Alfred Mann Foundation chairman looks outward to extend founder ’ s legacy
When medtech pioneer Alfred Mann died in February 2016, he left behind a rich legacy of pure innovation and patient impact spanning the breadth of healthcare, from cardiology to hearing impairment, blindness and diabetes that will improve the lives of patients for decades to come.
Extending and advancing that legacy is now the mission of Dr. Robert Greenberg, who took over as the foundation’s chairman in July. Speaking ahead of his appearance next week at MassDevice.com’s DeviceTalks West event in Costa Mesa, Greenberg told us that he’s looking to expand the foundation’s reach into the early-stage ...
Source: Mass Device - December 3, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Funding Roundup Alfred Mann Foundation DeviceTalks West Source Type: news
Axonics Hopes to Surpass Medtronic in Sacral Neuromodulation Market
Axonics’ CEO Raymond Cohen wants to have the top spot in the sacral neuromodulation market when it comes to treating patients with urinary and fecal dysfunction. But to reach this position, Axonics is going to have some pretty stiff competition from one of the largest players in the game – Medtronic.
And while going head-to-head with the medtech giant might be a lofty goal for some smaller companies, keep in mind the Irvine, CA-based company just raised $120 million in an initial public offering, one of the largest raises in the industry in the past few years.
“Axonics ...
Source: MDDI - November 15, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
Baby hears for first time with cochlear implants
One month after 7-month-old Aida Little was born, her parents realized she couldn't hear. Experts at Mayo Clinic diagnosed Aida with a condition called Waardenburg syndrome, a rare genetic disorder that causes deafness and pigment changes of the hair, eyes and skin.? In October, a surgical team at Mayo placed cochlear implants into Aida's head [...] (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - November 13, 2018 Category: Databases & Libraries Source Type: news
GI Dynamics eyes 2019 EU market return for EndoBarrier
GI Dynamics (ASX:GID) said yesterday that it tapped a new notified body in Europe, nearly a year after losing CE Mark approval there, as it eyes a market return for its EndoBarrier device by the end of next year.
In the European Union, notified bodies are used as part of the regulatory system to assess product conformity. The erstwhile notified body for Boston-based GI Dynamics, SGS United Kingdom, last November took the company by surprise when it withdrew CE Mark certification for the EndoBarrier obesity and diabetes treatment.
Yesterday GID said it named Intertek to replace SGS and review the technical file and clini...
Source: Mass Device - October 5, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Diabetes Featured Regulatory/Compliance Weight loss GI Dynamics Source Type: news
Can Medtech Manufacturing Benefit from Deep Learning?
Given medtech’s needs for high levels of quality and precision, machine learning could be put to good use in medical device manufacturing. One particular type of machine learning called “deep learning†could offer particular benefit as it could enable machine vision systems to learn how to recognize and respond to defects much like a human could, according to Bhaskar Ramakrishnan, technical sales engineer, DWFritz Automation.
Ramakrishnan will be speaking about potential manufacturing roles for deep learning in the MD&M Minneapolis October 31 presentation, â&#...
Source: MDDI - October 4, 2018 Category: Medical Devices Authors: Daphne Allen Tags: MD & M Minneapolis Assembly and Automation Source Type: news
Second Sight Medical wins $2m NIH grant for Orion sight implant
Second Sight Medical (NSDQ:EYES) said today that it won a grant of nearly $2 million from the National Institutes of Health to back the early feasibility trial of its Orion device for the visually impaired.
The Sylmar, Calif.-based company said the $1.6 million grant is part of a five-year, $6.3 million package that’s slated to fund the trial, which began in January. The NIH grant will cover the enrollment and treatment of five patients with Orion, a visual cortical implant that links to an eyeglass-worn camera, Second Sight said. The device is designed to bypass the optic nerve by sending the camera’s images t...
Source: Mass Device - September 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Optical/Ophthalmic Source Type: news
Glaucoma Surgery Space Heats Up with New Approval
Glaukos has received FDA approval to market the iStent inject Trabecular Micro-Bypass System. The nod gives the San Clementa, CA-based company an opportunity to pull ahead of competition in the minimally invasive glaucoma surgery (MIGS) market. Glaukos said the iStent inject is designed to optimize the natural physiological outflow of aqueous humor by creating two patent bypasses through the trabecular meshwork, the main source of resistance in glaucomatous eyes, resulting in multi-directional flow through Schlemm’s canal.
It includes two heparin-coated titanium stents preloaded into an auto-injection system that allo...
Source: MDDI - June 25, 2018 Category: Medical Devices Authors: Omar Ford Tags: Implants Source Type: news
FDA Approves First Artificial Iris
A German company has become the first to score FDA approval for a stand-alone prosthetic iris in the United States.
