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.
Johnson & Johnson accepts a binding, $2 billion offer from Cardinal Health for its Cordis business.
A former accountant for SpineFrontier sues the orthopedic company for wrongful termination, alleging she was fired for raising concerns about regulatory issues that eventually led to an FDA warning letter.
A former accountant for SpineFrontier sued the company this month for wrongful termination, alleging that the spinal implant maker fired her for raising concerns about manufacturing processes later flagged by the FDA in a warning letter.
The China Food & Drug Administration jacks up its registration fees for medical devices and drugs to help it cope with a rising backlog of applications.
(Reuters) — The China Food & Drug Administration steeply raised the fees required to register medical devices and drugs in the world's 2nd-biggest pharmaceutical market, as a lack of resources and expertise hinders its ability to process a rising number of applications.
Dr. John Halamka, Chief Information Officer for Beth Israel Deaconess Medical Center, records his experiences with infrastructure, applications, policies, management and governance.
A federal judge orders TIG Insurance to pay Stryker nearly $9 million to cover deals the orthopedics company made to settle product liability lawsuits concerning its Duracon Uni-Knee implants.
The FBI is reportedly investigating Johnson & Johnson's knowledge about the risks of laparoscopic power morcellators, which have been implicated in spreading cancer cells in the abdomen.
Penumbra says it won 510(k) clearance from the FDA for its Ace64 intra-arterial stent.
Penumbra said today that it has received 510(k) clearance from the FDA for its Ace64 aspiration thrombectomy device, based on data from the Mr. Clean trial and additional randomized controlled stroke trials.
Imris says it filed for Chapter 11 bankruptcy protection, with a bailout offer from Deerfield Management.
Imris Inc. (TSX:IM) said today that it and 2 subsidiaries, including its NeuroArm Surgical business, filed for Chapter 11 bankruptcy protection.
The FDA labels as Class I CareFusion's recall of its Avea ventilators over a possibly fatal malfunction.
CareFusion said it's recalling all of its Avea ventilators over a possible pressure transducer failure that may cause the units to stop functioning.
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.
Medtronic is reportedly looking to grow its presence in China with lower-cost devices, as well as search the Chinese domestic market for possible acquisitions.
Medtronic (NYSE:MDT) is reportedly looking to actively expand its low-cost medical device presence in China, as well as searching the domestic medical-device market for possible acquisitions.
China is investigating a former top healthcare official on suspicion of bribery.
(Reuters) — China is investigating the former head of a healthcare ministry unit responsible for drug trials and leading implementation of healthcare policy for bribery, a prosecutor said yesterday.
A court in Sichuan province said it was investigating Wang Yu, the former top official at the Bureau of Medical Administration, as part of a crackdown on corruption in the healthcare sector.
VertiFlex says it won pre-market approval from the FDA for its Superion interspinous spacer.
VertiFlex said today that it won pre-market approval from the FDA for its Superion interspinous spacer for treating moderate lumbar spinal stenosis.
Small medtech companies are finding value in outsourcing their research & development functions, according to a panel at a LifeScience Alley conference last week.
Starting a medtech company comes with a host of challenges, from regulation to financing to reimbursement. One way that companies can overcome those challenges, according to 2 industry experts, is to outsource some of the research and development work – and in the process, create a leaner, more flexible company.
The FDA sends a warning letter to Signal Medical, flagging it for making unapproved changes to its MicroSeal hip implants.
The FDA flagged Signal Medical Corp. for selling a hip implant after making changes that weren't approved by the federal safety watchdog.
Here's a look at some of the top mergers & acquisitions stories for medical device companies this week: ConMed ripe for M&A spree; Baxter looks to growth post-Baxalta spinout; Sorin shareholders OK Cyberonics Merger
A study of replacement heart valves treated with calcification-reducing coatings shows that the coatings prolong valve durability.
Mela Sciences recalls its flagship MelaFind melanoma diagnosis system because some of its software wasn't included in its FDA approval.
Mela Sciences (NSDQ:MELA) recalled its flagship MelaFind melanoma diagnosis aid because some of its software wasn't included in its pre-market approval from the FDA.
The founders of DiagnosisOne, which became Alere Analytics, buy the business back and rebrand as Persivia.
The husband-and-wife team that founded the company that eventually became Alere Analytics bought the business back and rebranded it as Persivia.
Financial terms were not disclosed.
A new study of patients treated with long-duration dual-antiplatelet therapies after the placement of drug-eluting stents shows a lower rate of heart attack but a higher risk for major bleeding events.
Patients treated with long-duration anti-platelet therapies after the placement of a drug-eluting stent showed lower rates of heart attack but higher rates of major bleeding events and a slight increase in mortality, according to a new study released today.
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.
A trio of medical device companies - Evolent Health, EndoChoice and Corindus Vascular Robotics - sets terms for public offerings today that could bring in a collective $297 million.
A trio of medtech companies set terms for their upcoming public offerings today, announcing plans to raise a collective $297 million.
Sorin's shareholders approve the Italian medical device firm's merger with U.S.-based Cyberonics.
St. Jude Medical calls another halt to its Nanostim clinical trial program in the U.S. and Europe after serious adverse events surfaced in several patients.
Intrinsic Therapeutics' founder George Lambrecht starts Coravin, a high-tech wine device company that allows for untapped wine access.
Medtech engineer and founder of Intrinsic Therapeutics George Lambrecht has formed Coravin, a high-tech wine company that produces a device for tapping wine bottles without removing the cork.
The life sciences industry is increasingly taking over from the tech sector in driving global innovation.
(Reuters) — The life sciences industry is increasingly taking over from the tech sector in driving global innovation, according to a Thomson Reuters analysis of global patents.
Oculus Health says it has launched an app designed for chronic care management and remote medical monitoring.
Oculus Health said last week that it launched a mobile application designed to connect patients and providers and make use of remote monitoring equipment.
Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine.
Breast reconstruction technology company AirXpanders says it's planning to enter the Australian market with an initial public offering worth as much as $36 million Australian.
Biotronik is launching a smartphone-like device in Japan designed to wirelessly transmit pacemaker and defibrillator data to patients' physicians and a refreshed line of MRI-safe ICDs that use the system.
