FDA puts Medtronic Valiant Navion stent graft recall in Class I category

The Latest

• 

  Deep Dive

  Medtronic's robotic spine market lead threatened as smaller rivals look to edge in

  Medtronic and Globus Medical are currently in a "two pony race" in the space, Wall Street analysts say, but market share can be stolen as other companies launch systems and adoption grows.

  Medical Devices

• 

  Deaths trigger new Class I recall for 6 Medtronic HeartWare products

  FDA has now categorized 13 HeartWare products recalled as Class I events in the past 13 months amid a stream of fault reports that have been implicated in the deaths.

  UPDATED: April 8, 2021 at 4:36 p.m.

  Medical Devices

• 

  MDMA, surgeons push Medicare to pull back prior authorization rules

  The medtech lobby and 39 stakeholders warned CMS that including cervical fusion with disc removal and implanted spinal neurostimulators as new service categories will delay patient access to medically necessary procedures.

  Medical Devices

• 

  LumiraDx lands on Nasdaq via SPAC with aim to undercut Abbott on price

  The COVID-19 test maker hopes to generate enough capital to pursue a point-of-care testing opportunity it values at $76 billion. It has a ways to go to deliver.

  M&A

• 

  Nevro shares full diabetic neuropathy SCS data as it pursues blockbuster opportunity

  If successful, the company would be the only FDA-approved spinal cord stimulation device with an on-label indication for painful diabetic neuropathy. Nevro estimates a market worth up to $5 billion, but analysts are skeptical.

  Medical Devices

• 

  Invitae inks $200M Genosity buyout, lands $1.2B investment to expand genetic testing

  The medical genetics company expects Genosity's capabilities to increase access to its cancer test and reduce turnaround time, while a sizable investment led by SoftBank will support growth initiatives.

  M&A

• 

  FDA-medtech consortium offers strategy to boost patient engagement in clinical trials

  The MDIC report, created by a working group including Exact Sciences and J&J, follows the agency's late 2019 draft guidance meant to increase the influence of patients in medical device clinical trial design. 

  Medical Devices

• 

  Suit alleging Medtronic misled FDA over spine fusion can proceed, appeals court says

  The court ruled the case can go forward on the question of whether the medtech defrauded the agency to gain 510(k) clearance for several products by failing to disclose the devices were intended for use in cervical spine.

  Medical Devices

• 

  Medtechs top pharma in cash to doctors for consulting, travel: Health Affairs study

  The majority of sector payments, also covering royalties, speaking fees and food, came from the likes of Medtronic, J&J, Zimmer, Stryker and Abbott. Specialties targeted included neurosurgery, orthopaedics and cardiology. 

  Medical Devices

• 

  Fewer heart tests ordered for telehealth patients in pandemic

  Research published in JAMA Network Open also found those using the virtual services were more likely to be Asian, Black or Hispanic.

  Research

• 

  FDA warns of patient deaths tied to reusable urological endoscopes

  The agency is sounding the alarm after receiving more than 450 adverse event reports in four years tying patient infections to the devices. Products from Olympus and Karl Storz were cited in the reports.

  UPDATED: April 5, 2021 at 1:30 p.m.

  Medical Devices

• 

  Digital health funding hits new high after Q1 rich in megadeals

  U.S. digital health companies raised a record $6.7 billion in the first quarter of 2021, putting the industry on track to easily top the $14 billion in investment last year.

  Digital Health

• 

  UCLA engineer calls for mitigation of biases of medical devices

  The perspective in the journal Science comes as the FDA has warned of social biases in data used to train artificial intelligence and bias against Black patients using pulse oximeters.

  Medical Devices

• 

  Liquid biopsies dominate FDA's latest breakthrough device nods

  Cancer tests feature heavily in the latest round of agency breakthrough designations, with Natera, Inivata and Bluestar Genomics all securing the status.

  Medical Devices

• 

  Abbott, BD, Quidel tests get EUAs for asymptomatic COVID-19 serial screening

  While the Abbott and Quidel authorizations are for over-the-counter use, BD's test requires a prescription, which "along with the fact an instrument is needed, limits the use-cases for the company significantly," William Blair analysts wrote.

  Policy & Regulation

• 

  FDA links certain breast reconstruction devices to risk of complications

  The analysis found Becton Dickinson's AlloMax and MTF's FlexHD may have higher major complication rates than devices made by companies including AbbVie's Allergan.

  Medical Devices

• 

  Medtronic inks value-based care pact with Spectrum Health

  The risk-based deal, initially focused on cardiac resynchronization therapy, will have the medtech giant paying the provider if certain patient metrics are not met, according to a spokesperson for the health system.

  Medical Devices

• 

  Quest sells minority share of Q2 Solutions for $760M

  IQVIA, which previously owned 60% of Q2 Solutions, will now become the sole owner of the clinical trials laboratory company. Quest and IQVIA established Q2 Solutions as a joint venture in 2015.

  Medical Devices

• 

  FTC challenges Illumina-Grail deal, putting $7B merger in jeopardy

  The commission said the union will "harm competition in the U.S. market for life-saving multi-cancer early detection tests." Illumina is opposing the action, but Wall Street analysts see no "easy fixes."

  Legal

• 

  FDA updates impact of mutations on COVID-19 tests, adds Cepheid to list of affected products

  A new agency webpage features the latest information about the potential impact of viral mutations on molecular diagnostics such as Cepheid's Xpert line of rapid SARS-CoV-2 tests.

  Policy & Regulation

• 

  A year into the pandemic, advanced cancer diagnoses are rising

  Research from radiation oncologists and molecular pathologists add to evidence showing that many people skipped getting cancer screenings in 2020 as they avoided going to the doctor to minimize the risk of COVID-19 infection.

  Diagnostics

• 

  FDA panel to probe Endologix, broader stent graft safety in Q4

  The agency is mulling further action to address blood leak risks with the medtech's grafts for abdominal aortic aneurysms and surveillance strategies for all AAA endovascular grafts. Medtronic and Cook also sell the products.

  Medical Devices

• 

  Analysts tip surgeries to rebound. Rising COVID-19 cases threaten those forecasts.

  Two Wall Street reviews suggest people are visiting hospitals more and are increasingly comfortable with undergoing elective care, but they come amid the CDC chief's warning that rising hospitalizations may jeopardize progress.

  Medical Devices

• 

  Medtronic's Harmony pulmonary valve wins FDA approval

  The device is the first non-surgical heart valve cleared in the U.S. to treat a severe form of pulmonary valve regurgitation that usually results from a congenital heart defect.

  Medical Devices

• 

  Helius gets FDA nod for neuromodulator after pivoting to multiple sclerosis

  The non-implantable device delivers neuromuscular stimulation to an MS patient's tongue, sending electrical signals to the central nervous system as a short-term treatment of gait deficit.

  Medical Devices

More stories