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 said.
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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 like...
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 (EM...
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 procedure f...
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, according to the ...
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 tracking of tis...
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 Scott G...
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, according to...
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 Burns. “Moreover,...
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 catheter until e...
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 charger,...
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 GRX is us...
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
