Policy & Regulation
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Industry sounds alarm on EU single-use device reprocessing regs
There remains a risk that the European Commission will miss its November target and fail to finalize the draft policy before MDR comes into force.
By Nick Paul Taylor • Aug. 22, 2019 -
ONC in talks with Congress, White House on third-party health app privacy
National Coordinator for Health Information Technology Don Rucker said there is bipartisan interest in taking action.
By Rebecca Pifer • Aug. 21, 2019 -
AdvaMed warns White House sterilization regs pose device shortage risk
The trade association's chief lobbyist told administration officials in a meeting an effective ban on ethylene oxide as a sterilant "poses an imminent public health threat through shortages of medical devices."
By David Lim • Aug. 21, 2019 -
FDA issues device sterilization warning letter
The notice accuses Innovative Sterilization Technologies of promoting the sterilization product in applications outside of the scope of its 510(k) clearance.
By Nick Paul Taylor • Aug. 21, 2019 -
FDA approves MRI labeling for Boston Scientific DBS system
CEO Michael Mahoney touted the growth of the company's deep brain stimulation products to investors during its second quarter earnings call.
By David Lim • Aug. 20, 2019 -
Italy's IMQ fourth notified body designated in EU
The firm joins Germany's Dekra and TÜV SÜD, as well as the United Kingdom's BSI, as the only four bodies designated less than a year before the new regulations take effect in May 2020.
By David Lim • Aug. 20, 2019 -
Edwards, Medtronic win expanded indications for low-risk TAVR patients
Roughly 165,000 low-risk patients per year in the U.S., Western Europe and Japan could now be eligible for the procedure, Medtronic estimates, a population both medtechs will be keen to treat.
By David Lim , Maria Rachal • UPDATED: Aug. 16, 2019 at 3:37 p.m. -
UK plans for express medical products shipping service ahead of Brexit
The announcement of the shipping service comes as the government, led by new prime minister Boris Johnson, steps up no-deal scenario preparations and downplays risks.
By Nick Paul Taylor • Aug. 16, 2019 -
Hearing industry calls Bose self-fit hearing aid study flawed in complaint to FDA
The Hearing Industries Association letter argues the device's Phase II clinical study "does not provide enough evidence of effectiveness of the self-fitting method given the study's initial reliance on professionals for fitting."
By David Lim • Aug. 15, 2019 -
Abbott poised to profit from CMS review of TMVR coverage
Analysts at Cowen estimate CMS coverage in a newly considered indication could triple the number of patients eligible for transcatheter mitral valve repair.
By Nick Paul Taylor • Aug. 15, 2019 -
Industry backs Australia's device identifier plan with caveats
The responses showed broad support for a unique device identification system based on global guidelines, but the Therapeutic Goods Administration also faced some pushback from J&J and Roche.
By Nick Paul Taylor • Aug. 15, 2019 -
Australia weighs in on paclitaxel-coated balloons
The Therapeutic Goods Administration said data on adverse events in Australia haven't shown a signal like the one described by FDA.
By Susan Kelly • Aug. 13, 2019 -
USTR: 10% tariffs on 'certain' electronics from China delayed to Dec. 15
Chinese imports not included on USTR's forthcoming list will still face 10% duties on Sept. 1, as President Donald Trump announced earlier this month.
By Shefali Kapadia • UPDATED: Aug. 13, 2019 at 3:27 p.m. -
Concept Medical nabs breakthrough designation for sirolimus-coated balloon for PAD
If granted FDA marketing authorization, the device may compete with paclitaxel devices sold by BD, Medtronic, Boston Scientific, Philips and Cook Medical.
By David Lim • Aug. 13, 2019 -
China grants innovative device designation to Novocure's Optune
Novocure's Chinese partner now gets the opportunity for more contact with regulators and an expedited review in a market estimated at $96.3 billion this year, up from $53.6 billion in 2016.
By Nick Paul Taylor • Aug. 13, 2019 -
CMS rejects industry bid to boost payments for device-based opioid alternatives
The agency said evidence submitted was plagued by potential conflicts of interest, inadequate sample sizes and lack of peer review.
By David Lim • Aug. 12, 2019 -
Wright Medical rocked by distributor disinterest and staff losses
"We will be bringing more knife fighters to the knife fight and having more motivated knife fighters in the knife fight," CEO Robert Palmisano said of a rivalry over sales reps.
By Nick Paul Taylor • Aug. 08, 2019 -
FDA grants breakthrough status to Perfuze stroke device
The startup is attempting to enter a field fought over by Johnson & Johnson, Medtronic and Stryker.
By Nick Paul Taylor • Aug. 08, 2019 -
FDA to update paclitaxel device labels with mortality signal warning
The agency and manufacturers such as BD, Medtronic and Boston Scientific are planning research into the devices' long-term safety profile using new randomized trials and registry datasets.
By David Lim • UPDATED: Aug. 8, 2019 at 10:08 a.m. -
iCubate lung infection test secures FDA breakthrough status
The in vitro diagnostics maker said it can accelerate diagnosis and treatment of a disease that affects more than 80,000 people in the U.S.
By Nick Paul Taylor • Aug. 07, 2019 -
US to slap 10% tariffs on $300B in Chinese goods as medtech seeks details
The tariffs are set to take effect on Sept. 1. AdvaMed said it "strongly opposes tariffs by both sides on medical technology products" and is lobbying U.S. trade negotiators.
By Shefali Kapadia • Aug. 02, 2019 -
Japan to reimburse TransEnterix's robotic surgery system
The decision positions the company to compete with Intuitive Surgical in one of the largest markets for the platforms.
By Nick Paul Taylor • Aug. 02, 2019 -
UnitedHealthcare's depression test decision boosts Myriad's prospects
While Medicare only permits psychiatrists to order the test, the private payer will reimburse requests from all providers.
By Nick Paul Taylor • Aug. 02, 2019 -
FDA grants breakthrough status to Procyrion's cardiac device
Procyrion's Aortix aims to offer physicians a minimally invasive, lower-risk alternative to left ventricular assist devices when treating patients with acute decompensated heart failure and worsening renal function.
By Nick Paul Taylor • Aug. 01, 2019 -
FDA announces fiscal 2020 device user fee rates
The fees, which cover medical device registration, submissions and certain periodic reports, show slight increases from the 2019 rates.
By Susan Kelly • July 31, 2019
