Myoscience secures $8.4 million in new funding for its 'frotox' device that applies extreme cold to the skin to temporarily treat pain and smooth wrinkles.
Myoscience said it landed $8.4 million of a hoped-for $11.5 million for a device that applies extreme cold to the skin as a way to temporarily treat pain and smooth wrinkles.
The government's new website on drug and device company ties to doctors will be incomplete and may be misleading - for now.
David Sleight/ProPublica
by Charles Ornstein, ProPublica
This story was co-published with NPR's Shots blog.
Activist investor fund Engaged Capital ups the pressure on Volcano Corp., scolding it for its $116 million AtheroMed acquisition and missing chances to sell itself at a premium.
Here's a look at some of the top regulatory stories for medical device companies this week: FDA guides on custom devices; FDA approves Gore's Viabahn for peripheral stent repair; Alcon wins date with FDA panel for AcrySof lens; FDA seeks public input on medtech hacking; ReFlow Medical wins CE Mark for crossing catheters;
Candidates in the race for Massachusetts governor race tell MassDevice.com that they're for a repeal of the medical device tax and would support exploring a potential offset for Bay State medtech companies.
The next Massachusetts governor won't be spending any political capital defending the medical device tax, a 2.3% excise tax on U.S. medtech sales. Both of the leading candidates told MassDevice.com yesterday that they would push for a federal appeal and consider a tax credit to offset the levy.
The FDA's less-stringent 510(k) clearance process comes under fire (again) in a pair of new studies.
NEW YORK (Reuters Health) - Information on the safety and effectiveness of medical devices before and after they are cleared by U.S. health regulators can be improved, according to 2 new studies.
Mitralign reports the 1st-in-human use of its minimally invasive device to treat tricuspid valve regurgitation under a compassionate use allowance in Germany.
Mitralign said today that surgeons in Germany implanted its tricuspid valve repair device in its 1st patient, under a "compassionate use" allowance in Germany.
Cohealo reports a $3.2 million debt round for the software it's developing to help hospitals manage their shared medical device inventory.
Cohealo reported raising $3.1 million of a hoped-for $5.8 million in debt financing as it develops software to help hospitals manage their shared medical device inventory.
Despite the widespread skepticism over renal denervation for hypertension after the failure of Medtronic's Symplicity-3 trial, St. Jude Medical could be poised to snatch victory from the jaws of defeat with its next-generation EnligHTN device.
CVRx adds CE Mark approval for treating heart failure patients to its European Union approval for hypertension treatment using its Barostim Neo device.
CVRx said today that it won CE Mark approval in the European Union for its Barostim Neo device to treat heart failure patients using vagus nerve stimulation.
Payments from pharmaceutical companies touch hundreds of thousands of doctors. The 17 companies we've tracked spent $1.4 billion in 2013 alone. Here are our top five takeaways from following all that money.
David Sleight/ProPublica
by Charles Ornstein, Eric Sagara and Ryann Grochowski Jones, ProPublica
The number of warning letters sent by the FDA last year to medical device companies fell for the 1st time since 2009, according to a report from the watchdog agency's Center for Devices & Radiological Health.
Click image to enlarge
The number of warning letters sent by the FDA to medical device companies dipped for the 1st time since 2009, according to a report from the agency's Center for Devices & Radiological Health.
Shares of pSivida and Alimera Sciences jump after the FDA approves their Iluvien treatment for diabetic macular edema.
Intuitive Surgical says the FDA cleared a new robotic 'wrist' for hysterectomies and other procedures for its da Vinci Si device.
Here's a look at some of the top legal news stories for medical device companies this week: Boston Scientific loses $309 million judgment in Mirowski patent war; Ex-Advanced Medical Optics CEO Mazzo indicted in insider trading case; Appeals court denies BD bid to revisit loss to Retractable Technologies; Ackman threatens to sue Allergan again over potential Salix deal; Judge upholds $30M infringement ruling against NuVasive, cancels trademark
A federal appeals court vacates the FDA's decision to rescind its 510(k) clearance for ReGen Biologics' MenaFlex knee implant, ordering the watchdog agency to conduct "further proceedings."
More and more patients are reportedly hacking into their glucose monitors to add functions like online data display and continuous glucose monitoring.
MASSDEVICE ON CALL — More and more patients are hacking into their glucose monitors to add functionality, with medical device companies lagging behind as they work their own improvements through the FDA, according to the Wall Street Journal.
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.
