Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com's coverage highlights our 3 biggest and most influential stories from the day's news to make sure you're up to date on the headlines that continue to shape the medical device industry.
StimGuard says preliminary patient outcomes from a trial of long-term patients treated with its over-active bladder stimulation device showed positive results.
StimGuard said yesterday that preliminary patient outcomes from a long-term trial of its over-active bladder stimulation device showed positive results.
Wright Medical and Tornier ink a deal to settle lawsuits filed to block their pending $3 billion merger.
SurgiQuest says it won 510(k) clearance from the FDA for its AirSeal system for use in transanal endoscopic surgeries.
SurgiQuest said it won 510(k) clearance from the FDA for its AirSeal system, with indications for use in transanal endoscopic surgeries.
Companion Medical says it raised $3.2m in a Series B round joined by pharma giant Eli Lilly.
Companion Medical says it raised $3.2m in Series B financing from 3 investors, including Eli Lilly, and seeks to pursue 510(k) clearance for its smartphone-connected insulin injector pen.
keys: companion medical, eli lilly, series b
Here's a look at some of the top legal news stories for medical device companies this week: NeuWave Med raises $25m; Medtech funding in today's environment; Medtech trio sets $297m offering terms; AirXpanders plans $28m IPO Down Under; ClarVista raises $14m Series B round
Steris and Synergy Health say they'll fight the U.S. Federal Trade Commission's move to block their proposed $1.8 billion merger.
Corindus prices a stock offering worth nearly $42 million at $3.80 per share as it uplists from the OTC to the New York Stock Exchange.
Zimmer Holdings says it's 'highly confident' that it will be able to close its $13 billion merger with Biomet in mid-June after inking deals to sell some of its U.S. knee and elbow assets.
The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.
By Stewart Eisenhart, Emergo Group
For those wanting to learn more about medical device registration in Japan, one of the world's largest medical device markets, this podcast from Emergo provides an overview of that country's approval process.
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com's coverage highlights our 3 biggest and most influential stories from the day's news to make sure you're up to date on the headlines that continue to shape the medical device industry.
Halloran's Kathi Shah explains how to create a compliant, lock-tight clinical trial site budget.
By Kathi Shah, MS, MBA
Creating a clinical trial site budget sounds simple right? A Sponsor contracts with an investigative site to conduct a clinical trial per the protocol. The Investigative site is compensated by the Sponsor to conduct the services outlined in the protocol. The relationship between the Sponsor and Investigative site is heavily weighted on the budget developed to compensate sites for their efforts to conduct the study.
Becton Dickinson is mulling a sale of its V. Mueller surgical instruments business as it seeks to digest its $12 billion CareFusion buy.
The Patient Safety Movement Foundation plans an innovation contest to create processes or products to help eradicate preventable patient deaths.
Endologix says its Nellix stent graft for treating abdominal aortic aneurysms met its primary safety endpoint.
The FDA wants companies that make dermal fillers to treat wrinkles to update their labeling to indicate the risk of injury from unintentional injection into blood vessels.
(Reuters) — The FDA today asked manufacturers of dermal fillers to update their labeling to reflect the possible risk of serious injuries caused by unintentional injection of the fillers into the blood vessels in the face.
A Delaware state jury reportedly slaps Boston Scientific with a $100 million judgment in a pelvic mesh lawsuit, the largest verdict so far against the medical device giant.
The FDA down-classifies Ergon Medical's Prolong premature ejaculation treatment from Class III to Class II.
The FDA said it down-classified the Prolong device, a vibrator used to treat premature ejaculation, from Class III to Class II after a request from Ergon Medical Ltd., creator of the device.
Ventripoint says won an expanded indication from the FDA for its VMS cardiac diagnostic device and is seeking to land a $700,000 private placement.
Si-Bone says it raised a $21 million funding round and appointed Laura Francis as its new CFO.
Si-Bone said yesterday that the medical device company raised a $21 million funding round and hired Laura Francis as its new CFO.
