News

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.

Philips to focus on informatics as part of HealthTech restructure

Royal Philips will make healthcare informatics a key emphasis as it pushes toward its previously announced shift toward organizing the company to focus on what it has dubbed "HealthTech."

Harvard researchers using 3-D printing to create customized airway stents

As 3-D printing gains traction within the industry, Harvard University Medical School researchers are using the technology to develop customized airway stents for patients with breathing problems.

Study shows artificial pancreas improves treatment for Type 1 diabetes

In what is being called a first-of-its-kind study, Canadian researchers confirmed that an external artificial pancreas was better at treating Type 1 diabetes than other alternative treatments.

U.K. rules tighten M&A window for Stryker, Smith & Nephew deal

A U.K. law successfully thwarts overly aggressive acquisition deals from taking large bites out of the medical device industry in the country.

The top 10 FierceMedicalDevices news stories in 2014

In med tech, here are the top 10 news stories of the year so far, based on web traffic.

Japan begins regulating medical devices separately from drugs, aims to approve them faster than U.S.

Industry applauded Japan's initiative to create a medical device regulatory regime distinct from that for pharmaceuticals.

JAMA study: Cochlear implants can cause pain during MRIs

Some patients with cochlear implants feel pain during an MRI that is strong enough to prevent them from completing the procedure, a recent study in the Journal of the American Medical Association shows.

Boston Scientific backs atrial fibrillation startup Iowa Approach

Boston Scientific has invested in Iowa Approach, a new startup devoted to its novel atrial fibrillation (AF) ablation technology. The technique is expected to be easier and cheaper than the current AF ablation procedures; there are about 400,000 ablations to treat AF annually. The company expects to be ready for testing in humans in 2016.

Strategic investors LabCorp, Envision put $15M into remote patient monitoring startup Vivify

Laboratory Corporation of America Holdings and Envision Healthcare Holdings have invested $15 million in a Series B in Vivify, a startup focused on patient engagement and remote patient monitoring.

Opponents of FDA's LDT regulations lawyer up, get in combat mode

The battle is heating up over the FDA's draft guidance on the oversight of lab-developed tests, says the FDA Law Blog, which detailed both sides' actions over the last couple of weeks.

WSJ: Ankle replacements look to be the next thing

Replacing worn out ankle joints with new and improved devices appears to be gaining ground on knee and hip replacement procedures, though recipients may have to repeat the surgery at least once more in their lifetime.

Covidien reveals that it is under federal subpoena

In its annual 10-K filing with the SEC, Covidien quietly noted that it is under a federal subpoena related to some of its peripheral vascular products.

Warburg Pincus' Silk Road gets pivotal stroke prevention data, FDA up next

Silk Road Medical has disclosed positive, pivotal data for its Enroute Transcarotid Neuroprotection System to reduce the risk of stroke. The device had the lowest stroke rate in any study of a carotid angioplasty and stenting device in a prospective trial, according to the company.

Congress considering bill to limit FDA regulation of EHRs, clinical decision support software

A bill circulating the halls of Congress would limit the FDA's oversight of electronic health records and clinical decision support software, but may not have much practical effect since the agency limited its role in the regulation of software in a June draft guidance.