He had called the other day to update me up on his condition. He did not sound upset, but resolute. "They offered me peritoneal dialysis," he said, "but I decided against it and figured I'd just let nature take its course. The hospice people are so wonderful - I've got things all set here at home, but I have two questions. What should I do about my warfarin? You know, I just don't want to have a stroke. And what I do about my defibrillator?"
Medtronic is likely to attempt a renegotiation of its $43 billion acquisition of Covidien now that the U.S. Treasury Dept. has changed the rules on tax inversion deals.
Researchers at Harvard's Wyss Institute say they have made progress on a "biospleen," which could combat against sepsis
NEW YORK (Reuters Health) - An extracorporeal blood cleansing device works well in rats and in experiments with human blood, according to researchers in the US and in France.
"Based on our exciting results in rats, we are actively moving to test this approach in a large animal as the next step towards moving this to human clinical trials," Donald E. Ingber of Harvard School of Engineering and Applied Sciences Wyss Institute in Boston told Reuters Health by email.
In a September 14th online paper in Nature Medicine, Dr. Ingber and colleagues explain that infected blood flowing into this "biospleen" is mixed with magnetic nanobeads.
ReFlow Medical wins CE Mark approval in the European Union for a pair of crossing catheters, the Wingman35 and Spex devices.
ReFlow Medical said physicians in Germany are already using its Wingman35 and Spex crossing catheters, after the San Clemente, Calif.-based company won CE Mark approval for both devices for treating lesions in the peripheral vasculature.
Alcon Laboratories wins a date with an FDA advisory panel to consider a new indication for its AcrySof IQ ReSTOR intraocular lens.
Alcon Laboratories won a date before an FDA advisory panel in November to review the data behind its application for a new indication for its AcrySof IQ ReSTOR intraocular lens, the watchdog agency said today.
The AcrySof IQ ReSTOR lens is already approved in the U.S. to treat presbyopia and cataracts.
Here's a look at some of the top legal news stories for medical device companies this week: What's behind the slump in early-stage medtech investment?; iHealth realigns, eyes the globe with new $25M investment; Ivantis adds $25M, eyes U.S. approval for glaucoma micro-stent; Minerva Surgical's just an inch away from closing a $25.5M round; Palmaz Scientific uncorks more funding
Researchers recommend quick surgery for patients with severe symptomatic aortic stenosis
NEW YORK (Reuters Health) - Patients with severe symptomatic aortic stenosis who need aortic valve replacement should have the surgery as soon as possible, new research suggests.
"Our research highlights the importance of treating aortic stenosis in a timely fashion. Delays lead to unnecessary risk and patients should ideally have an aortic valve replacement within a month of diagnosis," Dr. Chris Malaisrie of Northwestern University, Feinberg School of Medicine, in Chicago, Illinois, told Reuters Health by email.
Pharmaceutical companies have slashed sales staffs in favor of key account reps amid a drastic decline in access to physicians.
Image courtesy ZS Associates. Click to enlarge
Vector is Children's Hospital Boston's blog about research and innovation in pediatric and adult medicine. We report and comment on medical innovations and advances – from bench to bedside – touching on scientific, business and policy issues. Our ranks include science writers, physicians, lab researchers, market analysts and others inside and outside the hospital.
e-NABLE, an online group of 1,500 volunteers, uses 3D printing to build prosthetics for patients in need.
NEW YORK (Reuters Health) - An online organization of more than 1,500 volunteers is using 3D printers to produce prosthetic hands or fingers for people around the world who need them.
This Sunday, the group, called e-NABLE, will come together at the Johns Hopkins Hospital in Baltimore to further their goals of designing, printing and distributing their inexpensive plastic prostheses, in advance of an upcoming U.S. Food and Drug Administration public forum on 3D printing of medical devices.
Despite Boston Scientific having yet to debut a pacemaker that nestles inside the heart itself, an analyst said the company may be best positioned to capitalize on sales of such devices.
Nobel Biocare escalated its patent battle against Neodent by asking the International Trade Commission to intervene, after Neodent launched a line of dental implants last March that it imports from Brazil.
Cook Medical promotes Jean-Marc Creissel to be vice president of its urology business.
Cook Medical said it promoted Jean-Marc Creissel to vice president of its urology business, which Creissel has led since 2010.
Echo Therapeutics abruptly suspends operations, saying its cash resources will be drained by the end of the month and raising the possibility of a bankruptcy filing.
A federal judge in California upholds a $30 million trademark infringement judgment against NuVasive and revokes its registrations for the 'neurovision' name.
Orthofix International CFO Mark Heggestad steps down after just 6 months as a 3-year financial restatement deepens on new evidence of inventory control problems.
