News

Dexcom proposes Class I recall fix, 'on track' with Verily for next-gen glucose monitors

Dexcom is working to refocus in the wake of a recent Class I recall for its speakers that applied across several models of its continuous glucose monitors (CGM). The company has submitted a filing for a replacement speaker and related manufacturing changes with the FDA, it said on an April 27 earnings call.

Abbott changes its tune, snatches up St. Jude in $25B deal

Abbott said last year that it wasn't interested in St. Jude, but now, the company is changing its tune. The Illinois devicemaker will shell out $25 billion for St. Jude to gain ground in the cardiovascular and neuromodulation markets.

Aussie IPO for breast cancer imaging player Volpara raises almost $8M

The company markets a suite of breast imaging tools for personalized breast cancer screening based on objective measurements of volumetric breast density, compression and radiation dose.

Boston Sci up 10% as it raises guidance, nabs double-digit organic gains in 4 of 7 businesses

Wall Street heartily embraced Boston Scientific on its first-quarter earnings, driving shares up about 10% in early trading to give the medical device giant a market cap of nearly $30 billion.

Sorry, Theranos: CMS released a lightly redacted version of your proposed sanction letter

The Centers for Medicare and Medicaid Services (CMS) has tiptoed around releasing a copy of the letter it sent Theranos last month that proposed strict sanctions against the company. But now, CMS is letting most of the information in that note fly free to the wind.

JAMA: Adding 3-D mammography decreases patient recalls, increases cancer detection

New data indicates that 3-D mammography (or tomosynthesis), when added to standard digital mammography, can result in fewer patients being recalled for follow-up and more accurate cancer diagnosis.

Edwards rides strong TAVR sales to Q1 win, expects more growth ahead

Edwards Lifesciences counts on sales of transcatheter repair valves (TAVR) to power its engine, and the products didn't disappoint in the first quarter. The company's TAVR sales shot up in Q1 thanks to strong global adoption of the devices, a trend that Edwards sees continuing.

UPDATED: FDA rejects Otsuka, Proteus pill with medication adherence monitoring

The first U.S. regulatory test for a drug that incorporates medication adherence technology has been met with a rejection. The Food and Drug Administration issued a complete response letter to Otsuka Pharmaceutical and Proteus Digital Health for their drug/device combination of Abilify with Proteus' ingestible sensor.

Stryker rolls out joint replacement patient program to help hospitals appease CMS

Orthopedic specialist Stryker is launching an internet-based program for patients to offer support from the time joint replacement surgery is scheduled until 90 days after. The move is aimed at enabling its hospital customers to better secure payment for hip and knee replacement by helping to improve their patient outcomes.

Gelesis enrolls U.S. patients in pivotal trial for hydrogel capsule to induce weight loss

PureTech's Gelesis has moved into the U.S. with its pivotal trial for its Gelesis100.

Medtronic touts drug-coated balloon data in toughest peripheral artery disease cases

Medtronic has unveiled two-year data for a drug-coated balloon to treat peripheral artery disease that shows it can be effective in patient populations that are typically not good responders to balloon angioplasty: women and diabetics.

3-D printer maker Stratasys and nonprofit Jacobs Institute create medical device development center

Stratasys and the Jacobs Institute are partnering to create an R&D center aimed at using 3-D printing to test and develop new medical devices. The company, which is based in Minneapolis and Israel, is aiming at making further inroads into medical applications, which haven't been a major market for 3-D printers yet.

Philips nabs 5% growth in HealthTech with connected care and informatics leading

Royal Philips may be starting to achieve the mid- to high-single-digit growth it previously articulated for its HealthTech portfolio. But Wall Street remained a bit skeptical as the disposal of its Lighting businesses continues to drag on, muddying the new story Philips is trying to focus on.

Federal judge tosses out 150 vaginal mesh cases against Bard

A federal judge overseeing some lawsuits against C.R. Bard over its vaginal mesh products dismissed about 150 cases earlier this week. The decision marks a brighter point in the company's legal saga with the devices.

Nokia strikes $191M deal for French digital health startup

It seems like everyone is jumping into the health monitoring market these days, and Nokia is no exception. The company is snatching up French company Withings for €170 million ($191 million) to gain ground in digital health.

Ortho after the Carlyle takeover: A Q&A with CEO Martin Madaus

Ortho Clinical Diagnostics CEO Martin Madaus told FierceMedicalDevices in an interview that Ortho has been actively investing in building out as a standalone company, which has dragged on earnings in the near term. But he added that Ortho has returned to revenue growth--and is aiming to get to about a 4% run rate.

Nonprofit SRI spins off wearable robotics suit startup Superflex

Nonprofit research center SRI, which came out of Stanford University, is spinning out wearable robotics company Superflex. 

Startup raises $17M from 5 strategic investors to get docs to use Google Glass for charting

Reviewing and creating patient charts is among the more tedious physician tasks. The notion behind startup Augmedix is to eliminate the computer from sitting in the middle of the doctor-patient interaction. Healthcare systems are buying into the idea, literally, with a $17 million financing for the San Francisco-based company.

Michael J. Fox Foundation backs development of Parkinson's blood Dx

Researchers in Australia are working on a blood test for Parkinson's disease, and now their efforts just got a financial boost from The Michael J. Fox Foundation for Parkinson's Research.

Zimmer Biomet to buy soft tissue reconstruction startup Cayenne Medical

Zimmer Biomet Holdings will acquire Cayenne Medical to add to its sports medicine offerings. The deal will augment its Sports Medicine business, which is one of its top performers. The Scottsdale, AZ-based startup markets several knee, shoulder and extremity soft-tissue repair products.