• 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 San Jose, 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 a...
  • 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...
  • How One Entrepreneur Took The Road Less Traveled

    Scott Epstein shared how he took his structural hydrogel ureteral stent from concept to market without any government funding or strategic partnerships.Amanda PedersenBased on a unique new material, Q Urological's ureteral stent has the potential to reduce hospital-aquired infections.When Scott Epstein tells people about his medical device business in the Boston area and the technology he has developed, they often assume he is a product of Massachusetts Institute of Technology (...
  • How Deep Brain Stimulation Might Treat Paralysis

    A clinical trial's first-in-human implant seeks to determine whether brain stimulation can help restore motor function in stroke survivors.Nancy CrottiSurgeons at Cleveland Clinic have performed the first deep-brain stimulation (DBS) surgery to improve stroke recovery in humans.The six-hour procedure, conducted December 19, was part of a clinical trial using Boston Scientific's Vercise DBS system, which is also being studied in a U.S. trial for Parkinson's disease. A team led by Andre Machado,...
  • Some Like It Hot: Penis Implant Erects With Heat

    Researchers funded by Boston Scientific made a penile implant that remains flaccid at body temperature but becomes erect with heat.Amanda PedersenThis nitinol implant is flaccid at body temperature ... ... but returns to an expanded shape when heated  Researchers have developed a heat-activated implant that could be the biggest breakthrough for erectile dysfunction since Viagra.Don't miss the MD&M West conference and expo, February 7-9, 2017, in Anaheim, CA.Medication for...
  • How Did J&J Get $1B Lawsuit Award Halved?

    Judge upheld jury’s findings in faulty hip cases, but cut about $500M from the damages award. Amanda Pedersen Johnson & Johnson (J&J) will only have to shell out about half of what it was previously ordered to pay plaintiffs injured by defective hip implants.Learn how orthopedics companies and other medical device makers are adapting to value-based care at MD&M West on February 7, 2017.In December, a federal jury in Dallas ordered J&J and its DePuy...
  • PixarBio Ups The Ante For InVivo, Strings Attached

    PixarBio offered $100 million in stock for InVivo Therapeutics Corp., but only if certain directors to get the boot.Amanda Pedersen Frank Reynolds upped the ante in PixarBio Corp.’s hostile takeover bid for his former company, InViVo Therapeutics Corp., but there are strings attached.Don't miss the MD&M West conference and expo, February 7-9, 2017, in Anaheim, CA.PixarBio is now offering $100 million in stock to acquire Cambridge, MA-based InVivo, but only if board members Richard...
  • Johnson & Johnson’s Latest 3-D Printing Collaboration

    DePuy Synthes is collaborating with Aspect Biosystems on a 3-D printed artificial meniscus.Marie ThibaultJohnson & Johnson is adding another 3-D printing partnership to its resume.Johnson & Johnson Innovation LLC has announced that DePuy Synthes Products is collaborating with Aspect Biosystems on knee meniscus tissue to be created using Aspect’s Lab-on-a-Printer bioprinting technology. The innovation is aiming to improve patient results after treatment for a torn meniscus. The...
  • Is Reynolds Playing The Trump Card To Get InVivo Back?

    PixarBio CEO’s hostile takeover bid for InVivo Therapeutics, the company he abruptly quit three years ago, has current management shaking their heads. Amanda Pedersen Frank Reynolds wants to take over the company he abruptly quit three years ago, and he’s playing the Trump card to make it happen.In launching a hostile takeover bid for his former company, InVivo Therapeutics Holdings Corp., Reynolds not-so-subtly tied himself to President-Elect Donald Trump as a “fellow Wharton alumni...
  • Cleveland Clinic Team 'Navigates' Tricuspid Regurgitation Case

    Doctors implanted a new valved stent from Navigate Cardiac Structures Inc. into a patient with severe tricuspid regurgitation under a compassionate plea.Amanda PedersenLong and short axis TEE views of the Gate atrioventricular valved stent implanted in the tricuspid valve of a beating heart of swine  A 64-year-old woman with an extensive history of severe tricuspid regurgitation received a new valved stent for the condition through a compassionate plea.Don't miss the MD&...