• Alere Refuses To Fold On Abbott Deal

    Alere still isn't ready to fold, but Abbott is long past ready to walk away from the $5.8 billion deal the two companies agreed to a year ago. Amanda Pedersen In business, as in life, it’s important to “know when to fold ‘em,” as Kenny Rogers put it in his 1978 hit “The Gambler.”But that advice isn’t always easy to follow, especially when there’s a $5.8 billion deal at stake.Keep track of who's buying, selling, and spinning off with our list of medtech mergers and acquisitions of...
  • ‘Smart’ Inhaler System Improves Patient Outcomes in Study

    The Smartinhaler system from New Zealand-based Adherium Ltd. connects with an app to monitor medication adherence, usage, and dosage.Daphne AllenThe Smartinhaler system uses software to help providers gain insightsabout how patients use their medication.Smartinhaler, a “smart” personal medication monitoring system from Adherium Ltd., has shown effectiveness in reducing hospital admissions over a 12-month independent, randomized controlled trial involving children with poorly...
  • Will Stryker's Mako Knee Product Be Worth The Wait?

    Stryker's full release of Mako total knee product could steal the show at the annual AAOS meeting in March, after the company made the market wait more than a year after winning FDA approval for the product. Amanda PedersenStryker said it installed 86 Mako robots last year and is ready for the full launch of the Mako total knee system  Stryker has made the market wait for more than a year for the highly-anticipated release of the Mako total knee product.Stryker’s sales...
  • Could A Software Upgrade Make Mammography Better?

    FDA approved a software upgrade for the Aspire Cristalle digital mammography system from Fujifilm Medical Systems that enables U.S. customers to use 3-D mammography. Amanda PedersenU.S. radiologists using Fujifilm's Aspire Cristalle system can now offer 3-D mammograms FDA approval of a mammography software upgrade will allow Fujifilm Medical Systems' U.S. radiology customers to produce 3-D digital images of a patient’s breast. The advancement is particularly meaningful for...
  • New Autoinjector Options for Emergency-Use Drugs

    SMC's recent acquisition of Oval Medical Technologies Ltd. brings under its purview novel autoinjector platforms that could be used to deliver drugs during a crisis.Daphne AllenSMC Ltd. acquired Oval Medical Technologies, a maker ofautoinjectors, in December.Today’s patients want small devices that can be easily carried in a pocket or purse and are highly intuitive to use, explains Barbara Tischart, vice president of marketing for SMC Ltd. Such features are particularly important when it comes...
  • Could Device Tax Repeal Be Closer Than We Think?

    President Trump signaled his intention to move quickly on repealing and replacing Obamacare by signing an executive order to minimize the economic and regulatory burdens of the policy. But industry advocates are more concerned about getting the device tax repealed. Amanda PedersenPresident Donald Trump didn't say a word about healthcare during his inagural address, but wasted no time in signing an executive order to minimize economic and regulatory burdens imposed by the Affordable Care...
  • One Way ACA Uncertainty Could Hurt GE's Bottom Line

    GE executives said uncertainty around the repeal and replacement of the Affordable Care Act could hinder growth in its U.S. healthcare segment as customers may become cautious. Amanda PedersenGE CEO Jeff Immelt said U.S. healthcare customers could show caution around GOP efforts to kill Obamacare Industrial conglomerate’s like General Electric Corp. could start to see healthcare customers becoming more cautious in response to the GOP’s efforts to dismantle Obamacare.By segment,...
  • Why Did Healthcare Get Left Out Of Trump’s Inaugural Speech?

    President Trump touched on plenty of hot-button issues during his 16-minute inaugural address Friday. But not one of them had to do with healthcare. Amanda PedersenPresident Donald Trump In the 16 minutes that he spoke to the American people after being sworn in Friday as the 45th president of the United States, Donald Trump managed to use 1,433 words, 24 of which had never before been uttered during a U.S. inaugural address. And yet, not one of them had anything to do with healthcare...
  • Innovative Breast-Tissue Expander Gets FDA Nod

    The device could represent the first major change in expansion procedures in 40 years.Nancy CrottiFDA has granted de novo clearance to the first breast-tissue expander that uses air instead of saline and shortens the process from mastectomy to reconstruction.AirXpanders of Palo Alto, CA, recently completed the second phase of its XPAND clinical trial for the AeroForm device. Placed underneath the chest muscle, the needle-free device contains a reservoir of compressed carbon dioxide. Using...
  • How Pink Made One Ceramic Supplier See Red

    Amanda PedersenThe pink color of this ceramic hip component, the CeraSurf-p from CoorsTek, set CeramTec off in 2014. CoorsTek Inc.’s pink ceramic hip components made CeramTec GmbH see red in 2014, but a Colorado judge has ruled that CeramTec does not own trademark rights to the color pink.Learn about product differentiation in a commoditization-based marketplace at MD&M West, February 7-9 in Anaheim, CA.Back in 2014, CeramTec, of Plochingen, Germany, tried...
  • Were MiMedx Employees Coerced Into Supporting PAC?

