News

Quest gets FDA Emergency Use Authorization for first commercial Zika test

Quest Diagnostics got the FDA's emergency use authorization for its rapid Zika test, the first diagnostic from a commercial lab to receive the distinction.

Google sheds light on electronic eye lens development

Oft-secretive Alphabet is shedding light on one of its latest med tech plans: an intraocular electronic eye lens.

Apple launches CareKit with four iPhone apps to start

Apple's CareKit, which is aimed at helping patients to better track their own health, has started rolling out. And four iPhone apps are integrated with it already.

Chinese, British researchers create dissolvable electronics for medical implants

Researchers have created a functional dissolvable device component--out of egg, magnesium and tungsten. In early testing, its performance matched that of nondegradable memory resistors, a kind of passive circuit that maintains a relationship between two terminals.

Researchers create optofluidics biosensor to detect glucose levels in sweat

Early diagnosis and prevention of diabetes is the goal of researchers at The Hong Kong Polytechnic University and Zhejiang University in China. They have reported developing fiber-optic glucose sensors in a microfluidic chip that could be the basis of portable, accurate and inexpensive devices to measure glucose levels in sweat.

Alere rejects Abbott's $50M breakup offer for megamerger deal

Abbott has avoided addressing rumors that its deal with point-of-care diagnostics maker Alere is on the rocks. But according to Alere, the Illinois med tech wants out.

Stryker buys oncology limb salvage implant upstart for $52M

Orthopedic implant player Stryker has extended its acquisition tear to a purchase of limb salvage company Stanmore Implants. This is the fifth acquisition of companies or assets that Stryker has announced this year--with two of those being billion-dollar deals and the other three smaller acquisitions.

Fitbit lends wearable tech to Dana-Farber for breast cancer study

Fitbit is lending its wearable health trackers to the Dana-Farber Cancer Institute for a study on weight loss in breast cancer patients. The partnership could give the company more clout as it pursues its med tech ambitions.

VCs hope for Kythera replay with $34M Series A in aesthetics startup

Double-chin elimination player Kythera sold for $2.1 billion to Allergan last year. Now, VCs are getting the band back together in hopes of similar success with another aesthetics startup, Sienna Biopharmaceuticals. It's raised a $34 million Series A round to support ongoing clinical testing.

Glycomics oral care company Prisyna nabs $6M to gain FDA device nod

The oral care business of glycomics biotech Synedgen, Prisyna, has raised $6 million to back its oral rinse products. These include two marketed oral rinses, Synedent Oral Care and Synedent Plus Oral Care with fluoride, as well as the investigational Moistagen.

Aesthetic player Merz invests in Boston startup for nonsurgical excess skin removal

German aesthetic player Merz has invested in recently announced company Cytrellis Biosystems. The Boston-based startup is developing aesthetic medical devices to remove sagging skin without surgery or scarring.

FDA nod for Siemens MRI software to reduce time needed for brain imaging

Brain MRIs, which account for roughly one out of four MRI exams, typically require at least 20 to 45 minutes to conduct. Now, a pair of new software applications from Siemens Healthcare aim to reduce that time dramatically--to only about 5 minutes. With 45 million brain MRIs expected globally this year, the new software could translate into massive cost savings for hospitals.

Patient advocacy group asks Congress to probe FDA oversight for Bayer's Essure

An advocacy group for women affected by Bayer's contraceptive implant Essure has lambasted the FDA for its alleged lack of oversight for the products. Now, the group wants Congress to weigh in on the issue.

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.