A second patient using Carmat's artificial heart died over the weekend. Trading of the French company on the Euronext stock exchange was suspended.
Heart support tech company Abiomed beat analyst earnings and revenue estimates as well as raised its fiscal 2016 guidance on its latest earnings call. All of this is ahead of incorporating additional U.S. sales for its Impella 2.5, which was approved for a broader indication by FDA on March 23.
Clinical research analytics company Medidata has released the software that connects the Apple ResearchKit with its cloud platform onto open-source community GitHub. The company expects this will enable life sciences researchers to more easily link ResearchKit apps to its own cloud-based platform.
As the med tech industry targets innovative technologies to treat orthopedic injuries, scientists are developing artificial knee implants that could help ward off arthritis and surgery further down the road.
Researchers question safety of off-label device use in atrial fibrillation, call for 510(k) review process
Physicians conducted a systematic review of database reports of the outcomes associated with the off-label use of the Lariat device to prevent stroke in patients with atrial fibrillation. They found several instances of deaths and follow-up emergency surgery, which prompted the researchers to call for an evaluation of the device by the FDA in this indication and to question the safety of the 510(k) clearance process itself.
The U.S. National Institutes of Health's National Eye Institute is spending up to $17.9 million over the next 5 years to find new therapies for blindness. In addition, the NIH just unveiled its Alzheimer's disease research agenda.
Intraoperative imaging is at the forefront of advances in surgery, as researchers and engineers discover new uses of old technologies like MRIs and CT scans, which can now be used to guide physicians during surgery in real time.
Remote patient monitoring startup Sentrian has partnered with the Scripps Translational Science Institute to study 1,000 chronic obstructive pulmonary disease (COPD) patients. The one-year study will use biosensors to continuously monitor patients and analyze that data to offer alerts for any deterioration. The intention is to intervene before an even becomes acute and requires hospitalization.
China is looking inward to chart growth for its device sector, laying out guidelines to spur local innovation and move away from global imports. Now, the country is going after three med tech multinationals, launching a probe to investigate suspected bribery by some of the industry's top players.
At its investor day on May 1, Boston Scientific pledged to accelerate sales growth to 3% to 6% and boost its operating margins to 25% by 2017 on the back of a promising product pipeline, like the newly approved Watchman device for preventing stroke and the next generation of its fast selling S-ICD, which reduces implantable defibrillators' reliance on troublesome wires known as leads.
Startup Aegea raises $36M to back pivotal trial, PMA for water vapor device to reduce uterine bleeding
Aegea Medical expects to get a PMA application into the FDA for its water vapor device to treat abnormal uterine bleeding with a $36 million Series C financing. It's already completed enrollment on a multi-center, international pivotal trial that is slated to have final primary endpoint data in February 2016.
UPDATED: Under FDA investigation, Bayer releases new data on Essure contraceptive with a positive twist
Under investigation by the FDA following claims of dangerous side effects and fraudulent clinical trial data, Bayer has released new data from a long-term study the German drugmaker says supports the safety and effectiveness of its Essure contraceptive inserts.
The head of the FDA's device arm (CDRH) acknowledged that the division is failing to live up to its vision that "patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world" because advanced devices like transaortic valve replacements are regularly approved in Europe 5 years earlier than the U.S, but cited statistics showing that CRDH has been getting devices to market faster in an April 30 address.
Reuters takes a look at the technology revolution that's expected to enable the next step beyond wearables: devices that are so tiny and integrated with the human body that they are barely noticeable to the wearer or others.
Toronto-based patient monitoring company Ideal Life and vital sign device player Nonin Medical have partnered to provide remote patient monitoring for chronic obstructive pulmonary disease patients.
The Medicines Company is on a roll with the FDA, gaining two firsts for approvals: a spray powdered fibrin surgical sealant and a needle-free, patient-controlled fentanyl patch. The company was up 5% in early trading on the FDA approvals news, which came after market close on April 30.
Medtronic announced that enrollment is underway on an atrial fibrillation trial involving a trio of its devices: the Arctic Front Advance Cryoballoon for ablating heart tissue, Symplicity Spyral Catheter for delivering renal denervation to fight high cholesterol, and Reveal Linq insertable cardiac monitor.
Israeli startup Ninox Medical is betting that its $10 million Series B round will be sufficient to help it obtain both a CE mark and 510(k) clearance for its KeePAP device to treat obstructive sleep apnea. The device is designed to be smaller and more comfortable than the standard-of-care CPAP (continuous positive airway pressure) machines.
Texas-based medical device manufacturer Greatbatch is spinning off its neurostimulation unit, Algostim, as the company looks to beef up one of its core businesses and snag a bigger piece of a growing neurostimulation market.
Neuromodulation, electroceuticals, biomarkers make the top 12 list of most transformative neuro tech
Research hospital-based healthcare system Partners HealthCare disclosed the top 12 technologies it thinks could revolutionize neurological and psychiatric care in the next decade.