of 25-40 kg/m2 and is supposed to be used with diet and exercise. It can be used in people with and without comorbidities like hypertension, type 2 diabetes or dyslipidemia. The company says that there is no restriction on how long the drug can be used in weight management. “This FDA clearance is a major milestone for the Gelesis team and our technology, and we are thrilled to be able to bring th...
Source: Mass Device - April 15, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Pharmaceuticals Regulatory/Compliance Weight loss Gelesis Inc. Source Type: news

U.K. government requests Brexit deadline extension
By Ronald Boumans, Emergo Group The U.K. government has requested a further delay in implementing its withdrawal from the European Union, with an April 12 deadline for a no-deal Brexit outcome fast approaching. 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. (Source: Mass Device)
Source: Mass Device - April 15, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

EO plant shutdown leads to pediatric breathing tube shortage
Smiths Medical Bivona tracheostomy tubes are in short supply, according to the FDA. (Image from Smiths Medical) The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA. The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of April 22, according to a statement from Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH). The state o...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Featured Food & Drug Administration (FDA) Hospital Care News Well Pediatrics Respiratory Sterilization / Calibration Center for Devices and Radiological Health (CDRH) Smiths Medical Sterigenics Internatio Source Type: news

NuVasive launches X360 lateral single-position surgery device
NuVasive Inc. (NSDQ:NUVA) said yesterday that it launched its X360 system intended for lateral single-position surgery in the U.S. The newly launched X360 system features improvements intended to accommodate advanced techniques and technologies for enhanced operating room workflow and efficiency, the San Diego-based company said. The system also features integration with NuVasive’s Pulse surgical automation platform to allow surgeons to perform multiple procedures from the lateral position. “X360 has transformed my approach to treating patients, allowing me to customize my surgical workflow, reduce patient...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Surgical Nuvasive Source Type: news

Stryker wins FDA PMA, launches Lifepak CR2 AED
Stryker (NYSE:SYK) said yesterday that it launched its Lifepak CR2 defibrillator featuring the LifelinkCentral AED program manager after winning FDA premarket approval for the system. The newly launched Lifepak CR2 AED features new technology including CPRInsight, which allows users to continue chest compressions during ECG analysis and can improve survival outcomes, the Kalamazoo, Mich.-based company said. The Lifepak CR2 AED also features a child mode button to reduce defibrillation energy for pediatric patients and an optional bilingual feature. The system can be connected to the LifelinkCentral AED program manager...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Stryker Source Type: news

TissueTech raises $55m
TissueTech has raised approximately $55.3 million in a new round of equity financing, according to a recently posed SEC filing. The Doral, Fla.-based company makes amniotic membrane- and umbilical cord-based products designed to treat ocular surface diseases (its Bio-Tissue subsidiary) and musculoskeletal conditions and wound care (its Amniox Medical business). Money in the round came from three unnamed investors, with the first sale dated as having occurred on April 9, according to the filing. The company is looking to raise an additional $27 million, which would bring the total raised up to approximately $82.3 million, a...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Regenerative Medicine Wall Street Beat Tissuetech Source Type: news

FDA clears moldable OssiMend bioactive bone graft from Collagen Matrix
Collagen Matrix said today that it won FDA 510(k) clearance for its line of OssiMend Bioactive Moldable bone graft matrix products, intended for use in spinal procedures. The Oakland, N.J.-based company said that the newly cleared OssiMend product is composed of anorganic carbonate apatite bone mineral, 45S5 bioactive glass and highly purified Type I collagen, and that it can be molded into putty for filling irregular defect sites. The moldable Ossimend product is designed to be slowly resorbed and replaced by new bone tissue, and comes in various sizes, Collagen Matrix said. “We continue to expand our product portfo...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Spinal collagenmatrix Source Type: news

