Johnson & Johnson closes Auris Health buyout, sterilization biz sale
Johnson & Johnson (NYSE:JNJ) said yesterday that its Ethicon biz completed its $3.4 billion acquisition of robotic surgery dev Auris Health and the $2.8 billion divestiture of its Advanced Sterilization Products to Fortive (NTSE:FTV).
Redwood City, Calif.-based Auris Health, which was created by Intuitive Surgical (NSDQ:ISRG) founder and surgical robotics pioneer Dr. Fred Moll, developed and produces the robotic Monarch platform which has FDA clearance for diagnostic and therapeutic bronchoscopic procedures.
The Monarch system features a controller interface for navigating the integrated flexible robotic endoscope ...
Source: Mass Device - April 2, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Mergers & Acquisitions Robotics Sterilization / Calibration Wall Street Beat johnsonandjohnson Source Type: news
Medigate spreads into healthcare IOT
Medical device security firm Medigate said today that it is expanding into clinical IoT and general IoT devices.
The company developed and supports a medical device security and asset management platform designed to identify, tag and fingerprint individual medical devices beyond their IP address. Tags for devices are based on type, vendor and model, and allow for better visibility into types, vendors, protocols and operations systems, Medigate said. Now it says it can enable accurate and comprehensive device discovery, contextual and behavioral anomaly detection as well as clinical policy enforcement for health delivery ...
Source: Mass Device - April 1, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Business/Financial News Health Information Technology News Well medigate Source Type: news
Medical Alley companies beat Q1 investment total
A surge in first-quarter 2019 investments in Medical Alley Association member startups pushed them past their performance in the same quarter last year, according to the Minnesota-based trade group.
Seven of the 10 largest raises of the quarter went to medical device companies, which propelled the sector to its best first quarter on record, nearly doubling the second-best total. The funded companies make products ranging from cardiopulmonary intervention devices to novel orthopedic treatments for both chronic and acute conditions.
Get the full story on our sister site, Medical Design & Outsourcing.
The post Medical A...
Source: Mass Device - April 1, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Funding Roundup News Well CHF Solutions Inc. Medical Alley Assn. Monteris Medical nuvaira Source Type: news
SEC details Fresenius ’ $231m FCPA settlement
The U.S. Securities and Exchange Commission today detailed the more than $231 million that Fresenius Medical Care (NYSE:FMS; ETR:FRE) agreed to pay to resolve self-reported violations of the Foreign Corrupt Practices Act.
In its release, the SEC said that it found that Germany-based Fresenius engaged in misconduct in Saudi Arabia, Morocco, Angola, Turkey, Spain, China, Serbia, Bosnia, Mexico, and eight countries in the West African region. The agency added that the misconduct occurred “against a backdrop where the company failed to have sufficient internal accounting controls.”
The company made improper paymen...
Source: Mass Device - April 1, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Legal News Fresenius Source Type: news
Angel Medical Systems clears bankruptcy, raises $10m
Angel Medical Systems has raised $10 million in a new equity round of financing after clearing its Chapter 11 bankruptcy plans.
The Eatontown, N.J.-based company developed the FDA-cleared AngelMed implantable cardiac monitor system intended for patients who had prior acute coronary syndrome events, including myocardial infarctions or unstable angina, and who remained at high risk for recurrent ACS events.
Angel Medical Systems won approval for its Chapter II bankruptcy plans in January.
The company said last Friday that it has successfully exited from Chapter II as a private company, adding that the plan was supported by...
Source: Mass Device - April 1, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat Angel Medical Systems Inc. Source Type: news
Thank you for 10 great years
MassDevice.com went live on March 30, 2009. In the 10 years since then we’ve launched events, new publications, a print magazine and, with your help, become the #1 outlet covering the medical device industry.
We couldn’t have done it without your support. On behalf of all of us here, thank you for a decade’s worth of medtech news. We’re excited to see what the next 10 years bring!
The post Thank you for 10 great years appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 1, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Blog Featured MassDevice.com Source Type: news
3M debuts long-wearing medical adhesive
3M (NYSE:MMM) said that it has added an extended-wear medical transfer adhesive to its lineup of advanced adhesives for medical devices.
Designed to laminate many substrates, 3M medical transfer adhesive 4075 features an extended-wear pressure sensitive-transfer adhesive and allows design engineers to use a variety of backings. The new adhesive also offers up to a 14-day wear time, depending on the backing material used.
Get the full story on our sister site, Medical Design & Outsourcing.
The post 3M debuts long-wearing medical adhesive appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 1, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog News Well Research & Development 3m Source Type: news
Report: Departing FDA head Gottlieb looks back on his time at the agency ’ s head
Though he only held the position for just under two years, FDA Commissioner Dr. Scott Gottlieb said that he believes the agency’s scope has expanded significantly during his time at its head, according to a FierceBiotech report.
The report comes from a fireside-style chat hosted by the Alliance for a Stronger FDA and the Pew Charitable Trusts in Washington, D.C., according to the report, at which Gottlieb spoke to a group including former FDA head Mark McClellan.
