Policy & Regulation
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CMS pitches expanding bundled payments for joint replacements
Regulators want to include outpatient hip and knee replacements now that the procedures are off the inpatient-only list. Post-acute care providers may face more financial risk than device makers, some analysts believe.
By Ron Shinkman • Feb. 21, 2020 -
Cardiovalve gets FDA breakthrough status for tricuspid valve replacement system
The startup, spun out during Edwards' 2017 acquisition of Valtech Cardio, also received U.S. approval to run an early study of its transcatheter system targeting tricuspid regurgitation.
By Nick Paul Taylor • Feb. 21, 2020 -
DHS warns of WannaCry-like vulnerability in Spacelabs Healthcare systems
The homeland security agency revealed certain telemetry devices suffer from the weakness, scoring 9.8 out of 10 on a cybersecurity vulnerability scale.
By Nick Paul Taylor • Feb. 19, 2020 -
FDA tracks uptick in masks, other protective gear in coronavirus update
Commissioner Stephen Hahn said the shift in ordering patterns is yet to manifest in a shortage but warned Friday the situation is “evolving and very dynamic.”
By Nick Paul Taylor • Feb. 18, 2020 -
AdvaMed, state AGs weigh in ahead of EPA sterilization rule
About a year after FDA told the medical device industry the closure of an Illinois ethylene oxide facility could disrupt supply chains, environmental regulators are considering changes that could affect sterilizers across the country.
By Maria Rachal • Feb. 14, 2020 -
FDA folds Cook Medical asks into final peripheral vascular atherectomy device 510(k) guidance
The agency made some changes to advice on premarket submissions for technologies used to help remove plaque from diseased arteries.
By Nick Paul Taylor • Feb. 13, 2020 -
FDA OKs 'Inside-Out' device for enabling hemodialysis in hard-to-treat patients
Bluegrass Vascular Technologies plans to make its De Novo-winning venous access device available at select U.S. sites in the coming months, adding to the revenue it already generates in the EU, Canada and other markets.
By Nick Paul Taylor • Feb. 12, 2020 -
Emergency use coronavirus tests shows glitches at state level, CDC says
CDC officials said Wednesday that some of the test kits it distributed to states produced inconclusive results when tested independently. The agency noted the tests were not run on patients.
By Maria Rachal • UPDATED: Feb. 13, 2020 at 11:20 a.m. -
Brexit happened. EU MDR looms. 3 key questions on medtech's future in Europe
The U.K. can skip the new in vitro diagnostic rules entirely, and in theory, could unilaterally stop applying MDR after the transition period ends. Both scenarios seem unlikely.
By Nick Paul Taylor • Feb. 04, 2020 -
Medtech in limbo as Brexit arrives
Although the industry has lobbied for the departing member state to implement the Medical Device Regulation and stick closely to EU rules, a minister in the U.K. government said legislative alignment “just ain't happening.”
By Nick Paul Taylor • Feb. 03, 2020 -
Amid coronavirus outbreak, FDA and industry seek roadmap for emergency diagnostics
Taking lessons from the Ebola and Zika crises, regulators and manufacturers are meeting Monday to discuss how real-world data could be used to advance more emergency-use diagnostics to full marketing status.
By Maria Rachal • UPDATED: Jan. 31, 2020 at 4 p.m. -
UK moves to mitigate impact of notified body withdrawals
Several firms pulled their services amid uncertainty about the impact of Brexit, bringing risks into focus.
By Nick Paul Taylor • Jan. 30, 2020 -
Privacy versus access debate rages on, rekindled by Epic lobbying
Promoting interoperability without clear guardrails could lead to healthcare's version of Cambridge Analytica, Epic wrote in a public statement coinciding with ONC's annual health IT conference.
By Rebecca Pifer • Jan. 29, 2020 -
Backing for unique patient identifier picks up steam at ONC conference
A ban on funding UPIs is "misguided policy," Rep. Bill Foster, D-Ill., said Monday at the gathering of IT officials and industry. But other experts warned it's "not a panacea."
By Rebecca Pifer • Jan. 28, 2020 -
CMS widens NGS test coverage for inherited breast, ovarian cancers
The national decision on next generation sequencing tests doesn't go beyond breast and ovarian cancers, but local Medicare contractors are allowed discretion on coverage determinations with other germline cancer diagnoses.
By Maria Rachal • Jan. 28, 2020 -
FDA offers 510(k) advice for arthroscopy pump tubing to prevent cross-patient infections
In a draft guidance on the irrigation tubing used across minimally invasive joint procedures, the regulator said without proper design, testing and risk mitigation, backflow of patient fluid can present risk for disease transmission.
By Maria Rachal • Jan. 27, 2020 -
3 more notified bodies coming soon, EC says as MDR clock ticks down
New designations would move the Commission a step closer to its goal of having 20 notified bodies in place by the end of the first quarter of 2020.
By Nick Paul Taylor • Jan. 23, 2020 -
Surgical gown recall sets Cardinal back $96M
The company estimates a $96 million second quarter charge related to the recall, amid two new field actions affecting procedure kits with the gowns. Cardinal previously saw red flags with the supplier at the root of the problem.
By Nick Paul Taylor • UPDATED: Jan. 31, 2020 at 3:22 p.m. -
HHS price transparency efforts may decode only sliver of total spending
A new analysis focused on non-emergency care that a patient can choose deliberately, such as hip or knee replacements, as opposed to emergency services.
By Ron Shinkman • Jan. 21, 2020 -
Supreme Court declines to quickly hear ACA case
It's unlikely the case will be decided before the election, which will thrust the debate over the fate of the landmark law into the spotlight during another presidential campaign.
By Samantha Liss • Jan. 21, 2020 -
UK health authority 'proactively' monitoring breast implant illness reports
In guidance for patients and clinicians on symptoms "sometimes referred to as Breast Implant Illness," the Medicines and Healthcare products Regulatory Agency stopped short of linking the devices to reported illnesses.
By Susan Kelly • Jan. 21, 2020 -
Virtual, augmented reality in medicine pique FDA's interest
The agency scheduled a March meeting that will bring together regulators, researchers, big tech and health startups as it looks to better evaluate extended reality medical products.
By Nick Paul Taylor • Jan. 17, 2020 -
ArcherDX, Geneoscopy, Phagenesis win breakthrough device designations
A cancer relapse test, a colorectal cancer screening test and a device to restore swallowing control are among the latest technologies to benefit from certain regulatory perks.
By Nick Paul Taylor • Jan. 15, 2020 -
Enrollment has ended in Essure postmarket study, FDA says
Bayer discontinued sales of the permanent birth control implant more than a year ago but continues to study its safety profile, as directed by the agency.
By Susan Kelly • Jan. 13, 2020 -
Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound
FDA's device center issued just nine warning letters in the most recent fiscal year, down from 81 in 2015. But with a major reorganization complete, regulators say they can respond to compliance issues more quickly.
By David Lim • Jan. 10, 2020