Philips to private-label Demant hearing aids
William Demant (CPH:WDH) said this week that it inked a deal to market its line of hearing aid devices under Royal Philips (NYSE:PHG) brand. Denmark-based Demant said that Amsterdam-based Philips will offer a complete range of hearing aids, accessories and applications under the Philips HearLink brand “Based on a shared vision of improving the lives of people through innovative healthcare this new cooperation will not only change the way we see hearing healthcare, but also widen the definition of hearing healthcare, supporting healthier lifestyles and active aging. Combining Demant’s world-leadin...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Otolaryngology Ear, Nose & Throat Royal Philips William Demant Holding Source Type: news

Ajax Health raises $85m for medtech investment
Ajax Health, the company formed in 2017 by a pair of private equity giants to manage their medical device investments, said today that it has raised more than $85 million to help fund operations and expansions of select medical device companies. The round was led by HealthQuest Capital and joined by Aisling Capital and Polaris Partners, the Menlo Park, Calif.-based company said. “Ajax Health approaches medical device innovation in a novel way, applying best-in-class strategies to pinpoint technologies with the greatest opportunity to take off, then rapidly developing them into a fully integrated business. Ajax Health...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat ajaxhealth Source Type: news

FDA: Duodenoscope reprocessing is dirtier than we thought
The FDA said today that new data show that the contamination rate for “high-concern organisms” in duodenoscopes is nearly twice as high as previously thought and warned the devices three major manufacturers to get their required post-market studies in gear. Back in 2015 the federal safety watchdog warned Olympus (TYO:7733), Fujifilm Holdings (TSE:4901) and Hoya’s (TYO:7741) Pentax subsidiary following a string of deadly “superbug” infections attributed to their duodenoscopes. The FDA ordered the companies to run post-market surveillance studies to assess the effec...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Endoscopic / Arthroscopic Featured Food & Drug Administration (FDA) Regulatory/Compliance Fujifilm Hoya Corp. Olympus Pentax Source Type: news

Synaptive Medical raises $5m
Synaptive Medical has raised approximately $5 million in a new round of debt and options financing, according to a recently posted SEC filing. The Toronto-based company has not yet stated how it plans to spend funds raised in the round. Synaptive Medical produces medical devices intended to facilitate surgical planning, navigation, robotic automation, digital microscopy and informatics through an interconnected platform, according to its website. Money in the round came from a single unnamed investor, according to the filing, with the first date of sale noted as having occurred on March 26. Last month, Synaptive Medic...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat Synaptive Medical Source Type: news

Ex-MiMedx CEO Petit mounts proxy war
MiMedx (NSDQ:MDXG) is facing a proxy battle being led by former CEO Parker Petit, who was ousted last July “for cause”, according to a recently posted SEC filing. The ex chief-exec nominated himself alongside former Pulte Home Corp tax director David Furstenburger and George & Lorenson partner Shawn George as candidates for the company’s board of directors, set to be elected at an upcoming shareholder’s meeting. Petit said that he believes that the current MiMedx board has “failed shareholders with disappointing performance, failure to ensure competent leadership and lack of engagemen...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Wall Street Beat MiMedx Group Inc. Source Type: news

Pennsylvania appeals court upholds $14m plaintiff win in Ethicon mesh case
A state appeals court in Pennsylvania yesterday upheld the plaintiff’s $13.7 million win in a product liability lawsuit brought over one of Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon‘s pelvic mesh products. Plaintiff Sharon Carlino was awarded $13.5 million in damages in February 2016, after a Keystone State jury found that the Ethicon transvaginal polypropylene tape implanted during a 2005 hysterectomy was defective and that the company failed to adequately warn of its risks; Carlino needed three revision surgeries to remove the eroded mesh. That decision was upheld early the following year, with the ...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Product Liability Wall Street Beat Ethicon johnsonandjohnson Pelvic Mesh Lawsuits Source Type: news

Align Technology puts $31m price tag on forced retail store closures
Align Technology (NSDQ:ALGN) yesterday put a price tag of as much as $31 million on the forced closure of its Invisalign retail outlets after losing arbitration with SmileDirectClub last month. The March 4 decision required San Jose, Calif.-based Align Technology to close the stores by April 3 and enjoined it from opening new Invisalign stores or providing clear aligner devices in brick-and-mortar stores. First piloted in 2017, the number of Invisalign stores had risen to 12 by last year. Yesterday the company said it expects the closures to result in first-quarter charges of between $26 million and $31 million, inclu...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Dental Featured Wall Street Beat aligntechnology Source Type: news

