TransMedics registers for $86m IPO
TransMedics last week registered for an initial public offering worth more than $86 million for the organ transplant transportation system it developed.
The Organ Care System is designed to keep donated hearts, lungs and livers in near-living condition until transplantation; the company touts it as the only such system designed for more than one organ.
In Europe, the OCS Heart and OCS Lung devices are already on the market. A year ago the Andover, Mass.-based company won pre-market approval from the FDA for its OCS Lung transplant device for standard double-lung transplantation procedures.
In an April 5 regulatory filing T...
Source: Mass Device - April 8, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Funding Roundup Transplants Wall Street Beat transmedics Source Type: news
FDA recommendations from the annual Human Factors and Ergonomics Society symposium
By Erin Davis and Allison Strochlic, Emergo Group
Manufacturers, consultants, researchers, and regulators all descended upon Chicago this week for the annual Human Factors and Ergonomics Society Health Care Symposium. After taking in dozens of oral presentations and hundreds of posters, attendees often walk away from the event feeling invigorated that there are so many human factors (HF) professionals out there working to make medical technology, as well as clinical care environments, safe, effective, and satisfying.
Get the full story here at the Emergo Group’s blog.
The opinions expressed in this blog post are the auth...
Source: Mass Device - April 8, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news
Health Canada notifies Allergan on intent to suspend Biocell breast implant license
Health Canada said yesterday that it plans to suspend Allergan‘s (NYSE: AGN) licenses to sell its Biocell breast implants in the region due to a possible association with a rare immune system-cancer.
The move follows the agency’s completion of a scientific assessment of macro-textured implants, which it said is part of a larger safety review of breast implants and their association with breast implant-associated anapestic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.
Health Canada said it launched the review last November due to an increase in Canadian and international cases of BIA-ALCL, add...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cosmetic/Aesthetic Regulatory/Compliance Women's Health Allergan Source Type: news
Australia ’ s TGA looks to strengthen medical device oversight
Australia’s Therapeutic Goods Administration yesterday released a three-part action plan looking to strengthen the company’s medical device regulatory system.
The plan includes steps to improve oversight of new devices entering the market, strengthening post-market monitoring and providing more device information to patients.
The changes are slated to take effect in early-to-mid 2019 and continue into 2020, according to the official TGA posting.
The changes include open public consultations to seek feedback on the proposals, the TGA said, adding that decisions on specific policies and regulations would need to be made ...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Regulatory/Compliance Source Type: news
LivaNova shares plummet on prelim Q1 miss
LivaNova (NSDQ:LIVN) shares have plunged over 25% so far today after the medical device maker posted preliminary sales numbers for its first quarter that fell below expectations on Wall Street.
The London-based company said that it expects to post sales of $250.5 million for the quarter, well below the Wall Street expectations of $264.6 million.
The company reported preliminary sales of $121.5 million for its cardiopulmonary division, a drop of 2.9% compared with the same period during the previous year. Its heart valve business saw a larger drop, reporting preliminary sales of $25.6, down 17.5% from Q1 2018.
LivaNova’s...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Wall Street Beat LivaNova Source Type: news
Abiomed touts new Impella study results
Abiomed’s Impella 2.5 pump (Image from Abiomed)
New data on Abiomed (NSDQ:ABMD) Impella heart pumps show a 34% increase in survival among nearly 5,000 patients treated with the company’s devices intended to treat cardiogenic shock when combined with best practices, according to a company study.
The study of patients treated at 763 U.S. sites between April 1, 2018 and March 28, 2019 showed median survival rates had risen from 51% in 2016, when the FDA granted premarket approval for the Impella 2.5, CP, 5.0 and LD heart pumps, to 67%, the Danvers, Mass.-based company said. (The FDA approved Impella 2.5 for high-ris...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Source Type: news
Report: France to ban textured breast implants
France is planning to ban textured breast implants, which have been linked a rare immune-system cancer, according to a report from France24.
France’s National Agency for Medicines and Health Products began informing manufacturers on April 2 of its plans to ban manufacturing, distribution, importing, exporting, promotion and wearing of textured breast implants and polyurethane breast implants, according to the report.
The soon-to-be-banned implants have been linked to breast implant-associated anapestic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.
France’s ANSM has been tracking individuals with b...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Featured Regulatory/Compliance Women's Health Source Type: news
Medtronic touts stroke data for HeartWare LVAD
A retrospective analysis of two studies involved the HeartWare left-ventricular assist device Medtronic (NYSE:MDT) acquired in 2016 showed that managing blood pressure reduced the severity of strokes in patients implanted with the HVAD pump.
The analysis, of “destination therapy” patients who are not candidates for a heart transplant, took data from the Endurance and Endurance Supplemental studies. Results were presented this week at the annual meeting of the International Society for Heart & Lung Transplantation in London, Medtronic said.
