The most popular FierceMedicalDevices stories of 2015

Siemens plans 7,000+ layoffs after disappointing healthcare performance Following a 13% reduction in profit at Siemens Healthcare during the previous quarter, the conglomerate is reportedly planning...

Sweden's Lund University launching incubator for digital health startups

Sweden's Lund University is forming a med tech accelerator with an emphasis on digital health.

Abbott presents data showing strong health economics of its Supera peripheral stent

Abbott is promoting the health economics of its Supera Stent for peripheral artery disease, pointing to a yet-to-be-published study which found that the device is cost-effective because it reduces the need for interventions compared to competing therapies, like Medtronic's Protégé bare-metal peripheral stent and In.Pact Admiral drug-coated balloon.

Scientists make strides with real-time estrogen sensor

As scientists develop next-generation sensors to facilitate patient monitoring, researchers in New Zealand are rolling out a sensor device that can detect estrogen levels without some of the setbacks of current technology.

German startup gets CE mark for first cardiac assist system to work with an existing heartbeat

Startup Xenios has zeroed in its platform of minimally invasive products to treat patients with heart and lung problems. Its latest addition is i-cor, a synchronized cardiac assist system that just received a CE mark for marketing in Europe. This makes it the first heartbeat-synchronized cardiac assist device for cardiogenic shock and high-risk interventions.

Entellus wins FDA clearance for its endoscope to treat blocked sinus passages

Minneapolis' Entellus Medical announced FDA 510(k) clearance of its FinESS Endoscope to open narrowed sinus drainage paths in recurrent or chronic sinusitis patients.

Alphabet gives startups a lesson in financial management

Last month, Alphabet, née Google, said that it would give its new businesses plenty of breathing room as part of its reorganization, allowing startups including its Life Sciences division the freedom to operate more independently. But Alphabet also wants to make sure that its fledgling companies can bear the load themselves, so it's offering them a lesson in fiscal management.

GE Healthcare does molecular breast imaging distribution deal with Dilon

Imaging company Dilon Diagnostics has landed a partnership to distribute a molecular breast imaging system from GE Healthcare in select, undisclosed global geographies. The offering is intended to complement Dilon's own molecular imaging offerings.

FDA provides update on its evaluation of Bayer's Essure contraceptive

Reports of adverse events associated with use of Bayer's Essure birth control implant are among the FDA's most high-profile issues, at least on the device side, sparking interest from Congress and the media, as well as protest from patients who suffered harm.

Debiotech partners with Swiss academics to create a novel artificial pancreas

Swiss med tech player Debiotech has partnered to develop a next-gen artificial pancreas for diabetics with a pair of Swiss research centers. The aim is to improve upon the accuracy of automatic insulin delivery by using a microelectromechanical system to control the pump. It will be based on an algorithm designed to estimate patient needs based on their measured glucose levels, the time of day and anticipated activities to adjust the infusion rate from an insulin pump.

FDA report detailing faulty lab tests adds to pressure for increased regulation of diagnostics

The FDA's drive to regulate the molecular diagnostics industry is gaining steam. It finally provided specific examples of problematic tests in a report to Congress. The agency has made several general statements about inaccurate diagnostics over the years without naming any specific tests or providers.

Harvard's Wyss Institute successfully tests vibration-based infant apnea prevention device

Apnea, or a prolonged pause in breathing, is quite common among premature and low-birth-weight infants and can be life-threatening. A trial at the Beth Israel Deaconess Medical Center in 36 infants with apnea of a new mattress vibration device cut the number of apnea events in half. It also improved the infant's oxygenation levels and incidents of a too-slow heart rate.

Dell teams up with Zebra Medical Vision for data analytics initiative

Leveraging Big Data platforms is becoming increasingly important in the med tech realm, as companies know well. Technology giant Dell is wise to the trend and recently inked a deal with Israel's Zebra Medical Vision to get its hands on the company's data analytics platforms to flesh out its diagnostics and wellness services.

Cigna rolls out new coverage policy for whole exome sequencing

Cigna is teaming up with genetic counseling company InformedDNA for a new program that requires individuals to consult a genetic specialist before getting tested for certain hereditary conditions.

Startup launches app to enable patients to store, share medical images

NexGenic has launched its ImageInbox app for Android and Apple smartphones or tablets. The app enables patients to store medical images and to deliver them to future healthcare providers.

MIT researchers develop ingestible real-time vital sign monitor

Massachusetts Institute of Technology researchers have published an animal proof-of-concept study of their ingestible vital sign monitor that tracks heart and respiratory rates in real time.

Startup gets $36.5M to conduct U.S. pivotal trial for novel endoscopic weight loss device

Obesity treatment devices have been in the regulatory spotlight in 2015 with two approvals for balloon-based devices and another for a neurostimulator. That makes for a total of 5 FDA-approved obesity devices--including the two banding devices that were already approved.

CardioDiagnostics gets in on patient monitoring with plans for $7M fundraise

Med tech companies are jumping into the rapidly expanding patient monitoring market, with big names like St. Jude Medical and Boston Scientific looking for their piece of the pie. Startups are also getting in on the action, and one company is aiming to make progress with its cardiac monitoring technology with big plans for fundraising.

FDA warns of 9 deaths due to coatings on minimally invasive intravascular medical devices

The U.S. Food and Drug Administration has issued a safety communication regarding a wide array of intravascular implanted devices and delivery tools that have coatings designed to reduce friction and improve maneuverability.

EU study using nanoparticles, low-dose radiation to aid companion diagnostics in battling cancer

The European Union is funding a consortium that is looking into combining synthetic nanoparticles or antibodies with low-level radioactive substances to improve the use of companion diagnostics in battling cancer and other diseases.