Canadian regulators clarify changes in qualifications for medical device licenses following Sterigenics shutdown
By Stewart Eisenhart, Emergo Group Canadian medical device regulator Health Canada has issued a clarification on which changes to Medical Device License (MDL) holders’ sterilization processes constitute “significant changes” following the closure of a major sterilization facility in the US earlier in 2019. 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. (Source: Mass Device)
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

5 digital health startups you need to watch in 2019
(Image from Unsplash) Funding for digital health companies continues to rise, with 2018 the biggest year so far this decade, according to healthcare investment firm StartUp Health. Investors took a greater interest in machine learning, blockchain and artificial intelligence (AI). Digital health funding was 14 times greater than it was eight years ago, when New York-based StartUp Health began tracking these investments. From 2017 to 2018, the average deal size grew by $6 million. Machine learning companies cut 66 deals to raise $940 million, an 80% increase in funding compared to 2017. Patient empowerment received the ...
Source: Mass Device - April 11, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Big Data Blog Business/Financial News Featured Funding Roundup Health Information Technology mHealth (Mobile Health) News Well Software / IT adheretech carepredict devotedhealth jointacademy mediktor startuphealth Source Type: news

Smith & Nephew expands robotics R & D footprint in Pittsburgh
Smith & Nephew (NYSE:SNN) is slated to open a new robotics R&D and medical education center in Pittsburgh in 2020, according to a report from the Pittsburgh Post-Gazette. The facilities are located in the city’s Strip district, according to the report, and will triple the floor space for London-based Smith & Nephew’s robotics business, which currently employs approximately 100 individuals in the area, according to the report. “Pittsburgh is the R&D headquarters of our rapidly expanding robotics business and we are very excited to be the first tenants at The Stacks at 3 Crossings. This...
Source: Mass Device - April 11, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics Smith & Nephew Source Type: news

Second Sight Medical releases early feasibility data on Orion cortical implant
Second Sight Medical (NSDQ:EYES) today announced preliminary results from a small feasibility study of its Orion cortical implant, which is designed to give eyesight to the blind. Sylmar, Calif.-based Second Sight’s Orion is designed to connect the camera in a pair of eyeglasses with an implant that receives the camera signal and translates it to the visual cortex in the brain, bypassing the eye and the optic nerve entirely. The company’s Argus II device, which uses a retinal implant to receive the camera’s signal, is already on the U.S. market. Interim data from a five-year early feasibility study, prese...
Source: Mass Device - April 11, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Featured Optical/Ophthalmic Second Sight Source Type: news

DarioHealth touts updated diabetes management software
DarioHealth (NSDQ:DRIO) said yesterday it launched a new version of its Dario system and DarioEngage platform. The new V4.2.0 update to both digital health programs are intended to improve user engagement, lower barriers to behavioral change and to streamline the experience and process efficiency for both users and their coaches, the Israel-based company said. Read the whole story on our sister site, Drug Delivery Business News (Source: Mass Device)
Source: Mass Device - April 11, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Diabetes Patient Monitoring Software / IT DarioHealth Corp Source Type: news

Obalon taps Cowen to explore ‘ strategic alternatives ’
Obalon Therapeutics (NSDQ:OBLN) today tapped an advisory firm to explore “strategic alternatives,” a week after revealing plans to cut its workforce in half. The Carlsbad, Calif.-based company, which makes a gas-filled balloon designed to treat obesity, said April 3 that it would lay off 49 of its 100 employees, including all of its direct sales force, in a pivot toward retail. Today the company said it hired investment bank Cowen “as an independent financial advisor to assist in exploring financial and strategic alternatives” to explore “a wide range of financial and strategic alternativ...
Source: Mass Device - April 11, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Business/Financial News Mergers & Acquisitions Wall Street Beat Weight loss Obalon Therapeutics Source Type: news