MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » Cameron Health’s FDA date is good news for Boston Scientific

Cameron Health’s FDA date is good news for Boston Scientific

By

leadless ICD

Cameron Health landed an April date with the FDA’s circulatory devices panel to review a pre-market approval application for its lead-free subcutaneous implantable cardioverter defibrillator, or S-ICD.

The S-ICD system, unlike traditional ICDs, sits just beneath the skin and does not rely on wires relayed through blood vessels and connected to the heart in order to provide heart rhythm therapy.

The device, which has been the only lead-free cardiac rhythm implant on the market since winning CE Mark approval in the European Union in 2009, will get the FDA treatment on April 26, according to the watchdog agency.

That’s good news for Boston Scientific (NYSE:BSX), which earlier this month said it would pay up to $1.35 billion for Cameron Health.

Cameron filed its PMA in December 2011, making the quick FDA turnaround a positive sign for its steward-to-be. Nevertheless the news didn’t win much love from Wall Street today, where BSX shares were down 7¢ to $6.05 as of about 3 p.m.

"To us, FDA scheduling a panel to review the lead-less ICD so urgently … could suggest basically 2 things," analysts at Leerink Swann wrote in a note to investors. "(1) FDA must believe this is important new technology – particularly in the context of ongoing transvenous lead performance concerns (which the S-ICD aims to avoid), (2) FDA must have a basically positive bias toward the technology."

Either way, that’s a windfall for med-tech titan Boston Scientific and a possible setback for Edwards Lifesciences (NYSE:EW), which is not now likely to win its own panel date in April to review the "high-risk" patient group, cohort A, in its Sapien transcatheter heart valve PMA bid.

"Based on the FDA’s tentative panel meeting calendar, the next possible date for an EW Sapien panel now appears May 24," according to the analysts. "Clearly, the longer cohort A approval drags out, the more risk to numbers and the greater the likelihood of further downward estimate revisions."

EW shares were down 1% to $70.75 in late afternoon trading.

The April panel will also consider HeartWare’s implantable rotary blood pump, according to the FDA notice.

In case you missed it

RSS From Medical Design & Outsourcing

  • This imaging device could be a breakthrough for breast cancer treatment
    OncoRes Medical’s system may detect cancer cells on a microscopic scale during a lumpectomy, potentially averting the need for a second breast cancer surgery. Having breast surgery to remove a cancerous lump is traumatic enough. Learning that you’ll need another operation to remove cancer cells that the surgeon couldn’t detect the first time only adds… […]
  • Americans apparently trust healthcare professionals more than FDA, CDC
    As the U.S. tries to reach a post-COVID-19 pandemic “normal,” Americans are placing more trust in nurses and doctors than agencies such as the CDC and FDA, according to a new survey from the Robert Wood Johnson Foundation and Harvard T.H. Chan School of Public Health. The survey — conducted Feb. 11 – March 15,… […]
  • May 2021 Issue: Unmasking the response to the next pandemic
    3M, others may have unmasked a solution to future N95 shortages The 10 largest orthopedic device companies in the world How big medtech fared during a year of COVID-19 Medtech moves beyond the pandemic The COVID-19 pandemic is still very much with us, and medtech companies continue churning out devices to meet coronavirus patient needs.… […]
  • FDA warns about consumer electronics and implanted devices
    The FDA is advising the public that certain consumer devices have high-field strength-magnets that can send medical devices into “magnet mode.” Magnets of this nature can affect the normal operations of implanted medical devices until the magnetic field is moved, according to the FDA news release. These medical devices are designed with a “magnet mode”… […]
  • Abbott recalls pacemakers that may short circuit
    Abbott is recalling certain pacemakers that may short circuit because they can allow moisture inside, according to the FDA. The recall covers 61,973 Assurity and Endurity pacemakers manufactured by St. Jude Medical and distributed from April 2015 to February 2019. (Abbott acquired St. Jude in 2017). A small number of devices from that time frame… […]
  • Genesis shoulder surgery software gains FDA nod
    Genesis Software Innovations announced that it has received FDA clearance for its Preview 3D shoulder arthroplasty planning software. This clearance is the first orthopedic solution under the FDA’s new QIH classification for software solutions based on artificial intelligence (AI). Preview shows orthopedic surgeons a representation of the patient’s shoulder anatomy as a 3D model, allowing them… […]
  • Hologic launches $20M women’s health equity initiative
    Hologic this week announced an effort to improve healthcare for Black and Hispanic women in the U.S. Project Health Equality (PHE) will focus initially on how Black and Hispanic women experience healthcare in different regions of the country and on making meaningful, sustainable improvements, according to the Marlborough, Mass.-based company. Hologic’s partners in the $20… […]
  • Tech Etch names its first CFO
    Tech Etch today announced the appointment of Brian Roberts as chief financial officer. The Plymouth-Minn.-based company manufactures thin metal components, flexible printed circuits and EMI/RFI shielding for the medical, military and aerospace industries. “This newly created role will increase shareholder value, strengthen our employee-owner culture and values, expand our investment capabilities and support Tech Etch… […]
  • Bose jumps into hearing aid market
    Bose just introduced FDA-cleared, direct-to-consumer hearing aids for adults with mild to moderate hearing loss. Users can use a smartphone app to fit, program and control a SoundControl hearing aid without a doctor visit, hearing test or prescription, according to Framingham, Mass.-based Bose. Each hearing aid will retail for $849.95 starting May 18th in five… […]
  • Handwriting in your head could turn into words on a screen
    Stanford University researchers have developed a system that enables a paralyzed person to write letters just by thinking about them. They designed the novel brain-computer interface (BCI) to restore the ability to communicate in people with spinal cord injuries and neurological disorders such as amyotrophic lateral sclerosis (ALS). The study, published in Nature, was funded… […]
  • How PhysIQ is advancing digital therapeutics through its partnership with Janssen
    A partnership with J&J’s Janssen Pharmaceuticals is helping PhysIQ advance with its device-agnostic clinical data collection and analysis platform.  Over the course of the last year and some change, the impact of digital health and the need for it has increased by an immeasurable amount. Virtual care became the norm after the COVID-19 pandemic hit, and, although… […]

Leave a Reply