Medical Devices
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FDA plans to restart domestic inspections, contingent on local coronavirus trends
The agency is aiming to resume some on-site surveillance the week of July 20 after shutting down non-critical inspections in March due to the COVID-19 outbreak.
By Maria Rachal • July 10, 2020 -
Intersect ENT stock jumps on report of potential Medtronic takeover
A Bloomberg report published late Tuesday said the medtech giant had made an offer for the sinusitis tech maker, citing people with knowledge of the matter. Shares in Intersect were up around 35% early Wednesday.
By Maria Rachal • July 08, 2020 -
CMS not yet sold on Baxter, Outset tech in kidney care payment proposal
The agency said the need for more at-home care has never been more urgent, as the end-stage renal disease population has the highest rate of hospitalization due to COVID-19 among Medicare beneficiaries.
By Samantha Liss , Maria Rachal • July 08, 2020 -
Newest Medtronic implantable heart monitor gets FDA nod as remote device features proliferate
The U.S. marketing clearance comes on the heels of an FDA nod for Boston Scientific's LUX-Dx insertable cardiac monitor, which also can be programmed remotely by a physician.
By Susan Kelly • July 08, 2020 -
Kendall Davis / Supply Chain Dive
'If the public knew:' Ripple20 shows medical device software cyber weakness
Last month’s discovery that Baxter and B. Braun infusion pumps face risk of remote attacks by hackers comes as a medtech effort gains momentum to track third-party components in devices.
By Greg Slabodkin • July 07, 2020 -
Getty Images
Hospital traffic stalls as COVID-19 cases surge, analysts say
Some major chains saw volume dropping in the week ended June 28. HCA and Tenet saw 5.9% and 5.4% declines week over week when zeroing in on Texas, according to cell tower data tracked by Jefferies.
By Samantha Liss • July 06, 2020 -
Endologix files for Ch. 11 bankruptcy, plans to go private
The endovascular stent graft maker received FDA approval earlier this year for its newest abdominal aortic aneurysm technology, but has faced disruptions amid a high-risk recall and delays to elective procedures from COVID-19.
By Maria Rachal • July 06, 2020 -
CDC gets FDA nod for coronavirus-flu combination diagnostic
The emergency use authorization comes months after BioFire and Qiagen got backing for similar tests and as the coming flu season adds a new complexity to diagnosis.
By Nick Paul Taylor • July 06, 2020 -
Study design for CVRx device can serve as heart failure model: JACC editorial
Authors from Massachusetts General Hospital and Harvard Medical School say the adaptive design of the BeAT-HF trial used to support an FDA approval last year should be considered for future efforts on heart failure treatments.
By Susan Kelly • July 02, 2020 -
OTC hearing aid proposal, EtO sterilizer rule make 2020 regulatory agenda
Federal agencies also aim by year's end to issue updates to radiological health regulations, changes to the De Novo application process and modifications to streamline Medicare coverage of breakthrough technologies.
By Maria Rachal • July 02, 2020 -
Jacob Bell / BioPharma Dive
FDA delays UDI enforcement amid COVID-19, ongoing technical issues
The agency is holding off on enforcing unique device identification regulations until September 2022, four years later than was originally planned.
By Nick Paul Taylor • July 02, 2020 -
Courtesy of Centers for Disease Control and Prevention
BARDA backs push for clinical-grade wearable to detect signs of COVID-19
As companies like Fitbit aim to leverage their wrist-worn devices to monitor for disease symptoms, developers at Northwestern University argue that consumer tech falls short compared to clinical-grade, chest and neck-worn wearables.
By Nick Paul Taylor • July 02, 2020 -
UnitedHealthcare adds coverage of Tandem insulin pumps
The updated policy brings Tandem's technology in network for the nation's largest private payer, widening options for its estimated 250,000 members with Type 1 diabetes, four years after Medtronic pumps gained preferred status.
By Maria Rachal • July 01, 2020 -
UK raises red flags about Stryker's $4B bid for Wright Medical
The Competition and Markets Authority suggested the proposed acquisition would result in Stryker controlling 90% of Britain's total ankle replacement prostheses market.
By Greg Slabodkin • July 01, 2020 -
Getty Images
CMS proposes major market expansion in potential boost for Abbott's MitraClip
Analysts at Cowen estimate the agency's proposal could double or triple the number of U.S. mitral regurgitation patients eligible for the treatment.
By Nick Paul Taylor • July 01, 2020 -
Notified body poll finds multi-month waits for COVID-19 conformity assessments
More than half surveyed by the European Commission expect to spend six months to a year processing applications for certain devices addressing coronavirus.
By Nick Paul Taylor • July 01, 2020 -
Fotolia
Q&AQ&A: New NESTcc chief on the real-world evidence group's 'pivot point' and COVID-19
Sandra Siami, the new head of the National Evaluation System for health Technology Coordinating Center, says the pandemic's limitations on traditional clinical studies have put alternative sources of device data in the limelight.
By Maria Rachal • June 29, 2020 -
FDA nod to Boston Scientific cardiac monitor clears challenge to Abbott, Medtronic
The medtech giant is betting remote adjustment will put its LUX-Dx insertable system in a position to take on rivals, which have a years-long head start.
By Nick Paul Taylor • June 29, 2020 -
Texas again halts elective surgeries, showing fragile nature of rebound
The renewed restrictions spurred questions about whether states or individual health systems in other hotspots like Arizona and California will enforce similar pullbacks in procedures.
By Maria Rachal • June 26, 2020 -
CMS wants to make home health telemedicine permanent after COVID-19
Agencies would be able to keep using the tech for beneficiaries under the Medicare home health benefit beyond the public health emergency, including remote patient monitoring, according to a proposed rule fact sheet.
By Rebecca Pifer • June 26, 2020 -
Medtronic renal denervation registry shows blood pressure improvements persist at 3 years
The update on Thursday from the medtech giant comes months after Symplicity clinical trial results boosted its long-running effort to win FDA approval.
By Nick Paul Taylor • June 26, 2020 -
Polares raises $40M to target competitive mitral regurgitation market
The medtech plans to finish pilot clinical studies of a transcatheter mitral valve hemi-replacement device, seeking to treat a slice of a population that's proven worthwhile for MitraClip maker Abbott.
By Nick Paul Taylor • June 26, 2020 -
Courtesy of Tandem Diabetes
FDA signals support for automated insulin dosing tech, backing new development tool
As the diabetes technologies meet regulators' safety and efficacy benchmarks, the agency wants to help developers assess patient and family-reported quality of life factors.
By Maria Rachal • June 25, 2020 -
Baxter, B. Braun infusion pumps among millions of devices implicated in Ripple20 cyber alert
Despite warnings that a remote hacker could gain control of a pump, medtechs affected by the vulnerabilities described it as low risk and manageable.
By Greg Slabodkin • June 24, 2020 -
Medtronic Evolut TAVR system gets expanded label in Europe
New indications allow a less-invasive alternative to traditional open heart surgery for a group of severe aortic stenosis patients who tend to be younger and more active, and in higher-risk patients with bicuspid aortic valves.
By Susan Kelly • June 23, 2020