“I think what’s changed most notably about the agency from the time I was there was that the scope has expanded so dramatically, in not a long p...
Source: Mass Device - April 1, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Source Type: news
S & P boosts Integer Holdings ’ outlook
Integer Holdings (NYSE:ITGR) said it has received a positive outlook and a reaffirmed B+ long-term issuer credit rating from Standard & Poor’s (S&P). The positive outlook, which was revised from stable, is based on Integer’s debt reduction and expected future targeted debt-to-adjusted EBITDA leverage ratio between 2.5X – 3.5X.
S&P also cited Plano, Texas-based Integer’s customer relationships, array of product offerings and competitive advantage as the industry consolidates its supplier base with larger medical device manufacturers. S&P also hinted at an upgrade if Integer demonstrates consistent l...
Source: Mass Device - April 1, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Contract Manufacturing News Well Wall Street Beat integer S&P Source Type: news
Philips wins $450m DoD patient monitor supply contract
Royal Philips (NYSE:PHG) has won a $450 million contract to supply the U.S. Department of Defense with patient monitoring systems, accessories and training, according to a recently released DoD posting.
The deal comes through a five-year base contract with a single five-year option period. A total of 36 different companies competed for the contract that Amsterdam-based Philips won, according to the DoD release.
Patient monitoring systems, accessories and training will be supplied to the Army, Navy, Air Force, Marine Corps and other federal civilian agencies, with the location of performance noted as Massachusetts. The co...
Source: Mass Device - April 1, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Patient Monitoring Royal Philips Source Type: news
Is this the way to improve organ transportation?
Lisa Anderson, president, co-founder and COO of Paragonix Technologies
Organ transplants are performed annually to remove diseased organs and replace them with healthy ones to extend the lifespan of patients. Potential transplant recipients are placed on a waiting list by a doctor who has determined that a transplant is the best course of action. Once a donor organ is available, the organ transportation system becomes one of the most critical medical devices of the transplantation process, according to Lisa Anderson, president, co-founder and COO of Paragonix Technologies.
Before Anderson helped found Braintree, Mass.–b...
Source: Mass Device - April 1, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Research & Development Transplants MedTech paragonixtechnologies Women in Medtech Source Type: news
MPR: Getting medical device development back on track
In this podcast, experts from MPR discuss what medical device companies can do if things go sideways during the product development process. Drawing from their own experiences, engineers from the firm spoke with MassDevice.com editor Sarah Faulkner about how they tackle device development challenges when they are called into action.
Sarah Faulkner: Hey, everyone. Thanks for downloading this podcast. I’m really excited to bring you this conversation about what to do when things go sideways during the product development process.
Faulkner: I spoke with a group of experts from MPR. They’re a product development ...
Source: Mass Device - April 1, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Featured MPR Source Type: news
Treace Medical touts results of bunion surgery study
This study demonstrated positive bone healing rates over progressive timepoints when utilizing biplanar plating without a cross-joint compression screw in procedures used to treat bunions or arthritis of the big toe joint,” said lead author Dr. Paul Dayton of the Midwest Bunion Center (Des Moines, Iowa), in a prepared statement. “The bone healing rates were quite encouraging, given this unique fixation approach allowed patients to undergo an accelerated recovery protocol and to initiate weightbearing in a post-operative boot within their first week of surgery.
“Overall, I’m very pleased with these resul...
Source: Mass Device - April 1, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Clinical Trials Implants News Well Orthopedics Research & Development treacemedical Source Type: news
Medtronic seeks another bite at the apple in $24m patent loss to spine doc inventor
Medtronic (NYSE:MDT) asked a federal appeals court for a full-bench review of its nearly $24 million loss in a patent infringement lawsuit brought by a physician inventor.
In February 2014, Dr. Mark Berry alleged that Fridley, Minn.-based Medtronic infringed on three patents covering a “system and method for aligning vertebrae in the amelioration of aberrant spinal column deviation conditions.”
In November 2016, a jury in the U.S. District Court for Eastern Texas sided with Barry, awarding $15.1 million for infringement of one patent, more than $2.6 million for infringement on the second and $2.6 million for overseas...
Source: Mass Device - April 1, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Legal News Orthopedics Patent Infringement Spinal Medtronic Source Type: news
Smith & Nephew to acquire patient monitor dev Leaf Healthcare
Smith & Nephew (NYSE:SNN) said today that it inked a deal to acquire patient monitoring system developer Leaf Healthcare for an undisclosed amount.
London-based Smith & Nephew said that the acquisition follows a successful two-year partnership deal with Pleasanton, Calif.-based Leaf Healthcare in which Smith & Nephew served as its exclusive distributor and as a strategic investor.
Leaf Healthcare’s flagship product is their Leaf patient monitoring system, which features a wearable wireless sensor designed to track patient movement and notify caregivers to prevent immobility-related health complications...
Source: Mass Device - April 1, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured MassDevice Earnings Roundup Wall Street Beat Leaf Healthcare Smith & Nephew Source Type: news
