Medtronic Evolut TAVR gets expanded label in Europe

The Latest

• 

  Tracking the impact of coronavirus on the medtech industry

  Among the latest: Medtronic says electronics manufacturer Foxconn will help produce at least 10,000 ventilators over the next year.

  UPDATED: June 18, 2020 at 9:45 a.m.

  Medical Devices

• 

  Pandemic pushes FDA to 'accelerate' real-world evidence efforts, Hahn says

  The agency has grappled with how to leverage real-world data in regulating medical devices, and is now leaning on it to update emergency use izations, FDA chief Stephen Hahn said at a forum on Thursday.

  Medical Devices

• 

  Moody's: US healthcare rebounds from COVID-19 in May, but uneven road lies ahead

  Last month saw improvement in care volumes, but recent pullbacks in hot spots like Arizona may exemplify the bumpiness to come for recoveries at medical device companies.

  Medical Devices

• 

  Senators back sustaining telehealth momentum post pandemic

  Top priorities include axing geographic restrictions, expanding Medicare and Medicaid reimbursement for virtual care services, and upping use of remote patient monitoring and digital health tools for patients with chronic conditions.

  Policy & Regulation

• 

  FDA cracks down on sellers of at-网络百家家乐真人视频home COVID-19 antibody tests

  A series of warning letters is the latest example of U.S. regulators weeding out serology tests that don't meet the agency's standards.

  Policy & Regulation

• 

  TÜV SÜD becomes 4th notified body designated under IVDR

  It's the first notified body OK'd by the European Commission in 2020 to increase capacity for the forthcoming In Vitro Diagnostic Regulation, set to come into force in less than two years.

  Policy & Regulation

• 

  FDA revokes emergency ization for Chembio's COVID-19 antibody test

  It's the first time the agency has exercised such ity for a coronavirus test, citing more false results than expected. Chembio Diagnostics' stock plunged 60% Wednesday.

  Policy & Regulation

• 

  Endologix stent graft tied to 5 deaths gets high-risk recall label from FDA

  The Class I recall marks an escalation of a polymer leak issue first reported in 2018. Endologix now says the leaks are due to a "material weakness," not incorrect use as it originally concluded.

  Medical Devices

• 

  Tandem's insulin dosing algorithm OK'd for use in younger kids

  FDA's decision to expand the pediatric indication was supported by an NIH-funded trial that found the automated insulin dosing helped improve time in range for children ages 6 to 13.

  Medical Devices

• 

  NIH loops Quest into effort to test 10K Americans for antibodies against coronavirus

  The agency did not disclose which antibody test it will use as part of the All of Us initiative, saying only that the assay has FDA emergency use ization and is designed to detect IgG antibodies. 

  Research

• 

  Thermo Fisher, MedRhythms gain breakthrough device designations

  A companion diagnostic for certain brain tumor patients and a digital therapeutic for stroke patients with walking impairments are among the latest technologies tapped by FDA for the priority review program.

  Medical Devices

• 

  In FDA 1st, game-based therapeutic gets marketing OK

  Digital therapeutics developer Akili Interactive Labs won De Novo ization for a treatment meant to improve attention function in children with ADHD, building on a rollout it began under a special COVID-19 policy.

  Policy & Regulation

• 

  Heart rhythm bodies see 'clear concerns' with using wearables to detect arrhythmias

  A paper published on Monday by the Heart Rhythm Society, along with counterpart groups in Asia, Europe and Latin America, found wearable-triggered false positives can cause unwarranted concerns and screening.

  Medical Devices

• 

  Labs urge CDC to change COVID-19 antibody test guidelines

  The trade group for Quest Diagnostics and LabCorp criticized the federal agency's advice against use of serology test results to make decisions about who can return to work.

  Policy & Regulation

• 

  Abbott's FreeStyle Libre 2 gets long-awaited iCGM nod from FDA

  The designation may stiffen competition for Dexcom, whose G6 device was the sole integrated continuous glucose monitor on the U.S. market. But Abbott's device isn't yet OK'd for use with automated insulin dosing s.

  Medical Devices

• 

  Myriad prostate cancer test wins coverage from Aetna

  The decisions by the insurance giant and two others nearly double commercial coverage for the Prolaris test, days after a local Medicare contractor found there may be insufficient data to back Myriad's GeneSight combinatorial tests.

  Diagnostics

• 

  Medtronic inks up to $337M in diabetes funding, Blackstone Life Sciences' 1st medtech investment

  The announcement came in conjunction with the ADA's Scientific Sessions this weekend, which also featured data on its advanced hybrid closed loop that will back an FDA premarket approval submission.

  Medical Devices

• 

  Paclitaxel-coated balloon, stent labels in Europe to have mortality warning update

  A notice posted by British medical device regulators outlined 12 affected products including Boston Scientific's ELUVIA stent, Cook Medical's Zilver PTX stent, and Medtronic's IN.PACT Admiral balloon.

  Medical Devices

• 

  CMS to review at-网络百家家乐真人视频home ventilation of COPD patients amid variability in device use

  Findings from a July Medicare Evidence Development & Coverage Advisory Committee meeting and resulting policy changes could potentially impact ResMed and Philips Respironics.

  Medical Devices

• 

  Moody's lowers medtech earnings forecast, pegs J&J, Zimmer among hardest hit by COVID-19 fallout

  The ratings agency expects the pandemic to curb sales of the large, mostly investment-grade medtechs it covers by 10% this year, with earnings dropping as much as 30%.

  UPDATED: June 15, 2020 at 8:58 a.m.

  Medical Devices

• 

  Cue Health raises $100M to scale up rapid, portable coronavirus test

  The startup, which counts J&J among its backers, said on Friday it received FDA emergency use ization for its test, allowing use anywhere under the supervision of qualified medical personnel. 

  UPDATED: June 12, 2020 at 11:37 a.m.

  Manufacturing

• 

  Surgeons, device makers grow more confident in elective care comeback

  As some medtechs indicate forecasts entering Q2 may have been too conservative, a Bain & Co. survey of physicians and administrators suggests rising capacity for elective procedures, albeit without sales reps at full force.

  Medical Devices

• 

  COVID-19 diagnostic testing costs may hit $25B per year, AHIP study finds

  And on the antibody testing front, costs could range between $5.2 billion and $19.1 billion, according to a report commissioned by the payer trade group.

  Diagnostics

• 

  Key data on Medtronic's 780G, Insulet's Horizon kick off ADA 2020

  Abbott, Dexcom and Tandem will also present results at the virtual American Diabetes Association meeting that runs through Tuesday.

  Medical Devices

• 

  MedTech Europe pitches virtual audits to clear MDR coronavirus logjam

  The trade group contends technology such as smart glasses and webcams can enable notified bodies to view facilities without having to visit in person.

  Medical Devices

More stories