The agency said Wednesday afternoon that it approved the CustomFlex Artificial Iris, made by Erlangen, Germany-based HumanOptics. The device, which is surgically implanted, is approved to treat adults and children whose iris is completely missing or damaged due to a congenital condition called aniridia or other damage to the eye.
“Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye,” said Malvina Eydelman, MD, director of the divi...
Source: MDDI - May 30, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Source Type: news
Glaucoma Device Makers See a Bright Future Ahead
Were The Graduate's Ben Braddock to receive a one-word bit of career advice today, it might very well be "MIGS" instead of plastics.
MIGS stands for minimally invasive glaucoma surgery, and both financial analysts and developers of the tiny devices designed to treat the disease expect the market to pop for the foreseeable future.
"On a scale of one through 10, I would say the market is probably somewhere between one and two in terms of maturity," said Dave Van Meter, CEO of Irvine, CA-based Ivantis. "The market in the U.S. today is probably somewhere around a couple hundred million dollars, according to Market Scope, and ...
Source: MDDI - May 11, 2018 Category: Medical Devices Authors: Greg Goth Tags: Implants Source Type: news
Nadinne Bruna has 'sight of 90-year-old' after eye colour procedure
Nadinne Bruna, 32, who lives in Miami, has lost most of her vision after undergoing treatment in Colombia, to insert silicone implants in her hazel eyes to turn them light grey. (Source: the Mail online | Health)
Source: the Mail online | Health - April 12, 2018 Category: Consumer Health News Source Type: news
Curvy Instagram model, 32, left with 'the sight of a 90-year-old' after controversial procedure
Nadinne Bruna, 32, who lives in Miami, has lost most of her vision after undergoing treatment in Colombia, to insert silicone implants in her hazel eyes to turn them light grey. (Source: the Mail online | Health)
Source: the Mail online | Health - April 12, 2018 Category: Consumer Health News Source Type: news
Edwards Eyes Delay for its Sapien 3 Ultra TAVR
Edwards Lifesciences said it is delaying the launch of the Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) System in Europe until later this year. The Irvine, CA-based company said it would refocus on commercialization efforts after it submits data from the 30-patient, single-arm study of the device treating patients at intermediate risk from surgical valve replacement. The study data would help supplement the company’s bid to gain CE mark for the technology.
Edwards said the updated timing for the European launch of the Sapien 3 Ultra doesn’t change the company’s sales guidance for 2018 and that it sti...
Source: MDDI - March 22, 2018 Category: Medical Devices Authors: Omar Ford Tags: Implants Source Type: news
Glaukos touts IOP, medication use reductions in iStent trial
Glaukos (NYSE:GKOS) today released results from a study of its iStent trabecular micro-bypass stent exploring its use during cataract surgery in patients with severe open-angle glaucoma, touting significant reductions in intraocular pressure and medication use.
The San Clemente, Calif.-based company’s iStent micro-bypass stents are made from non-ferromagnetic titanium and coated in heparin, is designed to be implanted into multiple trabecular meshwork through a single corneal entry point to reduce IOP.
Results were published in the January issue of the Journal of Glaucoma.
“Although the iStent is currently ...
Source: Mass Device - February 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Optical/Ophthalmic Glaukos Source Type: news
How to Make Medical Devices Like a Magician
John Crombie has a few tricks up his sleeve and this magician isn't afraid to reveal his secrets.
During a product development workshop at MD&M West this week, Crombie explained how to apply the art of magical illusion to your next product development project.
First, Crombie performed what is known as the Penna coin trick in which he showed his spectators a glass that had a piece of rubber covering the top and secured with a rubber band a quarter on top. He then asked an audience volunteer to push down on the quarter with his finger, giving the illusion that the coin had passed through the piece of rubber into the sea...
Source: MDDI - February 7, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M West (Anaheim) R Source Type: news
Second Sight touts 1st-in-human Orion cortical implant
Second Sight Medical (NSDQ:EYES) today announced the first trial implantation of its Orion cortical visual prosthesis system and updated on implantations of its Argus device and enrollment in an upcoming study.
The first implantation procedure was performed late last month by Dr. Nader Pouratian at the Ronald Reagan UCLA Medical Center, the Sylmar, Calif.-based company said, as part of an FDA-cleared feasibility trial it won approval to launch last November.
The Orion cortical visual prosthesis system is designed to convert images captured by a miniature video camera, mounted on a patient’s glasses, into a series of el...
Source: Mass Device - February 5, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Optical/Ophthalmic Second Sight Source Type: news