The 465-patient Endurance Supplemental study compared 308 patients i...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Assist Devices Clinical Trials Featured Abbott HeartWare International Inc. Medtronic stjudemedical Thoratec Corp. Source Type: news
Drug delivery tech dev Modular Medical raises $4m
Drug delivery tech developer Modular Medical has raised $4.2 million in a new round of equity financing, according to an SEC filing.
The stealthy Escondido, Calif.-based company is developing a new medication delivery technology to “remove the burden of daily injections” and compliment individual lifestyles, according to its website.
Read the whole story on our sister site, Drug Delivery Business News
The post Drug delivery tech dev Modular Medical raises $4m appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Drug Pumps modularmedical Source Type: news
Presbia delays Flexivue Microlens FDA PMA approval timeline again
Presbia (NSDQ:LENS) has delayed the timeline for approval of its Flexivue Microlens for treating far-sightedness again due to an earlier request for more information from the FDA.
The Irvine, Calif.-based company was told last October that it had 180 days to provide the agency with 36-month data from all subjects enrolled in the staged pivotal clinical trial, as well as additional safety and efficacy information, before it can complete its premarket approval application review, according to an SEC filing.
Presbia submitted its final pre-market approval module to the FDA during the second quarter of last year, including 24...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Optical/Ophthalmic Pre-Market Approval (PMA) Regulatory/Compliance Presbia Source Type: news
Edwards Lifesciences doubles down on Irish plant
Edwards Lifesciences (NYSE:EW) reportedly plans to double its investment in a plant it’s building in Ireland that’s expected to add 600 jobs to the local economy.
Last year the Irvine, Calif.-based company said it planned to build a new, 170,000-square-foot facility in Limerick to manufacture delivery components for its transcatheter heart valves. At the time the project was slated to cost about $93.3 million (EU €80 million) and open in 2021.
Today Edwards said it will add another $93.3 million to the tab as it plans to build a larger plant but held to the 2021 timetable as it broke ground on the construc...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Business/Financial News Replacement Heart Valves Edwards Lifesciences Source Type: news
Brainsway sets terms for $30m IPO
Brainsway this week set the terms on its forthcoming initial public offering in the U.S., saying it hopes to raise nearly $30 million.
The Jerusalem-based company, which developed a transcranial magnetic stimulation device to treat psychological disorders, said it plans to float 2.5 million American Depository shares at roughly $11.94 apiece. Each ADS is slated to represent two ordinary shares, Brainsway said; the U.S. offering price is based on the April 2 closing price of ₪21.64, or roughly $5.97, and is subject to change.
The company plans to list on the NASDAQ exchange under the symbol “BWAY,” according to a regu...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Funding Roundup Neuromodulation/Neurostimulation Wall Street Beat Brainsway Source Type: news
How medical device human factors researchers can ensure GDPR compliance
By Stewart Eisenhart, Emergo Group
Following Emergo by UL’s recent webinar on the European Union’s General Data Protection Regulation (GDPR) and human factors studies for medical devices, we examine key GDPR compliance issues human factors researchers must address to avoid steep penalties. The webinar was presented by Allison Strochlic and Alexandria Trombley, Research Director and Human Factors Specialist, respectively, at Emergo by UL’s Human Factors Research & Design (HFR&D) division, as well as two legal experts from Sidley Austin, Geraldine Scali and Kate Heinzelman.
Get the full story here at the Emergo...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news
The 10 largest orthopedic device companies in the world
[Image courtesy of Unsplash]Robot-assisted surgery continues to generate headlines in the orthopedics space. But there is so much more going on among the world’s largest orthopedic device companies.
Go to our sister site Medical Design & Outsourcing and discover what’s new among the 10 largest companies in the medical device industry’s ortho sector.
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Note: Medical Design & Outsourcing drew on research for its annual Big 100 list of largest medical device companies to create the 10 largest orthopedic device companies list.
The post The 10 largest orthopedic device companies in the...
Source: Mass Device - April 4, 2019 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News Featured Orthopedics Robotics Spinal ConMed Corp. depuysynthes DJO Global johnson&johnson Medtronic Orthofix Smith & Nephew Stryker wrightmedical Zimmer Biomet Source Type: news
Seisa Medical acquires stent & delivery system maker Burpee MedSystems
Seisa Medical said today that it acquired stent and delivery device manufacturer Burpee MedSystems for an undisclosed amount.
New Jersey-based Burpee MedSystems was founded in 1998 and uses laser machining, surface finishing, nitinol forming and shaping and welding to create stents and delivery systems, El Paso, Texas-based Seisa Medical said.
“We are thrilled to be joining Seisa as it gives Burpee MedSystems the global infrastructure we’ve been aiming for to expand our offerings and capabilities to the market,” Burpee MedSystems CEO Janet Burpee said in a prepared statement.
Janet and co-founder Steve Burpee...
Source: Mass Device - April 4, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Stents seisamedical Source Type: news
