News

Zimmer makes a divestiture proposal to appease EU regulators in Biomet acquisition

To address the European Commission's concerns about its proposed $13.4 billion acquisition of Biomet, Zimmer Holdings has proposed the divestiture of "one unicompartmental knee brand and one elbow brand" in the European Economic Areas as well as "one total knee brand" in two European countries.

Hospital requires use of wireless, wearable sensors to prevent bedsores

Chino Valley Medical Center is the first hospital to write a requirement for use of the Leaf Patient Monitoring System to prevent pressure ulcers into its patient safety protocols.

HeartFlow's noninvasive test for coronary artery disease cleared by FDA

The FDA gave HeartFlow de novo clearance Monday for its FFRCT technology, the first and only noninvasive imaging technology for coronary artery disease (CAD) that shows the extent of a blockage and how it affects blood flow. HeartFlow FFRCT could potentially change the way that CAD is diagnosed and managed.

Britain's BTG scoops up pulmonology outfit PneumRx for up to $475M

British healthcare group BTG is snatching up interventional pulmonology outfit PneumRx in a deal worth up to $475 million, getting its hands on the company's device for severe emphysema and diversifying its product offerings.

Kinsa launches its smartphone thermometer at Apple, CVS

As the holiday shopping season begins to hit fever pitch in the coming weeks, Kinsa Health's smartphone-connected thermometer will be available at Apple and CVS stores across the U.S. so you can keep tabs on you or your loved-one's temperature while you're on the move.

iRhythm wearable cardiac monitor gets CE mark, CardioLogic partners to sell it in U.K.

iRhythm has received a CE mark in Europe for its continuous heart monitoring Zio Service. The technology enables up to 14 days of continuous heart monitoring via a wireless patch; it includes analytical software, as well as report to the physician. In addition, iRhythm has partnered with cardiology distributor CardioLogic to market Zio in the U.K. for the diagnosis of atrial fibrillation and other cardiac arrhythmias.

Deerfield leads $24M round for orthopedics startup Conventus

Conventus Orthopaedics received $24 million in its first equity financing that will go to launch its distal radius fracture implant as well as to advance other minimally invasive complex fracture treatments.

Illumina and Sequenom lay prenatal diagnostic patent feud to rest

Illumina and Sequenom settled the score in the companies' ongoing patent feud, agreeing to resolve all pending infringement claims and pool their resources to further develop noninvasive prenatal tests.

Startup gains FDA clearance for first tiny, injectable neuromodulation system for back pain

Physicians can add another tool to their arsenal that targets chronic back pain locally, without requiring surgery or an external device. The FDA has cleared Stimwave's Freedom Spinal Cord Stimulation System, which the company says is the smallest available neuromodulation device.

Direct Flow brings in $32M to support ongoing U.S. pivotal trial

Transcatheter heart valve developer Direct Flow Medical raked in $32 million in a recent financing round

New study supports effectiveness of 3-D breast cancer mammography

A new study supports the effectiveness of 3-D mammography, which researchers found has the potential to significantly increase the rate of identifying cancer in women with dense breasts who are screened using the digital technology.

Xeltis gets $34M to develop biodegradable heart valves and vessels

Swiss med tech Xeltis has raised €27 million ($34 million) in an oversubscribed Series B round. The financing will be used mostly to help get its first product to market, a biodegradable pulmonary valve intended for patients with severe congenital malformations of the heart, an orphan pediatric indication.

Medtronic sells $17B in bonds to fund Covidien buy

Medtronic has sold $17 billion in bonds to fund its $43 billion acquisition of Covidien that's still expected to close early next year. The medical device giant had been expecting to fund the deal mostly with ex-U.S. cash, but opted instead for debt in order to avoid potential issues with U.S. regulators seeking to crack down on tax inversion deals.

Masimo wireless, wearable patient monitor cleared by FDA

Masimo has gained FDA clearance for its wireless, wearable patient monitor, Radius-7. The device connects to Root, Masimo's open architecture, patient monitoring and connectivity platform that links a variety of devices regardless of company origin, which the company expects to be ubiquitous.

Class I recall for Siemens bacterial infection tests

Siemens Healthcare Diagnostics' device measuring bacteria to determine antibiotic treatment was recalled because of misreported results.

Roche jumps into prenatal testing market with Ariosa Diagnostics buy

Roche is diving into the prenatal testing business, snatching up Ariosa Diagnostics to expand its diagnostics offerings and to get its hands on the company's noninvasive prenatal test for genetic abnormalities.

Edison Nation and Mount Sinai team up for device innovation

Edison Nation Medical and Mount Sinai Health System have struck a partnership focused on bringing medical device and other healthcare-related inventions to market.

FDA approves Animas insulin pump, continuous glucose monitor combo device

The U.S. Food and Drug Administration has approved the Animas Vibe, a combination insulin pump and continuous glucose monitor. It allows patients with Type 1 diabetes to monitor blood glucose levels and adjust insulin delivery based on that data.

Medtronic gets EU regulatory green light for $43B merger with Covidien

Medtronic scored EU regulatory approval for its $43 billion acquisition of Covidien, days after U.S. antitrust authorities signed off on the deal subject to certain conditions.

Smith & Nephew CEO to stay, not making move to Sanofi

Rumors have been circulating in recent weeks that the French CEO of Smith & Nephew, Olivier Bohuon, would jump ship to run Paris-based Sanofi. But Bohuon told employees at a town hall meeting that he is "very happy" at Smith & Nephew, and several people with knowledge of the matter said he isn't planning to leave.