    MiMedx Group Inc. has been accused of demanding its managers give cash to a company-operated political action committee that was a top contributor to Tom Price, a Georgia congressman and President-elect Donald Trump’s pick for Health and Human Services secretary. Amanda Pedersen The storm clouds looming over regenerative medicine company MiMedx Group Inc. for the past couple of months are getting heavier as allegations roll in about employees being coerced into donating to...
  • Help for Europe’s Large-Valve Aortic Stenosis Patients

    Medtronic’s CoreValve Evolut R 34 mm valve, which already has FDA approval, has secured CE Mark, enabling minimally invasive treatment for a large portion of aortic stenosis patients.Marie ThibaultMedtronic announced another regulatory win for its largest size transcatheter aortic valve, the CoreValve Evolut R 34 mm valve, which has just received CE Mark. The 34 mm valve will be the largest transcatheter aortic valve commercially available in Europe.The CoreValve Evolut R 34 mm valve received...
  • Are Breast Cancer False Positives Akin To Racial Profiling?

    Danish breast cancer study sparks fiery debate over mammography false positives. Amanda Pedersen  Not all breast tumors pose the same risk, and treating them as though they do is akin to racial profiling, according to Otis Brawley, chief medical officer of the American Cancer Society.Brawley shared his views on “accepting the existence of breast cancer overdiagnosis” for an accompanying editorial to a Danish study recently published in the Annals of Internal Medicine.Don't miss the MD...
  • How To Fight Breast Cancer With Lemons

    Erin Smith Chieze posted a Facebook rant asking women to stop playing games and share something that might actually make a difference in the fight against breast cancer. Something like the picture of lemons that helped her spot cancer in her own breast. Amanda PedersenErin Smith Chieze said a picture like this helped her recognize breast cancer during a self-exam Erin Smith Chieze is fed up with the latest game going around Facebook under the auspices of breast cancer awareness."We...
  • Why VCs Are Backing Ivantis Without Batting An Eye

    A $25 million series C round extends Ivantis Inc.’s runway into 2020, and should help bring the Hydrus Microstent for glaucoma to U.S. market next year.Amanda PedersenIvantis Inc. added $25 million to its coffers Ivantis Inc. knows how to catch the eye of investors. The Irvine, CA-based company has raised more than $96 million in venture capital funding since 2011 to support the company's microstent for glaucoma.Don't miss the MD&M West conference and expo, February 7-9, 2017, in...
  • How A Classic Toy Inspired A 20-cent Device

    Using the same mechanical principles that makes a whirligig toy spin, Stanford bioengineers developed human-powered blood centrifuge using just 20 cents of paper, twine, and plastic.Amanda PedersenManu Prakash, an assistant professor of bioengineering at Stanford, designed a hand-spun centrifuge that could help detect diseases like malaria, HIV, and tuberculosis in poor, off-the-grid regions. The design was inspired by a whirligig toy. When Manu Prakash visited a rural clinic in Uganda and...
  • Could Illumina's New System Sequence Genome For Just $100?

    Illumina shares soared Tuesday after the company introduced its newest sequencer, the NovaSeq, that could one day enable researchers to sequence a genome for as little as $100.Amanda PedersenIllumina CEO Francis deSouza said the new NovaSeq, will enable genomic studies that were not possible before. Illumina Inc. hit the ground at full speed this week at the J.P. Morgan Healthcare Conference in San Francisco. The company announced a partnership with IBM Watson Health, a separate...
  • Muddy Waters Can Finally Tell St. Jude 'Told You So'

    St. Jude releases software patch to reduce hacking risk for its implantable heart devices, but is it enough of a fix? Not according to Muddy Waters.Amanda Pedersen It’s never fun to be on the receiving end of an “I told you so,” a position St. Jude Medical is finding itself in this week.After months of adamantly defending the cybersecurity of its implantable heart devices, the company released a software patch Monday afternoon for its Merlin@home transmitter to reduce the risk that St....
  • Will Congress Repeal the Medical Device Tax for Good?

    Maybe, but whether it would happen separately or as part of the repeal/replacement of the Affordable Care Act is anybody’s guess.Nancy CrottiWith nearly a year to go before the medical device tax suspension expires and Congressional Republicans determined to repeal the Affordable Care Act (ACA), why target the device tax again, and separately from the ACA?Upon his return to Washington, D.C. last week, U.S. Rep. Erik Paulsen (R-MN) wasted no time in reintroducing his perennial bill to excise the...
  • Why Theranos Should Have Had A Backup Plan, But Didn't

    As Theranos cuts another 155 jobs, CEO Elizabeth Holmes may be eating her words from a 2015 Stanford Business School interview.Amanda PedersenElizabeth Holmes, CEO of Theranos  Theranos CEO Elizabeth Holmes once boasted that she was “not big on backup plans.” That’s unfortunate, given that her once-thriving blood-testing startup just slashed its workforce for the second time in three months.Don't miss the MD&M West conference & expo, February 7-9, 2017, in Anaheim, CA.Theranos...