Here's a look at some of the top Wall Street stories for medical device companies this week: TriVascular Tech's stent graft recall could hurt the bottom line; Alere unveils $3.82B privatization plan; Medtronic, Covidien slide on new U.S. inversion rules; Baxano puts itself on the auction block; Philips to carve out lighting biz, merger healthcare & consumer units
The U.S. Defense Dept. awards rivals Philips Healthcare and Zoll Medical separate contracts to supply airworthy defibrillators.
The FDA releases its final recommendations on legal exemptions for customized medical devices.
The FDA yesterday released its final recommendations for legal exemptions for customized medical devices that deviate from already-approved systems by being tailored to the special needs of up to 5 patients.
Examples of such devices might include implantable devices like artificial discs or surgical screws for very tall people or infants that are otherwise unavailable in the correct size.
Vector is Children's Hospital Boston's blog about research and innovation in pediatric and adult medicine. We report and comment on medical innovations and advances – from bench to bedside – touching on scientific, business and policy issues. Our ranks include science writers, physicians, lab researchers, market analysts and others inside and outside the hospital.
By Tom Ulrich
The immune system, despite its immense complexity, really has only a few ways to kill bacteria:
Safety experts warn that U.S. hospitals may not be ready to safely dispose of infectious waste generated by Ebola virus should it spread to American cities.
CHICAGO (Reuters) - U.S. hospitals may be unprepared to safely dispose of the infectious waste generated by any Ebola virus disease patient to arrive unannounced in the country, potentially putting the wider community at risk, biosafety experts said.
A grand jury indicts former Advanced Medical Optics CEO James Mazzo in an insider trading case, charging Mazzo with leaking news of Abbott's 2009 buyout of AMO.
Boston Scientific loses a $309 million judgment in its long-running patent war with Mirowski Family ventures over cardiac pacemaker technology.
Security experts say cyber criminals are increasingly targeting the $3 trillion U.S. healthcare industry, which has many companies still reliant on aging computer systems that do not use the latest security features.
NEW YORK/BOSTON (Reuters) - Your medical information is worth 10 times more than your credit card number on the black market.
Last month, the FBI warned healthcare providers to guard against cyber attacks after one of the largest U.S. hospital operators, Community Health Systems Inc, said Chinese hackers had broken into its computer network and stolen the personal information of 4.5 million patients.
Billionaire William Ackman's Pershing Square Capital Management threatens to sue Allergan if it goes ahead with a deal to buy drugmaker Salix Pharmaceuticals.
(Reuters) - Billionaire William Ackman's Pershing Square Capital Management said on Tuesday that it would sue botox-maker Allergan Inc if the company went ahead with a deal to buy drugmaker Salix Pharmaceuticals Ltd.
Blame the medical device tax and the U.S. regulatory environment for the slump in investment in early-stage medical technologies, Silicon Valley Bank's Ben Johnson tells MassDevice.com.
It's a hard world out there for those looking to turn their cutting edge medical device ideas into commercial products, with investors shying away from early-stage companies in favor of more established medtech enterprises.
The Food & Drug Administration releases data on 510(k) clearances for medical devices it approved in August 2014.
510(k) summaries or 510(k) statements for final decisions rendered during the period August 2014.
Vital Therapies raises another $46 million in a public stock offering as it works on its liver regeneration technology.
Vital Therapies (NSDQ:VTL) raised $46 million in a public offering of stock for its technique for the regeneration of liver tissue.
Palmaz Scientific, founded by stent pioneer Dr. Julio Palmaz, raises another $1.3 million for the prosthetic implant technology it's developing.
Palmaz Scientific recorded $1.3 million of a planned $4.2 million funding round for the prosthetic implant technology it's developing in Dallas.
New U.S. Treasury rules on inversion deals are unlikely to scuttle Medtronic's pending $43 billion merger with Covidien, analysts say, but are likely to make it more complicated and expensive.
Boston Scientific launches a U.S. clinical trial of its Lotus transcatheter aortic valve implant in high-and extreme-risk patients.
Shares of T2 Biosystems jump nearly 10% after the FDA approves its MR-based tests designed to detect sepsis in a matter of hours rather than days.
FDA regulators and Dept. of Homeland Security officials are co-hosting a public meeting to discuss cybersecurity in medical devices.
MASSDEVICE ON CALL — The FDA announced that it will hold a public meeting in October to discuss cybersecurity in medical devices.
Co-hosted with the Dept. of Homeland Security, the 2-day summit will bring together a variety of healthcare stakeholders to discuss areas of vulnerability and best approaches to shoring up the digital defenses of medical systems.
