News

Med tech M&A beware: Top Senate Democrats reveal plan to crack down on inversions

Amid growing action from U.S. lawmakers to curb corporate inversions, top Senate Democrats revealed a plan to rein in the deals that would allow med tech companies to shift their domiciles abroad for tax-paying purposes.

Scripps starts pilot study of AirStrip mobile medical app

Scripps Health has launched a pilot study of AirStrip One, a software system that delivers hospital patient-monitoring data to physicians' mobile devices. The 60-day pilot study, which is slated to end in early October, is intended to evaluate the potential for broader adoption.

ACLA head makes case against FDA LDT regulation to Congress

Alan Mertz, president of the American Clinical Laboratory Association, ripped into the FDA's proposal to regulate lab-developed tests yesterday in testimony to Congress during a hearing of the 21st Century Cures initative. 

Parkinson's diagnostics expand as FDA clears wearable, researchers unveil smartphone app

Researchers are applying the full range of mobile technology to Parkinson's disease diagnostics. This week a pair of new technologies came to the fore, with a wearable device is cleared by FDA and a smartphone app unveiled at the British Science Festival.

Study shows COPD device effective in deterring mucus buildup

Data from a study on a new nondrug treatment for chronic obstructive pulmonary disease offered evidence that Trudell Medical's Aerobika OPEP hand-held device is beneficial for COPD patients with recurring mucus buildup.

Scientist who discovered BRCA breast cancer gene advocates for systematic screening

A researcher key in understanding the role the BRCA1 and BRCA2 genes play in breast and ovarian cancer, Mary-Claire King of the University of Washington, has called for women to be screened for these genes at around age 30 as part of routine care. Her latest research suggests that these genetic markers offer as much insight as a family cancer history into the risk faced by a particular woman.

Boston Scientific dealt $73M blow in vaginal mesh case

Boston Scientific was dealt a crushing blow in its vaginal mesh saga, as a Texas state jury ordered the devicemaker to pay $73 million to a woman who claimed chronic pain and injury from the company's vaginal mesh implant.

iPhone 6 and Apple Watch demonstrate healthcare ambitions

Apple just unveiled the iPhone 6 and its Apple Watch, and as expected, both have major healthcare implications. CEO Tim Cook described the innovations in a much-anticipated announcement about the company's new products as it attempts to show that it can continue to innovate in the post-Steve Jobs era.  

Wearable device company releases developer tool kit to encourage app development

Wearable device maker Misfit Wearables unveiled its developer toolkit to encourage the creation of apps that link to its products. Thirty companies have said they will use the kit, including many developers of health and wellness apps.

Treasury secretary: Obama administration action on inversion coming up

Treasury Secretary Jacob Lew told the Urban Institute yesterday that "in the very near future" he will decide on steps President Obama can take to curb tax inversion deals without congressional action.

Titan Spine offers first spine implant warranty

Titan Spine yesterday announced that it is becoming the first spine implant manufacturer to offer a warranty on its products. The 5-year warranty of its Endoskeleton line of spinal interbody fusion devices is the orthopedics industry's second product guarantee, joining Biomet's lifetime warranty of its Oxford Partial Knee. 

Israeli startup develops hand-held device for medical marijuana

As medical marijuana gains ground as a treatment for chronic pain, Israeli startup Syqe Medical is developing a hand-held device that yields more controlled cannabis dosage and provides an alternative to traditional delivery methods.

Study: Fecal incontinence implants reduce weekly incontinence episodes in women

A study by American Medical Systems, a unit of Endo Health Solutions, showed that the company's fecal incontinence implant product reduced by half the number of weekly bowel leakage incidents in nearly 70% of the female participants.

Stent developer Tryton gets $20M to complete FDA submission, market in EU

Startup Tryton Medical has raised $20 million in venture capital to submit its side branch stent to the FDA and market it in Europe. It hopes to have the first coronary stent approved to treat bifurcation lesions in the U.S. Nearly one-third of patients undergoing coronary angioplasty have bifurcation lesions, according to the company.

Abbott diagnostic enables faster, cheaper infection treatment

A new study suggests that a diagnostic from Abbott Laboratories offers a more accurate and faster diagnosis of the cause of blood-related infections. The in vitro diagnostic is expected to receive a CE mark in the coming months.

EU creates €1B fund for research on the use of graphene

The European Union is betting heavily on graphene, a potential material of the future with several med tech applications, via a €1 billion ($1.3 billion) research fund dubbed the Graphene Flagship.

First Dx for kidney failure approved by FDA

The FDA cleared the first and only diagnostic for acute kidney injury today, Astute Medical announced. A recent study found that hospitalized patients who got AKI had a 30% mortality rate at one year, twice that of a heart attack.

Top digital health startups taking the stage at TEDMED

This year, TEDMED has a series of digital health startup company presentations as part of its Hive collective.

J&J ordered to fork over $3M in vaginal mesh case

Johnson & Johnson's Ethicon unit lost a battle in its ongoing vaginal mesh litigation as a federal jury in West Virginia ordered the company to pay $3.27 million to a woman who claimed the device caused undue pain and serious side effects.

FDA clears Otoharmonic's iPad/iPod app to treat tinnitus

The FDA has given clearance to startup Otoharmonics for its iPad and iPod Touch application that uses sound therapy to teach the brain to ignore persistent ringing caused by tinnitus.